An Integrated and Personalized Lifestyle Approach for People With Parkinson's Disease (NCT06669455) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
An Integrated and Personalized Lifestyle Approach for People With Parkinson's Disease
Netherlands256 participantsStarted 2024-11-12
Plain-language summary
The goal of this study is to investigate the effects of a combined lifestyle program on the quality of life in people with Parkinson's Disease.
Participants will be randomly assigned to one of two groups, both receiving standard care, a Parkinson Lifestyle Decision aid and an intake meeting with a lifestyle coach. One group will work on their goals independently, while the other group will get guidance from the lifestyle coach throughout the 12-month program. The program focuses on self-management, exercise, nutrition, sleep and stress.
Participants will complete questionnaires after 0, 6 and 12 months, and use a wearable sensor for two weeks. The main outcome is quality of life over 12 months, measured with the PDQ-39 questionnaire. The study also examines personal goal achievements, symptom changes, and the economic effects of the program.
Who can participate
Age range
18 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:
* Parkinson's disease (idiopathic) in all stages of severity
* Proficient in Dutch, for both the data collection (questionnaires) and the intervention (all of the apps/modules are in Dutch)
* Aged 18 or older
Exclusion Criteria:
* Cognitive impairments that do not allow to fill out the questionnaires, as judged by the researcher during the screening call.
* Not in possession of or no access to an electronic device that allows for (video) calls with a lifestyle coach, and to complete questionnaires.
* Planned surgery or a planned major change in healthcare provision.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Change in quality of life measured with the PDQ-39.
Timeframe: Measured at baseline, and after 6 and 12 months.