Nudging for Anticoagulation Adherence in Atrial Fibrillation (NUDGE-AF)

April 14, 2026 updated by: Zhaokang Wan, Sun Yat-sen University

The Effects of Nudging Intervention in Promoting Adherence to Anticoagulation Among Patients With Atrial Fibrillation: a Randomized Controlled Trail

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Weekly feedback messages (positive reinforcement) sent on Sundays.

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.

Medication habit strength: measured by the Self-Report Behavioural Automaticity Index (SRBAI), a 4-item scale evaluating automaticity of pill-taking (e.g., "I do it without thinking").

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.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Gu'ang'zhou, Guangdong, China, 510120
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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; 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication Adherence measured by the Medication Adherence Estimation and Differentiation Scale (MEDS)
Time Frame: 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.
Baseline (week 0), end of intervention (week 8), and follow-up (week 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication Beliefs measured by the Beliefs about Medicines Questionnaire (BMQ)
Time Frame: Baseline (week 0), end of intervention (week 8), and follow-up (week 12)
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.
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)
Time Frame: Baseline (week 0), end of intervention (week 8), and follow-up (week 12)
The SRBAI is a 4-item scale measuring the automaticity of medication-taking behavior (e.g., "I do it without thinking"). Items are rated on a 5-point Likert scale (1=strongly disagree to 5=strongly agree). Total scores range from 4 to 20, with higher scores indicating stronger habit automaticity.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Xi Cao, PhD, RN, Sun Yat-sen University, School of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 18, 2026

Primary Completion (Estimated)

February 20, 2027

Study Completion (Estimated)

February 20, 2027

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L2026SYSU-HL-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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