Frontotemporal Dementia, Behavioral Variant@HOMENCT04865172

ECOCAPTURE for the Assessment of Apathy Under Real-life Conditions

An observational study of Frontotemporal Dementia, Behavioral Variant and Alzheimer Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Frontotemporal Dementia, Behavioral Variant, Alzheimer Disease
What is being tested?: Remote collection of passive and active data for 28 consecutive days
How many people: 44 participants
Where: 1 siteFrance
Study dates: 20 May 2022to 16 May 2026
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: 20 patient-caregiver dyads with patients suffering from behavioral variant front-temporal dementia, 20 patient-caregiver dyads with patients suffering from Alzheimer disease, 20 healthy control dyads

Who may be able to join

Diagnosis of bvFTD according to Rascovsky's international criteria for the bvFTD group / diagnosis of AD according to Dubois's international criteria for the AD group;
No evidence of any other cerebral pathology;
A Mini-Mental State Evaluation (MMSE) score superior or equal to 10 (to minimise the effect of confounding factors related to very severe cognitive impairment);
Aged between 40 and 85;
No evidence of any psychiatric condition and a Montgomery-Åsberg Depression Rating Scale (MADRS) score inferior to 20 (to avoid confusion between depression and apathy);
No evidence of excessive consumption of psychotropic drugs - for instance benzodiazepines, sleeping pills, etc. (due to their tranquilising effect);

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No major physical disability disrupting mobility;
No heart pacemaker (which would compromise heart rate measuring).
Inclusion Criteria for caregivers and partners of healthy control dyads:
Aged between 40 and 85;
No evidence of any psychiatric condition;
A MADRS score inferior to 20;
No evidence of excessive consumption of psychotropic drugs;
No major physical disability disrupting mobility;
No heart pacemaker.

Who cannot join

Persons in detention by judicial or administrative decision
Person who is subject to a legal protection order
Person submitted to an exclusion period due to the participation to another research

Trial locations and contacts

1 site in 1 country.

France1 site

ICM, Hôpital Salpêtrière
Paris, 75013

Other trials in France

About this study

Official title: ECOCAPTURE@HOME: Program for the Assessment of Behavioural Markers of Apathy Under Real-life Conditions Aimed at Patients With Neurodegenerative Dementias and Their Caregivers

ECOCAPTURE@HOME is a study which is currently being developed with the objective to capture the behavioral signature of apathy in everyday life context through remote monitoring of participants' behavior for about one month. Participants will not only be patients with apathy but also their spouse caregiver. Behavioral markers of apathy will be extracted from a combination of: 1/ objective physiological data from sensors on a bracelet worn by participants; 2/ subjective data filled by the caregiver through an application. Thus investigators will collect a pool of metrics and show they can measure three assumed behavioral markers of apathy (daytime activity, quality of sleep and emotional arousal), which in turn allow to predict caregiver's perception of the dyad's psychological state. The final goal is to lay the foundations for the development of a clinical tool for the remote follow-up of patient-caregiver couples.

Read the detailed description

Apathy, a common neuropsychiatric symptom associated with dementia, has a strong impact on both patients' and caregivers' quality of life. In spite of its debilitating consequences, apathy is still poorly understood and hard to define or measure objectively. The overall objective of the ECOCAPTURE programme is to define a precise behavioural signature of apathy, assessed by a multi-modal and ecological approach. This protocol called "ECOCAPTURE@HOME" aims to validate a novel method for the remote measurement of behavioural markers of apathy. The final purpose of such a protocol being to improve the diagnosis and long-term follow-up of apathy.

Investigators plan to recruit 60 couples aged between 40 and 85 years old and divided into three groups of dyads: one group of 20 patient-caregiver dyads in which patients suffer from the behavioral variant of Fronto-Temporal Dementia (bvFTD), one group of 20 patient-caregiver dyads in which patients suffer from Alzheimer Disease (AD) and one group of 20 healthy control couples. All recruited dyads will be followed in their everyday life for 28 consecutive days via a multi-sensor wearable bracelet (worn by both partners of the dyad) collecting passive behavioural data. Active behavioural data will also be collected using questionnaires available on a smartphone application (completed by caregiver in patient-caregiver dyads). Investigators will thus validate a measurement model for three theoretical behavioural markers of apathy (i.e., daytime activity, quality of sleep and emotional arousal) using a pool metrics extracted from passive behavioural data (acceleration, electrodermal activity and blood volume pulse) completed by active behavioural data (describing behaviour at meals, wake and bedtime). Moreover, investigators will investigate this measurement model on both a daily and a monthly scale and will attempt to show that the measured behavioural markers of apathy can predict caregiver's perception of the dyad's psychological state (collected through questionnaires) on these two time-scales.

This project carries great potential to improve both patients' care and caregivers' social support.

Conditions: Frontotemporal Dementia, Behavioral Variant, Alzheimer Disease
Being tested: Remote collection of passive and active data for 28 consecutive days
Medical subject headings: Pick Disease of the Brain, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Remote collection of passive and active data for 28 consecutive daysOther
Passive sensor data: collected continuously for 28 days, from a multi-sensor wearable bracelet worn by each member of the dyad; Active questionnaire data: collected once a week during the four weeks of monitoring (and at the end of the 28 days for patient-caregiver dyads), from questionnaires filled by one partner of the dyad (for patient-caregiver dyads, this will be the caregiver) using a smartphone application.

Study groups in NCT04865172
Study group	Role	What they receive
Patient-caregiver dyads, patients with behavioural variant frontotemporal dementia		20 patient-caregiver dyads, patients with behavioural variant frontotemporal dementia Receives: Other: Remote collection of passive and active data for 28 consecutive days
Patient-caregiver dyads, patients with Alzheimer disease		20 patient-caregiver dyads, patients with Alzheimer disease Receives: Other: Remote collection of passive and active data for 28 consecutive days
Healthy control dyads		20 healthy control dyads Receives: Other: Remote collection of passive and active data for 28 consecutive days

What is being measured

The primary outcome is the main question the study is designed to answer.

