Clinical trial NCT04915027: Rehabkompassen® - a Patient-centered Digital Follow-up Tool in the Post-stroke Continuum of Care
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke rehabilitation
Patient-tailored rehabilitation
Improvement of daily and social activity
Quality of life
Health economy
Pragmatic randomized clinical trial
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: Forte: Swedish research council for health, working life and welfare
name: Swedish Heart Lung Foundation
name: Vinnova
name: Strokeförbundet
name: Västerbotten County Council, Sweden
name: Göteborg University
name: Vastra Gotaland Region
name: Uppsala University
name: Uppsala County Council, Sweden
name: Karolinska Institutet
name: Region Stockholm
name: Västmanland County Council, Sweden
name: Västernorrland County Council, Sweden
name: Värmland County Council, Sweden
name: Sormland County Council, Sweden
First posted: 2021-06-07
Enrollment: 1106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Detailed description: Primary research question Q1-2 ( in corresponding to the outcomes 1-2). Does the usage of a digital Rehabkompassen® together with a usual care within 3-month follow-up, in comparison with a usual care with Post-stroke checklist (PSC), improve the patients' daily and social activities at 12-month after stroke?

Secondary research questions

In comparison with the control group (a usual care with PSC but without Rehabkompassen®), does the usage of an additional digital Rehabkompassen® within 3-month after stroke (the intervention):

Q3. improve the patients' health-related quality of life at 12-month after stroke? Q4. influence the secondary outcome measures at 12-month post stroke? Q5. demonstrate cost-effectiveness? Q6. further improve Rehabkompassen® based on feedbacks from the end-users (patients and health care professionals)? Q7. provide information that affect and/ or facilitate implementation of Rehabkompassen®?

Study design and patient selection.

In the pilot study

A total of 30 patients will be randomized 1:1 to the intervention group (a usual out-patient visit Rehabkompassen®) or the control group (a usual out-patient visit without Rehabkompassen®) with otherwise identical procedure as that described in the formal RCT below. The aim of the pilot study is to collect information on feasibility of the instrument, key metrics for the formal RCT; and to obtain preliminary efficacy data.

In the formal RCT

All patients who meet the selection criteria, together with the appointment for a usual out-patient follow-up or in the beginning of the inpatient care, receive an invitation to the study. Patients who give their consent are contacted via telephone or in-person by research staff at the local clinic in order to provide oral information about the study. All study participants will be followed-up at 3- and 12-months after stroke onset.

Patients in both control- and intervention groups then receive a message in their inbox at 1177.se. At home or in the inpatient care, patient-participants will be able to fill in the surveys concerning their health by clicking on the links in their e-mail inbox at 1177.se. In an out-patient setting, the questionnaires must be answered no later than one week before the visit. In the inpatient care, patient-participants need to answer the questionnaires in the beginning of the care. In order to facilitate the usage of the digital Rehabkompassen®, research staff will offer technical support via telephone or in-person.

Within 3-month follow-up (Control and Intervention)

A usual care consists of patient's history of disease taken, examination and rehabilitation treatment plan in either inpatient or outpatient settings.

Control group: a usual care + questionnaires

To collect the baseline data, the patient-participants in the control group will fill in only questionnaires of smRSq, SIS-D8 and EQ-5D-5L via 1177.se prior to a usual out-patient follow-up or in the beginning of the inpatient care. The Post-stroke Checklist (PSC) will be used together with the usual care.

Intervention group: a usual care + Rehabkompassen®

The patient-participants will fill in the Rehabkompassen® questionnaires 12. The Rehabkompassen® questionnaires consist of smRSq, SIS, EAT-10, FAS, HAD and EQ-5D-5L. The patient's own graphic Rehabkompassen® will be utilized at the usual care with otherwise identical procedures as the control group.

The replies from the questionnaires (control group) or Rehabkompassen® (intervention group) will be used by doctors / healthcare personnel before the usual in- or out-patient follow-up / team assessment as a basis for triage, and during the usual in- or out-patient follow-up / team assessment as a basis for assessing the patient's rehabilitation needs.

At 12-month follow-up

All participants from control- and intervention group will fill in the Rehabkompassen® questionnaires via 1177.se at home one week prior an out-patient visit. The patient's own graphic Rehabkompassen® will be utilized at the usual out-patient follow-up.

Post-acute continuum of care

In order to facilitate the patient's transfer between levels of care, regular referral meetings will be conducted with representatives from the clinics, primary care and the municipality (preliminary once / month) in the study with (Intervention) or without (control) Rehabkompassen® functions as a discussion platform for referring patients between caregivers.

Technical support and development

Technical support during the study will be carried out by our technical competencies within the research team. The feedback from the end-users (both patient and medical staff) at the 3-month follow-up and during the whole using process will be used to further develop and refine the tool by our technical competencies within the research team.

