Coronary Artery DiseaseeEduHeart INCT02475967
Study Assessing the Effectiveness of a Cardiac Web-based eLearning Platform
A study testing Intervention group in people with Coronary Artery Disease, run by Hasselt University at 2 sites in Belgium.
Trial summary
In the trial cardiac patients will be provided with unrestricted access to the web-based eLearing platform for a one-month period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesBelgium
- Study dates
- Jan 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from coronary artery disease for which they are treated conservatively, with a percutaneous coronary intervention or with coronary artery bypass grafting
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Intervention group, Control group
- Keywords
- E-Learning, coronary artery disease, telerehabilitation, e-health
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupOther
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.
Control groupOther
The control group patients receive conventional cardiac care alone.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group patients have access to the eLearning platform in addition to conventional cardiac care. Receives: Other: Intervention group |
| Control group | Active comparator | The control group patients receive conventional cardiac care alone. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life
Health-related quality of life, assessed by HeartQol
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 3 months
Effectiveness of E-learning packages
Effectiveness of intervention in improving patients' knowledge of cardiac diseases as assessed by questionnaire scores.
Measured: 3 months
User experience of eLearning platform
Asses user experience of eLearning platform by User Experience Questionnaire (UEQ)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startJan 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, prof. dr. Paul Dendale, Hasselt University
- Investigators
- Ines Frederix, drs., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475967
- Sponsor's protocol ID
- PDEN-IFRE 01
- Acronym
- eEduHeart I
- Status last verified
- Feb 2018
- First submitted
- 10 Jun 2015
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eEduHeart I: a Multi-center Randomized, Controlled Trial Investigating the Effectiveness of a Cardiac Web-based eLearning Platform
- ClinicalTrials.gov ID
- NCT02475967
- Acronym / sponsor ID
- eEduHeart I / PDEN-IFRE 01
- Conditions
- Coronary Artery Disease
- Keywords
- E-Learning, coronary artery disease, telerehabilitation, e-health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- Jan 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Intervention groupThe intervention group patients have access to the eLearning platform in addition to conventional cardiac care. |
| Control group | Active comparator | Other: Control groupThe control group patients receive conventional cardiac care alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients suffering from coronary artery disease for which they are treated conservatively, with a percutaneous coronary intervention or with coronary artery bypass grafting
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupThe 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. | Other | Intervention group |
| Control groupThe control group patients receive conventional cardiac care alone. | Other | Control group |
Primary outcome
Health-related quality of life
Time frame: 3 months
Health-related quality of life, assessed by HeartQol
3 secondary outcomes
Adherence to the E-learning packages
Time frame: 3 months
Effectiveness of E-learning packages
Time frame: 3 months
User experience of eLearning platform
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ines Frederix, drs. study chair
Hasselt University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Coronary Artery Disease, run by Hasselt University at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018; AzTrials last refreshed its copy on 28 Oct 2026.