Rehabkompassen® – A digital structured follow-up tool for facilitating patient-tailored rehabilitation in persons after stroke
| ISRCTN | ISRCTN63166587 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63166587 |
| ClinicalTrials.gov number | NCT04915027 |
| Secondary identifying numbers | Swedish research consul (2022-00316 and 2022-00746) |
- Submission date
- 18/08/2023
- Registration date
- 21/08/2023
- Last edited
- 10/10/2023
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Stroke is a leading cause of disability among adults worldwide. A timely structured follow-up tool to identify patients’ rehabilitation needs and develop patient-tailored rehabilitation regimens to decrease disability is largely lacking in current stroke care. The overall purposes of this study are to evaluate the effectiveness of a novel digital follow-up tool, Rehabkompassen®, among persons discharged from acute care settings after stroke.
Who can participate?
Adults aged 18 years or older, within the first 4 months after stroke
What does the study involve?
The intervention will consist of the usage of digital tool Rehabkompassen® (intervention) or a paper-version Post-stroke Check list (control) and usual in- or outpatient visits within 3 months after stroke onset. A treatment plan will then be generated and performed as the clinical rutine. All participants will use Rehabkompassen as a structured follow-up tool at the 12-month visit.
What are the possible benefits and risks of participating?
Benefits: 1. improving their function, activity and/or quality of life; 2. gaining greater influence over their individualized rehabilitation; 3. being able to follow their symptom changes over time and 4. being able to complete surveys in peace and quiet at home before a clinical visit.
Risks: The physical risk of participating in this study is extremely low. Some transient fatigue may be experienced when answering questionnaires. To avoid fatigue, it is possible to pause between the questionnaires and to continue later. No long-term risks are envisaged.
Where is the study run from?
University Hospital of Umeå (Sweden)
When is the study starting and how long is it expected to run for?
April 2021 to December 2026
Who is funding the study?
1. Swedish research consul (2022-00316 and 2022-00746)
2. Forte (2020-00136)
3. Västerbotten County Council and Umeå University (ALF Foundation, 2021-967513)
4. The Heart-Lung Foundation (2020676)
5. VINNOVA Medtech4Health (2019-01389)
6. The Swedish Stroke Foundation (Strokeförbundet)
Who is the main contact?
Dr Xiao Lei Hu, xiaolei.hu@umu.se
Contact information
Principal Investigator
Neuro-Rehabilitation
University Hospital of Umeå
Umeå
907 37
Sweden
 ORCID ID |
0000-0001-9864-7432 |
|---|---|
| Phone | +46 90 785 0000 |
| xiaolei.hu@umu.se |
Study information
| Study design | Parallel open-label two-arm prospective multicentre pragmatic randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Hospital |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A randomized, controlled, multicentre, pragmatic trial with Rehabkompassen® – A digital structured follow-up tool for facilitating patient-tailored rehabilitation in persons after stroke |
| Study objectives | The incorporation of the digital Rehabkompassen® tool in usual care within 3 months after stroke onset will improve daily and social activities for patients at the 12-month follow-up after stroke onset compared to those receiving usual care with the Post-Stroke Checklist (PSC). |
| Ethics approval(s) |
Approved 26/04/2021, Swedish Ethical Review Authority (Etikprövningsmyndigheten Box 2110, Uppsala, 750 02, Sweden; +46 010 475 08 00; registrator@etikprovning.se), ref: Dnr 2021-01880 |
| Health condition(s) or problem(s) studied | Stroke |
| Intervention | Rehabkompassen® is a novel digital graphic follow-up tool to embrace the heterogeneity of rehabilitation needs among stroke patients in real time based on 6 well-validated and reliable patient-reported outcome measures. This multicentre, parallel, open-label, two-arm pragmatic randomized controlled trial with an allocation ratio of 1:1 will be conducted in Sweden. Adult stroke patients will have follow-up visits in usual care settings at 3 and 12 months after stroke onset. At the 3-month follow-up, participants will have a usual outpatient visit without (control group) or with (intervention group) the Rehabkompassen® tool. All participants will receive the intervention at the 12-month follow-up visit. Feedback from the end-users (patient and health care practitioners) will be collected after the visits. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Rehabkompassen® |
| Primary outcome measure | 1. Daily activity measured using the smRSq at the 3- and 12-month visits 2. Social participation measured using Domain 8 of the SIS (SIS-D8) at the 3- and 12-month visits |
| Secondary outcome measures | Measured at the 3- and 12-month visits: 1. End-users’ satisfaction measured using a patient satisfaction questionnaire 2. Barriers and facilitators for adopting the instrument measured using a bespoke questionnaire 3. Other stroke impacts measured using Stroke Impact Scale (SIS) 4. Health-related quality of life measured using EQ-5D-5L 5. The cost-effectiveness of the instrument measured using resource utilization data |
| Overall study start date | 26/04/2021 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | Both |
| Target number of participants | 940 |
| Total final enrolment | 1106 |
| Key inclusion criteria | 1. Adults aged 18 years or older. 2. Time since stroke onset: Individuals must be within the first 4 months after stroke, starting from Day 1 after the occurrence of the stroke. 3. Patients discharged from acute care settings |
| Key exclusion criteria | 1. Unable to answer the evaluation questions 2. Unable to see the Rehabkompassen®graph 3. Not using BankID, an e-identification tool commonly used in Sweden |
| Date of first enrolment | 31/01/2022 |
| Date of final enrolment | 31/12/2025 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Umeå
907 37
Sweden
Umeå
907 37
Sweden
Västerås
721 89
Sweden
Uppsala
751 85
Sweden
Göteborg
421 37
Sweden
Karlstad
65185
Sweden
Sudsvall
851 86
Sweden
Nyköping
611 85
Sweden
Sponsor information
Hospital/treatment centre
Neuro-Rehabilitation
University Hospital of Umeå
Umeå
907 37
Sweden
| Phone | +46 90 785 00 00 |
|---|---|
| regionen@regionvasterbotten.se | |
| Website | https://www.regionvasterbotten.se/vara-sjukhus/norrlands-universitetssjukhus |
Funders
Funder type
Research council
No information available
No information available
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 30/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Published as a supplement to the results publication |
| Publication and dissemination plan | Upon completion of the trial, investigators will report results, regardless of the direction or magnitude of the effect, through peer-reviewed journal articles, scientific presentations, patient education websites, public media and ClinicalTrials.gov. We endeavour to facilitate knowledge transfer and exchange among different stakeholders. |
| IPD sharing plan | The study protocol, including statistical analyses, will be available in conjunction with the scientific publication. Upon study completion, anonymized data will also be available to the scientific community at large through publications. Moreover, any party may apply to the Chief Investigator for access to the full protocol, deidentified participant-level data, and the statistical code for academic research purposes by a study collaboration request. The steering committee will govern data access. xiaolei.hu@umu.se |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 06/10/2023 | 10/10/2023 | Yes | No |
Editorial Notes
10/10/2023: Publication reference added.
21/08/2023: Trial's existence confirmed by Vetenskapsradet.
