ReAHEAD: A Study to Find Out Whether Education Improves Adherence to Dabigatran in People With Atrial Fibrillation Who Are Younger Than 75 Years
- Registration Number
- NCT04532528
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 898
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.
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Standard of care (SOC) only Dabigatran 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. SOC with advanced educational intervention Dabigatran 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.
- Primary Outcome Measures
Name Time Method 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 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 Outcome Measures
Name Time Method 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 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.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 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.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 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.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 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.Number of Patients Who Discontinued Treatment With Dabigatran in Patients With and Without Advanced Educational Intervention up to 12 months Number of patients who discontinued treatment with dabigatran in patients with and without advanced educational intervention.
Number of Patients Who Discontinued Treatment With Dabigatran and Reasons Why They Discontinued in Patients With and Without Advanced Educational Intervention 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.
Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention 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
Trial Locations
- Locations (23)
Buddhist Tzu Chi General Hospital
🇨🇳Hualien, Taiwan
National Taiwan University Hospital-Hsin-Chu Branch
🇨🇳Hsinchu, Taiwan
Pingtung Christian Hospital
🇨🇳Pingtung, Taiwan
Kuang-Tien General Hospital
🇨🇳Taichung, Taiwan
Chia-Yi Christian Hospital
🇨🇳Chia-Yi City, Taiwan
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
🇨🇳Chia-Yi, Taiwan
Kaohsiung Municipal Da-Tung Hospital
🇨🇳Kaohsiung, Taiwan
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung, Taiwan
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Cathay General Hospital
🇨🇳Taipei, Taiwan
Tungs' Taichung MetroHarbor Hospital
🇨🇳Taichung, Taiwan
NCKUH
🇨🇳Tainan, Taiwan
Chi Mei Medical Center
🇨🇳Tainan,, Taiwan
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
Taipei Municipal Wanfang Hospital
🇨🇳Taipei, Taiwan
Chang Gung Memorial Hospital(Linkou)
🇨🇳Taoyuan, Taiwan
Taipei Medical University-Shuang Ho Hospital
🇨🇳New Taipei City, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Taipei Medical University Hospital
🇨🇳Taipei City, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Cheng Hsin General Hospital
🇨🇳Taipei, Taiwan