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Study protocol for a randomized, controlled, multicentre, pragmatic trial with Rehabkompassen®: a digital structured follow-up tool for facilitating patient-tailored rehabilitation in persons after stroke
Umeå University, Faculty of Medicine, Department of Community Medicine and Rehabilitation.ORCID iD: 0000-0001-9864-7432
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine.
Department of Medical Sciences, Neurology, Uppsala University, Akademiska Sjukhuset, Uppsala, Sweden.
Umeå University, Faculty of Medicine, Department of Epidemiology and Global Health.ORCID iD: 0000-0002-0457-2175
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2023 (English)In: Trials, E-ISSN 1745-6215, Vol. 24, no 1, article id 650Article in journal (Refereed) Published
Abstract [en]

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 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.

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).

Discussion: 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.

Trial registration: ClinicalTrials.gov NCT04915027. Registered on 4 June 2021. ISRCTN registry ISRCTN63166587. Registered on 21 August 2023.

Place, publisher, year, edition, pages
BioMed Central (BMC), 2023. Vol. 24, no 1, article id 650
Keywords [en]
Cost-effectiveness, Daily activity, Digital tool, Effectiveness, ePROM, Health economy, Precision medicine, Social participation, Stroke rehabilitation, Structured follow-up
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Identifiers
URN: urn:nbn:se:umu:diva-215396DOI: 10.1186/s13063-023-07673-7PubMedID: 37803460Scopus ID: 2-s2.0-85173330866OAI: oai:DiVA.org:umu-215396DiVA, id: diva2:1807392
Funder
Swedish Research Council, 2022–00316Swedish Research Council, 2022– 00746Forte, Swedish Research Council for Health, Working Life and Welfare, 2020–00136Swedish Heart Lung Foundation, 2020676Västerbotten County Council, 2022–967513Vinnova, 2019–01389The Swedish Stroke AssociationAvailable from: 2023-10-26 Created: 2023-10-26 Last updated: 2024-01-17Bibliographically approved

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Hu, Xiao-LeiLiv, PerNorström, FredrikLindahl, Olof A

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Department of Community Medicine and RehabilitationDepartment of Public Health and Clinical MedicineDepartment of Epidemiology and Global HealthRadiation Physics
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