Effect of Targeted Education for Atrial Fibrillation Patients

NCT03707873 | Completed

• 2 other identifiers: AF-EduCare / EC 18/12/171T002917N
• Study Type: interventional
• Target: 1,040
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Atrial Fibrillation and Flutter

Keywords

Education

Outcome Measures

Primary Outcomes (1)

• Cardiovascular events

  The occurrence of a composite endpoint of cardiovascular death, cardiovascular hospitalizations (first and recurrent) and unplanned cardiovascular or neurological consultations (first and recurrent).

  Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).

Secondary Outcomes (12)

• Patients' knowledge level, assessed by the Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ)

  at baseline, 1 month, 3-, 6-, 12- and 18 months and if applicable at 24-, 30- and 36 months or at the end of the study in the intervention groups. In the standard care group at 18 months and 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-, 12- and 18 months and if applicable at the end of the study in the intervention groups. In the standard care group at baseline and 18 months and if applicable at the end of the study.

• Patients' symptom burden, assessed by the Leuven ARrhythmia Questionnaire (LARQ).

  at baseline, 3-,12- and 18 months and if applicable at the end of the study in the intervention groups. In the standard care group at baseline and 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-,12- and 18 months and if applicable at the end of the study in the intervention groups. In the standard care group at baseline and 18 months and if applicable at the end of the study.

• Patients' adherence to medication (oral anticoagulation), measured by the Medication Events Monitoring System (MEMS).

  monitoring between 0-3 months and 12-15 months and feedback during 3-6 months and 15-18 months in those patients with a low adherence in the intervention groups

Other Outcomes (3)

• Time investments

  Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).

• Cost-utility analysis

  Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).

• Cost-effectiveness analysis

  Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).

Study Arms (3)

In-person education

EXPERIMENTAL

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.

Other: Education

Online education

EXPERIMENTAL

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.

Other: Education

Standard Care

NO INTERVENTION

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).

Interventions

Education OTHER

Education + Medication adherence monitoring + Feedback when low adherence

In-person education; Online education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• Fund for Scientific Research, Flanders, Belgium: collaborator

Study Sites (3)

Antwerp University Hospital

Edegem, Belgium

Location

Jessa Hospital

Hasselt, Belgium

Location

University Hospitals Leuven

Leuven, Belgium

Location

Related Publications (1)

• 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.

  PMID: 37332586 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Hein Heidbuchel, MD, PhD

  Universteit Antwerpen

  PRINCIPAL INVESTIGATOR

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

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 16, 2018
• Study Start: October 18, 2018
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)