ParkProReakt—evaluation of a proactive approach to healthcare in Parkinson’s disease: a study protocol for a randomised controlled trial

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Introduction: The complexity of Parkinson's disease (PD) symptoms and the necessity for individualised, multidisciplinary and digital health technology-based care are widely acknowledged; however, access to specialist care remains limited, particularly in rural areas. Current healthcare systems are frequently ill-equipped to deliver timely, personalised interventions. In response to these challenges, the ParkProReakt project aims to enhance PD care through a proactive, technology-enabled, multidisciplinary approach designed to improve patient health-related quality of life (HRQoL) and alleviate caregiver burden. Methods and analysis: A randomised controlled trial will assess the efficacy and cost-effectiveness of ParkProReakt-a proactive, multidisciplinary, digitally supported care model for community-dwelling people with Parkinson's disease (PwPD)-compared with standard care. We will recruit a total of 292 PwPD and their informal caregivers living in two diverse regions in Germany. The primary outcome measure will be patients' HRQoL as measured by the Parkinson's Disease Questionnaire, obtained at baseline, monthly and at completion of participation. Secondary outcomes comprise patients' subjective well-being, incidence or change of long-term care needs, global cognition and disease progression, utilisation of healthcare services, including hospitalisations, caregiver burden and healthcare costs. Statistical analysis will include t-tests for HRQoL changes, general linear model for confounders and multilevel models for centre effects. Secondary outcomes and cost-effectiveness (incremental cost-effectiveness ratio) will be analysed similarly using R and SPSS. Ethics and dissemination: The study protocol has been approved by the Ethics Committees of the Medical Associations of Hesse and Hamburg. The results of our study will be reported to the funding body and disseminated through scientific publications and presentations at national and international conferences. Trial registration number: This study was registered with the German Registry for Clinical Studies (DRKS) in both German and English; number: DRKS00031092.

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