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

Xiaolei Hu; Per Liv; Erik Lundström; Fredrik Norström; Olof Lindahl; Kristian Borg; Katharina S Sunnerhagen

doi:10.1186/s13063-023-07673-7

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

Trials. 2023 Oct 6;24(1):650. doi: 10.1186/s13063-023-07673-7.

Authors

Xiaolei Hu¹, Per Liv², Erik Lundström³, Fredrik Norström⁴, Olof Lindahl⁵, Kristian Borg⁶, Katharina S Sunnerhagen⁷

Affiliations

¹ Department of Community Medicine and Rehabilitation, Umeå University, Neuro-Head-Hals-Centrum, University Hospital of Umeå, Umeå, 901 87, Sweden. xiaolei.hu@umu.se.
² Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.
³ Department of Medical Sciences, Neurology, Uppsala University, Akademiska Sjukhuset, Uppsala, Sweden.
⁴ Department of Epidemiology and Global Health, Umeå University, Umeå, Sweden.
⁵ Department of Radiation Sciences, Radiation Physics, Biomedical Engineering, Umeå University, Umeå, Sweden.
⁶ Division of Rehabilitation Medicine, Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital, Stockholm, Sweden.
⁷ Department of Neuroscience and Physiology, Gothenburg University, Sahlgrenska University Hospital, Gothenburg, Sweden.

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.

Keywords: Cost-effectiveness; Daily activity; Digital tool; Effectiveness; Health economy; Precision medicine; Social participation; Stroke rehabilitation; Structured follow-up; ePROM.

Publication types

Clinical Trial Protocol

MeSH terms

Adult
Cost-Benefit Analysis
Follow-Up Studies
Humans
Multicenter Studies as Topic
Patients
Pragmatic Clinical Trials as Topic
Quality of Life
Social Participation
Stroke Rehabilitation*
Stroke* / diagnosis
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT04915027

Abstract

Publication types

MeSH terms

Associated data

Grants and funding