Study Design, Randomization and blinding

To evaluate the hypotheses in this proposed study, we have designed a parallel, open-label, 2-arm prospective multicenter pragmatic RCT with allocation ratio 1:1. We intend to use permuted block randomization with stratification at each clinic. We will use random block sizes between 2-8 to ensure participants randomly assigned to intervention respectively control group 15. The randomization list will be created centrally by REDCap, and handled by an investigator who will not be involved in outcome assessment or the patient's treatment.

Patients will be identified by approximately 15 participating centers from at least 4 regions. In a three-year recruitment period, we have estimated that approximately 21 000 stroke patients need structured follow-up in the catchment area. All patient-participants will receive two follow-ups, i.e one within 3-month and another at 12-month after stroke onset.

Estimated sample size and power

The study is dimensioned to reach 90% in the analysis of the two primary outcomes at a significance level of 2.5% for each individual test, to account for planned correction for multiple comparison with a target familywise error rate of 5%.

Sample size calculations have been performed assuming a difference of 4 points in SIS-p between, which is well below any concluded smallest important differences reported in the literature 20. A power analysis has been conducted using Monte Carlo simulations, in which SIS-p data for the control group was generated from a beta distribution with parameters α = 1.1 and β = 0.5, while Rehabkompassen® was generated under the assumption of α = 1.1 and β = 0.385. This corresponds to approximately to a mean value of 70 and standard deviation of 28 for the control group, in line with what Guidetti et al 18 reported for population of stroke patients at 12 months after stroke, and a difference of 4 points in mean values between groups. Under these assumptions, results showed that we need to include 940 patients to detect a statistically significant difference for SIS-p using a proportional odds model. The setting of the simulation corresponds to an odds ratio between groups of 1.5.

The marginal distribution of mRS score used for dimensioning was based on aggregated unpublished data from the Swedish Stroke Register (Riksstroke), collected 12-month after a stroke among Swedish patients: 0: 22.4%, 1: 18.0%, 2: 18.0 %, 3: 16.8%, 4: 11.1%, 5: 4.3%, 6: 9.4%. A sample size of 940 patients (470 in each group) is sufficient to detect a true odds ratio of 0.67 using an ordinal proportional odds model. The function popower from the package Hmisc in the statistical software R was used in this calculation.

Thus, 940 patients are required for both primary outcomes. To account for a 15% rate of patients being lost to follow up, we plan to recruit 1106 patients to the study.

Analysis and statistics

Group difference in mRS and SIS-p at the 12-month follow-up will be tested using ordinal logistic (proportional odds) regression, adjusted for clinic with fixed effects. For SIS-p, models will be adjusted for the baseline SIS-p with natural cubic splines to account for non-linearity in association. Results from the analyses will be presented as odds ratios with corresponding 95% confidence intervals, and p-values.

For the two primary outcomes, adjustments of the significance levels of the individual tests will be performed using the Holm-Bonferroni method to ensure that the familywise error rate will not be inflated above 0.05.

Secondary outcomes on ordinal scale will be analyzed similarly, using ordinal logistic regression. All analyses will primarily be conducted in consistence with the intention-to-treat principle. Multiple imputation of missing data will be employed in the primary analysis, using Multiple Imputation by Chained Equation (MICE). As complementary analyses, per-protocol analyses will be performed using data from patients will full availability of primary variables and with predefined criteria for adherence. Further details about the statistical analyses will be pre-defined and published in a separate statistical analysis plan. A data management plan has been established, providing details of the handling, organization and storing of study data.

Subgroup analyses, e.g. based on age (\< 65 years, 65-80 years and \> 80 years), gender (male and female), stroke severity (mild NIHSS 1- 8 moderate 9-15 and severe \> 15), stroke type (ischemic vs. haemorrhagic), treatment with tissue plasminogen activator and thrombectomy (Yes or No), and geographical region, will be conducted as complementary analyses.

A statistical significance level of p \< 0.05 (two-tailed) will be applied to all analyses. For the two primary outcomes, adjustments of the significance levels of the individual tests will be performed using the Holm-Bonferroni method to ensure that the familywise error rate will not be inflated above 0.05.

Further details about the statistical analyses will be pre-defined and published in a separate statistical analysis plan. A data management plan has been established, providing details of the handling, organization and storing of study data.

Time plan and implementation

The proposed study has already started the recruitment phase as from the beginning of 2022, aiming to recruit 15% of the participants this year. Approximately 40% and 45% of the sample size will be recruited in year 2023 and 2024 respectively. The 12-month follow-up will be completed at the end of 2025 followed by data analysis, manuscript preparations and submissions in 2026.

Eligibility criteria: 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.

Primary outcomes:
measure: Daily activities
timeFrame: 12 months follow-up after stroke
measure: Social activities
timeFrame: 12 months follow-up after stroke
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 12 months follow-up after stroke
measure: Stroke impacts
timeFrame: 12 months follow-up after stroke
measure: Health-economic evaluation
timeFrame: 12 months follow-up after stroke
measure: Clinicians' usability
timeFrame: 3 months follow-up after stroke
measure: End-users' experiences and feedback
timeFrame: 3 months follow-up after stroke
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University Hospital
Study officials:
affiliation: Umeå University
name: Xiaolei Hu, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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