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Completed

NCT Number: NCT03038685

A Personalized, Digital Coaching Program After Stroke

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).

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Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sint-Janhospital, Bruges, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strokecoach.be - digital coaching program for stroke patients

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.

Primary outcomes

  1. cardiovascular risk factor control

    Time frame: 6 months

    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).

Secondary outcomes

  1. Quality-of-life

    Time frame: 3-6months

    The impact on the quality-of-life will be evaluated by using the dutch version of the EQ-5D questionnaire

  2. Clinical outcome

    Time frame: 6 months

    The impact on the clinical outcome will be assessed by the modified Rankin Score (0-6, mRS).

  3. Stroke recurrence rate

    Time frame: 0.5-1-2-3-6 months

    At every teleconsultancy contact stroke recurrences will be demanded.

  4. Therapeutic adherence

    Time frame: 0.5-1-2-3-6 months

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • AZ Sint-Jan AV
  • Belgian Stroke Council
  • Groeningehospital, Kortrijk, Belgium
  • Interuniversity Centre For Health Economics Research, VUB, Brussels, Belgium
  • Sint-Lucashospital, Bruges, Belgium

Registry information

Official study title

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

Acronym: STROKECOACH

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 1, 2017
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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