Effect of Targeted Education for Atrial Fibrillation Patients

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).

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.

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.

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).

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.

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)

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.

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.

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.

Time frame: at 12 months in the intervention groups and 18 months in the standard care group.

Mortality

The occurrence of death will be followed.

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

The total number of hospitalization days during the follow-up period will be calculated.

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).