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PreprintCited by 4Stroke Rehabilitation and RecoveryMedical Practices and RehabilitationAcute Ischemic Stroke Management

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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

Open access
Hu, Xiaolei, Liv, Per, Lundström, Erik, Norström, Fredrik, Lindahl, Olof, Borg, Kristian, Sunnerhagen, Katharina S·2023·Trials
DOI 10.21203/rs.3.rs-3256871/v1PMC PMC10559468

Preprint — published as 10.1186/s13063-023-07673-7 · Paper page

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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 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). 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 postacute continuum of care after stroke. Trial registration ClinicalTrials.gov Identifier: NCT04915027, Registered on 4 June 2021.

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Metadata

Authors
Hu, X., Liv, P., Lundström, E., Norström, F., Lindahl, O., Borg, K., & Sunnerhagen, K. S.
Affiliations
  • University Hospital of Umeå (SE)
  • Umeå University (SE)
  • Uppsala University (SE)
  • Danderyds sjukhus (SE)
  • Sahlgrenska University Hospital (SE)
Corresponding author
Hu, Xiaolei
ORCID
Venue
Trials
Publisher
Springer Science and Business Media LLC
Published
2023-09-22
Volume
24
Issue
1
Pages
650-650
ISSN
1745-6215 (ISSN-L)
DOI
10.21203/rs.3.rs-3256871/v1
PMC
PMC10559468
OpenAlex
W4387399322
Cited by
4
References
41
Citations by year
2026: 2 · 2025: 2
FWCI
0.44
Type
journal article
Language
en
Open access
Licence
Locations
  • Trials (publishedVersion, cc-by)
  • Research Square (acceptedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Uppsala University Publications (Uppsala University) (submittedVersion, other-oa)
  • Diva portal (Dalarna University Library) (submittedVersion, other-oa)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
  • VINNOVA (2019-01389)
  • Västerbotten Läns Landsting (2021-967513)
  • Hjärt-Lungfonden (2020676)
  • Vetenskapsrådet (2022-00316, 2022-00746)
  • Umeå Universitet
  • Forskningsrådet om Hälsa, Arbetsliv och Välfärd (2020-00136)
Topics
  • Health Sciences › Medicine › Rehabilitation › Stroke Rehabilitation and Recovery
  • Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Medical Practices and Rehabilitation
  • Health Sciences › Medicine › Clinical Neurology › Acute Ischemic Stroke Management
Keywords
stroke, post-acute care, continuity of care, rehabilitation needs assessment, functional independence, social participation (health and rehabilitation), health-related quality of life, cost-effectiveness, user satisfaction, barriers and facilitators
MeSH terms
Stroke Rehabilitation, Adult, Cost-Benefit Analysis, Follow-Up Studies, Humans, Patients, Quality of Life, Multicenter Studies as Topic, Treatment Outcome, Stroke, Social Participation, Pragmatic Clinical Trials as Topic

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