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

Study Overview
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Brief Summary
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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
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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).]

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

Conditions
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Atrial Fibrillation and Flutter

Intervention / Treatment
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* Other: Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Application-driven education (AF-EduApp substudy)<br>Education will be given via a newly developed application. Medication adherence (oral anticoagulation) will be measured using a special bottle cap that fits on a medication bottle. The patients in this group will receive feedback (notification and/or alarm) during the entire study period via this application when these patients have to take their medication. | Other: Education<br>* Education + Medication adherence monitoring + Feedback when low adherence<br>|
| Experimental: In-person education (AF-EduCare study)<br>Education will be given on regular basis via predefined consultation visits. Medication adherence (oral anticoagulation) will also be measured using a special bottle 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. | Other: Education<br>* Education + Medication adherence monitoring + Feedback when low adherence<br>|
| Experimental: Online education (AF-EduCare study)<br>Education will be given on regular basis via a special designed online platform. Medication adherence (oral anticoagulation) will also be measured using a special bottle 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. | Other: Education<br>* Education + Medication adherence monitoring + Feedback when low adherence<br>|
| No Intervention: Standard care (AF-EduCare study and AF-EduAppsub study)<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' adherence to medication (oral anticoagulation), measured by the Medication Events Monitoring System (MEMS). |  | Monitored between 0-12 months and 12-15 months if resources allow. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 
| 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). | 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). | 
| Patients' quality of life, assessed by the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire. | 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. | 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). | 
| 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. | 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). | 
| 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. | 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). | 
| 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. | at 12 months in all intervention groups and 12 or 18 months in the standard care groups. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Education, Application, Adherence