Ireland
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Recruiting Not applicable

Rehabkompassen® - a Patient-centered Digital Follow-up Tool in the Post-stroke Continuum of Care

NCT04915027 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2020-08-26
Last updated
2025-07-09

Condition(s) studied

Stroke

Investigational drug(s) / intervention(s)

a usual follow-up with Rehabkompassen®a usual follow-up with Post-Stroke Checklist, i.e. without Rehabkompassen®

a usual follow-up with Rehabkompassen®: Rehabkompassen® is a patient-centered digital graphic tool for capturing the patient's rehabilitation needs in the follow-up after stroke.

a usual follow-up with Post-Stroke Checklist, i.e. without Rehabkompassen®: Post-Stroke Checklist consists of eleven questions concerning common and treatable post-stroke problems affecting quality of life.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria are 1. Adults aged 18 years or older. 2. 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 Exclusion criteria are 1. Unable to answer the evaluation questions. 2. Unable to see the Rehabkompassen®graph. 3. Not using BankID, an e-identification tool commonly used in Sweden.

Primary outcome measure(s)

  • Daily activities — 12 months follow-up after stroke
    The simplified modified Rankin Scale questionnaire (smRSq) will be used to measure daily activities and functional status. The smRSq is based on the yes/no responses to five questions, which in turn results an ordinal data of seven categories (0-6) of the modified Rankin Scale. A favorable outcome will be defined as mRS score of 0-2 (no symptoms to independent but with minor disability). A poor outcome will be defined as mRS score of 3-5 (disability but able to walk to bed-bound and in need of full nursing care) or 6 (death).
  • Social activities — 12 months follow-up after stroke
    Stroke Impact Scale 3.0 (SIS)-participation (SIS-p) will be used to measure social activities. SIS-p is the dominant problem among persons after stroke reported in previous Swedish stroke RCTs; but not covered by smRSq. The SIS-p score ranges from 0-100 and the higher the score the less impact of stroke.

Trial sites (1)

FacilityCityRegionStatus
Umeå University Hospital Umeå Sweden Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04915027 on ClinicalTrials.gov ↗ ← All trials in Sweden