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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

Tracking Information
First Submitted Date  ICMJE November 11, 2020
First Posted Date  ICMJE June 7, 2021
Last Update Posted Date June 7, 2021
Actual Study Start Date  ICMJE August 26, 2020
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2021)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2021)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rehabkompassen® - a Patient-centered Digital Follow-up Tool in the Post-stroke Continuum of Care
Official Title  ICMJE Rehabkompassen® - a Digital Tool for Facilitating Patient-tailored Rehabilitation in the Post-acute Continuum of Care After Stroke - A Multicenter Pragmatic Randomized Controlled Trial
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.

Detailed Description

Primary research question: Does the usage of a digital Rehabkompassen® together with the usual out-patient visit at 3-month after stroke follow-up, in comparison with the usual out-patient visit alone, improve the patients' daily and social activities at 12-months after stroke?

Secondary research questions will focus on the various challenges related to effectiveness, cost-effectiveness, functional aspects and satisfaction, technical development and implementation, respectively.

In comparison with a usual out-patient visit alone,

  1. Does an additional Rehabkompassen® at 3-month follow-up improve the patients' health-related quality of life at 12-month after stroke?
  2. Does an additional Rehabkompassen® influence other stroke impacts at 12-month post stroke?
  3. Is Rehabkompassen® cost-effective?
  4. Does Rehabkompassen® improve the triage, clinical assessments, decision-making, generating a rehabilitation plan, referral and outcome-evaluation for the healthcare professionals?
  5. How can Rehabkompassen® be further improved based on feedback from the end-users (patients and health care professionals)

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

The patients will be identified by participating outpatient clinics. All study participants will be followed-up at 3- and 12-months after stroke onset.

At 3-month follow-up after stroke (control and intervention groups)

All patients who meet the inclusion criteria receive an invitation to the study, together with the appointment for a doctor's visit, around 2 months after the stroke onset. Patients who give their informed consent are contacted by the research staff at the local clinic via telephone in order to provide oral information about the study. Study participants in both the control and intervention groups then receive a message in their inbox at Health Care Guide 1177.se with information about the Rehabkompassen® questionnaires. At home, study participants will be able to fill in the questionnaires concerning their health by clicking on the links in their e-mail inbox at Health Care Guide 1177.se. The questionnaires must be answered no later than one week before the 3-month out-patient visit. In order to facilitate the usage of the digital Rehabkompassen®, research staff will offer technical support via telephone and in-person.

A usual out-patient visit consists of the recording of the patient's medical history, the physical examination when necessary and the rehabilitation treatment plan.

Control group (The usual visit + Post-Stroke Checklist):

The study participants in the control group will only fill in Simplified modified Rankin Scale questionnaire (smRSq), Stroke Impact Scale 3.0 (SIS)-participation (SIS-p) and EuroQoL 5-dimension (EQ-5D) via Health Care Guide1177.se prior to a usual out-patient follow-up. The Post-Stroke Checklist (PSC) will be used at the usual out-patient visit.

Intervention group (The usual visit + Rehabkompassen®):

The study participants in the intervention group will fill in the Rehabkompassen® questionnaires (including smRSq, SIS, EQ-5D-5L, Fatigue Assessment Scale (FAS) and Hospital Anxiety and Depression Scale (HAD)). The patient's own graphic Rehabkompassen® will be utilized at the usual out-patient follow-up with otherwise identical procedures as the control group. The replies from the Rehabkompassen® questionnaires (intervention group) will be used by doctors / healthcare personnel before doctors´ visits / team assessment as a basis for triage, and during doctors´ visits / team assessment as a basis for assessing the patient's rehabilitation needs.

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.

To gather end-user feedback regarding users' experiences and to evaluate effectiveness of Rehabkompassen® and the satisfaction of the user process experience, a survey will be conducted among all study participants immediately after the 3-months visit. Healthcare professionals will fill in an evaluation questionnaire after using Rehabkompassen® for 5-10 patients and two regular referral meetings. The survey includes questions concerning the background of the healthcare staff, computer experience, user experience and the use of the tool in patient visits, as well as the evaluation on the implementation process. In order to assess costs, the time required for staff education, planning and visits by different occupational groups will be recorded and the use of medical resources in outpatient visits will be documented in detail by research staff.

At 12-month follow-up after stroke

All study participants in both control and intervention group will fill in the Rehabkompassen® questionnaires via Health Care Guide 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 for intervention group.

Randomization and blinding

The study is a multicenter pragmatic RCT with allocation ratio 1:1 between the intervention and control groups. The permuted block randomization with stratification at each clinic will be used. Random block sizes between 2-8 will be utilized to ensure participants randomly assigned to intervention respectively control group. The randomization list will be created centrally by the Study-Randomizer system, and handled by an investigator who will not be involved in outcome assessment or the patient's treatment.

Estimated sample size and power

We plan to recruit 1024 patients to the study (512 in each group). This dimensioning was based on assumptions of a 3.7% absolute mean improvement in percentage with mRS 0-2 with Rehabkompassen at an 80% power, a standard deviation of 0.2 and a significance level of 0.05 (n = 920). The number needed is 1024 with estimation of approximately 10% lost to follow-up. A sample size of 920 patients provides a near to 100% power to detect a difference of 15 points on the SIS-p assuming a standard deviation of 27.5.

Statistical methods

All analyses will be conducted in consistence with the intention-to-treat principle. The plan is to use the multiple imputation method for handling of missing data. Baseline characteristics for each of the two trial arms will be described as mean (SD), median (IQR) and counts (%) with corresponding confidence intervals when appropriate. A statistical significance level of p < 0.05 (two-tailed) will be applied to all analyses.

For outcomes where the mean value can be assumed as approximately normally distributed, groups will be compared using an unpaired Student's t-test. Otherwise, groups will be compared with the non-parametric test Wilcoxon-Mann-Whitney test if the assumptions for the test are suitable for the outcome variable. Subgroup analysis will also be conducted, 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 (Yes or No), and geographical region.

Analysis of co-primary endpoints

The dichotomous outcomes smRSq between the trial arms will be compared, thereby complicating the interpretation of odds ratios as a measure of relative risk, with respective 95% confidence interval (CI). In addition, differences in the distribution of patients across mRS categories at the 12-month follow-up between the two trial arms will be quantified using ordinal logistic regression ("shift analysis") and presented together with a stacked bar graph.

SIS-p will be reported as the difference in the medians with 95% CI. The effect of the intervention on the co-primary outcome SIS-p will be carried out by the aforementioned statistical analysis.

Time plan:

The pilot study started in October 2020. The main study will start in 2021 with 9-months set-up time and 24-month for participant recruitment, followed by 12-month follow-up. Data (collected to answer the secondary research questions 4-6) analysis will be started when the 3-month follow-up is completed. The primary outcome and the rest of the secondary outcomes will be analyzed after 12-month follow-up is completed, estimated to be in June 2025. It'll be followed by data summarizing and publishing in 2026.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Stroke
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Intervention i.e. with Rehabkompassen®
    The participants will use the digital graphic Rehabkompassen® at the out-patient follow-up.
    Intervention: Other: a usual follow-up with Rehabkompassen®
  • 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".
    Intervention: Other: a usual follow-up with Post-Stroke Checklist, i.e. without Rehabkompassen®
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2021)
1024
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiaolei Hu, MD PhD +46 90 785 00 00 xiaolei.hu@umu.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04915027
Other Study ID Numbers  ICMJE Rehabkompassen®
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Umeå University
Study Sponsor  ICMJE Umeå University
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Xiaolei Hu, MD PhD Umeå University
PRS Account Umeå University
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP