Clinical trial NCT03788044: Effect of Targeted Education for Atrial Fibrillation Patients (Application Substudy)
Official title: Effect of Targeted Education for Atrial Fibrillation Patients (Application Substudy)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation and Flutter
Keywords: Education
Application
Adherence
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: Universiteit Antwerpen
First posted: 2018-12-27
Enrollment: 194
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 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.
Primary purpose: TREATMENT

Brief 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.

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.

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).

\[An anticipated total of 1259 AF patients will be included for the AF-EduCare study (1038 AF patients) plus the AF-EduApp substudy (221 AF patients).\]

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: Patients' adherence to medication (oral anticoagulation), measured by the Medication Events Monitoring System (MEMS).
timeFrame: Monitored between 0-12 months and 12-15 months if resources allow.
Secondary outcomes:
measure: Patients' knowledge level, assessed by the Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ)
timeFrame: 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).
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- 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).
measure: Patients' quality of life, assessed by the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire.
timeFrame: 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).
measure: Patients' symptom burden, assessed by the Leuven ARrhythmia Questionnaire (LARQ).
timeFrame: 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).
measure: Patients' self-care capabilities, assessed by the Self-Care Questionnaire (SCQ).
timeFrame: 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).
measure: Patients' satisfaction of the intervention will be assessed by a study specific Patient Reported Outcome Measure (PROM) questionnaire.
timeFrame: at 12 months in all intervention groups and 12 or 18 months in the standard care groups.
Other outcomes:
measure: The first occurrence of a cardiovascular event
timeFrame: Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
measure: Mortality
timeFrame: Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
measure: Number of (un)planned hospital admissions
timeFrame: Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
measure: Hospital duration
timeFrame: Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
measure: Number of (un)planned cardiovascular and neurological visits
timeFrame: Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
measure: Number of cardiovascular emergency department visits
timeFrame: Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
measure: General practitioner visits
timeFrame: Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
measure: Exact time investments (in minutes)
timeFrame: Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
measure: Cost-utility analysis
timeFrame: Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
measure: Cost-effectiveness analysis
timeFrame: Patients (AF-EduCare study and AF-EduApp substudy) will be followed for a minimum of 12 months to a maximum of 36 months.
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Hasselt
country: Belgium
facility: Jessa Hospital
Study officials:
affiliation: University Hospital of Antwerp
name: Hein Heidbuchel, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References: