MobilityEFICISNCT05249504
Effectiveness of AMICOPE Intervention to Maintain Self-Perceived Health and Intrinsic Capacity in Older People
A study testing VIVIFRAIL, Nutrition and Psychology in people with Mobility and Depressive Symptoms, run by Fundacio Salut i Envelliment UAB.
Trial summary
In their day to day, persons do from simple to more or less complicated tasks and activities (ie: stand from a chair, open a door, shopping, read, drive, play chess, remind an appointment...). Such ability to do things is called capacity. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Mobility, Depressive Symptoms, Nutrition, Healthy
- What is being tested?
- VIVIFRAIL, Nutrition and Psychology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 31 Aug 2024
- Phase
- Interventional
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- To live in the community
- To be able to move autonomously to the intervention place
- To Have a deficit in at least one mobility, vitality or psychological domains in the Integrated Care for Older People (ICOPE) screening tool confirmed by a reference test, namely:
- A - Mobility: unable to stand up from a chair 5 times in less than 14 seconds AND having less than 10 points in the Short Physical Performance Battery (SPPB).
- B - Vitality: any nutritional problem from the ICOPE screening tool (loss of appetite OR losing more than 3 Kg not intentionally in the last 3 months) AND having less than 12 points in MNA (malnutrition or malnutrition risc).
- C - Psychological: any depressive symptoms from the ICOPE screening tool (answer that in the last two weeks has had feelings of sadness, melancholy OR hopelessness or refer lack of interest or pleasure when doing things) AND the presence of at least two or more symptoms on the 5-item Geriatric Depression Scale (GDS5).
Who cannot join
- People with previous diagnosis of dementia or cognitive decline with a score below 24 points in the Minimental State Examination (MMSE).
- People in the end of life.
- People who have factors that prevent or contraindicate the performance of the planned interventions, such as contraindication to physical activity, mental or (non-corrected) communication issues that makes it difficult to participate in group dynamics.
About this study
Official title: Efectividad de la intervención AMICOPE Para Mejorar y/o Mantener la Salud Autopercibida y la Capacidad intrínseca en Personas Mayores: un Ensayo clínico Aleatorizado (EFICIS)
In their day to day, persons do from simple to more or less complicated tasks and activities (ie: stand from a chair, open a door, shopping, read, drive, play chess, remind an appointment...). Such ability to do things is called capacity. Intrinsic capacity is the combination of all the physical and mental capacities that a person has, and reach its maximum in the early adulthood and then declines as the person ages. Each kind of capacity declines at her own speed (which may be faster or slower according to each person lifestyle), and once drops below a threshold may lead to a reduction in quality of life and loss of autonomy.
Nevertheless there are some actions that may be effective to prevent or slow such decline. To do so the investigators have design an intervention that combines several things of different nature (what is know as a complex intervention) called AMICOPE. The AMICOPE intervention is performed in the community or in primary care centers through 12 weekly group sessions of 2 h 30 min which combine structured and adapted physical activity, group dynamics to promote social support and address loneliness, social isolation and depressive symptoms, and dietary advice.
Read more
Our study is addressed to persons over 70 with light problems in mobility, nutrition or mood state.
The purpose of this study is to assess if the AMICOPE intervention is better than the standard advice to follow healthy lifestyles to improve or maintain self-perceived health, mobility, nutritional status an psychological wellbeing.
- Conditions
- Mobility, Depressive Symptoms, Nutrition, Healthy, Cognitive Decline, Hearing Loss, Visual Impairment
- Being tested
- VIVIFRAIL, Nutrition, Psychology, Personal autonomy, Community resources
- Keywords
- Frailty, Intrinsic capacity, Multicomponent intervention, Randomized clinical Trial, Quality of life
- Medical subject headings
- Depression, Cognitive Dysfunction, Hearing Loss, Vision Disorders, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIVIFRAILOther
VIVIFRAIL is a set of physical activity programs (designed according to several elderly functional level profiles) aimed to prevent motor disability and improve quality of life. It works endurance, flexibility, balance and strength.
https://web.archive.org/web/20210907041944/https://vivifrail.com/
NutritionOther
Sessions to learn about personal nutrition habits, offer nutritional advice, and acquire skills to incorporate simple healthy nutrition guidelines into everyday life. A visit to a supermarket to make it easier to read and understand the basic information on nutrition labels.
