Nudging for Anticoagulation Adherence in Atrial Fibrillation
ConditionAtrial Fibrillation (AF)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Disqualifiers
Severe cognitive impairment or psychiatric disorder that would preclude completion of questionnaires or adherence to the intervention
Trial design
Design model
Parallel
Treatments tested in this trial
Nudge Intervention
BehavioralParticipants 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Nudge InterventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (week 0), end of intervention (week 8), and follow-up (week 12)Secondary outcomes
1
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.
Time frame
Baseline (week 0), end of intervention (week 8), and follow-up (week 12)2
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.
Time frame
Baseline (week 0), end of intervention (week 8), and follow-up (week 12)3
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.
Time frame
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.Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Status unavailable 510120, Gu'ang'zhou, Guangdong
China
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Source ClinicalTrials.gov
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