Parkinson DiseaseNCT06209502
Quality-of-Life Index (Q-Index)
An observational study of Parkinson Disease, run by Koios Care at 4 sites in Belgium.
Trial summary
The main objective of this observational study is to use commonly-used connected objects (smartphones and smartwatches) to remotely assess and monitor the health-related quality of life (HrQoL) of people with Parkinson's disease at different stages of progression. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 95 participants
- Where
- 4 sitesBelgium
- Study dates
- 1 Nov 2023to 14 Aug 2025
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The recruitment process for Parkinson's Disease patients begins during a consultation taking place in one of the three participating clinics. Specifically, a member of the medical team informs the patient about the ongoing study, including but not limited to, its goals, the technology, and the timeline of the study. The recruitment of a Parkinson's Disease patient also appears as an opportunity to recruit healthy participants. Specifically, the study targets members of the close circle of the patient, i.e., age-matched friends and close family members. It should be noted that to avoid recruitment bias (e.g., the partner of the patient stays home to support their patient partner), the partner of the patient is left as the emergency (low recruitment rate for healthy controls) recruitment scenario. In addition, the recruitment procedure for healthy controls will be supported by wall posters in the hospital campus and web advertising.
Who may be able to join
- Males and females between the ages of 30 and 75
- Agree to download and install the Koios Care application to their personal Android smartphone.
- People diagnosed with idiopathic PD based on the MDS-PD criteria. The diagnosis must be confirmed by bradykinesia plus one of the other cardinal signs (resting tremor, rigidity or postural instability not caused by primary visual, vestibular, cerebellar, or proprioceptive dysfunction) being present, without any other known or suspected cause of Parkinson's Disease.
- o PD patients that are under the effects of a Deep Brain Stimulation (DBS) device or a levodopa pump (duodopa or lecigimon). Given that all other conditions are also met.
- Score between one-and-a-half (1.5) and three (3) at the H\&Y rating scale in the "ON" state (population A)
- Score of one (1) at the H\&Y rating scale in the "ON" state (population B)
Who cannot join
- The candidate cannot speak or comprehend the French/Dutch (depending on the clinical site s/he belongs to) language at a sufficient level.
- The reluctance of the candidate or her/his inability to provide written consent (e.g., due to mental health problems or severe physical disabilities).
- The candidate is not an Android smartphone owner and user for at least six (6) months.
- The candidate's Android smartphone is not compatible with the Koios Care application.
- The candidate suffers from dementia as judged by the investigator. For this we will use MMSE score with a cut-off value ≥ 24.
- The candidate has exhibited uncontrolled/extreme measures of depression as judged by the expert investigator, e.g., self-harm, suicide attempts or patient admitted to the hospital for a similar reason.
- -- If the participant develops such behavior or s/he is admitted to the hospital for the above reasons during the study, then the candidate is immediately removed from the study.
- Any Parkinson's disease-related feature or symptom that could interfere with the study conduct and results as assessed by the investigator.
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
CHU Charleroi, Department of Neurology, EC reference AH/SG-2023-037
Charleroi
CHU de Liege, Department of Neurology, EC reference 2023/173
Liège
AZ Oostende, Department of Neurology, EC reference OG-057
Ostend
AZ Delta, Department of Neurology, EC reference 23045
Roeselare, 8800
About this study
Official title: Q-Index: A Proof of Concept Investigation Towards Monitoring the Health-related Quality of Life of Parkinson's Disease Patients Using Wearable and Portable Devices.
The main objective of this observational study is to use commonly-used connected objects (smartphones and smartwatches) to remotely assess and monitor the health-related quality of life (HrQoL) of people with Parkinson's disease at different stages of progression.
Read the detailed description
The main objective of this observational study is to use commonly-used connected objects (smartphones and smartwatches) to remotely assess and monitor the health-related quality of life (HrQoL) of people with Parkinson's disease at different stages of progression.
The study takes place in hospitals in Belgium. The study populations are as follows: up to 100 patients between stages H\&Y 1.5 and 3 (population A), up to 15 patients with early-stage Parkinson's disease H\&Y 1 (population B), and up to 15 healthy controls (population C). The duration of the study is approximately 9 months, between September 2023 and November 2024, and will include a baseline clinical assessment (month 0), the first follow-up (month 4) and the second follow-up (month 8).
The main objective is to build an algorithm capable of remotely assessing the health-related quality of life (HrQoL) of patients belonging to population A. This objective will be achieved by formulating and estimating the quality of life index (Q-index) based on continuously and passively recorded data from commercially available wearable devices (an Android smartwatch and a smartphone). The secondary objective is to determine whether the Q index is sufficiently sensitive to monitor the quality of life of people who are in the early stages of the disease (population B). A group of healthy control subjects (population C) will be used to identify the range of Q index values corresponding to healthy and PD populations.