PsychologyBehavioural
Relaxation techniques to manage mood, a photo-elicitation dynamic to address loneliness, and a dynamic to collectively develop a map of health assets in the neighborhood or territory to obtain information on community resources. Finally, a group visit is planned to a community facility previously agreed upon by the participants.
Personal autonomyBehavioural
Review practical cases on personal autonomy, the proper use of medications, and discover basic cognitive stimulation strategies.
Community resourcesOther
Learn about community resources
Standard recommendationsOther
Usual advice provided at primary care office accompanied to booklets about healthy lifestyles
| Study group | Role | What they receive |
|---|---|---|
| 1. Intervention group | Experimental | AMICOPE multicomponent intervention:
* Physical activity (VIVIFRAIL program): 10 hours.
* Nutrition: 6,5 hours.
* Psychology: 6,5 hours.
* Personal autonomy: 4,5 hours
* Learn about community resources: 2, 5 hours Receives: Other: VIVIFRAIL; Other: Nutrition; Behavioral: Psychology; Behavioral: Personal autonomy; Other: Community resources |
| 2. Control group | Active comparator | Control group participants will receive usual advice on healthy lifestyle habits and a follow-up phone call from healthcare professionals. Receives: Other: Standard recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-perceived health
Change in self-perceived health status according to the Euroqol Visual Analogue Scale, where participants scores from 0 (worse state) to 100 (better state) their current perceived health
Measured: Baseline, after the intervention (average 16 weeks)
Secondary outcomes (8)
Functional status
Change in functional status according to the Short Physical Performance Battery (SPPB), a set of tests that measure balance, gait speed and strength (raising 5 times from a chair). Persons are classified in categories according to their final score (0-3, 4-6, 7-9, 10-12). Higher scores indicates robustness, lower scores are indicative of frailty and disability.
Measured: Baseline, after the intervention (average 16 weeks)
Nutritional status
Change in nutritional risks assessed by the abridged version of Mini-Nutritional Assessment (MNA), which classifies the persons as normal (12-14 points), at risk of malnutrition (8-11) or malnourished (0-7)
Measured: Baseline, after the intervention (average 16 weeks)
Depressive symptoms
Change in proportion of participants with depressive symptoms using the 5 items Geriatric Depression Scales (GDS5). Not depressed (0 or 1 point), Depressed (2-5).
Measured: Baseline, after the intervention (average 16 weeks)
Autonomy in daily life.
Change in the ability to perform basic and instrumental daily life activities will be measured with the Short-Form Late-Life Function and Disability Instrument (SF-LLFDI).
Higher scores indicates a higher level of autonomy.
Measured: Baseline, after the intervention (average 16 weeks)
Health related quality of life.
Change in health related quality of life will be assessed with the quality of life questionnaire EQ-5D-5L.
Measured: Baseline, after the intervention (average 16 weeks)
Physical activity.
Change in level of physical activity, which will be assessed with the Spanish Short Version of the Minnesota Leisure Time Physical Activity Questionnaire (VREM), which according to the time doing several activities computes the energy expenditure in units that can be compared between them, the Metabolic Equivalent of Task. (MET). Persons are categorized as sedentary (< 1.250 METs-min/14 days), moderately active (1.250 to 2.999 METs-min/14 days); active (3.000 to 4.999 METs-min/14 days) or very active (≥ 5.000 METs-min/14 days).)
Measured: Baseline, after the intervention (average 16 weeks)
Loneliness
Change in the degree of Loneliness, which will be assessed with De Jong Gierveld Loneliness Scale. The degree of loneliness is scored as no loneliness (0 to 2 points), mild loneliness ( 3 to 8), severe (9 to 10) or very severe (11)
Measured: Baseline, after the intervention (average 16 weeks)
Social support and risk of isolation
Change in social support and risk of isolation, which will be assessed with the Lubben Social Network Scale - Revised (LSNS-R). According the the LSNS-R score the persons will be classified as with low risk (30 to 60 points); mild (26 to 30); high (21 to 25) or socially isolated (0 to 20).
