ReAHEAD: A Study to Find Out Whether Education Improves Adherence to Dabigatran in People With Atrial Fibrillation Who Are Younger Than 75 Years

Study Overview
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Brief Summary
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Lifelong oral anticoagulant (OAC) therapy is the preferred treatment for the prevention of thromboembolic events in the majority of patients with Atrial Fibrillation (AF). Adherence to medication is essential for valid treatment for OAC therapy. The study aims to explore whether the advanced educational intervention would improve the adherence to dabigatran.

Official Title
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Relationship of Advanced Holding Education and ADherence on Antithrombotic in Younger SPAF Patients

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Dabigatran


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients can be included if ALL the following criteria are met: Provide written informed consent prior to participation Female or male adult patients aged ≥ 20 years and < 75 years, newly diagnosed with non-valvular atrial fibrillation (NVAF) within 1 month and has newly prescribed with dabigatran on physician's decision before study enrolment. Exclusion Criteria: Patients should not be included if ANY ONE of the following criteria is met: Contraindication to the use of dabigatran (i.e., active pathological bleeding, history of a serious hypersensitivity reaction to dabigatran [e.g., anaphylactic reaction or anaphylactic shock], severely impaired renal function [Creatinine clearance rate (Ccr) < 30 mL/min], hemorrhagic manifestations, bleeding diathesis, mechanical prosthetic heart valve, congenital or acquired coagulation disorders, organic lesions with bleeding tendency, or concomitantly use systemic ketoconazole, cyclosporine, and itraconazole) Participate in other interventional trials currently or in the past 30 days

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients receiving standard of care (SOC)<br>(without advanced educational Intervention) | Drug: Dabigatran<br>* Dabigatran<br>|
| Patients receiving SOC with advanced educational intervention<br> | Drug: Dabigatran<br>* Dabigatran<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with high adherence to dabigatran treatment at month 12 in patients with and without advanced educational intervention | High adherence is defined as achieving a Morisky 8-Item Medication Adherence Questionnaire (MMAS-8) score of 8 Points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. If a patient scores higher on the scale, they are evaluated as more adherent. If they score lower on the scale, they are presumed to be struggling with non-adherence. | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with high adherence to dabigatran treatment at 3, 6, and 9 months in patients with and without advanced educational intervention |  | up to 9 months | 
| Proportion of patients with medium (MMAS-8 score: 6 - 7 points) and low (MMAS-8 score < 6 points) adherence to dabigatran treatment at 3, 6, 9, and 12 months in patients with and without advanced educational intervention |  | up to 12 months | 
| Mean MMAS-8 score at 3, 6, 9, and 12 months in patients with and without advanced educational intervention |  | up to 12 months | 
| Discontinuation rate of dabigatran in patients with and without advanced educational intervention |  | up to 12 months | 
| Percentage of patients with reasons for discontinuation of dabigatran |  | up to 12 months |