Acceleration (in g)
In all the dyads included in the study for a remote follow-up, investigators will collect the acceleration signal recorded by a bracelet (Empatica E4) including a 3-axis accelerometer, continuously for 28 days. Data of acceleration will be collected in both partners of the dyad.
Measured: 28 days
Electrodermal activity (in microsiemens)
In all the dyads included in the study for a remote follow-up, investigators will collect the electrodermal activity signal recorded by a bracelet (Empatica E4) including an EDA sensor, continuously for 28 days. Data of electrodermal activity will be collected in both partners of the dyad.
Measured: 28 days
Blood volume pulse (or relative blood flow)
In all the dyads included in the study for a remote follow-up, investigators will collect the blood volume pulse recorded by a bracelet (Empatica E4) including a photoplethysmogram (PPG) sensor, continuously for 28 days. Data of blood volume pulse will be collected in both partners of the dyad. Heart rate (number of beats per minute) can be derived from the blood volume pulse.
Measured: 28 days
Bedtime and getting up time (Week 1)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete bedtime (using a drop-menu with hours and minutes) and getting up time next day. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the first week of the follow-up
Bedtime and getting up time (Week 2)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete bedtime (using a drop-menu with hours and minutes) and getting up time next day. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the second week of the follow-up
Bedtime and getting up time (Week 3)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete bedtime (using a drop-menu with hours and minutes) and getting up time next day. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the third week of the follow-up
Bedtime and getting up time (Week 4)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete bedtime (using a drop-menu with hours and minutes) and getting up time next day. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the fourth week of the follow-up
Meal times (Week 1)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete meal times (start time and end time, using a drop-menu with hours and minutes), including breakfast time, lunch time and dinner time. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the first week of the follow-up
Meal times (Week 2)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete meal times (start time and end time, using a drop-menu with hours and minutes), including breakfast time, lunch time and dinner time. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the second week of the follow-up
Meal times (Week 3)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete meal times (start time and end time, using a drop-menu with hours and minutes), including breakfast time, lunch time and dinner time. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the third week of the follow-up
Meal times (Week 4)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete meal times (start time and end time, using a drop-menu with hours and minutes), including breakfast time, lunch time and dinner time. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the fourth week of the follow-up
Autonomy for going to bed and getting up (Week 1)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete two questions about autonomy to go to bed and to get up: "Your partner went to bed / got up:". The answers are provided using a Visual Analogue Scale with "entirely at your initiative" at one end and "entirely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the first week of the follow-up
Autonomy for going to bed and getting up (Week 2)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete two questions about autonomy to go to bed and to get up: "Your partner went to bed / got up:". The answers are provided using a Visual Analogue Scale with "entirely at your initiative" at one end and "entirely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the second week of the follow-up
Autonomy for going to bed and getting up (Week 3)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete two questions about autonomy to go to bed and to get up: "Your partner went to bed / got up:". The answers are provided using a Visual Analogue Scale with "entirely at your initiative" at one end and "entirely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the third week of the follow-up
Autonomy for going to bed and getting up (Week 4)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete two questions about autonomy to go to bed and to get up: "Your partner went to bed / got up:". The answers are provided using a Visual Analogue Scale with "entirely at your initiative" at one end and "entirely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the fourth week of the follow-up
Signs of tiredness (Week 1)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete two questions about signs of tiredness: "Did your partner show signs of tiredness before going to bed / after getting up?". The answers are provided using a Visual Analogue Scale with "Yes, numerous signs of tiredness" at one end and "No, no signs of tiredness" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the first week of the follow-up
Signs of tiredness (Week 2)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete two questions about signs of tiredness: "Did your partner show signs of tiredness before going to bed / after getting up?". The answers are provided using a Visual Analogue Scale with "Yes, numerous signs of tiredness" at one end and "No, no signs of tiredness" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the second week of the follow-up
Signs of tiredness (Week 3)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete two questions about signs of tiredness: "Did your partner show signs of tiredness before going to bed / after getting up?". The answers are provided using a Visual Analogue Scale with "Yes, numerous signs of tiredness" at one end and "No, no signs of tiredness" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the third week of the follow-up
Signs of tiredness (Week 4)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete two questions about signs of tiredness: "Did your partner show signs of tiredness before going to bed / after getting up?". The answers are provided using a Visual Analogue Scale with "Yes, numerous signs of tiredness" at one end and "No, no signs of tiredness" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the fourth week of the follow-up
Involvement in the activities related to meal (Week 1)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the partner's involvement in the activities related to meal: "How did you perceive your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "No involvement at all" at one end and "Large amount of involvement" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the first week of the follow-up
Involvement in the activities related to meal (Week 2)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the partner's involvement in the activities related to meal: "How did you perceive your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "No involvement at all" at one end and "Large amount of involvement" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the second week of the follow-up
Involvement in the activities related to meal (Week 3)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the partner's involvement in the activities related to meal: "How did you perceive your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "No involvement at all" at one end and "Large amount of involvement" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the third week of the follow-up
