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

Marlena van Munster^{1

2

3}, Johanne Stümpel^{1

4}, Anna J Pedrosa¹, Kati Niemand¹, Ingmar Wellach⁵, Dirk Becker⁵, Isabel Doblinger⁵, Kristina Schmidt⁵, René Reiners⁶, Daniel Wolferts⁶, Anika Martin⁶, Marius Nisslmüller⁶, Keywan Sohrabi⁷, Volker Groß⁸, Birgit Samans⁸, Patrick Fischer⁸, Mohammed Osman Ashraf⁸, Rebecca Wichartz⁸, Marcin Grzegorzek⁹, Xinyu Huang^{9

10}, Artur Piet^{9

10}, Mona Irsfeld⁹, Christian Trense⁹, Paulina M Olgemöller¹¹, Ümran Seven¹¹, Ann-Kristin Folkerts¹¹, Elke Kalbe¹¹, Hannes Böbinger¹², Jens Dapper¹³, Lars Wohlfahrt¹⁴, Max Geraedts¹⁵, Natalie Altschuck¹⁵, Linda Kerkemeyer¹⁶, Carsten Eggers^{1

17}, David J Pedrosa^{1

18}

Affiliations

¹ Department of Neurology, Philipps-Universität Marburg, Marburg, Germany.
² Department of International Health, CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.
³ Institute for General Practice, Working Group Health Policy and Systems Research and Innovation, Charité Universitätsmedizin Berlin, Berlin, Germany.
⁴ Center for Life Ethics, University of Bonn, Bonn, Germany.
⁵ Praxis für Neurologie und Psychiatrie Hamburg Walddörfer, Hamburg, Germany.
⁶ Fraunhofer Institute for Applied Information Technology FIT, Sankt Augustin, Germany.
⁷ Faculty of Medicine, Institute of Medical Informatics, Justus Liebig University Giessen, Giessen, Germany.
⁸ Faculty of Health Sciences, University of Applied Sciences, Giessen, Germany.
⁹ Institute for Medical Informatics, University of Lübeck, Lübeck, Germany.
¹⁰ Department of Knowledge Engineering, University of Economics in Katowice, Katowice, Poland.
¹¹ Faculty of Medicine and University Hospital Cologne, Medical Psychology / Neuropsychology and Gender Studies, University of Cologne, Köln, Germany.
¹² Innovationsfonds & Produktportfolio, Techniker Krankenkasse, Hamburg, Germany.
¹³ AWO Stadtkreis Giessen e.V, Giessen, Germany.
¹⁴ AWO Stadtkreis Hamburg e.V, Hamburg, Germany.
¹⁵ Institute for Health Services Research and Clinical Epidemiology, Philipps-Universität Marburg, Marburg, Germany.
¹⁶ LiKe Healthcare Research GmbH, Berlin, Germany.
¹⁷ Department of Neurology, Knappschaftskrankenhaus Bottrop GmbH, Bottrop, Germany.
¹⁸ Center for Mind, Brain and Behaviour (CMBB), Marburg, Germany.

PMID: 40697406
PMCID: PMC12281329
DOI: 10.1136/bmjph-2024-002265

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

Marlena van Munster et al. BMJ Public Health. 2025.

. 2025 Jul 21;3(2):e002265.

doi: 10.1136/bmjph-2024-002265. eCollection 2025.

