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

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).

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.

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.

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.

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.

The first occurrence of a composite of cardiovascular death, a first cardiovascular hospitalization (i.e. hospitalization with overnight stay) and a first unplanned cardiovascular or neurological visit.

The occurrence of death will be followed.

Time investments will be tracked (e.g. timing of the initiation session, the education sessions, feedback during medication telemonitoring, time spended on the application time and content usage).

In all groups, the economic impact of hospitalizations, consultations, emergency department visits will be calculated using all relevant costs of inpatient and outpatient diagnostic/interventional procedures, based on the mean of hospital bills of each participating hospital. Since quality of life is evaluated throughout the trial, a cost-utility analysis will be performed.

In all groups, the economic impact of hospitalizations, consultations, emergency department visits will be calculated using all relevant costs of inpatient and outpatient diagnostic/interventional procedures, based on the mean of hospital bills of each participating hospital. With this data, a cost-effectiveness analysis will be performed.