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

Study Protocol

Xiaolei Hu¹  Fredrik Norström²  Erik Lundström³  Katharina S. Sunnerhagen⁴  Per Liv⁵  Olof Lindahl⁶  Kristian Borg⁷ 

[1] Department of Community Medicine and Rehabilitation, Umeå University, Neuro-Head-Hals-Centrum, University Hospital of Umeå, 901 87, Umeå, Sweden;Department of Epidemiology and Global Health, Umeå University, Umeå, Sweden;Department of Medical Sciences, Neurology, Uppsala University, Akademiska Sjukhuset, Uppsala, Sweden;Department of Neuroscience and Physiology, Gothenburg University, Sahlgrenska University Hospital, Gothenburg, Sweden;Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden;Department of Radiation Sciences, Radiation Physics, Biomedical Engineering, Umeå University, Umeå, Sweden;Division of Rehabilitation Medicine, Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital, Stockholm, Sweden;

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

DOI  :  10.1186/s13063-023-07673-7

 received in 2023-08-11, accepted in 2023-09-25,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundStroke 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.MethodsThis 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).DiscussionThe 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 registrationClinicalTrials.gov NCT04915027. Registered on 4 June 2021. ISRCTN registry ISRCTN63166587. Registered on 21 August 2023.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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