Involvement in the activities related to meal (Week 4)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the partner's involvement in the activities related to meal: "How did you perceive your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "No involvement at all" at one end and "Large amount of involvement" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the fourth week of the follow-up
Usefulness of involvement in the activities related to meal (Week 1)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the usefulness of the partner's involvement in the activities related to meal: "How did you perceive the usefulness of your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "Completely useless" at one end and "Very useful" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the first week of the follow-up
Usefulness of involvement in the activities related to meal (Week 2)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the usefulness of the partner's involvement in the activities related to meal: "How did you perceive the usefulness of your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "Completely useless" at one end and "Very useful" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the second week of the follow-up
Usefulness of involvement in the activities related to meal (Week 3)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the usefulness of the partner's involvement in the activities related to meal: "How did you perceive the usefulness of your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "Completely useless" at one end and "Very useful" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the third week of the follow-up
Usefulness of involvement in the activities related to meal (Week 4)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the usefulness of the partner's involvement in the activities related to meal: "How did you perceive the usefulness of your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "Completely useless" at one end and "Very useful" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the fourth week of the follow-up
Autonomy of the involvement in the activities related to meal (Week 1)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the autonomy of the partner's involvement in the activities related to meal: "If your partner did help you in the activities involved at breakfast/lunch/dinner, were these:". The answers are provided using a Visual Analogue Scale with "Completely at your initiative" at one end and "Completely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the first week of the follow-up
Autonomy of the involvement in the activities related to meal (Week 2)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the autonomy of the partner's involvement in the activities related to meal: "If your partner did help you in the activities involved at breakfast/lunch/dinner, were these:". The answers are provided using a Visual Analogue Scale with "Completely at your initiative" at one end and "Completely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the second week of the follow-up
Autonomy of the involvement in the activities related to meal (Week 3)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the autonomy of the partner's involvement in the activities related to meal: "If your partner did help you in the activities involved at breakfast/lunch/dinner, were these:". The answers are provided using a Visual Analogue Scale with "Completely at your initiative" at one end and "Completely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the third week of the follow-up
Autonomy of the involvement in the activities related to meal (Week 4)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the autonomy of the partner's involvement in the activities related to meal: "If your partner did help you in the activities involved at breakfast/lunch/dinner, were these:". The answers are provided using a Visual Analogue Scale with "Completely at your initiative" at one end and "Completely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the fourth week of the follow-up
Quantity of interactions during meals (Week 1)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the quantity of interactions with the partner during meals: "How would you consider the interactions between you and your partner during breakfast/lunch/dinner?". The answers are provided using a Visual Analogue Scale with "None at all" at one end and "Very numerous" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the first week of the follow-up
Quantity of interactions during meals (Week 2)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the quantity of interactions with the partner during meals: "How would you consider the interactions between you and your partner during breakfast/lunch/dinner?". The answers are provided using a Visual Analogue Scale with "None at all" at one end and "Very numerous" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the second week of the follow-up
Quantity of interactions during meals (Week 3)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the quantity of interactions with the partner during meals: "How would you consider the interactions between you and your partner during breakfast/lunch/dinner?". The answers are provided using a Visual Analogue Scale with "None at all" at one end and "Very numerous" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the third week of the follow-up
Quantity of interactions during meals (Week 4)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the quantity of interactions with the partner during meals: "How would you consider the interactions between you and your partner during breakfast/lunch/dinner?". The answers are provided using a Visual Analogue Scale with "None at all" at one end and "Very numerous" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the fourth week of the follow-up
Quality of interactions during meals (Week 1)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the quality of interactions with the partner during meals: "Your partner's emotional reactions to your interactions seemed:". The answers are provided using a Visual Analogue Scale with "Entirely inappropriate" at one end and "Entirely appropriate" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the first week of the follow-up
Quality of interactions during meals (Week 2)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the quality of interactions with the partner during meals: "Your partner's emotional reactions to your interactions seemed:". The answers are provided using a Visual Analogue Scale with "Entirely inappropriate" at one end and "Entirely appropriate" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the second week of the follow-up
Quality of interactions during meals (Week 3)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the quality of interactions with the partner during meals: "Your partner's emotional reactions to your interactions seemed:". The answers are provided using a Visual Analogue Scale with "Entirely inappropriate" at one end and "Entirely appropriate" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the third week of the follow-up
Quality of interactions during meals (Week 4)
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the quality of interactions with the partner during meals: "Your partner's emotional reactions to your interactions seemed:". The answers are provided using a Visual Analogue Scale with "Entirely inappropriate" at one end and "Entirely appropriate" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Measured: once during the fourth week of the follow-up

Secondary outcomes (6)

Patient's apathy perceived by caregiver (day scale)
The secondary outcome measures will be collected through questionnaires completed by the caregiver (only in patient-caregiver dyads) using a smartphone application. For the measure of patient's apathy perceived by caregiver on a day scale (once a week), caregivers have to complete one question: "How did you perceive your partner's level of apathy (= lack of ability to initiate activities) during the day?" using a visual analogue scale from "Very low" to "Very high".
Measured: once a week during the 4 weeks of the follow-up
Patient's apathy perceived by caregiver (month scale)
The secondary outcome measures will be collected through questionnaires completed by the caregiver (only in patient-caregiver dyads) using a smartphone application. For the measure of patient's apathy perceived by caregiver on the month scale (at the end of the 28 days of follow-up), investigators use a validated questionnaire: Starkstein Apathy Scale (SAS) in caregiver's version (Starkstein et al., 1992). SAS score varies between 0 and 42, higher score meaning higher apathy.
Measured: at the end of the 28-day follow-up
Caregiver's burden (day scale)
The secondary outcome measures will be collected through questionnaires completed by the caregiver (only in patient-caregiver dyads) using a smartphone application. For the measure of caregiver's burden on a day scale (once a week), caregivers have to complete one question: "How did you perceive the level of burden related to your partner's care during the day?" using a visual analogue scale from "Very low" to "Very high".
Measured: once a week during the 4 weeks of the follow-up
Caregiver's burden (month scale)
The secondary outcome measures will be collected through questionnaires completed by the caregiver (only in patient-caregiver dyads) using a smartphone application. For the measure of caregiver's burden on the month scale (at the end of the 28 days of follow-up), investigators use a validated questionnaire: Zarit Burden Interview (ZBI) (Hébert et al., 2010). ZBI score varies between 0 and 48, higher score meaning higher perceived burden.
Measured: at the end of the 28-day follow-up
Caregiver's health-related quality of life (day scale)
The secondary outcome measures will be collected through questionnaires completed by the caregiver (only in patient-caregiver dyads) using a smartphone application. For the measure of caregiver's quality of life on a day scale (once a week), caregivers have to complete one question: "How did you perceive your overall health state (physical and psychological) during the day?" using a visual analogue scale from "Very bad health state" to "Very good health state".
Measured: once a week during the 4 weeks of the follow-up
Caregiver's health-related quality of life (month scale)
The secondary outcome measures will be collected through questionnaires completed by the caregiver (only in patient-caregiver dyads) using a smartphone application. For the measure of caregiver's quality of life on the month scale (at the end of the 28 days of follow-up), investigators use a validated questionnaire: Short Form 36 (SF36) (Stewart, 2007). The SF-36 consists of eight scaled scores on a 0-100 scale. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: at the end of the 28-day follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 202216 May 2026

First posted29 Apr 2021
Study start20 May 2022
Primary completion18 Apr 2025
Study completion16 May 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Frontotemporal Dementia, Behavioral VariantStudies of the same condition, open and under way.
More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Cross-sectional
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04865172
Sponsor's protocol ID: C20-23
Other IDs: 2020-A03305-34
Acronym: @HOME
Status last verified: Jul 2026
First submitted: 24 Mar 2021
Last updated: 17 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Godefroy V, Levy R, Bouzigues A, Rametti-Lacroux A, Migliaccio R, Batrancourt B. ECOCAPTURE@HOME: Protocol for the Remote Assessment of Apathy and Its Everyday-Life Consequences. Int J Environ Res Public Health. 2021 Jul 23;18(15):7824. doi: 10.3390/ijerph18157824.
PubMed 34360133

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ECOCAPTURE@HOME: Program for the Assessment of Behavioural Markers of Apathy Under Real-life Conditions Aimed at Patients With Neurodegenerative Dementias and Their Caregivers
ClinicalTrials.gov ID: NCT04865172
Acronym / sponsor ID: @HOME / C20-23
Conditions: Frontotemporal Dementia, Behavioral Variant, Alzheimer Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, FranceOther government
Study start: 20 May 2022 (actual)
Primary completion: 18 Apr 2025 (actual)
Study completion: 16 May 2026 (actual)
First posted: 29 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This project carries great potential to improve both patients' care and caregivers' social support.

Study design

Observational model: Other
Time perspective: Cross-sectional
Number of arms: 3

Arm	Type	Receives
Patient-caregiver dyads, patients with behavioural variant frontotemporal dementia	–	Other: Remote collection of passive and active data for 28 consecutive days20 patient-caregiver dyads, patients with behavioural variant frontotemporal dementia
Patient-caregiver dyads, patients with Alzheimer disease	–	Other: Remote collection of passive and active data for 28 consecutive days20 patient-caregiver dyads, patients with Alzheimer disease
Healthy control dyads	–	Other: Remote collection of passive and active data for 28 consecutive days20 healthy control dyads

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: 20 patient-caregiver dyads with patients suffering from behavioral variant front-temporal dementia, 20 patient-caregiver dyads with patients suffering from Alzheimer disease, 20 healthy control dyads

Key inclusion criteria (15 listed)

