Quality-of-Life Index (Q-Index) (NCT06209502) | Clinical Trial Compass
CompletedNot Applicable
Quality-of-Life Index (Q-Index)
Belgium95 participantsStarted 2023-11-01
Plain-language 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.
Who can participate
Age range
30 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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 c…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focused on Parkinson's Disease and measuring quality of life using something called a Q-Index — can you explain what that index actually measures and whether it captures the symptoms that matter most to me personally?
2Since this trial is already completed, have the results been published anywhere, and if so, what did they find about how Parkinson's affects quality of life across different patients?
3Could the Q-Index tool studied in this trial be something my care team would use to track how I'm doing over time, or is it mainly a research instrument?
4How does measuring quality of life in a study like this one actually influence the way doctors choose or adjust treatments for Parkinson's patients — would findings from this trial change anything about my care?
5Are there other active trials or standard-of-care approaches for Parkinson's that we should be prioritizing alongside or instead of following up on tools like the ones studied here?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary objective
Timeframe: 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.