NCT02475967

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 19, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

2.1 years

First QC Date

June 10, 2015

Last Update Submit

February 26, 2018

Conditions

Coronary Artery Disease

Keywords

E-Learningcoronary artery diseasetelerehabilitatione-health

Outcome Measures

Primary Outcomes (1)

  • Health-related quality of life

    Health-related quality of life, assessed by HeartQol

    3 months

Secondary Outcomes (3)

  • Adherence to the E-learning packages

    3 months

  • Effectiveness of E-learning packages

    3 months

  • User experience of eLearning platform

    3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group patients have access to the eLearning platform in addition to conventional cardiac care.

Other: Intervention group

Control group

ACTIVE COMPARATOR

The control group patients receive conventional cardiac care alone.

Other: Control group

Interventions

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.

Intervention group
Control groupOTHER

The control group patients receive conventional cardiac care alone.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from coronary artery disease for which they are treated conservatively, with a percutaneous coronary intervention or with coronary artery bypass grafting

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ZOL

Genk, 3600, Belgium

Location

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ines Frederix, drs.

    Hasselt University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 19, 2015

Study Start

January 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

February 27, 2018

Record last verified: 2018-02

Locations

BE(2)