Diagnosis of bvFTD according to Rascovsky's international criteria for the bvFTD group / diagnosis of AD according to Dubois's international criteria for the AD group;
No evidence of any other cerebral pathology;
A Mini-Mental State Evaluation (MMSE) score superior or equal to 10 (to minimise the effect of confounding factors related to very severe cognitive impairment);
Aged between 40 and 85;
No evidence of any psychiatric condition and a Montgomery-Åsberg Depression Rating Scale (MADRS) score inferior to 20 (to avoid confusion between depression and apathy);

Key exclusion criteria (3 listed)

Persons in detention by judicial or administrative decision
Person who is subject to a legal protection order
Person submitted to an exclusion period due to the participation to another research

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Remote collection of passive and active data for 28 consecutive daysPassive sensor data: collected continuously for 28 days, from a multi-sensor wearable bracelet worn by each member of the dyad; Active questionnaire data: collected once a week during the four weeks of monitoring (and at the end of the 28 days for patient-caregiver dyads), from questionnaires filled by one partner of the dyad (for patient-caregiver dyads, this will be the caregiver) using a smartphone application.	Other	Healthy control dyads, Patient-caregiver dyads, patients with Alzheimer disease, Patient-caregiver dyads, patients with behavioural variant frontotemporal dementia

Primary outcome

Acceleration (in g)
Time frame: 28 days
In all the dyads included in the study for a remote follow-up, investigators will collect the acceleration signal recorded by a bracelet (Empatica E4) including a 3-axis accelerometer, continuously for 28 days. Data of acceleration will be collected in both partners of the dyad.
Electrodermal activity (in microsiemens)
Time frame: 28 days
In all the dyads included in the study for a remote follow-up, investigators will collect the electrodermal activity signal recorded by a bracelet (Empatica E4) including an EDA sensor, continuously for 28 days. Data of electrodermal activity will be collected in both partners of the dyad.
Blood volume pulse (or relative blood flow)
Time frame: 28 days
In all the dyads included in the study for a remote follow-up, investigators will collect the blood volume pulse recorded by a bracelet (Empatica E4) including a photoplethysmogram (PPG) sensor, continuously for 28 days. Data of blood volume pulse will be collected in both partners of the dyad. Heart rate (number of beats per minute) can be derived from the blood volume pulse.
Bedtime and getting up time (Week 1)
Time frame: once during the first week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete bedtime (using a drop-menu with hours and minutes) and getting up time next day. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Bedtime and getting up time (Week 2)
Time frame: once during the second week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete bedtime (using a drop-menu with hours and minutes) and getting up time next day. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Bedtime and getting up time (Week 3)
Time frame: once during the third week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete bedtime (using a drop-menu with hours and minutes) and getting up time next day. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Bedtime and getting up time (Week 4)
Time frame: once during the fourth week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete bedtime (using a drop-menu with hours and minutes) and getting up time next day. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Meal times (Week 1)
Time frame: once during the first week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete meal times (start time and end time, using a drop-menu with hours and minutes), including breakfast time, lunch time and dinner time. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Meal times (Week 2)
Time frame: once during the second week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete meal times (start time and end time, using a drop-menu with hours and minutes), including breakfast time, lunch time and dinner time. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Meal times (Week 3)
Time frame: once during the third week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete meal times (start time and end time, using a drop-menu with hours and minutes), including breakfast time, lunch time and dinner time. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Meal times (Week 4)
Time frame: once during the fourth week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete meal times (start time and end time, using a drop-menu with hours and minutes), including breakfast time, lunch time and dinner time. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Autonomy for going to bed and getting up (Week 1)
Time frame: once during the first week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete two questions about autonomy to go to bed and to get up: "Your partner went to bed / got up:". The answers are provided using a Visual Analogue Scale with "entirely at your initiative" at one end and "entirely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Autonomy for going to bed and getting up (Week 2)
Time frame: once during the second week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete two questions about autonomy to go to bed and to get up: "Your partner went to bed / got up:". The answers are provided using a Visual Analogue Scale with "entirely at your initiative" at one end and "entirely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Autonomy for going to bed and getting up (Week 3)
Time frame: once during the third week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete two questions about autonomy to go to bed and to get up: "Your partner went to bed / got up:". The answers are provided using a Visual Analogue Scale with "entirely at your initiative" at one end and "entirely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Autonomy for going to bed and getting up (Week 4)
Time frame: once during the fourth week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete two questions about autonomy to go to bed and to get up: "Your partner went to bed / got up:". The answers are provided using a Visual Analogue Scale with "entirely at your initiative" at one end and "entirely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Signs of tiredness (Week 1)
