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

NCT04915027 | Recruiting

• 1 other identifier: Rehabkompassen®
• Study Type: interventional
• Target: 1,106
• Locations: 1 country
• Sites: 1

Brief 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

Stroke

Keywords

Stroke rehabilitation; Patient-tailored rehabilitation; Improvement of daily and social activity; Quality of life; Health economy; Pragmatic randomized clinical trial

Outcome Measures

Primary Outcomes (2)

• 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).

  12 months follow-up after stroke

• Social activities

  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.

  12 months follow-up after stroke

Secondary Outcomes (5)

• Health-related quality of life

  12 months follow-up after stroke

• Stroke impacts

  12 months follow-up after stroke

• Health-economic evaluation

  12 months follow-up after stroke

• Clinicians' usability

  3 months follow-up after stroke

• End-users' experiences and feedback

  3 months follow-up after stroke

Study Arms (2)

Intervention i.e. with Rehabkompassen®

EXPERIMENTAL

The participants will use the digital graphic Rehabkompassen® at follow-up.

Other: a usual follow-up with Rehabkompassen®

Control exposure i.e. without Rehabkompassen®

ACTIVE COMPARATOR

The participants will use Post-Stroke Checklist at follow-up as recommended by "Socialstyrelsen".

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

Interventions

a usual follow-up with Rehabkompassen® OTHER

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

Intervention i.e. with Rehabkompassen®

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

Post-Stroke Checklist consists of eleven questions concerning common and treatable post-stroke problems affecting quality of life.

Control exposure i.e. without Rehabkompassen®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• With a stroke diagnosis
• Time since stroke onset:
• a) 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.
• b) For primary care group, Individuals 3 months after stroke

You may not qualify if:

• Unable to answer the evaluation questions.
• Unable to see the Rehabkompassen®graph.
• Not using BankID, an e-identification tool commonly used in Sweden.

Sponsors & Collaborators

• Umeå University: lead
• The Swedish Research Council: collaborator
• Forte: Swedish research council for health, working life and welfare: collaborator
• Swedish Heart Lung Foundation: collaborator
• Vinnova: collaborator
• Strokeförbundet: collaborator
• Västerbotten County Council, Sweden: collaborator
• Göteborg University: collaborator
• Vastra Gotaland Region: collaborator
• Uppsala University: collaborator
• Uppsala County Council, Sweden: collaborator
• Karolinska Institutet: collaborator
• Region Stockholm: collaborator
• Västmanland County Council, Sweden: collaborator
• Värmland County Council, Sweden: collaborator
• Sormland County Council, Sweden: collaborator
• Region Skane: collaborator

Study Sites (1)

Umeå University Hospital

Umeå, 90737, Sweden

RECRUITING

Related Publications (13)

• Hu X, Wester P, Stibrant Sunnerhaagen K. [Evidence-based methods in the clinical practice in updated Swedish national stroke guidelines]. Lakartidningen. 2018 Dec 17;115:FDIX. Swedish.

  PMID: 30561751 BACKGROUND

• Hudon C, Fortin M, Haggerty JL, Lambert M, Poitras ME. Measuring patients' perceptions of patient-centered care: a systematic review of tools for family medicine. Ann Fam Med. 2011 Mar-Apr;9(2):155-64. doi: 10.1370/afm.1226.

  PMID: 21403143 BACKGROUND

• Magaard G, Wester P, Levi R, Lindvall P, Gustafsson E, Nazemroaya Sedeh A, Lonnqvist M, Berggren S, Nyman K, Hu X. Identifying Unmet Rehabilitation Needs in Patients After Stroke With a Graphic Rehab-CompassTM. J Stroke Cerebrovasc Dis. 2018 Nov;27(11):3224-3235. doi: 10.1016/j.jstrokecerebrovasdis.2018.07.013. Epub 2018 Aug 8.

  PMID: 30097401 BACKGROUND

• Devlin NJ, Brooks R. EQ-5D and the EuroQol Group: Past, Present and Future. Appl Health Econ Health Policy. 2017 Apr;15(2):127-137. doi: 10.1007/s40258-017-0310-5.

