Clinical trial NCT03038685: A Personalized, Digital Coaching Program After Stroke
Official title: A Personalized, Digital Coaching Program With Teleconsultancy to Improve Secondary Prevention After Ischemic Stroke: a Pilot, Multicenter Pre/Post Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Keywords: Secondary prevention
Web-based intervention
Strokecoach
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Sint-Lucashospital, Bruges, Belgium
name: AZ Sint-Jan AV
name: Groeningehospital, Kortrijk, Belgium
name: Belgian Stroke Council
name: Interuniversity Centre For Health Economics Research, VUB, Brussels, Belgium
First posted: 2017-02-01
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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)
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: cardiovascular risk factor control
timeFrame: 6 months
Secondary outcomes:
measure: Quality-of-life
timeFrame: 3-6months
measure: Clinical outcome
timeFrame: 6 months
measure: Stroke recurrence rate
timeFrame: 0.5-1-2-3-6 months
measure: Therapeutic adherence
timeFrame: 0.5-1-2-3-6 months
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Sint-Janhospital
city: Brugge
country: Belgium
facility: Sint-Lucashospital
city: Edegem
country: Belgium
facility: University Hospital Antwerp
city: Kortrijk
country: Belgium
facility: Groeningehospital
Study officials:
affiliation: University Hospital, Antwerp
name: Peter Vanacker, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: