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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1024 participants|
|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)|
|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|
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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Xiaolei Hu, MD PhD||+46 90 785 00 firstname.lastname@example.org|
|Umeå University Hospital||Recruiting|
|Umeå, Sweden, 90737|
|Contact: Xiaolei Hu, MD PhD|
|Principal Investigator:||Xiaolei Hu, MD PhD||Umeå University|