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

ConditionStroke

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUmeå University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years or older.

With a stroke diagnosis

Disqualifiers

Unable to answer the evaluation questions.

Unable to see the Rehabkompassen®graph.

Not using BankID, an e-identification tool commonly used in Sweden.

Trial design

Design model

Parallel

Treatments tested in this trial

a usual follow-up with Rehabkompassen®
Other intervention
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®
Other intervention
Post-Stroke Checklist consists of eleven questions concerning common and treatable post-stroke problems affecting quality of life.

Treatment groups

1,106 Participants

are divided into 2 treatment groups

Group A: Intervention i.e. with Rehabkompassen®Experimental treatment 1 intervention

Group B: Control exposure i.e. without Rehabkompassen®Active comparator 1 intervention

Trial outcomes

Primary outcomes

Daily activities

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).

Time frame