Study Assessing the Effectiveness of a Cardiac Web-based eLearning Platform (eEduHeart I)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Intervention group
Control group
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring E-Learning, coronary artery disease, telerehabilitation, e-health
Eligibility Criteria
Inclusion Criteria:
- Patients suffering from coronary artery disease for which they are treated conservatively, with a percutaneous coronary intervention or with coronary artery bypass grafting
Exclusion Criteria:
- Patients with dementia or cognitive impairment not being able to sufficiently understand the E-Learning packages content
- (Foreign) patients unable to speak Dutch, thereby not being able to understand the content of the E-Learning packages
- Patients with advanced visual and/or auditory impairments, hindering them to adequately understand the E-earning packages
- Patients participating in another trial during the Pilot study period
- Patients refusing to provide signed consent
Sites / Locations
- ZOL
- Jessa Ziekenhuis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
The intervention group patients have access to the eLearning platform in addition to conventional cardiac care.
The control group patients receive conventional cardiac care alone.
Outcomes
Primary Outcome Measures
Health-related quality of life
Health-related quality of life, assessed by HeartQol
Secondary Outcome Measures
Adherence to the E-learning packages
Adherence to the E-learning packages as assessed by the number of logs and the cumulative log time on the E-learning platform per patient.
Effectiveness of E-learning packages
Effectiveness of intervention in improving patients' knowledge of cardiac diseases as assessed by questionnaire scores.
User experience of eLearning platform
Asses user experience of eLearning platform by User Experience Questionnaire (UEQ)
Full Information
NCT ID
NCT02475967
First Posted
June 10, 2015
Last Updated
February 26, 2018
Sponsor
Hasselt University
Collaborators
Jessa Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02475967
Brief Title
Study Assessing the Effectiveness of a Cardiac Web-based eLearning Platform
Acronym
eEduHeart I
Official Title
eEduHeart I: a Multi-center Randomized, Controlled Trial Investigating the Effectiveness of a Cardiac Web-based eLearning Platform
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Jessa Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In the trial cardiac patients will be provided with unrestricted access to the web-based eLearing platform for a one-month period.
Detailed Description
Patients participating in the trial will be provided with a cardiac web-based eLearning platform for one month during study period. The medical content of the packages will be gathered from a multidisciplinary input of both medics (e.g. cardiologists) and paramedics (e.g. psychologists).
E-Learning packages type I: videos with information from caregivers. In these videos, medics and paramedics are interviewed to highlight the etiology, pathophysiology and treatment of coronary artery disease; the associated comorbidities and the ways to prevent recurrence.
E-Learning packages type II: videos in which patients are interviewed. Patients can help each other to adhere to their treatment plan, by sharing stories from their own experience about their illness and the rehabilitation afterwards. Short clips of maximum 2 minutes will be provided to study participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
E-Learning, coronary artery disease, telerehabilitation, e-health
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention group patients have access to the eLearning platform in addition to conventional cardiac care.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The control group patients receive conventional cardiac care alone.
Intervention Type
Other
Intervention Name(s)
Intervention group
Intervention Description
The intervention group patients have access to the eLearning platform in addition to conventional cardiac care.The content of platform will be gathered from a multidisciplinary input of both medics (e.g. cardiologists) and paramedics (e.g. psychologists). Patients will also contribute to platform content.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
The control group patients receive conventional cardiac care alone.
Primary Outcome Measure Information:
Title
Health-related quality of life
Description
Health-related quality of life, assessed by HeartQol
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Adherence to the E-learning packages
Description
Adherence to the E-learning packages as assessed by the number of logs and the cumulative log time on the E-learning platform per patient.
Time Frame
3 months
Title
Effectiveness of E-learning packages
Description
Effectiveness of intervention in improving patients' knowledge of cardiac diseases as assessed by questionnaire scores.
Time Frame
3 months
Title
User experience of eLearning platform
Description
Asses user experience of eLearning platform by User Experience Questionnaire (UEQ)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients suffering from coronary artery disease for which they are treated conservatively, with a percutaneous coronary intervention or with coronary artery bypass grafting
Exclusion Criteria:
Patients with dementia or cognitive impairment not being able to sufficiently understand the E-Learning packages content
(Foreign) patients unable to speak Dutch, thereby not being able to understand the content of the E-Learning packages
Patients with advanced visual and/or auditory impairments, hindering them to adequately understand the E-earning packages
Patients participating in another trial during the Pilot study period
Patients refusing to provide signed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ines Frederix, drs.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
ZOL
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Study Assessing the Effectiveness of a Cardiac Web-based eLearning Platform
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