A Personalized, Digital Coaching Program After Stroke

NCT03038685 | Completed DMC

• 1 other identifier: UHAntwerp
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 4

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).

Conditions

Stroke, Ischemic

Keywords

Secondary prevention; Web-based intervention; Strokecoach

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Quality-of-life

  3-6months

• Clinical outcome

  6 months

• Stroke recurrence rate

  0.5-1-2-3-6 months

• Therapeutic adherence

  0.5-1-2-3-6 months

Study Arms (2)

prospective, multicenter cohort

EXPERIMENTAL

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.

Behavioral: Strokecoach.be - digital coaching program for stroke patients

historical, single center cohort

NO INTERVENTION

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

Interventions

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.

prospective, multicenter cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Sint-Lucashospital, Bruges, Belgium: collaborator
• AZ Sint-Jan AV: collaborator
• Groeningehospital, Kortrijk, Belgium: collaborator
• Belgian Stroke Council: collaborator
• Interuniversity Centre For Health Economics Research, VUB, Brussels, Belgium: collaborator

Study Sites (4)

Sint-Janhospital

Bruges, 8000, Belgium

Location

Sint-Lucashospital

Bruges, 8310, Belgium

Location

University Hospital Antwerp

Edegem, 2650, Belgium

Location

Groeningehospital

Kortrijk, 8500, Belgium

Location

Related Links

• Related Info

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Peter Vanacker, MD PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: neurovascular consultant

Model Details: 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)

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 1, 2017
• Study Start: May 1, 2017
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4)