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

Antwerp University Hospital (UZA)

Status: Completed

Conditions: Atrial Fibrillation and Flutter

Treatments: Other: Education

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03788044

CV185-696 (Other Grant/Funding Number)

AF-EduApp / EC 18/12/171

Details and patient eligibility

About

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.

Full 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).]

Enrollment: 194 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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194 participants in 4 patient groups

Application-driven education (AF-EduApp substudy)

Experimental group

Description:

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.

Treatment:

Other: Education

In-person education (AF-EduCare study)

Experimental group

Description:

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.

Treatment:

Other: Education

Online education (AF-EduCare study)

Experimental group

Description:

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.

Treatment:

Other: Education

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

No Intervention group

Description:

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).