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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04532528
• Collaborator: (none)
• Enrollment: 898
• Locations: 23
• Anticipated Duration (Months): 36.1
• Patients Per Site: 39
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: Dabigatran

Study Design

• Study Type: Observational
• Actual Enrollment: 898 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Relationship of Advanced Holding Education and ADherence on Antithrombotic in Younger SPAF Patients
• Actual Study Start Date: Aug 27, 2020
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Proportion of patients with high adherence to dabigatran treatment at month 12 in patients with and without advanced educational intervention [up to 12 months]

   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.

Secondary Outcome Measures

1. 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]

2. 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]

3. Mean MMAS-8 score at 3, 6, 9, and 12 months in patients with and without advanced educational intervention [up to 12 months]

4. Discontinuation rate of dabigatran in patients with and without advanced educational intervention [up to 12 months]

5. Percentage of patients with reasons for discontinuation of dabigatran [up to 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chia-Yi Christian Hospital	Chia-Yi City		Taiwan	40705
2	Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation	Chia-Yi		Taiwan	622
3	National Taiwan University Hospital-Hsin-Chu Branch	Hsinchu		Taiwan	300
4	Buddhist Tzu Chi General Hospital	Hualien		Taiwan	970
5	Kaohsiung Municipal Da-Tung Hospital	Kaohsiung		Taiwan	801
6	Kaohsiung Veterans General Hospital	Kaohsiung		Taiwan	81362
7	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung		Taiwan	83301
8	Taipei Medical University-Shuang Ho Hospital	New Taipei City		Taiwan	235
9	Pingtung Christian Hospital	Pingtung		Taiwan	900
10	Taichung Veterans General Hospital	Taichung		Taiwan	40705
11	Tungs' Taichung MetroHarbor Hospital	Taichung		Taiwan	435
12	Kuang-Tien General Hospital	Taichung		Taiwan	437
13	Chi Mei Medical Center	Tainan,		Taiwan	71004
14	NCKUH	Tainan		Taiwan	704
15	Taipei Medical University Hospital	Taipei City		Taiwan	110
16	National Taiwan University Hospital	Taipei		Taiwan	10016
17	Mackay Memorial Hospital	Taipei		Taiwan	10449
18	Cathay General Hospital	Taipei		Taiwan	106
19	Taipei Veterans General Hospital	Taipei		Taiwan	11217
20	Cheng Hsin General Hospital	Taipei		Taiwan	112
21	Tri-Service General Hospital	Taipei		Taiwan	11490
22	Taipei Municipal Wanfang Hospital	Taipei		Taiwan	11696
23	Chang Gung Memorial Hospital(Linkou)	Taoyuan		Taiwan	330

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT04532528
• Other Study ID Numbers: 1160-0304
• First Posted: Aug 31, 2020
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Additional relevant MeSH terms: Atrial Fibrillation; Dabigatran

Study Results

No Results Posted as of Aug 9, 2022