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

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ClinicalTrials.gov Identifier: NCT04915027
Recruitment Status : Recruiting
First Posted : June 7, 2021
Last Update Posted : June 7, 2021
Sponsor:
Collaborators:
Västerbotten County Council
Göteborg University
Vastra Gotaland Region
Karolinska Institutet
Region Stockholm
Uppsala University
Uppsala County Council, Sweden
Strokeförbundet
Forte
The Swedish Heart and Lung Association
Information provided by (Responsible Party):
Umeå University

Brief Summary:

Stroke is a leading cause of disability with various long-term impairments, restrictions in social participation and decreased quality of life among adults worldwide. The new Swedish stroke guidelines has recently recommended that structured follow-up should be provided to all patients with stroke. It results in enormous financial and personnel demands on the already time- and resource-constrained healthcare. To meet these challenges, a novel digital graphic follow-up tool, Rehabkompassen® has been developed.

The Rehabkompassen® is based on a number of well validated and reliable patient-reported outcome measurements (PROMs) that provides an easy-to-understand and comprehensive picture of the stroke patient's multidimensional problems in real-time. With the instrument, the patient responds to PROMs questionnaires at home via Health Care Guide 1177.se before the clinical visit. Healthcare professionals can thereafter smoothly interpret responses graphically in the out-patient clinic. The tool can be used as decision support for initial triage before the clinical visit and/or as a communication platform during the clinical visit and/or during the patient's transfer between different care levels.

The overall aims of the study are to determine whether Rehabkompassen® with a usual out-patient visit, in comparison with a usual out-patient visit alone, improves daily and social activities and quality of life for patients discharged from hospital after stroke, and is cost-effective.

The study starts with a pilot to evaluate the feasibility of the study. The single-center pilot study with allocation ratio 1:1 will be carried out during years 2020-2021 in University Hospital of Umeå. The main study is a multicenter randomized controlled trial that will be carried out under 2021-2026. All patient participants (n =1024) will be randomized according to permuted block design. At 3-month out-patient visit, participants will have a usual out-patient visit without (Control group, n = 512) or with (Intervention group, n = 512) Rehabkompassen®. The effectiveness of the tool on daily and social activities, quality of life and its health-economic effects will be compared at 12-month out-patient visit post stroke.

The hypothesis of the study is that a digital tool, Rehabkompassen®, in combination with the usual out-patient visit will provide a patient-tailored rehabilitation that improve recovery, independence, and quality of life among people with stroke in a cost-effective way.


Condition or disease Intervention/treatment Phase
Stroke Other: a usual follow-up with Rehabkompassen® Other: a usual follow-up with Post-Stroke Checklist, i.e. without Rehabkompassen® Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1024 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rehabkompassen® - a Digital Tool for Facilitating Patient-tailored Rehabilitation in the Post-acute Continuum of Care After Stroke - A Multicenter Pragmatic Randomized Controlled Trial
Actual Study Start Date : August 26, 2020
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Arm Intervention/treatment
Experimental: Intervention i.e. with Rehabkompassen®
The participants will use the digital graphic Rehabkompassen® at the out-patient follow-up.
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.

Active Comparator: Control exposure i.e. without Rehabkompassen®
The participants will use Post-Stroke Checklist at the out-patient follow-up as recommended by "Socialstyrelsen".
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.




Primary Outcome Measures :
  1. Daily activities [ Time Frame: 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).

  2. Social activities [ Time Frame: 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.


Secondary Outcome Measures :
  1. Health-related quality of life [ Time Frame: 12 months follow-up after stroke ]
    Health-related quality of life will be measured by five-level EuroQoL 5-dimension (EQ- 5D-5L) at both follow-ups in all participants. EQ-5D is a validated instrument that has often been used in RCTs. It consists of two parts: a visual analogue scale and a descriptive system covering five dimensions of health (mobility, hygiene, usual activities, pain/discomfort, and anxiety/depression) with five response alternatives (ranging from no problems to extreme problems). The latter can be translated to index value with anchor points 0 (death) and 1 (full health), which corresponds to a QALY score.

  2. Stroke impacts [ Time Frame: 12 months follow-up after stroke ]
    Stroke impacts will be assessed by the Stroke Impact Scale 3.0 (SIS) except the participation domain. SIS is a patient-reported, stroke-specific, outcome measurement containing 59 questions with eight domains, namely strength, memory/ cognition, feelings/ emotions, communication, personal activities of daily living (ADL), instrumental ADL, mobility, and motor impact. Each question is answered using the Likert scale ranging from 1 to 5 with higher scores indicating better outcomes. Also, the SIS includes a visual analogue scale where 0 represents no perceived stroke recovery and 100 represents full recovery.

  3. Health-economic evaluation [ Time Frame: 12 months follow-up after stroke ]
    The cost-effectiveness will be assessed in term of the quality-adjusted life year (QALY), that will be calculated by the utilities multiplying the time spent in each health state.

  4. Clinicians' usability [ Time Frame: 3 months follow-up after stroke ]
    System usability scale consists of a 10-item questionnaire with five response options for respondents from strongly agree to strongly disagree.

  5. Clinicians' experience and feedback [ Time Frame: 3 months follow-up after stroke ]
    Clinicians' satisfaction questionnaire consists of a 17-item questionnaire concerning their experiences of using the Rehabkompassen®. Each question is answered using the Likert scale ranging from 1 to 5 with higher scores indicating better outcomes.

  6. Patients' experiences and feedback [ Time Frame: 3 months follow-up after stroke ]
    Patient satisfaction questionnaire consists of a 15-item questionnaire concerning patients' experiences of using the Rehabkompassen®. Each question is answered using the Likert scale ranging from 1 to 5 with higher scores indicating better outcomes.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria are

  • Male and female aged > 18 years;
  • A stroke at least 3 months before the fist study visit
  • Discharged from hospital and
  • Living in the community.

Exclusion criteria are

  • Unable to answer the evaluation questions because of language barrier, grave aphasia, cognitive impairment or unstable medical condition
  • Unable to see the picture of the Rehabkompassen® due to blindness / severe visual impairment
  • Patients not having the BankID (a Swedish digital identification solution).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04915027


Contacts
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Contact: Xiaolei Hu, MD PhD +46 90 785 00 00 xiaolei.hu@umu.se

Locations
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Sweden
Umeå University Hospital Recruiting
Umeå, Sweden, 90737
Contact: Xiaolei Hu, MD PhD         
Sponsors and Collaborators
Umeå University
Västerbotten County Council
Göteborg University
Vastra Gotaland Region
Karolinska Institutet
Region Stockholm
Uppsala University
Uppsala County Council, Sweden
Strokeförbundet
Forte
The Swedish Heart and Lung Association
Investigators
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Principal Investigator: Xiaolei Hu, MD PhD Umeå University
Publications:

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Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT04915027    
Other Study ID Numbers: Rehabkompassen®
First Posted: June 7, 2021    Key Record Dates
Last Update Posted: June 7, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Umeå University:
Stroke rehabilitation
Patient-tailored rehabilitation
Improvement of daily and social activity
Quality of life
Health economy
Pragmatic randomized clinical trial
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases