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Atrial Fibrillation and FlutterAF-EduAppNCT03788044

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

A study testing Education in people with Atrial Fibrillation and Flutter, run by University Hospital, Antwerp at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation and Flutter
What is being tested?
Education
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
194 participants
Where
2 sitesBelgium
Study dates
28 Oct 2019to 30 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

  • Antwerp University Hospital

    Edegem

  • Jessa Hospital

    Hasselt

Other trials in Belgium

About this study

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.

Read the detailed 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).]

Being tested
Education
Keywords
Education, Application, Adherence
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EducationOther

    Education + Medication adherence monitoring + Feedback when low adherence

Study groups in NCT03788044
Study groupRoleWhat they receive
Application-driven education (AF-EduApp substudy)ExperimentalEducation 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.
Receives: Other: Education
In-person education (AF-EduCare study)ExperimentalEducation 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.
Receives: Other: Education
Online education (AF-EduCare study)ExperimentalEducation 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.
Receives: Other: Education
Standard care (AF-EduCare study and AF-EduAppsub study)No interventionThis 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 being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Monitored between 0-12 months and 12-15 months if resources allow.

Secondary outcomes (6)

  1. 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).

    Measured: at baseline,1 month,3-,6-,12 months in the application group.(+18-and if applicable at 24-,30-,36 months/at the end of the study in the other intervention groups).In the standard care groups at 12 or 18 months (if applicable at the end of the study).

  2. 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).

    Measured: at baseline, 3- and 12 months in the application group.(+18-and if applicable at 36 months/at the end of the study in the other intervention groups.) In the standard care groups at baseline and 12 or 18 months (and if applicable at the end of the study).

  3. Patients' quality of life, assessed by the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire.

    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.

    Measured: at baseline and 12 months in the application group.(+18-and if applicable at 36 months/at the end of the study in the other intervention groups.) In the standard care groups at baseline and 12 or 18 months (and if applicable at the end of the study).

  4. 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.

    Measured: at baseline,3- and 12 months in the application group.(+18-and if applicable at 36 months/at the end of the study in the other intervention groups).In the standard care groups at baseline and 12 or 18 months (and if applicable at the end of the study).

  5. 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.

    Measured: at baseline, 3- and 12 months in the application group. (+18-and if applicable 36 months/at the end of the study in the other intervention groups).In the standard care groups at baseline and 12 or 18 months (and if applicable at the end of the study).

  6. 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.

    Measured: at 12 months in all intervention groups and 12 or 18 months in the standard care groups.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2018
  2. Study start28 Oct 2019
  3. Primary completion30 Sep 2022
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
AF patients will be divided in four groups (AF-EduCare study and AF-EduApp substudy): one group will have application-based education (AF-EduApp substudy), the second group will have in-person education (AF-EduCare study), the third group will have online education (AF-EduCare study) and the fourth group will receive standard AF care (AF-EduCare study and not eligible for AF-EduApp substudy). NOAC adherence will be compared between these groups.
Masking
None (open label)
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03788044
Sponsor's protocol ID
AF-EduApp / EC 18/12/171
Other IDs
CV185-696
Acronym
AF-EduApp
Status last verified
Nov 2022
First submitted
5 Dec 2018
Last updated
3 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Knaepen L, Desteghe L, Delesie M, Onder R, Vijgen J, Dendale P, Ector J, Heidbuchel H. Effectiveness of the AF-EduCare and AF-EduApp approach to improve atrial fibrillation knowledge and risk factor awareness in patients with atrial fibrillation: a randomized controlled trial. Eur J Cardiovasc Nurs. 2025 Mar 3;24(2):266-276. doi: 10.1093/eurjcn/zvae164.

    PubMed 39780354

  • 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.

    PubMed 37332586

Questions about this trial

What is this clinical trial studying?

A study testing Education in people with Atrial Fibrillation and Flutter, run by University Hospital, Antwerp at 2 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients' adherence to medication (oral anticoagulation), measured by the Medication Events Monitoring System (MEMS). (time frame: Monitored between 0-12 months and 12-15 months if resources allow.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03788044, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.

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