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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Intervention group receiving:
|
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| Control | No Intervention | Control group receiving:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized and combined lifestyle approach | Behavioral | 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'. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life | EuroQol 5D-5L (EQ-5D-5L); The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' and 'The worst health you can image'. |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare costs | Data on the used healthcare services used in the past 6 months will be collected with a questionnaire. The calculation uses tarrifs as determined for services for the healthcare in the Netherlands. | At 6 and 12 months. |
| Intervention costs |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Medical Center | Nijmegen | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41853177 | Derived | 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. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Measured at baseline, and after 6 and 12 months. |
| Parkinson's Disease Symptoms | The Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) part 1b and part 2. Questions are answered using a 0-4 likert scale ranging from 0 normal to 4 severe. | Measured at baseline, and after 6 and 12 months. |
| Fatigue | Fatigue Severity Scale (FSS); This questionnaire consists of nine questions, each rated on a 7-point scale from 1 (strongly disagree) to 7 (strongly agree). A higher score indicates greater fatigue or a more significant impact of fatigue on daily life. | Measured at baseline, and after 6 and 12 months. |
| Goal Attainment | The visual analogue scale (VAS) is used to evaluate the lifestyle goals that participants set at the start of the intervention. The VAS is a non-specific measurement tool where patients rate their experience of a given sensation on a scale from 0 to 10. | Measured at baseline, and after 6 and 12 months. |
| Diet quality | The Dutch Healthy Diet index 2015 (DHD15-index) consists of fifteen components representing the fifteen food-based Dutch dietary guidelines of 2015. Per component the score ranges between 0 and 10, resulting in a total score between 0 (no adherence) and 150 (complete adherence). | Measured at baseline, and after 6 and 12 months. |
| Mood (Anxiety and Depression) | The Hospital Anxiety and Depression Scale (HADS) measures symptoms of anxiety and depression using a 14-item self-report questionnaire, over the past four weeks. It consists of a 7-item anxiety subscale and a 7-item depression subscale. Higher scores on the HADS indicate more symptoms, with a total score range of 0-42. | Measured at baseline, and after 6 and 12 months. |
| Physical activity level | The LASA Physical Activity Questionnaire (LAPAQ) consists of 37 items designed to measure physical activities performed over the past week. The questionnaire assesses the frequency and duration of various physical activities. A higher score on the LAPAQ indicates a greater amount of time spent on physical activities. | Measured at baseline, and after 6 and 12 months. |
| Insomnia | The Insomnia Severity Index (ISI) consists of seven items that assess various aspects of insomnia. The questionnaire includes the insomnia severity, satisfaction with sleep and impact on daily functioning. Each item is rated on a five-point Likert scale from 0 (not at all) to 4 (extremely), based on the last two weeks. The total score ranges from 0 to 28, with higher scores indicating greater insomnia severity. | Measured at baseline, and after 6 and 12 months. |
| Sleepiness | The Epsworth Sleepiness Scale (ESS) is a questionnaire that measures daytime sleepiness by assessing the likelihood of dozing or sleeping in eight different situations on a scale from 0 (would never doze or sleep) to 3 (high chance of dozing or sleeping). The total score ranges from 0 to 24, with higher scores indicating greater sleepiness. | Measured at baseline, and after 6 and 12 months. |
| Self-Efficacy | The General Self-Efficacy Scale (GSES) is a 10-item questionnaire (total score range of 10-40) designed to measure a general sense of perceived self-efficacy. A higher score represents higher self-efficacy. | Measured at baseline, and after 6 and 12 months. |
| Ilness Acceptance | Acceptance of Disease and Impairments Questionnaire (ADIQ); The questionnaire contains 14 items with a 4-point Likert scale ranging from 1 (disagree) to 4 (entirely agree). | Measured at baseline, and after 6 and 12 months. |
| Coping | The ways of coping questionnaire (WCQ); Measures coping on eight dimensions. The questionnaire consists of 67 statements regarding coping in stressful situations. Participants have to score how much they think each statement applies to their situation on a 4-points Likert scale ranging from 0 ("does not apply and/or not used") to 3 ("used a great deal"). | At baseline. |
| Self-management | The Patient Activation Measure (PAM) is a 13-item survey that assesses an individual's self-reported knowledge, skills, and confidence in managing their health or chronic condition. Each item is rated on a 4-point Likert scale from "totally disagree" to "totally agree" or "non-applicable. | Measured at baseline, and after 6 and 12 months. |
| Change in physical activity from baseline to 12 months | Movement data captured with accelerometry data from a wrist worn wearable sensor (Empatica EmbracePlus). | Measured one week at baseline and one week after 12 months. |
| Change in sleep time from baseline to 12 months | Captured with accelerometry and photoplethysmogry data from a wrist worn wearable sensor (Empatica EmbracePlus). | Measured one week at baseline and one week after 12 months. |
| Change in sleep quality from baseline to 12 months | Captured with accelerometry and photoplethysmogry data from a wrist worn wearable sensor (Empatica EmbracePlus). | Measured one week at baseline and one week after 12 months. |
The costs of the intervention consists of the amount of guidance provided by the lifestyle coach and the facilities used within the intervention, such as usage of a digital tool or online training. In the monitoring sessions with the lifestyle coach participants are asked what facilities they used in the prior period. This is registered by the lifestyle coach for each participant.
| During the intervention (from baseline until 12 months). |
| Process Evaluation | In a process evaluation, caried out alongside the RCT, we aim to explore the experiences of participants and the lifestyle coaches with the SENSS approach. This process evaluation will take place through interviews with a selection of the participants and the lifestyle coaches. | After completion of the 12 months intervention. |
| Caregiver strain | If the participants have a caregiver that is willing to participate in the study they receive a questionnaire and some follow-up questions about their task as caregiver and working life. Care Giver Strain Index (CSI); consists of 13 yes/no questions about the perceived strain. A higher score represents more strain. The caregivers will receive some questions about the amount of care they give and if/how this affects their working life. The results of these questions will be used in the analysis on (socio)economic impact. | Measured at baseline, and after 6 and 12 months. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |