Effect of Targeted Education for Atrial Fibrillation Patients

NCT ID: NCT03707873

Last Updated: 2022-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1040 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-18

Study Completion Date

2022-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation and Flutter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

AF patients will be divided in three groups: one group will have in-person education, the second group will have online education and the third group will receive standard AF care. Cardiovascular outcomes will be compared between these groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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In-person education

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.

Group Type EXPERIMENTAL

Education

Intervention Type OTHER

Education + Medication adherence monitoring + Feedback when low adherence

Online education

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.

Group Type EXPERIMENTAL

Education

Intervention Type OTHER

Education + Medication adherence monitoring + Feedback when low adherence

Standard Care

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

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Education

Education + Medication adherence monitoring + Feedback when low adherence

Intervention Type OTHER

Eligibility Criteria

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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

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Fund for Scientific Research, Flanders, Belgium

OTHER

Sponsor Role collaborator

Universiteit Antwerpen

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Hein Heidbuchel

Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hein Heidbuchel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universteit Antwerpen

Locations

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Antwerp University Hospital

Edegem, , Belgium

Site Status

Jessa Hospital

Hasselt, , Belgium

Site Status

University Hospitals Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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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

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T002917N

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AF-EduCare / EC 18/12/171

Identifier Type: -

Identifier Source: org_study_id

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