Atrial Fibrillation and FlutterAF-EduCareNCT03707873
Effect of Targeted Education for Atrial Fibrillation Patients
A study testing Education in people with Atrial Fibrillation and Flutter, run by Universiteit Antwerpen at 3 sites in Belgium.
Trial 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. 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
- 1,040 participants
- Where
- 3 sitesBelgium
- Study dates
- 18 Oct 2018to 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
3 sites in 1 country.
Belgium3 sites
Antwerp University Hospital
Edegem
Jessa Hospital
Hasselt
University Hospitals Leuven
Leuven
About this study
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
- Being tested
- Education
- Keywords
- Education
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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- 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: at 12 months in the intervention groups and 18 months in the standard care group.
Mortality
The occurrence of death will be followed.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start18 Oct 2018
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation and FlutterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 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.
- Masking
- None (open label)
- Enrolment
- 1,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Responsible party
- Principal investigator, Prof. Dr. Hein Heidbuchel, Universiteit Antwerpen
- Investigators
- Hein Heidbuchel, MD, PhD, Principal investigator, Universteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707873
- Sponsor's protocol ID
- AF-EduCare / EC 18/12/171
- Other IDs
- T002917N
- Acronym
- AF-EduCare
- Status last verified
- Nov 2022
- First submitted
- 2 Oct 2018
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Targeted Education for Atrial Fibrillation Patients
- ClinicalTrials.gov ID
- NCT03707873
- Acronym / sponsor ID
- AF-EduCare / AF-EduCare / EC 18/12/171
- Conditions
- Atrial Fibrillation and Flutter
- Keywords
- Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,040 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| In-person education | Experimental | Other: EducationEducation 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. |
| Online education | Experimental | Other: EducationEducation 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationEducation + Medication adherence monitoring + Feedback when low adherence | Other | In-person education, Online education |
Primary outcome
Cardiovascular events
Time frame: Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
The occurrence of a composite endpoint of cardiovascular death, cardiovascular hospitalizations (first and recurrent) and unplanned cardiovascular or neurological consultations (first and recurrent).
12 secondary outcomes
Patients' knowledge level, assessed by the Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ)
Time frame: 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.
Time frame: 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).
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: at 12 months in the intervention groups and 18 months in the standard care group.
Mortality
Time frame: 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
Time frame: Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Hospital duration
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Derived from this study: PubMed 37332586Delesie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hein Heidbuchel, MD, PhD principal investigator
Universteit Antwerpen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Atrial Fibrillation and Flutter, run by Universiteit Antwerpen at 3 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 9 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 3 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?
Cardiovascular events (time frame: Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).). 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 NCT03707873, which also lists 1 linked publication.
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 9 Nov 2022.