van der Wardt Veronika, Seipp Hannah, Becker Annette, Maulbecker-Armstrong Catharina, Kraicker Rebecca, Schneider Annika, Heitz Andreas, Seifart Ulf
Department of General Practice/Family Medicine, Philipps-University of Marburg, Karl-von-Frisch-Straße 4, 35032, Marburg, Germany.
Faculty of Health Sciences, University of Applied Sciences Central Hesse (Technische Hochschule Mittelhessen), Wiesenstraße 14, 35390, Giessen, Germany.
Pilot Feasibility Stud. 2021 Dec 21;7(1):221. doi: 10.1186/s40814-021-00957-2.
Long-term disability to work is a risk factor for a permanent reduction in income. Rehabilitation care can support people to return to work. In Germany, rehabilitation care to return to work is mostly provided in specialised clinics. The aim of the Rehapro-SERVE study is to reduce work disability days by facilitating rehabilitation care planning using a digital communication platform. To investigate the feasibility, we will test the implementation of the digital platform and evaluate the study procedures. The Rehapro-SERVE study is funded by the German Federal Ministry of Labour and Social Affairs (BMAS) (grant number: 661R0053K1).
The feasibility study includes a two-armed unblinded block randomised controlled study (RCT) without follow-up assessments as well as an interview study. Participants for the RCT (n = 16) are primary care patients with a minimum of 4 weeks of absence from work due to musculoskeletal, oncological or psychological conditions and at high risk of early retirement. Eligibility criteria are age 40 to 60 years; minimum of 4 weeks continuous sick leave before recruitment due to musculoskeletal, mental health or oncological conditions; and being at high risk of early retirement. Patients will be recruited from 8 primary care practices in urban and rural areas in Hesse, Germany. Following baseline assessments, patients will be randomised to either digitalised care planning (treatment) or a control group. The digitalised care planning platform will include the patients' primary care physicians, jobcentres and public health physicians to decide on a tailored return-to-work programme. The collaboration will be supported by a case administrator and, if considered beneficial, a social worker for the patient. An interview study will evaluate the acceptability of the study procedures and the intervention.
The use of a digital communication platform enables stakeholders to exchange information and discuss rehabilitation care planning in a timely fashion. The results of the feasibility study will lead to the adaptation of study procedures for the main study. The results will support the design and conduct of similar studies including digital applications in primary care or across different healthcare settings.
DRKS - German Clinical Trials Register, DRKS00024207 . Registered on 22 March 2021.
长期无法工作是导致收入永久性减少的一个风险因素。康复护理有助于人们重返工作岗位。在德国,帮助人们重返工作岗位的康复护理大多在专门诊所提供。Rehapro-SERVE研究的目的是通过使用数字通信平台促进康复护理规划,减少无法工作的天数。为了调查可行性,我们将测试数字平台的实施情况并评估研究程序。Rehapro-SERVE研究由德国联邦劳动和社会事务部(BMAS)资助(资助编号:661R0053K1)。
可行性研究包括一项双臂非盲区组随机对照试验(RCT),不进行随访评估,以及一项访谈研究。RCT的参与者(n = 16)是因肌肉骨骼、肿瘤或心理疾病而至少连续4周无法工作且有提前退休高风险的初级保健患者。纳入标准为年龄40至60岁;招募前因肌肉骨骼、心理健康或肿瘤疾病连续病假至少4周;有提前退休的高风险。患者将从德国黑森州城乡地区的8家初级保健机构招募。在进行基线评估后,患者将被随机分为数字化护理规划组(治疗组)或对照组。数字化护理规划平台将包括患者的初级保健医生、就业中心和公共卫生医生,以确定量身定制的重返工作计划。这种合作将得到一名病例管理员的支持,如果认为有必要,还会为患者配备一名社会工作者。一项访谈研究将评估研究程序和干预措施的可接受性。
使用数字通信平台能使利益相关者及时交流信息并讨论康复护理规划。可行性研究的结果将促使对主要研究的程序进行调整。这些结果将为包括初级保健或不同医疗环境中的数字应用在内的类似研究的设计和开展提供支持。
DRKS - 德国临床试验注册中心,DRKS00024207。于2021年3月22日注册。