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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02475967
Other study ID # PDEN-IFRE 01
Secondary ID
Status Completed
Phase N/A
First received June 10, 2015
Last updated February 26, 2018
Start date January 2016
Est. completion date February 2018

Study information

Verified date February 2018
Source Hasselt University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date February 2018
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.
Control group
The control group patients receive conventional cardiac care alone.

Locations

Country Name City State
Belgium ZOL Genk
Belgium Jessa Ziekenhuis Hasselt

Sponsors (2)

Lead Sponsor Collaborator
Hasselt University Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Health-related quality of life Health-related quality of life, assessed by HeartQol 3 months
Secondary 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. 3 months
Secondary Effectiveness of E-learning packages Effectiveness of intervention in improving patients' knowledge of cardiac diseases as assessed by questionnaire scores. 3 months
Secondary User experience of eLearning platform Asses user experience of eLearning platform by User Experience Questionnaire (UEQ) 3 months
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