A Personalized, Digital Coaching Program After Stroke

NCT ID: NCT03038685

Last Updated: 2021-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-02-28

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.

Conditions

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Stroke, Ischemic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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)
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Strokecoach.be - digital coaching program for stroke patients

Intervention Type BEHAVIORAL

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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Strokecoach.be - digital coaching program for stroke patients

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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sint-Lucashospital, Bruges, Belgium

UNKNOWN

Sponsor Role collaborator

AZ Sint-Jan AV

OTHER

Sponsor Role collaborator

Groeningehospital, Kortrijk, Belgium

UNKNOWN

Sponsor Role collaborator

Belgian Stroke Council

UNKNOWN

Sponsor Role collaborator

Interuniversity Centre For Health Economics Research, VUB, Brussels, Belgium

UNKNOWN

Sponsor Role collaborator

University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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PVanacker

neurovascular consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Vanacker, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

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Sint-Janhospital

Bruges, , Belgium

Site Status

Sint-Lucashospital

Bruges, , Belgium

Site Status

University Hospital Antwerp

Edegem, , Belgium

Site Status

Groeningehospital

Kortrijk, , Belgium

Site Status

Countries

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Belgium

Related Links

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Other Identifiers

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UHAntwerp

Identifier Type: -

Identifier Source: org_study_id

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