Clinical trial NCT03707873: Effect of Targeted Education for Atrial Fibrillation Patients
Official title: Effect of Targeted Education for Atrial Fibrillation Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation and Flutter
Keywords: Education
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
First posted: 2018-10-16
Enrollment: 1040
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular events
timeFrame: Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Secondary outcomes:
measure: Patients' knowledge level, assessed by the Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ)
timeFrame: 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.
measure: Patients' quality of life, assessed by the EQ-5D-3L questionnaire and the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire.
timeFrame: 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.
measure: Patients' symptom burden, assessed by the Leuven ARrhythmia Questionnaire (LARQ).
timeFrame: 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.
measure: Patients' self-care capabilities, assessed by the Self-Care Questionnaire (SCQ)
timeFrame: 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.
measure: Patients' adherence to medication (oral anticoagulation), measured by the Medication Events Monitoring System (MEMS).
timeFrame: 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
measure: Patients' satisfaction of the intervention will be assessed by a study specific Patient Reported Outcome Measure (PROM) questionnaire.
timeFrame: at 12 months in the intervention groups and 18 months in the standard care group.
measure: Mortality
timeFrame: Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
measure: (Un)planned hospital admissions
timeFrame: Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
measure: Hospital duration
timeFrame: Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
measure: (Un)planned cardiovascular and neurological visits
timeFrame: Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
measure: Cardiovascular emergency department visits
timeFrame: Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
measure: General practitioner visits
timeFrame: Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Other outcomes:
measure: Time investments
timeFrame: Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
measure: Cost-utility analysis
timeFrame: Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
measure: Cost-effectiveness analysis
timeFrame: Patients will be followed for a minimum of 18 months (=last included patient) to a maximum of 36 months (=first included patient).
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Hasselt
country: Belgium
facility: Jessa Hospital
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universteit Antwerpen
name: Hein Heidbuchel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: