Effect of Targeted Education for Atrial Fibrillation Patients (AF-EduCare)

Universiteit Antwerpen

Status: Completed

Conditions: Atrial Fibrillation and Flutter

Treatments: Other: Education

Study type: Interventional

Funder types: Other

Identifiers

NCT03707873

AF-EduCare / EC 18/12/171

T002917N (Other Grant/Funding Number)

Details and patient eligibility

About

The aim of this study is to evaluate the effect of targeted in-person and online education on cardiovascular outcomes of AF patients (inpatient and outpatient), compared with standard care. Several other parameters (i.e. knowledge level, quality of life, symptom burden, self-care capabilities, adherence to oral anticoagulation, and an evaluation of the educational efforts) will be studied. Cost-effectiveness and cost-utility will also be investigated.

The main research hypothesis is that individualized education based on the knowledge gaps measured with the JAKQ (Jessa Atrial fibrillation Knowledge Questionnaire) in each individual patient (called 'targeted education') is superior when compared to current AF care, both from an efficacy perspective (evaluated by different outcome measures) and from a cost-effectiveness perspective.

Enrollment: 1,040 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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1,040 participants in 3 patient groups

In-person education

Experimental group

Description:

Education will be given on a regular basis via predefined consultation visits. Medication adherence (oral anticoagulation) will also be measured using a special 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

Experimental group

Description:

Education will be given on a regular basis via a special designed online platform. Medication adherence (oral anticoagulation) will also be measured using a special 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

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).