Atrial Fibrillation (AF)NCT07174778
Episodic Future Thinking to Improve Anticoagulant Adherence in Atrial Fibrillation
A study testing Episodic future thinking in people with Atrial Fibrillation (AF), run by Jiawen You at 2 sites in China.
Trial summary
The purpose of this study is to assess the effectiveness of Episodic Future Thinking (EFT) on improving medication adherence in atrial fibrillation (AF) patients taking oral anticoagulants. A total of 68 participants will be randomly assigned to the intervention group or the control group. 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?
- Episodic future thinking
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 2 sitesChina
- Study dates
- 15 Sep 2025to 31 Mar 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
- Meets diagnostic criteria for atrial fibrillation per the Chinese Guidelines for the Diagnosis and Management of Atrial Fibrillation, with clinically stable condition
- Current or previous use of oral anticoagulants
- Age ≥18 years
- Capable of using WeChat mobile application
- Willing to provide informed consent
Who cannot join
- Comorbid severe impairment of major organ systems or end-stage disease
- Significant visual or auditory impairments
- Documented cognitive dysfunction or psychiatric disorders (e.g., major depressive disorder, schizophrenia, bipolar disorder)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Guangdong Provincial People's Hospital
Guangzhou, Gangdong, 510080
Jiawen You, 0086-15280095563, youjw@mail2.sysu.edu.cn
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Gangdong, 510080
Jiawen You, 0086-15280095563, youjw@mail2.sysu.edu.cn
About this study
Official title: The Effects of Episodic Future Thinking in Promoting Adherence to Anticoagulation Among Patients With Atrial Fibrillation: a Randomized Controlled Trail
The purpose of this study is to assess the effectiveness of Episodic Future Thinking (EFT) on improving medication adherence in atrial fibrillation (AF) patients taking oral anticoagulants. A total of 68 participants will be randomly assigned to the intervention group or the control group. Those in the intervention group will receive a 3-week EFT intervention in addition to the usual care, while those in the control group will receive the usual care only. Data on medication adherence, delay discounting (DD), and anticoagulation knowledge will be collected at baseline, end of intervention, and 3-month follow-up.
Read the detailed description
Participants (N = 68) will be randomly assigned to either an episodic future thinking (EFT) group or attention control group. We will use stratified block randomization. The randomization will be stratified by study site. Within each site, participants will be randomly assigned to either the intervention or control group in a 1:1 ratio using a computer-generated random allocation sequence with variable block sizes (e.g., 4 and 6). A research assistant not involved in recruitment or assessment will generate the sequence. To ensure allocation concealment, sequentially numbered, opaque, sealed envelopes will be prepared according to the generated sequence. After obtaining consent and confirming eligibility, the enrolling investigator will open the next consecutive envelope in the presence of the participant to assign them to a group.
Participants in the intervention group will receive episodic future thinking intervention in addition to the routine health care. The intervention consists of three sessions. In session 1 (on discharge day), the researcher will first provide face-to-face health education on atrial fibrillation-related stroke prevention and a video on the same topics for participants. The health education cover four topics: 1) definition and causes of atrial fibrillation; 2) atrial fibrillation and stroke risk; 3) anticoagulation therapy for stroke prevention; 4) management of comorbidities and risk factors of atrial fibrillation.Then, participants will be instructed to generate individualized episodic future events by visualizing events that will happen or be planned to happen in the coming 1, 3, 6, and 12 months respectively. Participants will be guided to think the long-term impacts (including the benefits and consequences) of adhering or not adhering to oral anticoagulants on their health when imagining future scenario events. The detailed future scenario events imagined by the participants will be condensed into brief narrative statements and also matched with pictures to form text-based and picture-based cues respectively. During Session 2 (weeks 1-3 post-discharge), researchers will administer these cues to participants via WeChat, with two cues per day for the first week followed by one cue per day for the week 2 to week 3. Participants will be asked to complete episodic future thinking task by re-imagining the episodic event based on the content of the cues received within 24 hours. A total of three reminders including a first message reminder within six hours and a second message within 12 hours will be sent to participants to remind them complete the task if no response received in the required time frame. A nonresponse will be recorded if participants did not complete the task 24 hours later the first prompt was sent. Participants will be also encouraged to practice EFT to enhance their adherence to anticolagulation by themselves at home. Participants in the intervention group also will receive weekly education on atrial fibrillation-related stroke prevention. The topics of education are the same with the first session, with topic 1-2 for week 1, topic 3 for week 2, and topic 4 for week 3. In session 3 ( follow-up after the intervention), participants will be followed up once a month by researchers via WeChat or telephone. During each follow-up, adherence to oral anticoagulant will be assessed and issues relating to the management of the illness will be identified and addressed. Any emergent conditions such as major bleeding relating to anticoagulation will be referred to physicians.
