A Personalized, Digital Coaching Program After Stroke

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Personalized, Digital Coaching Program With Teleconsultancy to Improve Secondary Prevention After Ischemic Stroke: a Pilot, Multicenter Pre/Post Study.

Conditions
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Stroke, Ischemic

Intervention / Treatment
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* Behavioral: Strokecoach.be - digital coaching program for stroke patients


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: A pilot, double-arm, pre/post study design with compirason between historical, monocenter cohort (Sint-Janhospital, 2011) and prospective, multicenter cohort (4 Belgian Stroke centers, 2017)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prospective, multicenter cohort<br>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. | Behavioral: Strokecoach.be - digital coaching program for stroke patients<br>* 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.<br>|
| No Intervention: historical, single center cohort<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular risk factor control | 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). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality-of-life | The impact on the quality-of-life will be evaluated by using the dutch version of the EQ-5D questionnaire | 3-6months | 
| Clinical outcome | The impact on the clinical outcome will be assessed by the modified Rankin Score (0-6, mRS). | 6 months | 
| Stroke recurrence rate | At every teleconsultancy contact stroke recurrences will be demanded. | 0.5-1-2-3-6 months | 
| Therapeutic adherence | 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. | 0.5-1-2-3-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Secondary prevention, Web-based intervention, Strokecoach