Atrial Fibrillation (AF)NUDGE-AFNCT07543393
Nudging for Anticoagulation Adherence in Atrial Fibrillation
A study testing Nudge Intervention in people with Atrial Fibrillation (AF), run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Nudge Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 20 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Gu'ang'zhou, Guangdong, 510120
Huiyu Zhou, RN,MSN, +8619864784496, 1205928513@qq.com
About this study
Official title: 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:
Read more
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
Read the 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.
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.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Nudge Intervention
- Keywords
- Nudge, Medication Adherence, Anticoagulation, Atrial Fibrillation, Randomized Controlled Trial
- Medical subject headings
- Atrial Fibrillation, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nudge InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start30 Jun 2026 (estimated)
- Primary completion20 Feb 2027 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaokang Wan, Sun Yat-sen University
- Investigators
- Xi Cao, PhD, RN, Principal investigator, Sun Yat-sen University, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543393
- Sponsor's protocol ID
- L2026SYSU-HL-009
- Acronym
- NUDGE-AF
- Status last verified
- Jun 2026
- First submitted
- 14 Apr 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Nudging Intervention in Promoting Adherence to Anticoagulation Among Patients With Atrial Fibrillation: a Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT07543393
- Acronym / sponsor ID
- NUDGE-AF / L2026SYSU-HL-009
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Nudge, Medication Adherence, Anticoagulation, Atrial Fibrillation, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nudge Intervention | Experimental | Behavioral: Nudge InterventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nudge InterventionParticipants 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. | Behavioural | Nudge Intervention |
Primary outcome
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.
3 secondary outcomes
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)
Illness perception measured by the Revised Illness Perception Questionnaire in patients with atrial fibrillation（AF-IPQ-R）
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xi Cao, PhD, RN principal investigator
Sun Yat-sen University, School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nudge Intervention in people with Atrial Fibrillation (AF), run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhaokang Wan, RN, MSN candidate (+8615919327731, wanzhk@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.