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Study Assessing the Effectiveness of a Cardiac Web-based eLearning Platform (eEduHeart I)

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ClinicalTrials.gov Identifier: NCT02475967
Recruitment Status : Completed
First Posted : June 19, 2015
Last Update Posted : February 27, 2018
Sponsor:
Collaborator:
Jessa Hospital
Information provided by (Responsible Party):
prof. dr. Paul Dendale, Hasselt University

Brief Summary:
In the trial cardiac patients will be provided with unrestricted access to the web-based eLearing platform for a one-month period.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Other: Intervention group Other: Control group Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: eEduHeart I: a Multi-center Randomized, Controlled Trial Investigating the Effectiveness of a Cardiac Web-based eLearning Platform
Study Start Date : January 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Arm Intervention/treatment
Experimental: Intervention group
The intervention group patients have access to the eLearning platform in addition to conventional cardiac care.
Other: Intervention group
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.

Active Comparator: Control group
The control group patients receive conventional cardiac care alone.
Other: Control group
The control group patients receive conventional cardiac care alone.




Primary Outcome Measures :
  1. Health-related quality of life [ Time Frame: 3 months ]
    Health-related quality of life, assessed by HeartQol


Secondary Outcome Measures :
  1. Adherence to the E-learning packages [ Time Frame: 3 months ]
    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.

  2. Effectiveness of E-learning packages [ Time Frame: 3 months ]
    Effectiveness of intervention in improving patients' knowledge of cardiac diseases as assessed by questionnaire scores.

  3. User experience of eLearning platform [ Time Frame: 3 months ]
    Asses user experience of eLearning platform by User Experience Questionnaire (UEQ)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT02475967


Locations
Belgium
ZOL
Genk, Belgium, 3600
Jessa Ziekenhuis
Hasselt, Belgium, 3500
Sponsors and Collaborators
Hasselt University
Jessa Hospital
Investigators
Study Chair: Ines Frederix, drs. Hasselt University

Responsible Party: prof. dr. Paul Dendale, prof. dr., Hasselt University
ClinicalTrials.gov Identifier: NCT02475967     History of Changes
Other Study ID Numbers: PDEN-IFRE 01
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by prof. dr. Paul Dendale, Hasselt University:
E-Learning
coronary artery disease
telerehabilitation
e-health

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases