An Integrated and Personalized Lifestyle Approach for People with Parkinson's Disease (SENSS)

Radboud University Medical Center

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Behavioral: Personalized and combined lifestyle approach

Study type: Interventional

Funder types: Other

Identifiers

NCT06669455

115891

Details and patient eligibility

About

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.

Enrollment: 256 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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256 participants in 2 patient groups

Intervention

Experimental group

Description:

Intervention group receiving: * Intake with lifestyle coach * Usual Care * Integrated, combined lifestyle approach (SENSS), including continuous monitoring by lifestyle coach.

Treatment:

Behavioral: Personalized and combined lifestyle approach

Control

No Intervention group

Description:

Control group receiving: * Intake with lifestyle coach * Usual care