To achieve this objective, we will compare the information extracted from connected devices (micro-indicators) with the responses of participants to questionnaires and clinical tests aimed at evaluating PROMs (patient-related outcome measures). The list of data collected is included in the following table.
To calculate the Q index, we plan to use a combination of several micro-indicators, each acting as a surrogate for the subject's ability to effectively perform certain activities of daily living; communication, sleep, eating, sociability and physical independence. An example of a micro-indicator is Plate-to-Mouth1 (PtM), which measures the individual's eating behavior by estimating the time required to transfer a quantity of food ready to be consumed, from the plate to the mouth.
The ability to accurately monitor health-related quality of life (HrQoL) characteristics will be assessed initially by examining how each micro-indicator correlates with appropriate items from validated questionnaires such as the Health-Related Quality of Life Questionnaire. Parkinson's disease, called PDQ-39. For example, eating behavior (and more specifically Plate-to-Mouth) is associated with upper limb sluggishness and is linked to items 11, 12, 13, 14 and 16 of the PDQ-39. After assessing each micro-indicator, the combined ability of the Q index to monitor HrQoL as a whole will be realized by comparing it to scores and subscores from validated PROMs scales, such as the PDQ-39.
- Conditions
- Parkinson Disease
- Keywords
- Smartwatch, Smartphone, Quality of life, Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Population A | Parkinson's disease patients between H\&Y stages 1.5 and 3 | |
| Population B | Early Parkinson's disease patients of H\&Y stage 1 | |
| Population C | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective
Primarily, this longitudinal study targets patients with Parkinson's Disease between the stages of one-and-a-half (1.5) and three (3) in the Hoehn \& Yahr scale (in the context of this study; population A). By considering the aforementioned population, the primary objective is to build an algorithm towards the remote assessment of the individuals' Health-related QoL (HrQoL). This is to be achieved by formulating and estimating the Quality-of-Life index (Q-index) based on continuously and passively recorded data from commercially available wearable and portable technology (i.e., an Android smartwatch and an Android smartphone).
Measured: Clinical assessments are collected in the clinic at month 0, month 4 and month 8 of the study. Moreover, two self-assessment questionnaires are collected remotely (a) once per month, and (b) once per week.
Secondary outcomes (1)
Secondary objective
Investigate whether the Q-index is sensitive enough to monitor the HrQoL of early PD patients that belong in H\&Y stage 1 (population B).
Measured: Clinical assessments are collected in the clinic at month 0, month 4 and month 8 of the study. Moreover, two self-assessment questionnaires are collected remotely (a) once per month, and (b) once per week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Nov 2023
- Primary completion14 Aug 2025
- Study completion14 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koios Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209502
- Sponsor's protocol ID
- KC-QI-2023
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Q-Index: A Proof of Concept Investigation Towards Monitoring the Health-related Quality of Life of Parkinson's Disease Patients Using Wearable and Portable Devices.
- ClinicalTrials.gov ID
- NCT06209502
- Acronym / sponsor ID
- KC-QI-2023
- Conditions
- Parkinson Disease
- Keywords
- Smartwatch, Smartphone, Quality of life, Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Koios CareIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 14 Aug 2025 (actual)
- Study completion
- 14 Aug 2025 (actual)
- First posted
- 17 Jan 2024 (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.
The main objective of this observational study is to use commonly-used connected objects (smartphones and smartwatches) to remotely assess and monitor the health-related quality of life (HrQoL) of people with Parkinson's disease at different stages of progression.
Detailed description
The main objective of this observational study is to use commonly-used connected objects (smartphones and smartwatches) to remotely assess and monitor the health-related quality of life (HrQoL) of people with Parkinson's disease at different stages of progression.
The study takes place in hospitals in Belgium. The study populations are as follows: up to 100 patients between stages H\&Y 1.5 and 3 (population A), up to 15 patients with early-stage Parkinson's disease H\&Y 1 (population B), and up to 15 healthy controls (population C). The duration of the study is approximately 9 months, between September 2023 and November 2024, and will include a baseline clinical assessment (month 0), the first follow-up (month 4) and the second follow-up (month 8).
The main objective is to build an algorithm capable of remotely assessing the health-related quality of life (HrQoL) of patients belonging to population A. This objective will be achieved by formulating and estimating the quality of life index (Q-index) based on continuously and passively recorded data from commercially available wearable devices (an Android smartwatch and a smartphone). The secondary objective is to determine whether the Q index is sufficiently sensitive to monitor the quality of life of people who are in the early stages of the disease (population B). A group of healthy control subjects (population C) will be used to identify the range of Q index values corresponding to healthy and PD populations.
