Effect of Targeted Education for Atrial Fibrillation Patients (Application Substudy)
AF-EduApp
2 other identifiers
interventional
194
1 country
2
Brief Summary
The aim of this study is to evaluate a new and innovative educational application based on targeted education on the adherence level for NOACs (non-vitamin K antagonist oral anticoagulants) in AF patients, compared with standard care, online targeted education and in-person targeted education. Several other parameters (knowledge level, quality of life, symptom burden, self-care capabilities, evaluation of educational efforts) will be studied. If resources allow, cardiovascular outcomes, cost-effectiveness and cost-utility will also be investigated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2018
CompletedFirst Posted
Study publicly available on registry
December 27, 2018
CompletedStudy Start
First participant enrolled
October 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedNovember 3, 2022
November 1, 2022
2.9 years
December 5, 2018
November 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patients' adherence to medication (oral anticoagulation), measured by the Medication Events Monitoring System (MEMS).
Monitored between 0-12 months and 12-15 months if resources allow.
Secondary Outcomes (6)
Patients' knowledge level, assessed by the Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ)
at baseline,1 month,3-,6-,12 months in the application group.(+18-and if applicable at 24-,30-,36 months/at the end of the study in the other intervention groups).In the standard care groups at 12 or 18 months (if applicable at the end of the study).
Patients' quality of life, assessed by the EQ-5D-3L questionnaire and the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire.
at baseline, 3- and 12 months in the application group.(+18-and if applicable at 36 months/at the end of the study in the other intervention groups.) In the standard care groups at baseline and 12 or 18 months (and if applicable at the end of the study).
Patients' quality of life, assessed by the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire.
at baseline and 12 months in the application group.(+18-and if applicable at 36 months/at the end of the study in the other intervention groups.) In the standard care groups at baseline and 12 or 18 months (and if applicable at the end of the study).
Patients' symptom burden, assessed by the Leuven ARrhythmia Questionnaire (LARQ).
at baseline,3- and 12 months in the application group.(+18-and if applicable at 36 months/at the end of the study in the other intervention groups).In the standard care groups at baseline and 12 or 18 months (and if applicable at the end of the study).
Patients' self-care capabilities, assessed by the Self-Care Questionnaire (SCQ).
at baseline, 3- and 12 months in the application group. (+18-and if applicable 36 months/at the end of the study in the other intervention groups).In the standard care groups at baseline and 12 or 18 months (and if applicable at the end of the study).
- +1 more secondary outcomes
Other Outcomes (10)
The first occurrence of a cardiovascular event
Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
Mortality
Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
Number of (un)planned hospital admissions
Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
- +7 more other outcomes
Study Arms (4)
Application-driven education (AF-EduApp substudy)
EXPERIMENTALEducation will be given via a newly developed application. Medication adherence (oral anticoagulation) will be measured using a special bottle cap that fits on a medication bottle. The patients in this group will receive feedback (notification and/or alarm) during the entire study period via this application when these patients have to take their medication.
In-person education (AF-EduCare study)
EXPERIMENTALEducation will be given on regular basis via predefined consultation visits. Medication adherence (oral anticoagulation) will also be measured using a special bottle cap that fits on a medication bottle. If adherence is low, the patient will get additional feedback when he does not take this medication as prescribed.
Online education (AF-EduCare study)
EXPERIMENTALEducation will be given on regular basis via a special designed online platform. Medication adherence (oral anticoagulation) will also be measured using a special bottle cap that fits on a medication bottle. If adherence is low, the patient will get additional feedback when he does not take this medication as prescribed.
Standard care (AF-EduCare study and AF-EduAppsub study)
NO INTERVENTIONThis group of AF patients will serve as a control group and no extra focused educational reinforcements will be provided beyond standard care (i.e. information of the treating physician and a brochure).
Interventions
Education + Medication adherence monitoring + Feedback when low adherence
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years.
- Patients in whom AF or atrial flutter is diagnosed with an electrocardiogram (12-lead, holter,...).
- Patients who are capable to sign the informed consent.
You may not qualify if:
- Not able to speak and read Dutch.
- Cognitive impaired (e.g. severe dementia).
- Life expectancy is estimated to be less than 1 year.
- Ongoing participation in another clinical trial.
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Antwerplead
- Bristol-Myers Squibbcollaborator
- Universiteit Antwerpencollaborator
Study Sites (2)
Antwerp University Hospital
Edegem, Belgium
Jessa Hospital
Hasselt, Belgium
Related Publications (2)
Knaepen L, Desteghe L, Delesie M, Onder R, Vijgen J, Dendale P, Ector J, Heidbuchel H. Effectiveness of the AF-EduCare and AF-EduApp approach to improve atrial fibrillation knowledge and risk factor awareness in patients with atrial fibrillation: a randomized controlled trial. Eur J Cardiovasc Nurs. 2025 Mar 3;24(2):266-276. doi: 10.1093/eurjcn/zvae164.
PMID: 39780354DERIVEDDelesie M, Knaepen L, Dendale P, Vijgen J, Ector J, Desteghe L, Heidbuchel H. Baseline demographics of a contemporary Belgian atrial fibrillation cohort included in a large randomised clinical trial on targeted education and integrated care (AF-EduCare/AF-EduApp study). Front Cardiovasc Med. 2023 Jun 2;10:1186453. doi: 10.3389/fcvm.2023.1186453. eCollection 2023.
PMID: 37332586DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hein Heidbuchel, MD, Phd
University Hospital of Antwerp
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Doctor
Study Record Dates
First Submitted
December 5, 2018
First Posted
December 27, 2018
Study Start
October 28, 2019
Primary Completion
September 30, 2022
Study Completion
September 30, 2022
Last Updated
November 3, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share