The control group will receive usual care, including brief information on atrial fibrilation from ward nurses and one post-discharge telephone follow-up. To reduce potential attention bias, the control group will receive greeting calls from researcher during follow-up with same frequency as the intervention group. In each greeting call, the research will only make greetings or give general information on the illness to participants, no health education will be delivered, and health problems will be addressed.
Data on adherence to anticoagulation, delay discounting and anticoagulation knowledge will be collected at baseline (T0), immediately after the intervention (T1), as well at 3-month follow up (T2). Trained outcome assessors, blinded to group allocation and independent of all other trial procedures, will perform all endpoint evaluations.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Episodic future thinking, attention control
- Keywords
- Atrial Fibrillation, Stroke, Episodic Future Thinking, Delay Discounting
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Episodic future thinkingBehavioural
Participants will engage in episodic future thinking prompted via text-based cues and picture-based cues to help them adhere to oral anticoagulants. Participants will also receive health education on atrial fibrillation-related stroke prevention.
attention controlBehavioural
The control group will receive standard care, including routine health education from ward nurses and one post-discharge telephone follow-up. In additon, participants will receive a message from the researcher at the same time point each day, but the message will only involve daily greetings.
| Study group | Role | What they receive |
|---|---|---|
| Episodic future thinking | Experimental | Participants will generate individualized episodic future events and transform them to text-based and picture-based cues which will reminder participants to re-imagine their future events in their daily life. Receives: Behavioral: Episodic future thinking |
| Attention control | Placebo comparator | Researchers will maintain equal contact frequency with controls, limited to general check-in messages. Receives: Behavioral: attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
This study assessed oral anticoagulant adherence using the General Medication Adherence Scale (GMAS) . The 11-item scale evaluates three dimensions: (1) patient behavior related non-adherence (five items), (2) additional disease and pill burden (four items) and (3) cost-related non-adherence (two items). Each item is rated on the scale that 0 = always, 1 = mostly, 2 = sometimes, and 3 = never. Higher scores indicate better adherence and it was divided into five levels according to different scores: 30-33 (high adherence), 27-29 (good adherence), 17-26 (moderate adherence), 11-16 (low adherence), and 0-10 (poor adherence).
Measured: Baseline, 3 weeks and 15 weeks
Secondary outcomes (3)
Delay discounting for money
Delay discounting for money was measured through the Monetary Choice Questionnaire (MCQ). In this test, participants were asked to make a series of choices between smaller-immediate and larger-delayed hypothetical monetary rewards. An example of a question is "Would you prefer $54 today, or $55 in 117 days?". Based on the participants' responses, the delay discounting rate (k) can be calculated. Higher k values indicate a pattern for choosing the rewards in the proximal time frame. All monetary options presented in the questionnaire are entirely hypothetical scenarios. They are designed solely to measure participants' decision-making preferences in an imagined context and do not, in any way, represent the actual compensation or rewards that will be paid to participants in this study.