Time frame: once during the first week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete two questions about signs of tiredness: "Did your partner show signs of tiredness before going to bed / after getting up?". The answers are provided using a Visual Analogue Scale with "Yes, numerous signs of tiredness" at one end and "No, no signs of tiredness" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Signs of tiredness (Week 2)
Time frame: once during the second week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete two questions about signs of tiredness: "Did your partner show signs of tiredness before going to bed / after getting up?". The answers are provided using a Visual Analogue Scale with "Yes, numerous signs of tiredness" at one end and "No, no signs of tiredness" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Signs of tiredness (Week 3)
Time frame: once during the third week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete two questions about signs of tiredness: "Did your partner show signs of tiredness before going to bed / after getting up?". The answers are provided using a Visual Analogue Scale with "Yes, numerous signs of tiredness" at one end and "No, no signs of tiredness" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Signs of tiredness (Week 4)
Time frame: once during the fourth week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete two questions about signs of tiredness: "Did your partner show signs of tiredness before going to bed / after getting up?". The answers are provided using a Visual Analogue Scale with "Yes, numerous signs of tiredness" at one end and "No, no signs of tiredness" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Involvement in the activities related to meal (Week 1)
Time frame: once during the first week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the partner's involvement in the activities related to meal: "How did you perceive your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "No involvement at all" at one end and "Large amount of involvement" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Involvement in the activities related to meal (Week 2)
Time frame: once during the second week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the partner's involvement in the activities related to meal: "How did you perceive your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "No involvement at all" at one end and "Large amount of involvement" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Involvement in the activities related to meal (Week 3)
Time frame: once during the third week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the partner's involvement in the activities related to meal: "How did you perceive your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "No involvement at all" at one end and "Large amount of involvement" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Involvement in the activities related to meal (Week 4)
Time frame: once during the fourth week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the partner's involvement in the activities related to meal: "How did you perceive your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "No involvement at all" at one end and "Large amount of involvement" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Usefulness of involvement in the activities related to meal (Week 1)
Time frame: once during the first week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the usefulness of the partner's involvement in the activities related to meal: "How did you perceive the usefulness of your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "Completely useless" at one end and "Very useful" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Usefulness of involvement in the activities related to meal (Week 2)
Time frame: once during the second week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the usefulness of the partner's involvement in the activities related to meal: "How did you perceive the usefulness of your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "Completely useless" at one end and "Very useful" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Usefulness of involvement in the activities related to meal (Week 3)
Time frame: once during the third week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the usefulness of the partner's involvement in the activities related to meal: "How did you perceive the usefulness of your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "Completely useless" at one end and "Very useful" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Usefulness of involvement in the activities related to meal (Week 4)
Time frame: once during the fourth week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the usefulness of the partner's involvement in the activities related to meal: "How did you perceive the usefulness of your partner's involvement in activities related to breakfast/lunch/dinner". The answers are provided using a Visual Analogue Scale with "Completely useless" at one end and "Very useful" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Autonomy of the involvement in the activities related to meal (Week 1)
Time frame: once during the first week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the autonomy of the partner's involvement in the activities related to meal: "If your partner did help you in the activities involved at breakfast/lunch/dinner, were these:". The answers are provided using a Visual Analogue Scale with "Completely at your initiative" at one end and "Completely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Autonomy of the involvement in the activities related to meal (Week 2)
Time frame: once during the second week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the autonomy of the partner's involvement in the activities related to meal: "If your partner did help you in the activities involved at breakfast/lunch/dinner, were these:". The answers are provided using a Visual Analogue Scale with "Completely at your initiative" at one end and "Completely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Autonomy of the involvement in the activities related to meal (Week 3)
