A Personalized, Digital Coaching Program After Stroke (STROKECOACH)
January 11, 2021 updated by: PVanacker, University Hospital, Antwerp
A Personalized, Digital Coaching Program With Teleconsultancy to Improve Secondary Prevention After Ischemic Stroke: a Pilot, Multicenter Pre/Post Study.
The Belgian Stroke Council initiated a project to improve risk factor control and medication adherence in ischemic stroke patients by developing an individualized in-hospital initiated and post- discharge, digital coaching program addition to standard practice (strokecoach.be).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The overall aim of this project is to further improve subacute and chronic stroke care in the Belgian context with main focus on the patients' quality of life, stroke recurrence and secondary cardiovascular prevention. Main focuses are on patient-empowerment, shared-decision making and health literacy, as these items are linked with better therapeutic adherence and self-care for chronic diseases.
In case of a positive result, implementation of this individualized chronic stroke care program executed by a personal stroke coach, initiated during hospitalization and using a web-based intervention program, can easily be unrolled in other Belgian stroke units. The program can be cost-effective if better clinical outcome, stroke recurrence rates, number of in-hospital consultations, number of rehospitalisations are reduced. This will be evaluated in a in-depth healt-economic analysis.
Study Type
Interventional
Enrollment (Actual)
148
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brugge, Belgium, 8000
- Sint-Janhospital
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Brugge, Belgium, 8310
- Sint-Lucashospital
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Edegem, Belgium, 2650
- University Hospital Antwerp
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Kortrijk, Belgium, 8500
- Groeningehospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Patients with an acute ischemic stroke hospitalized at a participating stroke center can be included during hospitalisation if fulfilling following three criteria: - they will return back home or be discharged to a rehabilitation center
- have a life expectancy of more than 6 months
- have experience with internet use (at least weekly checking emails) or a caregiver accepts to help with the digital platform.
Exclusion Criteria:
- Age < 18 years
- Patients unable or unwilling to be followed post-discharge for 6 months
- Patients with a major neurologic post-stroke and no caregiver participation
- Cognitive impairment limiting use of digital platform and no caregiver participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: prospective, multicenter cohort
A group of 175 patients will be recruited in 4 Belgian stroke centers during the six months period.
All data will be collected prospectively and patients will be treated during six months period.
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The stroke coach gives patients two education sessions during hospitalization (risk factor management, review of medications and clinical evolution).
During these sessions, study participation will be proposed.
Eligibility will partially depend on their historical use of the internet and e-mail.
The aim is to have the digital platform personalized for his/her individual needs, risk factors and remaining neurologic signs/symptoms.
Tips and tricks to deal with lifestyle modification will be delivered on regular basis.
Meanwhile, patients will be asked to complete on a pre-specified frequency their data regarding their cardiovascular risk profile.
Additionally, participants will be contacted at 0.5-1-2 and 6 months by phone calls or videoconsultancy.
To standardize, an adapted, digital version of the standardized WSO Post-Stroke Checklist shall be used as a decision-support flowchart.
A report of the consultation will be derived after the videoconsultancy.
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No Intervention: historical, single center cohort
A historical cohort of Sint-Janhospital (2011 - Bruges, Belgium) with prospectively collected data will be used as comparator for the experimental arm.
These data were published in Vanacker P, Couvreur T, Vanhooren G. Can we improve cerebrovascular risk reduction in real-life?
A single centre's experience.
Cerebrovasc Dis 2011;31(suppl 2):289
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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cardiovascular risk factor control
Time Frame: 6 months
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The primary endpoint is the impact of the intervention on the cardiovascular risk factor control by assessing the evolution of the SCORE (Systematic COronary Risk Evaluation: High & Low cardiovascular Risk Charts) risk pre- and postintervention.
An official program to analyze these parameter will be used (AOST©, Crethsoft).
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Quality-of-life
Time Frame: 3-6months
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The impact on the quality-of-life will be evaluated by using the dutch version of the EQ-5D questionnaire
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3-6months
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Clinical outcome
Time Frame: 6 months
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The impact on the clinical outcome will be assessed by the modified Rankin Score (0-6, mRS).
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6 months
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Stroke recurrence rate
Time Frame: 0.5-1-2-3-6 months
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At every teleconsultancy contact stroke recurrences will be demanded.
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0.5-1-2-3-6 months
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Therapeutic adherence
Time Frame: 0.5-1-2-3-6 months
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A selfreport of the therapeutic adherence will be checked at every consultation by asking them if any medication had been skipped during last 10 days.
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0.5-1-2-3-6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter Vanacker, MD PhD, University Hospital, Antwerp
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Actual)
February 28, 2018
Study Completion (Actual)
February 28, 2018
Study Registration Dates
First Submitted
January 30, 2017
First Submitted That Met QC Criteria
January 30, 2017
First Posted (Estimate)
February 1, 2017
Study Record Updates
Last Update Posted (Actual)
January 14, 2021
Last Update Submitted That Met QC Criteria
January 11, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHAntwerp
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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