Department of Community Medicine and Rehabilitation, Umeå University, Neuro-Head-Hals-Centrum, University Hospital of Umeå, Umeå, 901 87, Sweden.
Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.
Trials. 2023 Oct 6;24(1):650. doi: 10.1186/s13063-023-07673-7.
Stroke is a leading cause of disability among adults worldwide. A timely structured follow-up tool to identify patients' rehabilitation needs and develop patient-tailored rehabilitation regimens to decrease disability is largely lacking in current stroke care. The overall purpose of this study is to evaluate the effectiveness of a novel digital follow-up tool, Rehabkompassen®, among persons discharged from acute care settings after a stroke.
This multicentre, parallel, open-label, two-arm pragmatic randomized controlled trial with an allocation ratio of 1:1 will be conducted in Sweden. A total of 1106 adult stroke patients will have follow-up visits in usual care settings at 3 and 12 months after stroke onset. At the 3-month follow-up, participants will have a usual outpatient visit without (control group, n = 553) or with (intervention group, n = 553) the Rehabkompassen® tool. All participants will receive the intervention at the 12-month follow-up visit. Feedback from the end-users (patient and health care practitioners) will be collected after the visits. The primary outcomes will be the patients' independence and social participation at the 12-month visits. Secondary outcomes will include end-users' satisfaction, barriers and facilitators for adopting the instrument, other stroke impacts, health-related quality of life and the cost-effectiveness of the instrument, calculated by incremental cost per quality-adjusted life year (QALY).
The outcomes of this trial will inform clinical practice and health care policy on the role of the Rehabkompassen® digital follow-up tool in the post-acute continuum of care after stroke.
ClinicalTrials.gov NCT04915027. Registered on 4 June 2021. ISRCTN registry ISRCTN63166587. Registered on 21 August 2023.
脑卒中是全球成年人致残的主要原因。目前，在脑卒中护理中，迫切需要一种及时的结构化随访工具，以确定患者的康复需求，并制定针对患者的康复方案，以减少残疾。本研究的总体目的是评估一种新型数字随访工具——康复手册（Rehabkompassen®）在急性护理后出院的脑卒中患者中的有效性。
这是一项在瑞典进行的多中心、平行、开放标签、双臂实用随机对照试验，分配比例为 1:1。共有 1106 名成年脑卒中患者将在脑卒中发病后 3 个月和 12 个月在常规护理环境中进行随访。在 3 个月随访时，参与者将进行常规门诊就诊，其中（对照组，n=553）或不（干预组，n=553）使用康复手册工具。所有参与者将在 12 个月随访时接受干预。在就诊后将收集终端用户（患者和医疗保健从业者）的反馈。主要结局将是患者在 12 个月随访时的独立性和社会参与度。次要结局将包括终端用户的满意度、采用该工具的障碍和促进因素、其他脑卒中影响、健康相关生活质量以及该工具的成本效益，通过增量成本每质量调整生命年（QALY）计算。
该试验的结果将为临床实践和医疗保健政策提供信息，了解康复手册数字随访工具在脑卒中后急性护理连续体中的作用。
ClinicalTrials.gov NCT04915027。于 2021 年 6 月 4 日注册。ISRCTN 注册表 ISRCTN63166587。于 2023 年 8 月 21 日注册。
