Atrial Fibrillation (Paroxysmal)
Conditions
Keywords
Atrial fibrillation, Physical activity, Behavioural economics, Nudge theory, Wrist worn technology, mHealth
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.
Interventions
BEHAVIORALBiofeedback intervention
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.
Sponsors
Liverpool John Moores University
Liverpool Heart and Chest Hospital NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Immediately after the 3-week usability testing iterations. | 1\) Patients' qualitative data (workshops and/or 1:1 feedback meetings) investigating nudges and report: A) Content B) Layout C) Delivery Intervals |
| Phase 2: Determine the number of patients identified, screened, appraoched eligable, consented, completed the trial, withdrew from the trial, and adherence to the trial. | Through study recruitment and all data collection, an average of 2 years. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Receive feedback on the usability and acceptability of the biofeedback intervention | Immediately after the 3-week usability testing iterations | 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. |
| 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 | Information will be collected on: 1\) The average time taken to produce each nudge (measured from accessing patient account to sending item). A) Any identified issues with the intervention (via researcher diary). |
| Phase 1: Investigate the validity and quantify the error of the Polar Pacer smartwatch HRV data against a clinical-grade Holter monitor, or the Polar H10 chest strap. | First 24-hour periprocedural period. | 1\) Continuous HRV data from both devices simultaneously to evaluate: A) Validity and reliability of the Polar Pacer HRV data. B) Error associated with Polar Pacer HRV data. C) Measurement error at each MET threshold. D) Optimal MET threshold cut off for HRV (risk of AF) analysis. E) Considerations for any future validation studies. |
| Phase 1: Investigate the reliability and quantify the error of the Polar Pacer activity score as a measurement of PA against the GENEactiv wrist-based accelerometer | First 7-days of periprocedural period. | 1\) Simultaneous collection of accelerometer and PA data from both devices to evaluate: A) Reliability of the Polar Pacer activity score as a measure of PA. B) PA measurement error of the Polar Pacer. C) Considerations for any future validation studies. |
| Phase 2: 2) Evaluate the acceptability of the intervention to patients, assessing the feasibility of delivering the biofeedback intervention to patients with paroxysmal AF | Within 1 month of completing all 6-month post-intervention data collection. | Qualitative acceptability assessment through topic-guided semi-structured 1:1 interviews post-intervention, investigating: 1. The acceptability of the intervention components and barriers and facilitators to the intervention. 2. Acceptability of the study design and process (recruitment, randomisation, remote design) 3. Acceptability of the measurement instruments. |
| Phase 2: Assess the suitability of outcome measures for future full-scale RCT. | 7-days pre and 7-days post intervention. (*Intervention group only*: Polar Pacer steps additionally measured throughout 6-month intervention). | 1.1) Physical activity (steps) measured via Polar Pacer smartwatch and GENEactiv wrist-based accelerometer. |
Countries
United Kingdom
Contacts
CONTACTLuca J Howard
CONTACTBenjamin Buckley
Outcome results
None listed