Measured: Baseline, 3 weeks, 15 weeks
Delay discounting for health
A self-developed Health Intertemporal Choice Questionnaire was used to measure individual delay discounting rates for health outcomes. Patients with atrial fibrillation were presented with a series of choices between a near-term option-"X% reduction in stroke risk after one month of oral anticoagulant therapy"-and a delayed option-"a 65% reduction in stroke risk after one year of oral anticoagulant therapy." The value of Y in the delayed option was fixed at 65%, while the near-term option X ranged from 5% to 60%, increasing in increments of 5%. An example of a question is "Which would you prefer: a 5% reduction in stroke risk after one month of oral anticoagulant use, or a 65% reduction in stroke risk after one year of oral anticoagulant use?"
Measured: Baseline, 3 weeks and 15 weeks
Anticoagulation knowledge
The Anticoagulation Knowledge Tool (AKT) was employed to measure participants' anticoagulation knowledge. The AKT assesses five domains: basic drug information, adverse effects, therapeutic monitoring, drug interactions, and dietary considerations. Section I (20 items) evaluates knowledge of both novel oral anticoagulants and warfarin, while Section II (8 items) focuses specifically on warfarin. Only Section I was utilized in this study.
Measured: Baseline, 3 weeks, 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Mar 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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiawen You
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiawen You, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174778
- Sponsor's protocol ID
- L2025SYSU-HL-022
- Status last verified
- Sep 2025
- First submitted
- 6 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Episodic Future Thinking in Promoting Adherence to Anticoagulation Among Patients With Atrial Fibrillation: a Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT07174778
- Acronym / sponsor ID
- L2025SYSU-HL-022
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Atrial Fibrillation, Stroke, Episodic Future Thinking, Delay Discounting
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Jiawen YouUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 16 Sep 2025 (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 purpose of this study is to assess the effectiveness of Episodic Future Thinking (EFT) on improving medication adherence in atrial fibrillation (AF) patients taking oral anticoagulants. A total of 68 participants will be randomly assigned to the intervention group or the control group. Those in the intervention group will receive a 3-week EFT intervention in addition to the usual care, while those in the control group will receive the usual care only. Data on medication adherence, delay discounting (DD), and anticoagulation knowledge will be collected at baseline, end of intervention, and 3-month follow-up.
Detailed description
Participants (N = 68) will be randomly assigned to either an episodic future thinking (EFT) group or attention control group. We will use stratified block randomization. The randomization will be stratified by study site. Within each site, participants will be randomly assigned to either the intervention or control group in a 1:1 ratio using a computer-generated random allocation sequence with variable block sizes (e.g., 4 and 6). A research assistant not involved in recruitment or assessment will generate the sequence. To ensure allocation concealment, sequentially numbered, opaque, sealed envelopes will be prepared according to the generated sequence. After obtaining consent and confirming eligibility, the enrolling investigator will open the next consecutive envelope in the presence of the participant to assign them to a group.
Participants in the intervention group will receive episodic future thinking intervention in addition to the routine health care. The intervention consists of three sessions. In session 1 (on discharge day), the researcher will first provide face-to-face health education on atrial fibrillation-related stroke prevention and a video on the same topics for participants. The health education cover four topics: 1) definition and causes of atrial fibrillation; 2) atrial fibrillation and stroke risk; 3) anticoagulation therapy for stroke prevention; 4) management of comorbidities and risk factors of atrial fibrillation.Then, participants will be instructed to generate individualized episodic future events by visualizing events that will happen or be planned to happen in the coming 1, 3, 6, and 12 months respectively. Participants will be guided to think the long-term impacts (including the benefits and consequences) of adhering or not adhering to oral anticoagulants on their health when imagining future scenario events. The detailed future scenario events imagined by the participants will be condensed into brief narrative statements and also matched with pictures to form text-based and picture-based cues respectively. During Session 2 (weeks 1-3 post-discharge), researchers will administer these cues to participants via WeChat, with two cues per day for the first week followed by one cue per day for the week 2 to week 3. Participants will be asked to complete episodic future thinking task by re-imagining the episodic event based on the content of the cues received within 24 hours. A total of three reminders including a first message reminder within six hours and a second message within 12 hours will be sent to participants to remind them complete the task if no response received in the required time frame. A nonresponse will be recorded if participants did not complete the task 24 hours later the first prompt was sent. Participants will be also encouraged to practice EFT to enhance their adherence to anticolagulation by themselves at home. Participants in the intervention group also will receive weekly education on atrial fibrillation-related stroke prevention. The topics of education are the same with the first session, with topic 1-2 for week 1, topic 3 for week 2, and topic 4 for week 3. In session 3 ( follow-up after the intervention), participants will be followed up once a month by researchers via WeChat or telephone. During each follow-up, adherence to oral anticoagulant will be assessed and issues relating to the management of the illness will be identified and addressed. Any emergent conditions such as major bleeding relating to anticoagulation will be referred to physicians.
The control group will receive usual care, including brief information on atrial fibrilation from ward nurses and one post-discharge telephone follow-up. To reduce potential attention bias, the control group will receive greeting calls from researcher during follow-up with same frequency as the intervention group. In each greeting call, the research will only make greetings or give general information on the illness to participants, no health education will be delivered, and health problems will be addressed.
Data on adherence to anticoagulation, delay discounting and anticoagulation knowledge will be collected at baseline (T0), immediately after the intervention (T1), as well at 3-month follow up (T2). Trained outcome assessors, blinded to group allocation and independent of all other trial procedures, will perform all endpoint evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Episodic future thinking | Experimental | Behavioral: Episodic future thinkingParticipants will generate individualized episodic future events and transform them to text-based and picture-based cues which will reminder participants to re-imagine their future events in their daily life. |
| Attention control | Placebo comparator | Behavioral: attention controlResearchers will maintain equal contact frequency with controls, limited to general check-in messages. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meets diagnostic criteria for atrial fibrillation per the Chinese Guidelines for the Diagnosis and Management of Atrial Fibrillation, with clinically stable condition
- Current or previous use of oral anticoagulants
- Age ≥18 years
- Capable of using WeChat mobile application
- Willing to provide informed consent
Key exclusion criteria (3 listed)
- Comorbid severe impairment of major organ systems or end-stage disease
- Significant visual or auditory impairments
- Documented cognitive dysfunction or psychiatric disorders (e.g., major depressive disorder, schizophrenia, bipolar disorder)
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 |
|---|---|---|
| Episodic future thinkingParticipants will engage in episodic future thinking prompted via text-based cues and picture-based cues to help them adhere to oral anticoagulants. Participants will also receive health education on atrial fibrillation-related stroke prevention. | Behavioural | Episodic future thinking |
| attention controlThe control group will receive standard care, including routine health education from ward nurses and one post-discharge telephone follow-up. In additon, participants will receive a message from the researcher at the same time point each day, but the message will only involve daily greetings. | Behavioural | Attention control |
Primary outcome
Medication adherence
Time frame: Baseline, 3 weeks and 15 weeks
This study assessed oral anticoagulant adherence using the General Medication Adherence Scale (GMAS) . The 11-item scale evaluates three dimensions: (1) patient behavior related non-adherence (five items), (2) additional disease and pill burden (four items) and (3) cost-related non-adherence (two items). Each item is rated on the scale that 0 = always, 1 = mostly, 2 = sometimes, and 3 = never. Higher scores indicate better adherence and it was divided into five levels according to different scores: 30-33 (high adherence), 27-29 (good adherence), 17-26 (moderate adherence), 11-16 (low adherence), and 0-10 (poor adherence).
3 secondary outcomes
Delay discounting for money
Time frame: Baseline, 3 weeks, 15 weeks
Delay discounting for health
Time frame: Baseline, 3 weeks and 15 weeks
Anticoagulation knowledge
Time frame: Baseline, 3 weeks, 15 weeks
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 16 Sep 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Episodic future thinking in people with Atrial Fibrillation (AF), run by Jiawen You at 2 sites 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 3 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 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 Jiawen You (0086-15280095563, youjw@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 (time frame: Baseline, 3 weeks and 15 weeks). 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 16 Sep 2025.