A Personalized, Digital Coaching Program After Stroke (STROKECOACH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03038685|
Recruitment Status : Active, not recruiting
First Posted : February 1, 2017
Last Update Posted : November 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stroke, Ischemic||Behavioral: Strokecoach.be - digital coaching program for stroke patients||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||148 participants|
|Intervention Model:||Single Group Assignment|
|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)|
|Masking:||None (Open Label)|
|Official Title:||A Personalized, Digital Coaching Program With Teleconsultancy to Improve Secondary Prevention After Ischemic Stroke: a Pilot, Multicenter Pre/Post Study.|
|Actual Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||February 28, 2018|
|Estimated Study Completion Date :||February 28, 2018|
Experimental: prospective, multicenter cohort
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
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.
No Intervention: historical, single center cohort
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
- 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).
- 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
- Clinical outcome [ Time Frame: 6 months ]The impact on the clinical outcome will be assessed by the modified Rankin Score (0-6, mRS).
- Stroke recurrence rate [ Time Frame: 0.5-1-2-3-6 months ]At every teleconsultancy contact stroke recurrences will be demanded.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03038685
|Brugge, Belgium, 8000|
|Brugge, Belgium, 8310|
|University Hospital Antwerp|
|Edegem, Belgium, 2650|
|Kortrijk, Belgium, 8500|
|Principal Investigator:||Peter Vanacker, MD PhD||University Hospital, Antwerp|