Biofeedback Intervention for Paroxysmal Atrial Fibrillation
ConditionAtrial Fibrillation (Paroxysmal)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLiverpool John Moores University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Any concurrent cardiac arrhythmia
Blood pressure >180/100
Unstable angina
Myocardial infarction within the previous 3 months
Trial design
Design model
Parallel
Treatments tested in this trial
Biofeedback intervention
BehavioralParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Group 1- Biofeedback intervention + standard careExperimental treatment 1 intervention
Group B: Group 2: Standard careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Immediately after the 3-week usability testing iterations.2
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.
Time frame
During each 3-week usability testing period.3
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.
Time frame
Through study recruitment and all data collection, an average of 2 years.Secondary outcomes
1
Phase 1: Receive feedback on the usability and acceptability of the biofeedback intervention
1\) Multidisciplinary stakeholder groups including the research team and patients' qualitative data (workshops and/or 1:1 feedback meetings) investigating: A) General usability and acceptability. B) Faults or problem identification. C) Intervention delivery optimisation.
Time frame
Immediately after the 3-week usability testing iterations2
Phase 1: Receive feedback on the usability and acceptability of the biofeedback intervention
2\) Participants reflection / feedback via user diaries.
Time frame
During each 3-week usability testing period.3
Phase 1: Receive feedback on the usability and acceptability of the biofeedback intervention
3\) Researcher observations
Time frame
Through study recruitment and data collection, an average of 4 months4
Phase 1: Receive feedback on the usability and acceptability of the biofeedback intervention
4\) Systems usability scale (SUS) questionnaire during the first co-design workshop. Scored from 0-100. Higher score = better usability (outcome).
Time frame
Immediately after the first 3-week usability testing iteration.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Liverpool John Moores University
Lead sponsor
Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov