Effect of Targeted Education for Atrial Fibrillation Patients (Application Substudy)

NCT ID: NCT03788044

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-28
• Study Completion Date: 2022-09-30

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.

Detailed Description

This substudy is part of the AF-EduCare study (NCT03707873): an extra study arm will be added to the main trial in which eligible AF patients (= in possession of a smartphone and capable working with their smartphone) will test this new educational application. Not eligible patients randomized to this group, will receive standard care.

This extra study arm will additionally include an anticipated 221 patients (eligible plus not eligible patients).

[An anticipated total of 1259 AF patients will be included for the AF-EduCare study (1038 AF patients) plus the AF-EduApp substudy (221 AF patients).]

Conditions

Atrial Fibrillation and Flutter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Application-driven education (AF-EduApp substudy)

Education 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.

Group Type: EXPERIMENTAL

Education

Intervention Type: OTHER

Education + Medication adherence monitoring + Feedback when low adherence

In-person education (AF-EduCare study)

Education 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.

Group Type: EXPERIMENTAL

Education

Intervention Type: OTHER

Education + Medication adherence monitoring + Feedback when low adherence

Online education (AF-EduCare study)

Education 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.

Group Type: EXPERIMENTAL

Education

Intervention Type: OTHER

Education + Medication adherence monitoring + Feedback when low adherence

Standard care (AF-EduCare study and AF-EduAppsub study)

This 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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Education

Education + Medication adherence monitoring + Feedback when low adherence

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years.

2. Patients in whom AF or atrial flutter is diagnosed with an electrocardiogram (12-lead, holter,...).

3. Patients who are capable to sign the informed consent.

Exclusion Criteria

1. Not able to speak and read Dutch.

2. Cognitive impaired (e.g. severe dementia).

3. Life expectancy is estimated to be less than 1 year.

4. Ongoing participation in another clinical trial.

5. Pregnant women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Universiteit Antwerpen

OTHER

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Hein Heidbuchel

Professor Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hein Heidbuchel, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Antwerp

Locations

Antwerp University Hospital

Edegem, , Belgium

Jessa Hospital

Hasselt, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 39780354 (View on PubMed)

Delesie 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.

Reference Type: DERIVED

PMID: 37332586 (View on PubMed)

Other Identifiers

CV185-696

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AF-EduApp / EC 18/12/171

Identifier Type: -

Identifier Source: org_study_id