SENSS (Stress, Exercise, Nutrition, Sleep, Self-management): an Integrated, Personalized and Stepped Care Lifestyle Approach for People with Parkinson's Disease: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Radboud University Medical Center
RECRUITING
Nijmegen
Contact Information
Primary
Ties Gaveel
ties.gaveel@radboudumc.nl
+31615565773
Time Frame
Start Date: 2024-11-12
Estimated Completion Date: 2026-12
Participants
Target number of participants: 256
Treatments
Experimental: Intervention
Intervention group receiving:~* Intake with lifestyle coach~* Usual Care~* Integrated, combined lifestyle approach (SENSS), including continuous monitoring by lifestyle coach.
No_intervention: Control
Control group receiving:~* Intake with lifestyle coach~* Usual care
Related Therapeutic Areas
Sponsors
Leads: Radboud University Medical Center

This content was sourced from clinicaltrials.gov