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

NCT04532528 | Completed Results FDA Drug

• 1 other identifier: 1160-0304
• Study Type: observational
• Target: 897
• Locations: 1 country
• Sites: 23

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.

Conditions

Atrial Fibrillation

Outcome Measures

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

  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.

  at 12 months

Secondary Outcomes (7)

• 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

  at 3, 6, and 9 months

• 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

  At 3, 6, 9, and 12 months

• 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

  At 3, 6, 9, and 12 months

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

  At 3, 6, 9, and 12 months

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

  up to 12 months

Study Arms (2)

Standard of care (SOC) only

This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling.

Drug: Dabigatran

SOC with advanced educational intervention

This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention. The educational intervention was based on material of the "Shared decision making of treatment of New Oral AntiCoagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit.

Drug: Dabigatran

Interventions

Dabigatran DRUG

Dabigatran

SOC with advanced educational intervention; Standard of care (SOC) only

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (23)

Chia-Yi Christian Hospital

Chia-Yi City, 40705, Taiwan

Location

Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Chiayi City, 622, Taiwan

Location

National Taiwan University Hospital-Hsin-Chu Branch

Hsinchu, 300, Taiwan

Location

Buddhist Tzu Chi General Hospital

Hualien City, 970, Taiwan

Location

Kaohsiung Municipal Da-Tung Hospital

Kaohsiung City, 801, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

Taipei Medical University-Shuang Ho Hospital

New Taipei City, 235, Taiwan

Location

Pingtung Christian Hospital

Pingtung City, 900, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Tungs' Taichung MetroHarbor Hospital

Taichung, 435, Taiwan

Location

Kuang-Tien General Hospital

Taichung, 437, Taiwan

Location

NCKUH

Tainan, 704, Taiwan

Location

Chi Mei Medical Center

Tainan, 71004, Taiwan

Location

National Taiwan University Hospital

Taipei, 10016, Taiwan

Location

Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

Cathay General Hospital

Taipei, 106, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Cheng Hsin General Hospital

Taipei, 112, Taiwan

Location

Tri-Service General Hospital

Taipei, 11490, Taiwan

Location

Taipei Municipal Wanfang Hospital

Taipei, 11696, Taiwan

Location

Chang Gung Memorial Hospital(Linkou)

Taoyuan District, 330, Taiwan

Location

Related Publications (1)

• Chu CS, Tsai CT, Huang CY, Li CH, Tsai HL, Liu YB, Liu JC, Chang HR, Lin WS, Chao TF, Tsao TP, Shih JY, Chong JT, Huang SC, Wu CC, Lin CS, Shih CC, Cheng CI, Chao TH, Chiang CH, Huang CH, Chien CY, Lei WY, Lin KR, Chu PH, Lin TH. The RElationship of Advanced Education and ADherence (ReAHEAD) on antithrombotic in younger patients with non-valvular atrial fibrillation in Taiwan. J Formos Med Assoc. 2025 Oct 13:S0929-6646(25)00529-7. doi: 10.1016/j.jfma.2025.10.002. Online ahead of print.

  PMID: 41087222 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Document date is not required in the title page of the protocol/SEAP according to Boehringer Ingelheim internal policy.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 31, 2020
• Study Start: August 27, 2020
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: May 15, 2025
• Results First Posted: September 19, 2024

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (23)