Clinical trial NCT06669455: An Integrated and Personalized Lifestyle Approach for People with Parkinson's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Lifestyle
Personalized
Stepped Care
Quality of life
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in quality of life measured with the PDQ-39.
timeFrame: Measured at baseline, and after 6 and 12 months.
Secondary outcomes:
measure: Health related quality of life
timeFrame: Measured at baseline, and after 6 and 12 months.
measure: Parkinson's Disease Symptoms
timeFrame: Measured at baseline, and after 6 and 12 months.
measure: Fatigue
timeFrame: Measured at baseline, and after 6 and 12 months.
measure: Goal Attainment
timeFrame: Measured at baseline, and after 6 and 12 months.
measure: Diet quality
timeFrame: Measured at baseline, and after 6 and 12 months.
measure: Mood (Anxiety and Depression)
timeFrame: Measured at baseline, and after 6 and 12 months.
measure: Physical activity level
timeFrame: Measured at baseline, and after 6 and 12 months.
measure: Insomnia
timeFrame: Measured at baseline, and after 6 and 12 months.
measure: Sleepiness
timeFrame: Measured at baseline, and after 6 and 12 months.
measure: Self-Efficacy
timeFrame: Measured at baseline, and after 6 and 12 months.
measure: Ilness Acceptance
timeFrame: Measured at baseline, and after 6 and 12 months.
measure: Coping
timeFrame: At baseline.
measure: Self-management
timeFrame: Measured at baseline, and after 6 and 12 months.
measure: Change in physical activity from baseline to 12 months
timeFrame: Measured one week at baseline and one week after 12 months.
measure: Change in sleep time from baseline to 12 months
timeFrame: Measured one week at baseline and one week after 12 months.
measure: Change in sleep quality from baseline to 12 months
timeFrame: Measured one week at baseline and one week after 12 months.
Other outcomes:
measure: Healthcare costs
timeFrame: At 6 and 12 months.
measure: Intervention costs
timeFrame: During the intervention (from baseline until 12 months).
measure: Process Evaluation
timeFrame: After completion of the 12 months intervention.
measure: Caregiver strain
timeFrame: Measured at baseline, and after 6 and 12 months.
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
Study officials:
References: