Department of Primary Care, University of Marburg, Karl-Von-Frisch-Straße 4, Marburg, 35032, Germany.
Hospital Sonnenblick, German Pension Insurance, Amöneburger Straße 1-6, Marburg, 35043, Germany.
Trials. 2024 Oct 29;25(1):728. doi: 10.1186/s13063-024-08571-2.
Chronic diseases are a significant and growing problem of our time. They impair the ability to work and increase the risk of early retirement. To support the return to work, rehabilitation services can be applied for in Germany. Currently, the application system for rehabilitation allows only a limited degree of individualisation of the treatment and is associated with a lack of multidisciplinary communication. To facilitate rehabilitation care planning, we developed a complex intervention. A digital, platform-based case management approach (intervention) will ensure multidisciplinary communication and the tailored selection of medical treatments and/or non-medical support measures. The overall objective is to assess the effectiveness of the intervention compared to treatment as usual (control condition). The German Federal Ministry of Labour and Social Affairs (BMAS) funds the RehaPro-SERVE study (grant number: 661R0053K1).
This is the protocol for an investigator-initiated, pragmatic, multicentre, randomised and controlled two-arm parallel-group superiority trial with embedded qualitative process evaluation. The study will be conducted in Hesse state, Germany. N = 59 primary care physicians will be recruited and tasked with the recruitment of six eligible patients each.
age 40-60; minimum of 4-week work disability due to musculoskeletal, oncologic or psychological conditions or the post-COVID-19 syndrome within the last 6 months; at high risk for early retirement. In total, n = 352 patients will be randomised with a 1:1 allocation to intervention or control group and stratified by primary care practice using permuted blocks. The primary outcome is the number of days of sick leave during a 12-month period after the assumed completion of treatments (t1 to t2). Secondary outcomes include the number of days of sick leave (self-report), work ability, and health-related quality of life, as well as data from the qualitative process evaluation.
The results of the study will inform the design of future care services and provide valuable information on multidisciplinary case management in the context of rehabilitation care planning. The results of the qualitative process evaluation will further contribute to the understanding of facilitating and hindering factors.
DRKS-German Clinical Trials Register, DRKS0 00242 07. Registered on 22 March 2021.
慢性病是我们这个时代的一个重大且日益严重的问题。它们会损害工作能力并增加提前退休的风险。为了支持重返工作岗位，在德国可以申请康复服务。目前，康复申请系统只能在一定程度上实现治疗的个性化，并且缺乏多学科沟通。为了方便康复护理计划，我们开发了一种复杂的干预措施。一种数字化、基于平台的病例管理方法（干预措施）将确保多学科沟通以及医疗和/或非医疗支持措施的针对性选择。总体目标是评估干预措施与常规治疗（对照条件）相比的有效性。德国联邦劳工和社会事务部（BMAS）为 RehaPro-SERVE 研究提供资金（资助编号：661R0053K1）。
这是一项由研究人员发起的、实用的、多中心、随机对照、双臂平行组优势试验，嵌入定性过程评估。该研究将在德国黑森州进行。将招募 59 名初级保健医生，并要求每位医生招募 6 名符合条件的患者。
年龄 40-60 岁；过去 6 个月内，因肌肉骨骼、肿瘤或心理疾病或新冠后综合征导致至少 4 周的工作能力丧失；有提前退休的高风险。总共将招募 352 名患者，采用 1:1 随机分组，分为干预组和对照组，并按初级保健实践使用随机化块分层。主要结局是假设治疗结束后 12 个月内的病假天数（t1 至 t2）。次要结局包括病假天数（自我报告）、工作能力和健康相关生活质量，以及定性过程评估的数据。
该研究的结果将为未来护理服务的设计提供信息，并为康复护理计划背景下的多学科病例管理提供有价值的信息。定性过程评估的结果将进一步有助于了解促进和阻碍因素。
DRKS-German Clinical Trials Register，DRKS0 00242 07。于 2021 年 3 月 22 日注册。
