A Personalized, Digital Coaching Program After Stroke

Stroke, Ischemic Clinical Trial

— STROKECOACH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03038685
• Other study ID #: UHAntwerp
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: January 2021
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Ischemic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Belgium	Sint-Janhospital	Brugge
Belgium	Sint-Lucashospital	Brugge
Belgium	University Hospital Antwerp	Edegem
Belgium	Groeningehospital	Kortrijk

Sponsors (6)

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

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Clinical outcome	The impact on the clinical outcome will be assessed by the modified Rankin Score (0-6, mRS).	6 months
Secondary	Stroke recurrence rate	At every teleconsultancy contact stroke recurrences will be demanded.	0.5-1-2-3-6 months
Secondary	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

External Links

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