Nudging for Anticoagulation Adherence in Atrial Fibrillation

NCT07543393 | Not Yet Recruiting

• 1 other identifier: L2026SYSU-HL-009
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation (AF)

Keywords

Nudge; Medication Adherence; Anticoagulation; Atrial Fibrillation; Randomized Controlled Trial

Outcome Measures

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.

  Baseline (week 0), end of intervention (week 8), and follow-up (week 12)

Secondary Outcomes (3)

• 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.

Study Arms (2)

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.

Behavioral: Nudge Intervention

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.

Interventions

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.

Nudge Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Gu'ang'zhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Atrial Fibrillation; Medication Adherence

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Xi Cao, PhD, RN

  Sun Yat-sen University, School of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaokang Wan, RN, MSN candidate

CONTACT

+8615919327731; wanzhk@mail2.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): February 20, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)