Abstract

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.

Details

Title
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
Author
Hu, Xiaolei 1   VIAFID ORCID Logo  ; Liv, Per 2 ; Lundström, Erik 3 ; Norström, Fredrik 4 ; Lindahl, Olof 5 ; Borg, Kristian 6 ; Sunnerhagen, Katharina S. 7 

1  Umeå University, Neuro-Head-Hals-Centrum, University Hospital of Umeå, Department of Community Medicine and Rehabilitation, Umeå, Sweden (GRID:grid.412215.1) (ISNI:0000 0004 0623 991X) 
2  Umeå University, Department of Public Health and Clinical Medicine, Umeå, Sweden (GRID:grid.12650.30) (ISNI:0000 0001 1034 3451) 
3  Uppsala University, Department of Medical Sciences, Neurology, Uppsala, Sweden (GRID:grid.8993.b) (ISNI:0000 0004 1936 9457) 
4  Umeå University, Department of Epidemiology and Global Health, Umeå, Sweden (GRID:grid.12650.30) (ISNI:0000 0001 1034 3451) 
5  Umeå University, Department of Radiation Sciences, Radiation Physics, Biomedical Engineering, Umeå, Sweden (GRID:grid.12650.30) (ISNI:0000 0001 1034 3451) 
6  Karolinska Institutet Danderyd Hospital, Division of Rehabilitation Medicine, Department of Clinical Sciences, Stockholm, Sweden (GRID:grid.4714.6) (ISNI:0000 0004 1937 0626) 
7  Gothenburg University, Sahlgrenska University Hospital, Department of Neuroscience and Physiology, Gothenburg, Sweden (GRID:grid.8761.8) (ISNI:0000 0000 9919 9582) 
Pages
650
Publication year
2023
Publication date
Dec 2023
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-023-07673-7
ProQuest document ID
2873641487
Copyright
© The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.