Remote Physical Activity Biofeedback Intervention for Patients With Paroxysmal Atrial Fibrillation Using Mobile Health Technology.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Group 1- Biofeedback intervention + standard care
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.*
干预措施: Biofeedback intervention (Behavioral)
Group 2: Standard care
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.
结局指标
主要结局
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.
时间窗: 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 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.
时间窗: During each 3-week usability testing period.
2\) Participants' reflection/feedback via user diaries.
Phase 2: Determine the number of patients identified, screened, appraoched eligable, consented, completed the trial, withdrew from the trial, and adherence to the trial.
时间窗: 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.
次要结局
- 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 HRV additionally measured throughout 6-month intervention).)
- 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)
- 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.)
- 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.)
- 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.)
- 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).)
- 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 time spent sleeping additionally measured throughout 6-month intervention).)
- 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 time spent sitting additionally measured throughout 6-month intervention).)
- 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 time spent standing additionally measured throughout 6-month intervention).)
- 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 time spent in light activity additionally measured throughout 6-month intervention).)
- 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 time spent in moderate activity additionally measured throughout 6-month intervention).)
- 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 time spent in vigorous activity additionally measured throughout 6-month intervention).)
- 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 calories additionally measured throughout 6-month intervention).)
- 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 total METs additionally measured throughout 6-month intervention).)
- Phase 2: Assess the suitability of outcome measures for future full-scale RCT.(4 timepoints: Baseline (pre-intervention), month-1, month-3 and month-6 (post-intervention))