An Integrated and Personalized Lifestyle Approach for People with Parkinson's Disease
NCT ID: NCT06669455
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
256 participants
INTERVENTIONAL
2024-11-12
2026-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intervention
Intervention group receiving:
* Intake with lifestyle coach
* Usual Care
* Integrated, combined lifestyle approach (SENSS), including continuous monitoring by lifestyle coach.
Personalized and combined lifestyle approach
In the SENSS approach five different and complementary lifestyle domains (self-management, exercise, nutrition, sleep and stress) are combined. The process will be guided by a lifestyle coach. The intervention is personalised for each participant. The personal goals are decided based on 'shared decision making' together with the lifestyle coach after using a Parkinson lifestyle decision aid. The level of guidance needed throughout the intervention is based on a 'stepped care approach'.
Control
Control group receiving:
* Intake with lifestyle coach
* Usual care
No interventions assigned to this group
Interventions
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Personalized and combined lifestyle approach
In the SENSS approach five different and complementary lifestyle domains (self-management, exercise, nutrition, sleep and stress) are combined. The process will be guided by a lifestyle coach. The intervention is personalised for each participant. The personal goals are decided based on 'shared decision making' together with the lifestyle coach after using a Parkinson lifestyle decision aid. The level of guidance needed throughout the intervention is based on a 'stepped care approach'.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Locations
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Radboud University Medical Center
Nijmegen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Ties Gaveel
Role: primary
Other Identifiers
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115891
Identifier Type: -
Identifier Source: org_study_id