An Integrated and Personalized Lifestyle Approach for People With Parkinson's Disease
SENSS
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
1 other identifier
interventional
256
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable parkinson-disease
Started Nov 2024
Typical duration for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2024
CompletedFirst Posted
Study publicly available on registry
November 1, 2024
CompletedStudy Start
First participant enrolled
November 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
April 1, 2026
March 1, 2026
2.3 years
October 29, 2024
March 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in quality of life measured with the PDQ-39.
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.
Measured at baseline, and after 6 and 12 months.
Secondary Outcomes (16)
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.
- +11 more secondary outcomes
Other Outcomes (4)
Healthcare costs
At 6 and 12 months.
Intervention costs
During the intervention (from baseline until 12 months).
Process Evaluation
After completion of the 12 months intervention.
- +1 more other outcomes
Study Arms (2)
Intervention
EXPERIMENTALIntervention group receiving: * Intake with lifestyle coach * Usual Care * Integrated, combined lifestyle approach (SENSS), including continuous monitoring by lifestyle coach.
Control
NO INTERVENTIONControl group receiving: * Intake with lifestyle coach * Usual care
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radboud University Medical Center
Nijmegen, Netherlands
Related Publications (1)
Gaveel TJ, Postma EM, Bloem BR, Darweesh SKL, Munneke M, Overbeek K, Helmich R, Zeevat F, Zijlstra M, Boersma C, Overeem S, Pijpers A, Jakimowicz C, van Gilst MM, Speckens AEM, The R, Manhoudt G, van der Wel A, Duits AA, de Vries NM. The SENSS (Stress, Exercise, Nutrition, Sleep, Self-management) study: study protocol for a randomized controlled trial to evaluate an integrated, personalized and stepped care lifestyle approach for people with Parkinson's disease. Front Neurol. 2026 Mar 3;17:1752073. doi: 10.3389/fneur.2026.1752073. eCollection 2026.
PMID: 41853177DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2024
First Posted
November 1, 2024
Study Start
November 12, 2024
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
April 1, 2026
Record last verified: 2026-03