NCT06209502Completed
Quality-of-Life Index (Q-Index)
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.
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 95 (actual)
- First submitted
- 8 Jan 2024
- Start date
- 1 Nov 2023
- Primary completion date
- 14 Aug 2025
- Lead sponsor
- Koios Care
- Diseases
- Parkinson disease
- NCT number
- NCT06209502
What you commit to
- Study type: Observational
- Participants enrolled: 95
- From 1 Nov 2023 to the primary completion date, 14 Aug 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- The candidate suffers from dementia as judged by the investigator. For this we will use MMSE score with a cut-off value ≥ 24.
- Any Parkinson's disease-related feature or symptom that could interfere with the study conduct and results as assessed by the investigator.
Other
- 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 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.
Who the study is looking for
- 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)
Age in the registry: 30 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Charleroi, Department of Neurology, EC reference AH/SG-2023-037 Coordinator of this site? Confirm its status | Charleroi | Belgium | Unknown status |
| CHU de Liege, Department of Neurology, EC reference 2023/173 Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| AZ Oostende, Department of Neurology, EC reference OG-057 Coordinator of this site? Confirm its status | Ostend | Belgium | Unknown status |
| AZ Delta, Department of Neurology, EC reference 23045 Coordinator of this site? Confirm its status | Roeselare | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.