Research project A randomized, controlled, multicentre, pragmatic trial with Rehabkompassen® – A digital structured follow-up tool for facilitating patient-tailored rehabilitation in persons after stroke
The purpose of the planned project is to develop and evaluate a functional prototype of Rehabkompassen ™ with both stroke patients and healthcare professionals throughout the stroke care system (hospital, primary care and community) in the Northern Region by a randomized controlled multicenter study.
Background: 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 purposes of this study are to evaluate the effectiveness of a novel digital follow-up tool, Rehabkompassen®, among persons discharged from acute care settings after stroke.
Methods: 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).
Significances: 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 postacute continuum of care after stroke.
Trial registration: ClinicalTrials.gov Identifier: NCT04915027, Registered on 4 June 2021. ISRCTN registry with study registration number ISRCTN63166587, Registered on 21 August 2023.
Home page: https://rehabkompassen.se
