The Effects of Nudging Intervention in Promoting Adherence to Anticoagulation Among Patients With Atrial Fibrillation: a Randomized Controlled Trail
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Medication Adherence measured by the Medication Adherence Estimation and Differentiation Scale (MEDS)
研究概览
简要总结
The goal of this clinical trial is to learn if a nudging intervention (using text message reminders, a medication calendar, and action planning) can help people with atrial fibrillation take their blood-thinning medication (anticoagulants) as prescribed.
The main questions it aims to answer are:
Does the nudging intervention improve medication adherence compared to usual care?
How does the intervention affect patients' beliefs about their medication and the automaticity of pill-taking?
Is the intervention cost-effective?
Researchers will compare participants who receive the nudging intervention with those who receive usual care.
Participants will:
Watch a short educational video about atrial fibrillation and stroke prevention
Make a personal plan to take their medication at the same time each day (for example, after breakfast)
Receive text message reminders 1 to 3 times per week, with fewer messages over time
Get a medication calendar to track daily doses
Answer a few questionnaires at the start, at 8 weeks, and at 12 weeks
详细描述
Study Design This is a prospective, randomized, parallel-group, controlled trial. A total of 84 adults with atrial fibrillation (AF) who are prescribed oral anticoagulants will be enrolled from a cardiology clinic. Participants will be randomly assigned to either the intervention group or the control group (usual care) in a 1:1 ratio using block randomization.
Intervention
The intervention group will receive a multi-component nudging program designed to support medication adherence. The program is based on behavioral economics principles (System 1 automatic processing) and includes:
A short educational video that uses vivid examples and social norms to raise awareness of stroke risk and the benefits of anticoagulation.
A personalized action plan (implementation intention) that links pill-taking to a daily routine (e.g., "after breakfast, I will take my pill").
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and intervention providers cannot be blinded due to the nature of the behavioral intervention. However, outcome assessors (data collectors and statisticians) will be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Diagnosed with non-valvular atrial fibrillation (AF) confirmed by medical records
- •Prescribed oral anticoagulants (e.g., warfarin, rivaroxaban, apixaban, dabigatran, edoxaban) for at least 3 months
- •Own a personal mobile phone capable of receiving SMS messages
- •Willing and able to provide written informed consent
排除标准
- •Severe cognitive impairment or psychiatric disorder that would preclude completion of questionnaires or adherence to the intervention
- •Life expectancy <6 months due to comorbid conditions
- •Currently enrolled in another medication adherence intervention study
- •Unable to read or understand Chinese (since validated Chinese scales are used)
研究组 & 干预措施
Nudge Intervention
Participants receive a multi-component nudge intervention including: an educational video on atrial fibrillation and stroke prevention; a personalized action plan linking pill-taking to a daily routine (e.g., after breakfast); a paper medication calendar with check-off grid and visual cues; tapered SMS reminders (3 times/week for weeks 1-3, 2 times/week for weeks 4-6, 1 time/week for weeks 7-8); weekly feedback messages on Sundays; and a mid-point telephone call at week 4 to address barriers and adjust the plan.
干预措施: Nudge Intervention (Behavioral)
Usual Care
Participants receive usual care as routinely provided by the cardiology clinic, including standard discharge education and regular follow-up visits. No additional adherence support is given during the study period. After the study is completed, participants in this arm will be offered the same medication calendar and text message templates as the intervention group.
结局指标
主要结局
Medication Adherence measured by the Medication Adherence Estimation and Differentiation Scale (MEDS)
时间窗: Baseline (week 0), end of intervention (week 8), and follow-up (week 12)
The MEDS is a 16-item, 5-point Likert scale (1=never to 5=always) assessing medication adherence across five dimensions: side effects, drug addiction, drug cost, lack of need/deliberate non-adherence, and unintentional non-adherence. Total scores range from 16 to 80, with higher scores indicating worse adherence.
次要结局
- Medication Beliefs measured by the Beliefs about Medicines Questionnaire (BMQ)(Baseline (week 0), end of intervention (week 8), and follow-up (week 12))
- Medication Habit Strength measured by the Self-Report Behavioural Automaticity Index (SRBAI)(Baseline (week 0), end of intervention (week 8), and follow-up (week 12))
- Cost-Utility Analysis: Incremental Cost-Effectiveness Ratio (ICER) using EQ-5D-5L and direct/indirect costs(Baseline (week 0), end of intervention (week 8), and follow-up (week 12) for EQ-5D-5L; costs collected continuously over the 12-week study period.)
- Illness perception measured by the Revised Illness Perception Questionnaire in patients with atrial fibrillation（AF-IPQ-R）(Baseline (week 0), end of intervention (week 8), and follow-up (week 12))
研究者
Zhaokang Wan
Principal Investigator
Sun Yat-sen University