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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
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").
A paper medication calendar with a check-off grid and visual cues (e.g., icons for brushing teeth or meals) to serve as an environmental reminder.
Tapered SMS reminders: 3 times/week during weeks 1-3, 2 times/week during weeks 4-6, and 1 time/week during weeks 7-8. Reminders are sent 30 minutes before the participant's chosen dosing time.
A mid-point telephone call (week 4) to address barriers and adjust the action plan if needed.
The control group will receive usual care, which includes standard discharge education and routine clinic visits. After the study ends, control participants will be given the same medication calendar and text message templates.
Outcome Measures The primary outcome is medication adherence, measured at baseline, week 8 (end of intervention), and week 12 (follow-up) using the Medication Adherence Estimation and Differentiation Scale (MEDS). MEDS is a 16-item, 5-level Likert scale that captures adherence across five dimensions: side effects, drug addiction, drug cost, lack of need/deliberate non-adherence, and unintentional non-adherence.
Secondary outcomes include:
Medication beliefs: measured by the Beliefs about Medicines Questionnaire (BMQ), which assesses perceived necessity and concerns about anticoagulants.
Illness perception: measured by the Revised Illness Perception Questionnaire in patients with atrial fibrillation（AF-IPQ-R）, a 36-item scale evaluating illness perception of atrial fibrillation.
Cost-effectiveness: assessed by collecting direct medical costs (medication, clinic visits, hospitalizations) and indirect costs (time lost, travel), combined with quality-of-life data from EQ-5D-5L to estimate incremental cost-effectiveness ratios.
Data Collection and Analysis All outcomes will be collected by a research assistant blinded to group assignment. Statistical analysis will follow the intention-to-treat principle. The primary analysis will use a mixed-effects linear model to compare changes in adherence between groups over time. Mediation analysis will test whether medication beliefs and habit strength mediate the intervention effect on adherence, using bootstrapping methods. Cost-effectiveness will be analyzed from a societal perspective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nudge Intervention | Experimental | 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. |
|
| Usual Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nudge Intervention | Behavioral | 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; a paper medication calendar with check-off grid and visual cues; tapered SMS reminders (weekly frequency declines from 3 to 1 over 8 weeks); weekly feedback messages; and a mid-point telephone call at week 4. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence measured by the Medication Adherence Estimation and Differentiation Scale (MEDS) | 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. | Baseline (week 0), end of intervention (week 8), and follow-up (week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Beliefs measured by the Beliefs about Medicines Questionnaire (BMQ) | The BMQ assesses patients' perceptions of the necessity of their prescribed medication and concerns about potential adverse effects. It consists of two subscales: Necessity (5 items) and Concerns (5 items), each scored from 5 to 25. Higher necessity scores and lower concerns scores indicate stronger positive beliefs about medication. |
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Inclusion Criteria:
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
Exclusion Criteria:
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)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaokang Wan, RN, MSN candidate | Contact | +8615919327731 | wanzhk@mail2.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xi Cao, PhD, RN | Sun Yat-sen University, School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Gu'ang'zhou | Guangdong | 510120 | China |
Individual participant data (IPD) will not be shared because this is a small-scale, single-center master's thesis study. The informed consent form does not include provisions for data sharing beyond the immediate research team and the approved ethical protocol. Moreover, sharing IPD could compromise participant privacy given the sensitive nature of medication adherence data, and the study does not have the resources to establish a secure, publicly accessible data repository.
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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.
|
| Baseline (week 0), end of intervention (week 8), and follow-up (week 12) |
| Illness perception measured by the Revised Illness Perception Questionnaire in patients with atrial fibrillation（AF-IPQ-R） | TheAF-IPQ-R is to measure the subjective cognition of patients with atrial fibrillation regarding the entire process of atrial fibrillation characteristics, treatment measures (such as oral anticoagulant drugs), prognosis (stroke occurrence), etc. It is specific to patients with atrial fibrillation. This scale consists of 7 dimensions and 36 items: timeline (chronic/acute) 6 items, disease consequences 6 items, personal control 6 items, disease consistency 5 items, circadian rhythm 4 items, emotional expression 6 items, and treatment control 5 items. The questionnaire uses the Likert 5-point rating method, with the options being: "Strongly disagree", "Disagree", "Neutral", "Agree", and "Strongly agree", corresponding to scores of 1, 2, 3, 4, and 5 respectively. The total score of the scale is the sum of the scores of the 7 dimensions, with a total score range of 36 to 180 points. The higher the score, the higher the level of perception of atrial fibrillation disease. | 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 | Quality-adjusted life years (QALYs) will be estimated from the EQ-5D-5L (5 dimensions, each rated 1-5; visual analog scale 0-100). Direct medical costs (medications, clinic visits, hospitalizations) and indirect costs (time loss, travel) will be collected via patient diaries and hospital records. The ICER will be calculated as incremental cost per QALY gained. | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |