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

February 26, 2018 updated by: prof. dr. Paul Dendale, Hasselt University

eEduHeart I: a Multi-center Randomized, Controlled Trial Investigating the Effectiveness of a Cardiac Web-based eLearning Platform

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Genk, Belgium, 3600
        • ZOL
      • Hasselt, Belgium, 3500
        • Jessa Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life
Time Frame: 3 months
Health-related quality of life, assessed by HeartQol
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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 months
User experience of eLearning platform
Time Frame: 3 months
Asses user experience of eLearning platform by User Experience Questionnaire (UEQ)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasselt University

Collaborators

Jessa Hospital

Investigators

  • Study Chair: Ines Frederix, drs., Hasselt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

June 10, 2015

First Submitted That Met QC Criteria

June 16, 2015

First Posted (Estimate)

June 19, 2015

Study Record Updates

Last Update Posted (Actual)

February 27, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDEN-IFRE 01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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