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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Dabigatran

• Study Type: Observational
• Enrollment (Actual): 898

Contacts and Locations

Study Locations

• Taiwan
  • Chia-Yi, Taiwan, 622
    • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
  • Chia-Yi City, Taiwan, 40705
    • Chia-Yi Christian Hospital
  • Hsinchu, Taiwan, 300
    • National Taiwan University Hospital-Hsin-Chu Branch
  • Hualien, Taiwan, 970
    • Buddhist Tzu Chi General Hospital
  • Kaohsiung, Taiwan, 81362
    • Kaohsiung Veterans General Hospital
  • Kaohsiung, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital
  • Kaohsiung, Taiwan, 801
    • Kaohsiung Municipal Da-Tung Hospital
  • New Taipei City, Taiwan, 235
    • Taipei Medical University-Shuang Ho Hospital
  • Pingtung, Taiwan, 900
    • Pingtung Christian Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 435
    • Tungs' Taichung MetroHarbor Hospital
  • Taichung, Taiwan, 437
    • Kuang-Tien General Hospital
  • Tainan, Taiwan, 704
    • NCKUH
  • Tainan,, Taiwan, 71004
    • Chi Mei Medical Center
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 11490
    • Tri-service general hospital
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital
  • Taipei, Taiwan, 112
    • Cheng Hsin General Hospital
  • Taipei, Taiwan, 106
    • Cathay General Hospital
  • Taipei, Taiwan, 10016
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11696
    • Taipei Municipal Wanfang Hospital
  • Taipei City, Taiwan, 110
    • Taipei Medical University Hospital
  • Taoyuan, Taiwan, 330
    • Chang Gung Memorial Hospital(Linkou)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients newly diagnosed with AF within 1 month, under 75 years old, and newly prescribed with dabigatran on physician's decision per local labelling will be equally randomized to receive standard of care (routine clinical practice) or standard of care (routine clinical practice) with advanced educational intervention.

Description

Inclusion Criteria:

Patients can be included if ALL the following criteria are met:

1. Provide written informed consent prior to participation
2. 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:

1. 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)
2. Participate in other interventional trials currently or in the past 30 days

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients receiving standard of care (SOC); (without advanced educational Intervention)	Drug: Dabigatran; Dabigatran
Patients receiving SOC with advanced educational intervention	Drug: Dabigatran; Dabigatran

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2020
• Primary Completion (Actual): May 8, 2023
• Study Completion (Actual): May 8, 2023

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Dabigatran
• Other Study ID Numbers: 1160-0304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

• IPD Sharing Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• IPD Sharing Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No