Authors

Affiliations

¹ Department of Neurology, Philipps-Universität Marburg, Marburg, Germany.
² Department of International Health, CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.
³ Institute for General Practice, Working Group Health Policy and Systems Research and Innovation, Charité Universitätsmedizin Berlin, Berlin, Germany.
⁴ Center for Life Ethics, University of Bonn, Bonn, Germany.
⁵ Praxis für Neurologie und Psychiatrie Hamburg Walddörfer, Hamburg, Germany.
⁶ Fraunhofer Institute for Applied Information Technology FIT, Sankt Augustin, Germany.
⁷ Faculty of Medicine, Institute of Medical Informatics, Justus Liebig University Giessen, Giessen, Germany.
⁸ Faculty of Health Sciences, University of Applied Sciences, Giessen, Germany.
⁹ Institute for Medical Informatics, University of Lübeck, Lübeck, Germany.
¹⁰ Department of Knowledge Engineering, University of Economics in Katowice, Katowice, Poland.
¹¹ Faculty of Medicine and University Hospital Cologne, Medical Psychology / Neuropsychology and Gender Studies, University of Cologne, Köln, Germany.
¹² Innovationsfonds & Produktportfolio, Techniker Krankenkasse, Hamburg, Germany.
¹³ AWO Stadtkreis Giessen e.V, Giessen, Germany.
¹⁴ AWO Stadtkreis Hamburg e.V, Hamburg, Germany.
¹⁵ Institute for Health Services Research and Clinical Epidemiology, Philipps-Universität Marburg, Marburg, Germany.
¹⁶ LiKe Healthcare Research GmbH, Berlin, Germany.
¹⁷ Department of Neurology, Knappschaftskrankenhaus Bottrop GmbH, Bottrop, Germany.
¹⁸ Center for Mind, Brain and Behaviour (CMBB), Marburg, Germany.

PMID: 40697406
PMCID: PMC12281329
DOI: 10.1136/bmjph-2024-002265

Abstract

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.

Keywords: Data Collection; Public Health; economics.

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Conflict of interest statement

MvM, JS, AJP, KN, IW, AM, MN, PF, MOA, AP, MI, CT, PMO, ÜS and NA are funded via the ParkProReakt project. IW, DB, KSc, ID, RR, KSo, VG, BS, MGR, XH, HB, JD, LW, MGE and LK declare no competing interests. EK has received grants from the German Ministry of Education and Research, the General Joint Committee Germany, the German Parkinson Society and STADAPHARM GmbH, as well as honoraria from AbbVie GmbH Germany, memodio GmbH Germany, and licence fees from Prolog GmbH Germany, all outside the submitted work. IW has received honoraria as a speaker at symposia sponsored by STADAPHARM GmbH, Esteve Pharmaceuticals GmbH, Bial Germany GmbH, Fagron GmbH & Co. KG, Zambon GmbH, Bayer HealthCare AG, Nutrichem Diät + Pharma GmbH and AbbVie Inc. He received payments as a consultant for Bial Germany GmbH, Fagron GmbH & Co. KG and Nutrichem Diät + Pharma GmbH. He was reimbursed travel expenses by Esteve Pharmaceuticals GmbH for attending a congress in 2023. A-KF has received grants from the German Parkinson Society, the German Alzheimer’s Society, the German Parkinson Foundation, STADAPHARM GmbH, and the General Joint Committee Germany, as well as honoraria from Springer Medizin Verlag GmbH, Springer-Verlag GmbH, ProLog Wissen GmbH, Seminar- und Fortbildungszentrum Rheine, LOGOMANIA, LOGUAN, dbs e.V., STADAPHARM GmbH, NEUROPSY, Multiple Sclerosis Society Vienna and the Gossweiler Foundation. A-KF is the author of the cognitive intervention series 'NEUROvitalis' but receives no corresponding honoraria. CE received honoraria in the last 12 months for consultation or as a speaker from AbbVie Inc, STADAPHARM Inc, Bial Inc and Bristol-Myers Squibb Inc. DJP has received honoraria as a speaker at symposia sponsored by Boston Scientific Corp, Medtronic, AbbVie Inc, Zambon, and Esteve Pharmaceuticals GmbH. He received payments as a consultant for Boston Scientific Corp and Bayer, and a scientific grant from Boston Scientific Corp for a project titled Sensor-based optimisation of Deep Brain Stimulation settings in Parkinson's disease (COMPARE-DBS). Finally, DJP was reimbursed by Esteve Pharmaceuticals GmbH and Boston Scientific Corp for travel expenses to attend congresses.

Figures

Figure 1. Outline of ParkProReakt (icons: Flaticon.com): at the heart of the complex intervention is the data integration centre, which is the key communication tool with patients and caregivers. Depending on the data collected via the app or wearables, different escalation levels of care are derived for the individual patient, which are delivered by a telenurse, a community nursing service, a Parkinson’s nurse and/or a neurologist. The care provider platform enables patient monitoring, multidisciplinary exchange and therapy planning.

See this image and copyright information in PMC

References

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

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