Rehabkompassen® - a Novel Digital Tool for Facilitating Patient-tailored Rehabilitation in the Post-acute Continuum of Care After Stroke - A Multicenter Pragmatic Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Stroke is a leading cause of disability and with a heavy burden for the society. Despite the demands from 'Socialstyrelsen' of improving post-acute care, an effective structured follow-up to promote a patient-tailored rehabilitation remains largely lacking in the current stroke care. The overall aim of this study is to find a cost-effective solution to facilitate patient-tailored rehabilitation that improves daily and social activities and health-related quality of life for persons discharged from the acute care after stroke. We have recently developed a novel digital graphic tool, Rehabkompassen®, which based on patient-reported outcome measurements captures the patient's complex health status after stroke. Here, this tool will be used in a parallel, open-label, 2-arm prospective and multicenter pragmatic randomized controlled trial between 2022-2026. All participants (n = 1106) will be randomized according to permuted block design; and receive a usual care without (control group, n = 553) or with (intervention group, n = 553) Rehabkompassen®, within 3-month after stroke. The effectiveness of the tool on daily and social activities, quality of life and its health-economic effects will be compared at 12-month follow-up post stroke. We hypothesize that the digital tool Rehabkompassen® will provide a patient-tailored rehabilitation that improves recovery, independence, and quality of life among people with stroke in a cost-effective way.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults aged 18 years or older.

• With a stroke diagnosis

⁃ Time since stroke onset:

⁃ 3a) For the big RCT group, Individuals must be within the first 4 months after stroke, starting from Day 1 after the occurrence of the stroke.

⁃ 3b) For primary care group, Individuals 3 months after stroke

Locations
Other Locations
Sweden
Umeå University Hospital
RECRUITING
Umeå
Contact Information
Primary
Xiaolei Hu, MD PhD
xiaolei.hu@umu.se
+46 90 785 00 00
Time Frame
Start Date: 2020-08-26
Estimated Completion Date: 2027-12
Participants
Target number of participants: 1106
Treatments
Experimental: Intervention i.e. with Rehabkompassen®
The participants will use the digital graphic Rehabkompassen® at follow-up.
Active_comparator: Control exposure i.e. without Rehabkompassen®
The participants will use Post-Stroke Checklist at follow-up as recommended by Socialstyrelsen.
Related Therapeutic Areas
Sponsors
Leads: Umeå University
Collaborators: Karolinska Institutet, Sormland County Council, Sweden, Värmland County Council, Sweden, Region Skane, Västerbotten County Council, Sweden, Vastra Gotaland Region, Swedish Heart Lung Foundation, Strokeförbundet, The Swedish Research Council, Vinnova, Västmanland County Council, Sweden, Uppsala County Council, Sweden, Uppsala University, Region Stockholm, Göteborg University, Forte: Swedish research council for health, working life and welfare

This content was sourced from clinicaltrials.gov