To achieve this objective, we will compare the information extracted from connected devices (micro-indicators) with the responses of participants to questionnaires and clinical tests aimed at evaluating PROMs (patient-related outcome measures). The list of data collected is included in the following table.
To calculate the Q index, we plan to use a combination of several micro-indicators, each acting as a surrogate for the subject's ability to effectively perform certain activities of daily living; communication, sleep, eating, sociability and physical independence. An example of a micro-indicator is Plate-to-Mouth1 (PtM), which measures the individual's eating behavior by estimating the time required to transfer a quantity of food ready to be consumed, from the plate to the mouth.
The ability to accurately monitor health-related quality of life (HrQoL) characteristics will be assessed initially by examining how each micro-indicator correlates with appropriate items from validated questionnaires such as the Health-Related Quality of Life Questionnaire. Parkinson's disease, called PDQ-39. For example, eating behavior (and more specifically Plate-to-Mouth) is associated with upper limb sluggishness and is linked to items 11, 12, 13, 14 and 16 of the PDQ-39. After assessing each micro-indicator, the combined ability of the Q index to monitor HrQoL as a whole will be realized by comparing it to scores and subscores from validated PROMs scales, such as the PDQ-39.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Population A | – | –Parkinson's disease patients between H\&Y stages 1.5 and 3 |
| Population B | – | –Early Parkinson's disease patients of H\&Y stage 1 |
| Population C | – | –Healthy controls |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The recruitment process for Parkinson's Disease patients begins during a consultation taking place in one of the three participating clinics. Specifically, a member of the medical team informs the patient about the ongoing study, including but not limited to, its goals, the technology, and the timeline of the study. The recruitment of a Parkinson's Disease patient also appears as an opportunity to recruit healthy participants. Specifically, the study targets members of the close circle of the patient, i.e., age-matched friends and close family members. It should be noted that to avoid recruitment bias (e.g., the partner of the patient stays home to support their patient partner), the partner of the patient is left as the emergency (low recruitment rate for healthy controls) recruitment scenario. In addition, the recruitment procedure for healthy controls will be supported by wall posters in the hospital campus and web advertising.
Key inclusion criteria (6 listed)
- Males and females between the ages of 30 and 75
- Agree to download and install the Koios Care application to their personal Android smartphone.
- People diagnosed with idiopathic PD based on the MDS-PD criteria. The diagnosis must be confirmed by bradykinesia plus one of the other cardinal signs (resting tremor, rigidity or postural instability not caused by primary visual, vestibular, cerebellar, or proprioceptive dysfunction) being present, without any other known or suspected cause of Parkinson's Disease.
- o PD patients that are under the effects of a Deep Brain Stimulation (DBS) device or a levodopa pump (duodopa or lecigimon). Given that all other conditions are also met.
- Score between one-and-a-half (1.5) and three (3) at the H\&Y rating scale in the "ON" state (population A)
Key exclusion criteria (8 listed)
- The candidate cannot speak or comprehend the French/Dutch (depending on the clinical site s/he belongs to) language at a sufficient level.
- The reluctance of the candidate or her/his inability to provide written consent (e.g., due to mental health problems or severe physical disabilities).
- The candidate is not an Android smartphone owner and user for at least six (6) months.
- The candidate's Android smartphone is not compatible with the Koios Care application.
- The candidate suffers from dementia as judged by the investigator. For this we will use MMSE score with a cut-off value ≥ 24.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary objective
Time frame: Clinical assessments are collected in the clinic at month 0, month 4 and month 8 of the study. Moreover, two self-assessment questionnaires are collected remotely (a) once per month, and (b) once per week.
Primarily, this longitudinal study targets patients with Parkinson's Disease between the stages of one-and-a-half (1.5) and three (3) in the Hoehn \& Yahr scale (in the context of this study; population A). By considering the aforementioned population, the primary objective is to build an algorithm towards the remote assessment of the individuals' Health-related QoL (HrQoL). This is to be achieved by formulating and estimating the Quality-of-Life index (Q-index) based on continuously and passively recorded data from commercially available wearable and portable technology (i.e., an Android smartwatch and an Android smartphone).
1 secondary outcome
Secondary objective
Time frame: Clinical assessments are collected in the clinic at month 0, month 4 and month 8 of the study. Moreover, two self-assessment questionnaires are collected remotely (a) once per month, and (b) once per week.
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 5 Aug 2026.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Koios Care at 4 sites in Belgium.
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 8 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 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. 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?
Primary objective (time frame: Clinical assessments are collected in the clinic at month 0, month 4 and month 8 of the study. Moreover, two self-assessment questionnaires are collected remotely (a) once per month, and (b) once per week.). 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 5 Aug 2026.