Measured: Baseline, after the intervention (average 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start1 Apr 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MobilityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open and Pragmatic Parallel Randomized Controlled Clinical Trial
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio Salut i Envelliment UAB
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249504
- Sponsor's protocol ID
- FSIEPI2100537
- Other IDs
- PI21/00537, 5876
- Acronym
- EFICIS
- Status last verified
- Feb 2022
- First submitted
- 15 Dec 2021
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The sponsor only will share data from participants that have provided written consent to share its anonymized data for studies with scientific purposes related with well-being, quality of life and autonomy of the elderly persons. Once the database is closed all identifying data collected to develop the study (ie: names and contact phones to make appointments) will be removed from the database. Any date variable will be replaced by a time reference variable, taking as reference the day of the first visit (ie: instead of date of birth and date of visit, will be replaced by the age). Other actions may be performed to ensure a reasonable balance between the data loss and the risk of re-identification, as editing quasi-identificatory variables (ie categorizing/aggregating participant data, as creating age groups) or removed (ie removing the data identifying the centers) or removing cases with a high degree of singularity given the quasi-identificatory variables combination.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efectividad de la intervención AMICOPE Para Mejorar y/o Mantener la Salud Autopercibida y la Capacidad intrínseca en Personas Mayores: un Ensayo clínico Aleatorizado (EFICIS)
- ClinicalTrials.gov ID
- NCT05249504
- Acronym / sponsor ID
- EFICIS / FSIEPI2100537
- Conditions
- Mobility, Depressive Symptoms, Nutrition, Healthy, Cognitive Decline, Hearing Loss, Visual Impairment
- Keywords
- Frailty, Intrinsic capacity, Multicomponent intervention, Randomized clinical Trial, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Fundacio Salut i Envelliment UABUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 21 Feb 2022 (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.
In their day to day, persons do from simple to more or less complicated tasks and activities (ie: stand from a chair, open a door, shopping, read, drive, play chess, remind an appointment...). Such ability to do things is called capacity. Intrinsic capacity is the combination of all the physical and mental capacities that a person has, and reach its maximum in the early adulthood and then declines as the person ages. Each kind of capacity declines at her own speed (which may be faster or slower according to each person lifestyle), and once drops below a threshold may lead to a reduction in quality of life and loss of autonomy.
Nevertheless there are some actions that may be effective to prevent or slow such decline. To do so the investigators have design an intervention that combines several things of different nature (what is know as a complex intervention) called AMICOPE. The AMICOPE intervention is performed in the community or in primary care centers through 12 weekly group sessions of 2 h 30 min which combine structured and adapted physical activity, group dynamics to promote social support and address loneliness, social isolation and depressive symptoms, and dietary advice.
Our study is addressed to persons over 70 with light problems in mobility, nutrition or mood state.
The purpose of this study is to assess if the AMICOPE intervention is better than the standard advice to follow healthy lifestyles to improve or maintain self-perceived health, mobility, nutritional status an psychological wellbeing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open and Pragmatic Parallel Randomized Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| 1. Intervention group | Experimental | Other: VIVIFRAIL, Other: Nutrition, Behavioral: Psychology, Behavioral: Personal autonomy, Other: Community resourcesAMICOPE multicomponent intervention: * Physical activity (VIVIFRAIL program): 10 hours. * Nutrition: 6,5 hours. * Psychology: 6,5 hours. * Personal autonomy: 4,5 hours * Learn about community resources: 2, 5 hours |
| 2. Control group | Active comparator | Other: Standard recommendationsControl group participants will receive usual advice on healthy lifestyle habits and a follow-up phone call from healthcare professionals. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- To live in the community
- To be able to move autonomously to the intervention place
- To Have a deficit in at least one mobility, vitality or psychological domains in the Integrated Care for Older People (ICOPE) screening tool confirmed by a reference test, namely:
- A - Mobility: unable to stand up from a chair 5 times in less than 14 seconds AND having less than 10 points in the Short Physical Performance Battery (SPPB).
