NCT07454317

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Apr 2026Feb 2028

First Submitted

Initial submission to the registry

January 28, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

1.8 years

First QC Date

January 28, 2026

Last Update Submit

May 20, 2026

Conditions

Atrial Fibrillation (Paroxysmal)

Keywords

Atrial fibrillationPhysical activityBehavioural economicsNudge theoryWrist worn technologymHealth

Outcome Measures

Primary Outcomes (3)

  • Phase 1: Co-design biofeedback nudges and report content, layout and the optimal time/frequency of nudges. Underpinned by a double diamond framework, through an iterative co-design process.

    1\) Patients' qualitative data (workshops and/or 1:1 feedback meetings) investigating nudges and report: A) Content B) Layout C) Delivery Intervals

    Immediately after the 3-week usability testing iterations.

  • Phase 1: Co-design biofeedback nudges and report content, layout and the optimal time/frequency of nudges. Underpinned by a double diamond framework, through an iterative co-design process.

    2\) Participants' reflection/feedback via user diaries.

    During each 3-week usability testing period.

  • Phase 2: Determine the number of patients identified, screened, appraoched eligable, consented, completed the trial, withdrew from the trial, and adherence to the trial.

    Outcome measure: Information will be collected on: 1. The number of patients screened, eligible and approached. 2. The percentage of patients that: A) Decline the biofeedback intervention (including reasons for declining). B) Agree to the biofeedback intervention. C) Consent to being part of the study. 3. The percentage of patients that take up the biofeedback intervention and reasons for drop out. 4. The percentage of participants that complete outcome assessments and reasons for drop out. 5. The percentage time individuals wear the devices.

    Through study recruitment and all data collection, an average of 2 years.

Secondary Outcomes (22)

  • Phase 1: Receive feedback on the usability and acceptability of the biofeedback intervention

    Immediately after the 3-week usability testing iterations

  • Phase 1: Receive feedback on the usability and acceptability of the biofeedback intervention

    During each 3-week usability testing period.

  • Phase 1: Receive feedback on the usability and acceptability of the biofeedback intervention

    Through study recruitment and data collection, an average of 4 months

  • Phase 1: Receive feedback on the usability and acceptability of the biofeedback intervention

    Immediately after the first 3-week usability testing iteration.

  • Phase 1: Quantify the time taken and resources required to produce nudges to gain an understanding of the maximum potential active intervention participants that can be simultaneously ongoing in Phase-2 feasibility RCT

    Through study recruitment and data collection, an average of 4 months

  • +17 more secondary outcomes

Study Arms (2)

Group 1- Biofeedback intervention + standard care

EXPERIMENTAL

If allocated to the intervention group, you will be sent a smartwatch and device introduction pack with information on how to download a custom mobile application named Motivate-cloud and the Polar Flow mobile application, with instructions on how to sync your Polar device. Once set up, you will wear the smartwatch device for 6-months that records heart rate and physical activity. During this time, you will be sent regular text messages with motivating information on your activity (steps, time sitting, standing and moving) and AF. \*Important note: when we send you messages regarding your risk of AF, this is based on your heart rate variability (i.e. the variation in time between heart beats), and based on this variation, we predict we can determine whether the risk of being in AF has gone up or down for a given period of time.\*

Behavioral: Biofeedback intervention

Group 2: Standard care

NO INTERVENTION

You would have had a conversation about the benefits of lifestyle and physical activity with your direct health care team prior to agreeing to receiving contact with the research team. If you are allocated to this group, you will continue with usual medical treatment for your atrial fribrillation as determined by your healthcare team. You will receive adequate information and support, lifestyle advice about smoking, exercise, diet, and weight control.

Interventions

Biofeedback interventionBEHAVIORAL

Participants wearing a smartwatch will receive feedback on their paroxysmal atrial fibrillation and physical activity. This feedback will hopefully nudge them to become more physically active.

Group 1- Biofeedback intervention + standard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool John Moores University

Liverpool, Merseyside, L3 3AF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationMotor Activity

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

Luca J Howard

CONTACT

+ 151 231 2121l.j.howard@ljmu.ac.uk

Benjamin Buckley

CONTACT

0151 231 2121B.J.Buckley@ljmu.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2026

First Posted

March 6, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations

GB(1)