NCT07454317 Biofeedback Intervention for Paroxysmal Atrial Fibrillation
| NCT ID | NCT07454317 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Liverpool John Moores University |
| Condition | Atrial Fibrillation (Paroxysmal) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-04-15 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-04-15 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This project aims to bridge the gap between technology and healthcare by developing a biofeedback intervention that enables daily monitoring of atrial fibrillation episodes and physical activity levels. The main question it aims to answer is: Is a co-designed, usability-tested, bio-feedback intervention aimed at nudging patients with paroxysmal atrial fibrillation to increase physical activity feasible for a larger randomised control trial? The trial is split into two separate phases, each adopting different study designs, data collection, and data analysis methods. Phase 1 Co-design and usability testing: In this phase, we aim to test if smartwatches can be used to monitor AF and physical activity so that personalised atrial fibrillation-specific summaries can be created and sent to participants as text message nudges. The aim is to encourage participants to be more physically active. Participants will wear a smartwatch for 3 weeks, during which they will receive text messages giving them feedback on their atrial fibrillation and physical activity. After the 3 weeks, all participants will take part in a workshop to provide feedback on what they thought and what could be improved. Improvements will be implemented by the researchers, and the process will repeat for a total of two iterations. On the first iteration only, participants will also be asked to wear a Holter monitor OR chest strap and an additional smartwatch for the first 24 hours, alongside an accelerometer watch for the first 7 days. Phase 2 Feasibility study with embedded process evaluation: This phase aims to assess whether it is feasible and acceptable to run a larger trial across the UK (i.e. can the intervention be delivered properly and do patients think it is useful). Participants will be randomly allocated to either their normal standard of care, or to receive a smartwatch with the biofeedback messaging service in addition to their normal standard of care. The study will take 6 and a half months in total. Both groups will complete online questionnaires periodically over this period. Both groups will also need to wear a smartwatch and accelerometer watch for 7 days before and after testing.
Eligibility Criteria
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study. * Aged 18 or over. * Diagnosed with paroxysmal AF * Deemed medically stable and well managed. Exclusion Criteria: * Any concurrent cardiac arrhythmia * Blood pressure \>180/100 * Unstable angina * Myocardial infarction within the previous 3 months * Valvular heart disease * Heart failure NYHA class 4 * \<6 months post-transplant * Resting/uncontrolled tachycardia * Stroke in last 6 weeks * Cardiac sarcoidosis * Injury or disability preventing exercise
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07454317 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation (Paroxysmal). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07454317 currently recruiting?
Yes, NCT07454317 is actively recruiting participants. Contact the research team at l.j.howard@ljmu.ac.uk for enrollment information.
Where is the NCT07454317 trial being conducted?
This trial is being conducted at Liverpool, United Kingdom.
Who is sponsoring the NCT07454317 clinical trial?
NCT07454317 is sponsored by Liverpool John Moores University. The trial plans to enroll 40 participants.
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