- B - Vitality: any nutritional problem from the ICOPE screening tool (loss of appetite OR losing more than 3 Kg not intentionally in the last 3 months) AND having less than 12 points in MNA (malnutrition or malnutrition risc).
Key exclusion criteria (3 listed)
- People with previous diagnosis of dementia or cognitive decline with a score below 24 points in the Minimental State Examination (MMSE).
- People in the end of life.
- People who have factors that prevent or contraindicate the performance of the planned interventions, such as contraindication to physical activity, mental or (non-corrected) communication issues that makes it difficult to participate in group dynamics.
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 |
|---|---|---|
| VIVIFRAILVIVIFRAIL is a set of physical activity programs (designed according to several elderly functional level profiles) aimed to prevent motor disability and improve quality of life. It works endurance, flexibility, balance and strength. https://web.archive.org/web/20210907041944/https://vivifrail.com/ | Other | 1. Intervention group |
| NutritionSessions to learn about personal nutrition habits, offer nutritional advice, and acquire skills to incorporate simple healthy nutrition guidelines into everyday life. A visit to a supermarket to make it easier to read and understand the basic information on nutrition labels. | Other | 1. Intervention group |
| PsychologyRelaxation techniques to manage mood, a photo-elicitation dynamic to address loneliness, and a dynamic to collectively develop a map of health assets in the neighborhood or territory to obtain information on community resources. Finally, a group visit is planned to a community facility previously agreed upon by the participants. | Behavioural | 1. Intervention group |
| Personal autonomyReview practical cases on personal autonomy, the proper use of medications, and discover basic cognitive stimulation strategies. | Behavioural | 1. Intervention group |
| Community resourcesLearn about community resources | Other | 1. Intervention group |
| Standard recommendationsUsual advice provided at primary care office accompanied to booklets about healthy lifestyles | Other | 2. Control group |
Primary outcome
Self-perceived health
Time frame: Baseline, after the intervention (average 16 weeks)
Change in self-perceived health status according to the Euroqol Visual Analogue Scale, where participants scores from 0 (worse state) to 100 (better state) their current perceived health
8 secondary outcomes
Functional status
Time frame: Baseline, after the intervention (average 16 weeks)
Nutritional status
Time frame: Baseline, after the intervention (average 16 weeks)
Depressive symptoms
Time frame: Baseline, after the intervention (average 16 weeks)
Autonomy in daily life.
Time frame: Baseline, after the intervention (average 16 weeks)
Health related quality of life.
Time frame: Baseline, after the intervention (average 16 weeks)
Physical activity.
Time frame: Baseline, after the intervention (average 16 weeks)
Loneliness
Time frame: Baseline, after the intervention (average 16 weeks)
Social support and risk of isolation
Time frame: Baseline, after the intervention (average 16 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Individual participant dataSharing planned: Yes. The sponsor only will share data from participants that have provided written consent to share its anonymized data for studies with scientific purposes related with well-being, quality of life and autonomy of the elderly persons. Once the database is closed all identifying data collected to develop the study (ie: names and contact phones to make appointments) will be removed from the database. Any date variable will be replaced by a time reference variable, taking as reference the day of the first visit (ie: instead of date of birth and date of visit, will be replaced by the age). Other actions may be performed to ensure a reasonable balance between the data loss and the risk of re-identification, as editing quasi-identificatory variables (ie categorizing/aggregating participant data, as creating age groups) or removed (ie removing the data identifying the centers) or removing cases with a high degree of singularity given the quasi-identificatory variables combination.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing VIVIFRAIL, Nutrition and Psychology in people with Mobility and Depressive Symptoms, run by Fundacio Salut i Envelliment UAB.
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 6 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: status not confirmed, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Self-perceived health (time frame: Baseline, after the intervention (average 16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2022.