Time frame: once during the third week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the autonomy of the partner's involvement in the activities related to meal: "If your partner did help you in the activities involved at breakfast/lunch/dinner, were these:". The answers are provided using a Visual Analogue Scale with "Completely at your initiative" at one end and "Completely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Autonomy of the involvement in the activities related to meal (Week 4)
Time frame: once during the fourth week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the autonomy of the partner's involvement in the activities related to meal: "If your partner did help you in the activities involved at breakfast/lunch/dinner, were these:". The answers are provided using a Visual Analogue Scale with "Completely at your initiative" at one end and "Completely at their own initiative" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Quantity of interactions during meals (Week 1)
Time frame: once during the first week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the quantity of interactions with the partner during meals: "How would you consider the interactions between you and your partner during breakfast/lunch/dinner?". The answers are provided using a Visual Analogue Scale with "None at all" at one end and "Very numerous" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Quantity of interactions during meals (Week 2)
Time frame: once during the second week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the quantity of interactions with the partner during meals: "How would you consider the interactions between you and your partner during breakfast/lunch/dinner?". The answers are provided using a Visual Analogue Scale with "None at all" at one end and "Very numerous" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Quantity of interactions during meals (Week 3)
Time frame: once during the third week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the quantity of interactions with the partner during meals: "How would you consider the interactions between you and your partner during breakfast/lunch/dinner?". The answers are provided using a Visual Analogue Scale with "None at all" at one end and "Very numerous" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Quantity of interactions during meals (Week 4)
Time frame: once during the fourth week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the quantity of interactions with the partner during meals: "How would you consider the interactions between you and your partner during breakfast/lunch/dinner?". The answers are provided using a Visual Analogue Scale with "None at all" at one end and "Very numerous" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Quality of interactions during meals (Week 1)
Time frame: once during the first week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the quality of interactions with the partner during meals: "Your partner's emotional reactions to your interactions seemed:". The answers are provided using a Visual Analogue Scale with "Entirely inappropriate" at one end and "Entirely appropriate" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Quality of interactions during meals (Week 2)
Time frame: once during the second week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the quality of interactions with the partner during meals: "Your partner's emotional reactions to your interactions seemed:". The answers are provided using a Visual Analogue Scale with "Entirely inappropriate" at one end and "Entirely appropriate" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Quality of interactions during meals (Week 3)
Time frame: once during the third week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the quality of interactions with the partner during meals: "Your partner's emotional reactions to your interactions seemed:". The answers are provided using a Visual Analogue Scale with "Entirely inappropriate" at one end and "Entirely appropriate" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.
Quality of interactions during meals (Week 4)
Time frame: once during the fourth week of the follow-up
In all the dyads included in the study for a remote follow-up, investigators will collect information on the behaviour of one of the dyad's partners (the patient in patient-caregiver dyads) through a questionnaire completed once a week by the other partner (caregiver in patient-caregiver dyads) using an application installed on their smartphone. In particular, the questionnaire will require to complete three questions (one for each meal: breakfast, lunch and dinner) about the quality of interactions with the partner during meals: "Your partner's emotional reactions to your interactions seemed:". The answers are provided using a Visual Analogue Scale with "Entirely inappropriate" at one end and "Entirely appropriate" at the other end. Each week, all questions of the questionnaire will have to be completed at the same time in the application.

6 secondary outcomes

Patient's apathy perceived by caregiver (day scale)
Time frame: once a week during the 4 weeks of the follow-up
Patient's apathy perceived by caregiver (month scale)
Time frame: at the end of the 28-day follow-up
Caregiver's burden (day scale)
Time frame: once a week during the 4 weeks of the follow-up
Caregiver's burden (month scale)
Time frame: at the end of the 28-day follow-up
Caregiver's health-related quality of life (day scale)
Time frame: once a week during the 4 weeks of the follow-up
Caregiver's health-related quality of life (month scale)
Time frame: at the end of the 28-day follow-up

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
Background: PubMed 34360133Godefroy V, Levy R, Bouzigues A, Rametti-Lacroux A, Migliaccio R, Batrancourt B. ECOCAPTURE@HOME: Protocol for the Remote Assessment of Apathy and Its Everyday-Life Consequences. Int J Environ Res Public Health. 2021 Jul 23;18(15):7824. doi: 10.3390/ijerph18157824.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard Levy, MD, PhD principal investigator

Institut National de la Santé Et de la Recherche Médicale, France

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Frontotemporal Dementia, Behavioral Variant and Alzheimer Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceleration (in g) (time frame: 28 days). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04865172, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.