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A Personalized, Digital Coaching Program After Stroke

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03038685
Acronym
STROKECOACH
Enrollment
148
Registered
2017-02-01
Start date
2017-05-01
Completion date
2018-02-28
Last updated
2021-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Ischemic

Keywords

Secondary prevention, Web-based intervention, Strokecoach

Brief summary

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

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.

Interventions

BEHAVIORALStrokecoach.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.

Sponsors

Sint-Lucashospital, Bruges, Belgium
CollaboratorUNKNOWN
AZ Sint-Jan AV
CollaboratorOTHER
Groeningehospital, Kortrijk, Belgium
CollaboratorUNKNOWN
Belgian Stroke Council
CollaboratorUNKNOWN
Interuniversity Centre For Health Economics Research, VUB, Brussels, Belgium
CollaboratorUNKNOWN
University Hospital, Antwerp
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention 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)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
cardiovascular risk factor control6 monthsThe 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).

Secondary

MeasureTime frameDescription
Quality-of-life3-6monthsThe impact on the quality-of-life will be evaluated by using the dutch version of the EQ-5D questionnaire
Clinical outcome6 monthsThe impact on the clinical outcome will be assessed by the modified Rankin Score (0-6, mRS).
Stroke recurrence rate0.5-1-2-3-6 monthsAt every teleconsultancy contact stroke recurrences will be demanded.
Therapeutic adherence0.5-1-2-3-6 monthsA selfreport of the therapeutic adherence will be checked at every consultation by asking them if any medication had been skipped during last 10 days.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026