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A Personalized, Digital Coaching Program After Stroke (STROKECOACH)

Primary Purpose

Stroke, Ischemic

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Strokecoach.be - digital coaching program for stroke patients
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke, Ischemic focused on measuring Secondary prevention, Web-based intervention, Strokecoach

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sint-Janhospital
  • Sint-Lucashospital
  • University Hospital Antwerp
  • Groeningehospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

prospective, multicenter cohort

historical, single center cohort

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Quality-of-life
The impact on the quality-of-life will be evaluated by using the dutch version of the EQ-5D questionnaire
Clinical outcome
The impact on the clinical outcome will be assessed by the modified Rankin Score (0-6, mRS).
Stroke recurrence rate
At every teleconsultancy contact stroke recurrences will be demanded.
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.

Full Information

First Posted
January 30, 2017
Last Updated
January 11, 2021
Sponsor
University Hospital, Antwerp
Collaborators
Sint-Lucashospital, Bruges, Belgium, AZ Sint-Jan AV, Groeningehospital, Kortrijk, Belgium, Belgian Stroke Council, Interuniversity Centre For Health Economics Research, VUB, Brussels, Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT03038685
Brief Title
A Personalized, Digital Coaching Program After Stroke
Acronym
STROKECOACH
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp
Collaborators
Sint-Lucashospital, Bruges, Belgium, AZ Sint-Jan AV, Groeningehospital, Kortrijk, Belgium, Belgian Stroke Council, Interuniversity Centre For Health Economics Research, VUB, Brussels, Belgium

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
Secondary prevention, Web-based intervention, Strokecoach

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
prospective, multicenter cohort
Arm Type
Experimental
Arm Description
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.
Arm Title
historical, single center cohort
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Strokecoach.be - digital coaching program for stroke patients
Intervention Description
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 Outcome Measure Information:
Title
cardiovascular risk factor control
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality-of-life
Description
The impact on the quality-of-life will be evaluated by using the dutch version of the EQ-5D questionnaire
Time Frame
3-6months
Title
Clinical outcome
Description
The impact on the clinical outcome will be assessed by the modified Rankin Score (0-6, mRS).
Time Frame
6 months
Title
Stroke recurrence rate
Description
At every teleconsultancy contact stroke recurrences will be demanded.
Time Frame
0.5-1-2-3-6 months
Title
Therapeutic adherence
Description
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.
Time Frame
0.5-1-2-3-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Vanacker, MD PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sint-Janhospital
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Sint-Lucashospital
City
Brugge
ZIP/Postal Code
8310
Country
Belgium
Facility Name
University Hospital Antwerp
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Groeningehospital
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/31701472/
Description
Related Info

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A Personalized, Digital Coaching Program After Stroke

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