Achtert Katharina, Huchtemann Tessa, Altendorf Maria, Kerkemeyer Linda, Haring Malte, Lummer Carina, Frenz Lena, Becking Theresa, Friedmann Jonas, Mildner Philip, Schwarze Katharina, Steinhaus Lars, Amelung Volker, Warnecke Tobias
Institute for Applied Health Services Research (inav GmbH), Schiffbauerdamm 12, 10117, Berlin, Germany.
Department of Neurology, University of Münster, Albert-Schweitzer-Campus 1, 48149, Münster, Germany.
Neurol Res Pract. 2023 Jun 1;5(1):23. doi: 10.1186/s42466-023-00249-5.
Patients with Parkinson's Disease (PD) require an all-encompassing and individualized care including pharmacological as well as non-pharmacological treatment approaches, such as physical therapy, occupational therapy and speech and swallowing therapy. ParkinsonAKTIV is an innovative, multidisciplinary, and comprehensive approach to guide this non-pharmacological PD treatment in northwestern Germany. Its online communication platform called JamesAKTIV has been developed to enhance and standardize PD healthcare professionals' communication. The implementation of ParkinsonAKTIV and JamesAKTIV is accompanied through a detailed process evaluation and to gather evidence on the impact on patient-related outcomes, such as health-related quality of life and healthcare costs for people with PD through an effectiveness evaluation.
The study design contains two parts: (1) first, a quantitative effectiveness evaluation is conducted utilizing a prospective quasi-experimental approach with a control group which examines PD patient's health-related quality of life and physician-assessed PD patient's health status (Unified Parkinson Disease Rating Scale). Moreover, a health economic evaluation of the ParkinsonAKTIV intervention is conducted using patient-reported outcomes and cost data as well as routine data from a statutory health insurance. (2) Second, a mixed-methods process evaluation among healthcare professionals, which examines the feasibility and potential barriers and facilitators of ParkinsonAKTIV for routine care, is performed. Quantitative results from a social network analysis and a survey among healthcare professionals will be triangulated with data from qualitative stakeholder interviews and focus group discussions.
Findings are expected to provide evidence of an increase in quality of life of patients with PD, less severe PD symptoms, and a better ability to participate in activities of daily living. ParkinsonAKTIV has the potential of increasing PD patients' quality of care through sufficient and more tailored prescription of non-pharmacological therapies. It is anticipated that ParkinsonAKTIV will improve communication among health professionals. Results from the ParkinsonAKTIV study will provide first practice-oriented evidence and a roadmap for implementation of an online tool for a comprehensive, multidisciplinary care PD network for patients and their caregivers in routine care in Germany. Trial registration ClinicalTrials.gov: registration number NCT05251298 (retrospectively registered: https://clinicaltrials.gov/ct2/show/record/NCT05251298 ).
帕金森病（PD）患者需要全面且个性化的护理，包括药物治疗以及非药物治疗方法，如物理治疗、职业治疗和言语吞咽治疗。ParkinsonAKTIV是德国西北部指导这种帕金森病非药物治疗的一种创新、多学科且全面的方法。其名为JamesAKTIV的在线交流平台已开发出来，以加强和规范帕金森病医护专业人员的沟通。ParkinsonAKTIV和JamesAKTIV的实施伴随着详细的过程评估，并通过有效性评估收集关于对患者相关结局影响的证据，如帕金森病患者的健康相关生活质量和医疗费用。
该研究设计包含两个部分：（1）首先，采用前瞻性准实验方法并设立对照组进行定量有效性评估，该评估考察帕金森病患者的健康相关生活质量以及医生评估的帕金森病患者健康状况（统一帕金森病评定量表）。此外，利用患者报告结局、成本数据以及法定健康保险的常规数据对ParkinsonAKTIV干预措施进行健康经济评估。（2）其次，对医护专业人员进行混合方法过程评估，考察ParkinsonAKTIV用于常规护理的可行性以及潜在障碍和促进因素。来自社交网络分析和医护专业人员调查的定量结果将与来自定性利益相关者访谈和焦点小组讨论的数据相结合。
研究结果有望为帕金森病患者生活质量提高、帕金森病症状减轻以及参与日常生活活动能力增强提供证据。ParkinsonAKTIV有潜力通过充分且更具针对性地开具非药物治疗处方来提高帕金森病患者的护理质量。预计ParkinsonAKTIV将改善医护专业人员之间的沟通。ParkinsonAKTIV研究的结果将为德国常规护理中为患者及其护理人员建立全面、多学科护理帕金森病网络的在线工具的实施提供首个以实践为导向的证据和路线图。试验注册ClinicalTrials.gov：注册号NCT05251298（追溯注册：https://clinicaltrials.gov/ct2/show/record/NCT05251298 ）
