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

NCT04915027 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1106

Last updated 2025-07-09

No results posted yet for this 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.

Conditions

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • The Swedish Research Council

    collaborator OTHER_GOV
  • Forte: Swedish research council for health, working life and welfare

    collaborator UNKNOWN
  • Swedish Heart Lung Foundation

    collaborator OTHER
  • Vinnova

    collaborator OTHER_GOV
  • Strokeförbundet

    collaborator UNKNOWN
  • Västerbotten County Council, Sweden

    collaborator OTHER_GOV
  • Göteborg University

    collaborator OTHER
  • Vastra Gotaland Region

    collaborator OTHER_GOV
  • Uppsala University

    collaborator OTHER
  • Uppsala County Council, Sweden

    collaborator OTHER_GOV
  • Karolinska Institutet

    collaborator OTHER
  • Region Stockholm

    collaborator OTHER_GOV
  • Västmanland County Council, Sweden

    collaborator OTHER_GOV
  • Värmland County Council, Sweden

    collaborator OTHER_GOV
  • Sormland County Council, Sweden

    collaborator OTHER
  • Region Skane

    collaborator OTHER
  • Umeå University

    lead OTHER

Principal Investigators

  • Xiaolei Hu, MD PhD · Umeå University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-26
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04915027 on ClinicalTrials.gov