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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04532528
• Other study ID #: 1160-0304
• Status: Completed
• Start date: August 27, 2020
• Est. completion date: May 8, 2023

Study information

• Verified date: May 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 898
• Est. completion date: May 8, 2023
• Est. primary completion date: May 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Dabigatran
Dabigatran

Locations

Country	Name	City	State
Taiwan	Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation	Chia-Yi
Taiwan	Chia-Yi Christian Hospital	Chia-Yi City
Taiwan	National Taiwan University Hospital-Hsin-Chu Branch	Hsinchu
Taiwan	Buddhist Tzu Chi General Hospital	Hualien
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Municipal Da-Tung Hospital	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	Taipei Medical University-Shuang Ho Hospital	New Taipei City
Taiwan	Pingtung Christian Hospital	Pingtung
Taiwan	Kuang-Tien General Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Tungs' Taichung MetroHarbor Hospital	Taichung
Taiwan	NCKUH	Tainan
Taiwan	Chi Mei Medical Center	Tainan,
Taiwan	Cathay General Hospital	Taipei
Taiwan	Cheng Hsin General Hospital	Taipei
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Municipal Wanfang Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Taipei Medical University Hospital	Taipei City
Taiwan	Chang Gung Memorial Hospital(Linkou)	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Mean MMAS-8 score at 3, 6, 9, and 12 months in patients with and without advanced educational intervention		up to 12 months
Secondary	Discontinuation rate of dabigatran in patients with and without advanced educational intervention		up to 12 months
Secondary	Percentage of patients with reasons for discontinuation of dabigatran		up to 12 months

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