Episodic Future Thinking to Improve Anticoagulant Adherence in Atrial Fibrillation

NCT ID: NCT07174778

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2027-03-31

Brief Summary

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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

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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

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Atrial Fibrillation (AF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Episodic future thinking

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.

Group Type EXPERIMENTAL

Episodic future thinking

Intervention Type BEHAVIORAL

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 control

Researchers will maintain equal contact frequency with controls, limited to general check-in messages.

Group Type PLACEBO_COMPARATOR

attention control

Intervention Type BEHAVIORAL

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.

Interventions

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Episodic future thinking

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.

Intervention Type BEHAVIORAL

attention control

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiawen You

OTHER

Sponsor Role lead

Responsible Party

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Jiawen You

Postgraduate student

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Guangdong Provincial People's Hospital

Guangzhou, Gangdong, China

Site Status

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Gangdong, China

Site Status

Countries

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China

Central Contacts

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Jiawen You

Role: CONTACT

0086-15280095563

Facility Contacts

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Jiawen You

Role: primary

0086-15280095563

Jiawen You

Role: primary

0086-15280095563

Other Identifiers

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L2025SYSU-HL-022

Identifier Type: -

Identifier Source: org_study_id

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