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

Ties J. Gaveel^1*Elbrich M. Postma¹Bas Bloem¹Sirwan Darweesh¹Marten Munneke¹Karin Overbeek¹Rick Helmich¹Florian Zeevat^2,3Meine Zijlstra²Cornelis Boersma^2,3,4Sebastiaan Overeem^5,6Angelique Pijpers⁵Caroline Jakimowicz⁵Merel Van Gilst^5,6Anne Speckens⁷Regina Thé⁸Gert Manhoudt⁹Annemiek van der Wel⁹Annelien A. Duits^10,11,12Nienke M. de Vries¹³

• ¹Department of Neurology, Center of Expertise for Parkinson and Movement Disorders, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre, Nijmegen, Netherlands
• ²Health-Ecore, Zeist, Netherlands
• ³Department of Health Sciences, University Medical Center Groningen, Groningen, Netherlands
• ⁴Department of Management Sciences, Open University, Heerlen, Netherlands
• ⁵Sleep Medicine Center Kempenhaeghe, Heeze, Netherlands
• ⁶Biomedical Diagnostics Lab, dept of Electrical Engineering, Eindhoven University of Technology, Eindhoven, Netherlands
• ⁷Department of Psychiatry, Center of Expertise for Mindfulness, Donders Institute for Brain, Cognition and Behaviour, Radboud university medical center, Nijmegen, Netherlands
• ⁸Development and Implementation of Decision Aids, Zorgkeuzelab, Delft, Netherlands
• ⁹Patient Research Council, Dutch Parkinson Association, Utrecht, Netherlands
• ¹⁰School for Mental Health and Neuroscience, Faculty of Health, Medicine and Life Sciences, Department of Psychiatry and Neuropsychology, Maastricht University, Maastricht, Netherlands
• ¹¹Department of Medical Psychology, Maastricht University Medical Center, Maastricht, Netherlands
• ¹²Department of Medical Psychology, Radboud university medical center, Nijmegen, Netherlands
• ¹³University Medical Center Groningen, department of Human Movement Science, University of Groningen, Groningen, Netherlands

Background: Lifestyle interventions have potential to support people with Parkinson's disease (PD) in self-managing their disease and improving quality of life. Growing evidence suggests positive effects of singular lifestyle interventions, such as physical activity, stress or nutrition. However, several challenges remain. First, despite potential additive and perhaps even synergistic effects, research on combining lifestyle interventions is limited. Second, lifestyle interventions are not routinely addressed as part of standard medical care. Finally, there are significant challenges related to changing behavior and adherence to lifestyle interventions. This study aims to evaluate the effectiveness and cost-effectiveness of an integrated, personalized and stepped care lifestyle approach for people with PD. Methods: We will perform a 12-month single-blind randomized controlled trial. We aim to include 256 people with PD, randomized in a 1:1 ratio into a control and intervention group. Both groups receive a clinical assessment with a lifestyle coach and can partake in usual care. The intervention group receives an additional lifestyle intervention, consisting of guidance and interventions on different lifestyle domains: stress, exercise, nutrition, sleep and self-management (the SENSS approach). This intervention is offered remotely according to a stepped care model to personalize the intervention to the participants' needs and abilities. The primary endpoint is the between-group difference in quality of life at 12 months (Parkinson's Disease Questionnaire-39). Secondary endpoints include between-group differences in PD symptoms, health-related outcomes, self-management and personal goals. Cost-effectiveness and the experiences of participants and healthcare professionals will also be explored. Discussion: This study evaluates the effectiveness of an integrated personalized lifestyle intervention for people with PD on both clinical and socio-economic outcomes. We expect this intervention to improve quality of life and self-management of people with PD, without increasing healthcare costs. We also expect to offer valuable insights into how such an intervention can be integrated into current daily care for people with PD.