Stroke Clinical Trial
Official title:
Rehabkompassen® - a Novel Digital Tool for Facilitating Patient-tailored Rehabilitation in the Post-acute Continuum of Care After Stroke - A Multicenter Pragmatic Randomized Controlled 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.
Status | Recruiting |
Enrollment | 1106 |
Est. completion date | December 2026 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria are 1. Male and female aged 18 years or older; 2. Within 3 (day 1 until 4 months post stroke) months after stroke-onset 3. Discharged from the acute care settings Exclusion criteria are 1. Unable to answer the evaluation questions; 2. Unable to see the graph of the Rehabkompassen®; 3. without BankID. |
Country | Name | City | State |
---|---|---|---|
Sweden | Umeå University Hospital | Umeå |
Lead Sponsor | Collaborator |
---|---|
Umeå University | Forte: Swedish research council for health, working life and welfare, Göteborg University, Karolinska Institutet, Region Stockholm, Sormland County Council, Sweden, Strokeförbundet, Swedish Heart Lung Foundation, The Swedish Research Council, Uppsala County Council, Sweden, Uppsala University, Värmland County Council, Sweden, Västerbotten County Council, Sweden, Västernorrland County Council, Sweden, Västmanland County Council, Sweden, Vastra Gotaland Region, Vinnova |
Sweden,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Health-related quality of life | 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. | 12 months follow-up after stroke | |
Secondary | Stroke impacts | 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. | 12 months follow-up after stroke | |
Secondary | Health-economic evaluation | 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. | 12 months follow-up after stroke | |
Secondary | Clinicians' usability | System usability scale consists of a 10-item questionnaire with five response options for respondents from strongly agree to strongly disagree. | 3 months follow-up after stroke | |
Secondary | End-users' experiences and feedback | End-users' 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. | 3 months follow-up after stroke |
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