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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation and Flutter
• Intervention / Treatment: Other: Education

• Study Type: Interventional
• Enrollment (Actual): 1040
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium
    • Antwerp University Hospital
  • Hasselt, Belgium
    • Jessa Hospital
  • Leuven, Belgium
    • University Hospitals Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Education; Education + Medication adherence monitoring + Feedback when low adherence
Experimental: 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.	Other: Education; Education + Medication adherence monitoring + Feedback when low adherence
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' knowledge level, assessed by the Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ)	This questionnaire includes 16 knowledge questions: 8 about atrial fibrillation, 5 about oral anticoagulation medication and 3 about vitamine K antagonists or non-vitamin K antagonist oral anticoagulants. A total score between 0% and 100% will be generated in which 100% is the best possible score (all questions are answered correctly).	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.	The EQ-5D-3L descriptive system includes a total of 5 questions for 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each question has 3 levels (no problems, some problems, and extreme problems). The EQ Visual Analogue Scale records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0). The AFEQT is an atrial fibrillation-specific health-related quality of life questionnaire based on 18 questions in the domain of symptoms, daily activities and treatment concerns. A treatment satisfaction score can be calculated based on 2 additional questions. All questions are rated on a 7 point Likert scale. A scoring key is used to determine an overall AFEQT score and a treatment satisfaction score ranging from 0 to 100. A lower score indicates a worse health-related quality of life.	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).	The LARQ is based on 6 atrial fibrillation-related symptoms: palpitations, shortness of breath, chest pain, syncope, dizziness and fatigue. For each of these symptoms (except syncope), symptom prevalence, occurrence (frequency, duration, severity), distress, circumstances triggering the symptom, and effect on daily activities are requested. Subscale scores on five domains (symptom frequency, duration, effect on daily activities, severity and distress) are calculated by summing the raw scores and transforming them to a 0-100 scale. Higher scores represent a more pronounced symptom burden.	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)	This questionnaire includes a total of 15 questions. The first 6 questions will be scored on a 1 to 5 Likert scale. 1 is the best score and 5 is the worst score. The other 9 questions measure evolutions of self-care capabilities over time.	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
Patients' satisfaction of the intervention will be assessed by a study specific Patient Reported Outcome Measure (PROM) questionnaire.	The number of questions will depend on the specific group allocation, ranging from a minimum of 4 questions to a maximum of 20 questions. These questions assess patients' satisfaction and opinion about the education provided during the study.	at 12 months in the intervention groups and 18 months in the standard care group.
Mortality	The occurrence of death will be followed.	Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
(Un)planned hospital admissions		Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Hospital duration	The total number of hospitalization days during the follow-up period will be calculated.	Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
(Un)planned cardiovascular and neurological visits		Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Cardiovascular emergency department visits		Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
General practitioner visits		Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time investments	Time investments will be tracked (e.g. timing of the initiation session, the education sessions, feedback during medication telemonitoring).	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	A cost-utility analysis will be performed.	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	A cost-effectiveness analysis will be performed.	Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Collaborators: Fund for Scientific Research, Flanders, Belgium
• Investigators: Principal Investigator: Hein Heidbuchel, MD, PhD, Universteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2018
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Education
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: AF-EduCare / EC 18/12/171; T002917N (Other Grant/Funding Number: Fund for Scientific Research Flanders (FWO) as Applied Biomedical Research with a Primary Social finality (TBM))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No