  PMID: 28194657 BACKGROUND

• Copas AJ, Lewis JJ, Thompson JA, Davey C, Baio G, Hargreaves JR. Designing a stepped wedge trial: three main designs, carry-over effects and randomisation approaches. Trials. 2015 Aug 17;16:352. doi: 10.1186/s13063-015-0842-7.

  PMID: 26279154 BACKGROUND

• Hargreaves JR, Copas AJ, Beard E, Osrin D, Lewis JJ, Davey C, Thompson JA, Baio G, Fielding KL, Prost A. Five questions to consider before conducting a stepped wedge trial. Trials. 2015 Aug 17;16:350. doi: 10.1186/s13063-015-0841-8.

  PMID: 26279013 BACKGROUND

• EFFECTS Trial Collaboration. Safety and efficacy of fluoxetine on functional recovery after acute stroke (EFFECTS): a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2020 Aug;19(8):661-669. doi: 10.1016/S1474-4422(20)30219-2.

  PMID: 32702335 BACKGROUND

• White IR, Horton NJ, Carpenter J, Pocock SJ. Strategy for intention to treat analysis in randomised trials with missing outcome data. BMJ. 2011 Feb 7;342:d40. doi: 10.1136/bmj.d40.

  PMID: 21300711 BACKGROUND

• Optimising Analysis of Stroke Trials (OAST) Collaboration; Bath PM, Gray LJ, Collier T, Pocock S, Carpenter J. Can we improve the statistical analysis of stroke trials? Statistical reanalysis of functional outcomes in stroke trials. Stroke. 2007 Jun;38(6):1911-5. doi: 10.1161/STROKEAHA.106.474080. Epub 2007 Apr 26.

  PMID: 17463316 BACKGROUND

• Savitz SI, Lew R, Bluhmki E, Hacke W, Fisher M. Shift analysis versus dichotomization of the modified Rankin scale outcome scores in the NINDS and ECASS-II trials. Stroke. 2007 Dec;38(12):3205-12. doi: 10.1161/STROKEAHA.107.489351. Epub 2007 Nov 1.

  PMID: 17975102 BACKGROUND

• Hu X, Jonzen K, Karlsson M, Lindahl OA. Assessments of a novel digital follow-up tool Rehabkompassen(R) to identify rehabilitation needs among stroke patients in an outpatient setting. Digit Health. 2022 Jun 3;8:20552076221104662. doi: 10.1177/20552076221104662. eCollection 2022 Jan-Dec.

  PMID: 35677783 BACKGROUND

• Hu X, Jonzen K, Lindahl OA, Karlsson M, Norstrom F, Lundstrom E, Sunnerhagen KS. Digital Graphic Follow-up Tool (Rehabkompassen) for Identifying Rehabilitation Needs Among People After Stroke: Randomized Clinical Feasibility Study. JMIR Hum Factors. 2022 Jul 29;9(3):e38704. doi: 10.2196/38704.

  PMID: 35904867 BACKGROUND

• Hu X, Liv P, Lundstrom E, Norstrom F, Lindahl O, Borg K, Sunnerhagen KS. Study protocol for a randomized, controlled, multicentre, pragmatic trial with Rehabkompassen(R)-a digital structured follow-up tool for facilitating patient-tailored rehabilitation in persons after stroke. Trials. 2023 Oct 6;24(1):650. doi: 10.1186/s13063-023-07673-7.

  PMID: 37803460 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xiaolei Hu, MD PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaolei Hu, MD PhD

CONTACT

+46 90 785 00 00; xiaolei.hu@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pragmatic RCT with allocation ratio 1:1. The permuted block randomization with stratification at each clinic will be used, with random block sizes between 2-8 to ensure participants randomly assigned to intervention respectively control group. All study participants will be followed-up at two occations, at 3- and 12-months after stroke onset. The patients will be identified by participating outpatient clinics.

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: June 7, 2021
• Study Start: August 26, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 9, 2025

Record last verified: 2025-06

Locations

SE (1)