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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 256
- Locations
- 1
- Primary Endpoint
- Change in quality of life measured with the PDQ-39.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Intervention
Intervention group receiving:
- Intake with lifestyle coach
- Usual Care
- Integrated, combined lifestyle approach (SENSS), including continuous monitoring by lifestyle coach.
Intervention: Personalized and combined lifestyle approach (Behavioral)
Control
Control group receiving:
- Intake with lifestyle coach
- Usual care
Outcomes
Primary Outcomes
Change in quality of life measured with the PDQ-39.
Time Frame: Measured at baseline, and after 6 and 12 months.
The PDQ-39 consists of 39 questions across 8 dimensions of daily living including relationships, social situations and communication. Item scores range on a 5-point scale from "never" to "always". Both the total score of the PDQ-39 and the scores for each of the 8 dimensions are considered primary outcomes.
Secondary Outcomes
- Health related quality of life(Measured at baseline, and after 6 and 12 months.)
- Parkinson's Disease Symptoms(Measured at baseline, and after 6 and 12 months.)
- Fatigue(Measured at baseline, and after 6 and 12 months.)
- Goal Attainment(Measured at baseline, and after 6 and 12 months.)
- Diet quality(Measured at baseline, and after 6 and 12 months.)
- Mood (Anxiety and Depression)(Measured at baseline, and after 6 and 12 months.)
- Physical activity level(Measured at baseline, and after 6 and 12 months.)
- Insomnia(Measured at baseline, and after 6 and 12 months.)
- Sleepiness(Measured at baseline, and after 6 and 12 months.)
- Self-Efficacy(Measured at baseline, and after 6 and 12 months.)
- Ilness Acceptance(Measured at baseline, and after 6 and 12 months.)
- Coping(At baseline.)
- Self-management(Measured at baseline, and after 6 and 12 months.)
- Change in physical activity from baseline to 12 months(Measured one week at baseline and one week after 12 months.)
- Change in sleep time from baseline to 12 months(Measured one week at baseline and one week after 12 months.)
- Change in sleep quality from baseline to 12 months(Measured one week at baseline and one week after 12 months.)