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Completed

NCT Number: NCT04532528

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chia-Yi Christian Hospital, Chia-Yi City, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dabigatran

Drug

Dabigatran

Primary outcomes

  1. Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at Month 12 in Patients With and Without Advanced Educational Intervention

    Time frame: at 12 months

    Number of patients with high adherence to dabigatran treatment at month 12 in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A high adherence was defined as achieving a MMAS-8 score of 8 Points.

    The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence.

    The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.

Secondary outcomes

  1. Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at 3, 6, and 9 Months in Patients With and Without Advanced Educational Intervention

    Time frame: at 3, 6, and 9 months

    Number of patients with high adherence to dabigatran treatment at 3, 6, and 9 months in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A high adherence was defined as achieving a MMAS-8 score of 8 Points.

    The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence.

    The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.

  2. Number of Patients With Medium (MMAS-8 Score: 6 to 7 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention

    Time frame: At 3, 6, 9, and 12 months

    Number of patients with medium adherence to dabigatran treatment at 3, 6, 9, and 12 months in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A medium adherence was defined as achieving a MMAS-8 score of 6 or 7 points.

    The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence.

    The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.

  3. Number of Patients With Low (MMAS-8 Score: 0 to 5 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention

    Time frame: At 3, 6, 9, and 12 months

    Number of patients with low adherence to dabigatran treatment at 3, 6, 9, and 12 months in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A low adherence was defined as achieving a MMAS-8 score of 0, 1, 2, 3, 4, or 5 points.

    The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence.

    The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.

  4. Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention

    Time frame: At 3, 6, 9, and 12 months

    Mean Morisky 8-Item Medication Adherence Questionnaire (MMAS-8) score at 3, 6, 9, and 12 months in patients with and without advanced educational intervention.

    The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence.

    The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.

  5. Number of Patients Who Discontinued Treatment With Dabigatran in Patients With and Without Advanced Educational Intervention

    Time frame: up to 12 months

    Number of patients who discontinued treatment with dabigatran in patients with and without advanced educational intervention.

  6. Number of Patients Who Discontinued Treatment With Dabigatran and Reasons Why They Discontinued in Patients With and Without Advanced Educational Intervention

    Time frame: up to 12 months

    Number of patients who discontinued treatment with dabigatran and reasons why they discontinued in patients with and without advanced educational intervention.

  7. Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention

    Time frame: up to 12 months

    Number of patients who switched treatment with dabigatran and reasons why they switched in patients with and without advanced educational intervention

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2020
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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