Altschuck Natalie, van Munster Marlena, Stümpel Johanne, Pedrosa David Jose, Wellach Ingmar, Boebinger Hannes, Geraedts Max
Institute for Health Services Research and Clinical Epidemiology, Philipps University Marburg, Marburg, Germany.
Department of Health Sciences, Fulda University of Applied Sciences, Fulda, Germany.
BMJ Neurol Open. 2024 Dec 25;6(2):e000966. doi: 10.1136/bmjno-2024-000966. eCollection 2024.
People with Parkinson's disease (PwPD) experience a wide range of motor and non-motor symptoms that have a significant impact on their health and quality of life. Effective care management for PwPD involves monitoring symptoms at home, involving specialised multidisciplinary care providers and enhancing self-management skills. This study protocol describes the process evaluation within a randomised clinical trial to assess the implementation and its impact on patient health outcomes of ParkProReakt-a proactive, multidisciplinary, digitally supported care model for community-dwelling PwPD.
The hybrid efficacy-implementation study will assess key implementation outcomes using the Medical Research Council framework for complex interventions alongside a randomised controlled trial. A combination of quantitative and qualitative methods will be used to assess process data from care providers and patients. The main process outcomes are fidelity, dose, feasibility and context. Context will be analysed through semistructured interviews and focus groups using the Consolidated Framework of Implementation Research. To elucidate potential facilitators and barriers to implementation and to gain deeper insights into the efficacy outcome data, quantitative and qualitative process data will be integrated at an interpretative level using mixed methods. In addition to process evaluation, potential indirect mechanisms of impact will be measured.
Ethical approval for this study was obtained from the responsible state medical ethics committees in Hesse and Hamburg, Germany. Results will be communicated to the funding body and disseminated through scientific publications.
This study was registered with the German Registry for Clinical Studies (DRKS)-number: DRKS00031092.
帕金森病患者（PwPD）会经历多种运动和非运动症状，这些症状对他们的健康和生活质量有重大影响。对PwPD进行有效的护理管理包括在家中监测症状、让专业的多学科护理人员参与以及提高自我管理技能。本研究方案描述了一项随机临床试验中的过程评估，以评估ParkProReakt（一种针对社区居住的PwPD的主动、多学科、数字支持的护理模式）的实施情况及其对患者健康结果的影响。
这项混合疗效-实施研究将使用医学研究理事会针对复杂干预措施的框架以及一项随机对照试验来评估关键的实施结果。将结合定量和定性方法来评估来自护理人员和患者的过程数据。主要的过程结果包括保真度、剂量、可行性和背景。将通过半结构化访谈和焦点小组，使用实施研究综合框架来分析背景。为了阐明实施的潜在促进因素和障碍，并更深入地了解疗效结果数据，将在解释层面使用混合方法整合定量和定性的过程数据。除了过程评估外，还将测量潜在的间接影响机制。
本研究已获得德国黑森州和汉堡负责的州医学伦理委员会的伦理批准。研究结果将通报给资助机构，并通过科学出版物进行传播。
本研究已在德国临床研究注册中心（DRKS）注册，注册号：DRKS00031092。
