{
  "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.",
  "authors": [
    {
      "affiliations": [
        "Department of Neurology, Philipps-Universität Marburg, Marburg, Germany",
        "Department of International Health, CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands",
        "Institute for General Practice, Working Group Health Policy and Systems Research and Innovation, Charité Universitätsmedizin Berlin, Berlin, Germany"
      ],
      "name": "Marlena van Munster"
    },
    {
      "affiliations": [
        "Department of Neurology, Philipps-Universität Marburg, Marburg, Germany",
        "Center for Life Ethics, University of Bonn, Bonn, Germany"
      ],
      "name": "Johanne Stümpel"
    },
    {
      "affiliations": [
        "Department of Neurology, Philipps-Universität Marburg, Marburg, Germany"
      ],
      "name": "Anna J Pedrosa"
    },
    {
      "affiliations": [
        "Department of Neurology, Philipps-Universität Marburg, Marburg, Germany"
      ],
      "name": "Kati Niemand"
    },
    {
      "affiliations": [
        "Praxis für Neurologie und Psychiatrie Hamburg Walddörfer, Hamburg, Germany"
      ],
      "name": "Ingmar Wellach"
    },
    {
      "affiliations": [
        "Praxis für Neurologie und Psychiatrie Hamburg Walddörfer, Hamburg, Germany"
      ],
      "name": "Dirk Becker"
    },
    {
      "affiliations": [
        "Praxis für Neurologie und Psychiatrie Hamburg Walddörfer, Hamburg, Germany"
      ],
      "name": "Isabel Doblinger"
    },
    {
      "affiliations": [
        "Praxis für Neurologie und Psychiatrie Hamburg Walddörfer, Hamburg, Germany"
      ],
      "name": "Kristina Schmidt"
    },
    {
      "affiliations": [
        "Fraunhofer Institute for Applied Information Technology FIT, Sankt Augustin, Germany"
      ],
      "name": "René Reiners"
    },
    {
      "affiliations": [
        "Fraunhofer Institute for Applied Information Technology FIT, Sankt Augustin, Germany"
      ],
      "name": "Daniel Wolferts"
    },
    {
      "affiliations": [
        "Fraunhofer Institute for Applied Information Technology FIT, Sankt Augustin, Germany"
      ],
      "name": "Anika Martin"
    },
    {
      "affiliations": [
        "Fraunhofer Institute for Applied Information Technology FIT, Sankt Augustin, Germany"
      ],
      "name": "Marius Nisslmüller"
    },
    {
      "affiliations": [
        "Faculty of Medicine, Institute of Medical Informatics, Justus Liebig University Giessen, Giessen, Germany"
      ],
      "name": "Keywan Sohrabi"
    },
    {
      "affiliations": [
        "Faculty of Health Sciences, University of Applied Sciences, Giessen, Germany"
      ],
      "name": "Volker Groß"
    },
    {
      "affiliations": [
        "Faculty of Health Sciences, University of Applied Sciences, Giessen, Germany"
      ],
      "name": "Birgit Samans"
    },
    {
      "affiliations": [
        "Faculty of Health Sciences, University of Applied Sciences, Giessen, Germany"
      ],
      "name": "Patrick Fischer"
    },
    {
      "affiliations": [
        "Faculty of Health Sciences, University of Applied Sciences, Giessen, Germany"
      ],
      "name": "Mohammed Osman Ashraf"
    },
    {
      "affiliations": [
        "Faculty of Health Sciences, University of Applied Sciences, Giessen, Germany"
      ],
      "name": "Rebecca Wichartz"
    },
    {
      "affiliations": [
        "Institute for Medical Informatics, University of Lübeck, Lübeck, Germany"
      ],
      "name": "Marcin Grzegorzek"
    },
    {
      "affiliations": [
        "Institute for Medical Informatics, University of Lübeck, Lübeck, Germany",
        "Department of Knowledge Engineering, University of Economics in Katowice, Katowice, Poland"
      ],
      "name": "Xinyu Huang"
    },
    {
      "affiliations": [
        "Institute for Medical Informatics, University of Lübeck, Lübeck, Germany",
        "Department of Knowledge Engineering, University of Economics in Katowice, Katowice, Poland"
      ],
      "name": "Artur Piet"
    },
    {
      "affiliations": [
        "Institute for Medical Informatics, University of Lübeck, Lübeck, Germany"
      ],
      "name": "Mona Irsfeld"
    },
    {
      "affiliations": [
        "Institute for Medical Informatics, University of Lübeck, Lübeck, Germany"
      ],
      "name": "Christian Trense"
    },
    {
      "affiliations": [
        "Faculty of Medicine and University Hospital Cologne, Medical Psychology / Neuropsychology and Gender Studies, University of Cologne, Köln, Germany"
      ],
      "name": "Paulina M Olgemöller"
    },
    {
      "affiliations": [
        "Faculty of Medicine and University Hospital Cologne, Medical Psychology / Neuropsychology and Gender Studies, University of Cologne, Köln, Germany"
      ],
      "name": "Ümran Seven"
    },
    {
      "affiliations": [
        "Faculty of Medicine and University Hospital Cologne, Medical Psychology / Neuropsychology and Gender Studies, University of Cologne, Köln, Germany"
      ],
      "name": "Ann-Kristin Folkerts"
    },
    {
      "affiliations": [
        "Faculty of Medicine and University Hospital Cologne, Medical Psychology / Neuropsychology and Gender Studies, University of Cologne, Köln, Germany"
      ],
      "name": "Elke Kalbe"
    },
    {
      "affiliations": [
        "Innovationsfonds & Produktportfolio, Techniker Krankenkasse, Hamburg, Germany"
      ],
      "name": "Hannes Böbinger"
    },
    {
      "affiliations": [
        "AWO Stadtkreis Giessen e.V, Giessen, Germany"
      ],
      "name": "Jens Dapper"
    },
    {
      "affiliations": [
        "AWO Stadtkreis Hamburg e.V, Hamburg, Germany"
      ],
      "name": "Lars Wohlfahrt"
    },
    {
      "affiliations": [
        "Institute for Health Services Research and Clinical Epidemiology, Philipps-Universität Marburg, Marburg, Germany"
      ],
      "name": "Max Geraedts"
    },
    {
      "affiliations": [
        "Institute for Health Services Research and Clinical Epidemiology, Philipps-Universität Marburg, Marburg, Germany"
      ],
      "name": "Natalie Altschuck"
    },
    {
      "affiliations": [
        "LiKe Healthcare Research GmbH, Berlin, Germany"
      ],
      "name": "Linda Kerkemeyer"
    },
    {
      "affiliations": [
        "Department of Neurology, Philipps-Universität Marburg, Marburg, Germany",
        "Department of Neurology, Knappschaftskrankenhaus Bottrop GmbH, Bottrop, Germany"
      ],
      "name": "Carsten Eggers"
    },
    {
      "affiliations": [
        "Department of Neurology, Philipps-Universität Marburg, Marburg, Germany",
        "Center for Mind, Brain and Behaviour (CMBB), Marburg, Germany"
      ],
      "name": "David J Pedrosa"
    }
  ],
  "title": "ParkProReakt—evaluation of a proactive approach to healthcare in Parkinson’s disease: a study protocol for a randomised controlled trial",
  "uid": "7ff9f825-0872-5eda-a53d-39c650940dc5"
}