Atrial fibrillation (AF) is chargeable for vital affected person morbidity, and weight problems is a significant contributor to AF incidence and symptom burden. Weight reduction has been proven to positively modify AF signs, however weight reduction in a real-world inhabitants is usually solely short-term. This randomised examine got down to study if smartphone-based app expertise might improve weight reduction in a affected person inhabitants with weight problems and AF.
People have been screened following outpatient referral to Leeds Educating Hospitals NHS Belief for symptomatic AF. Block randomisation was carried out to allocate the therapy teams to both medical follow-up or app-based follow-up, with weight reduction updates deliberate fortnightly. Sufferers randomised to medical follow-up acquired nurse-led phone calls each two weeks, whereas these within the app arm acquired automated reminder messages each two weeks. Ultimate follow-up at six months included medical and weight information and a quality-of-life questionnaire.
Sixty-four sufferers underwent randomisation. No vital distinction in weight reduction was seen between the teams. Affected person engagement was much more constant within the phone follow-up group.
In conclusion, no vital distinction in weight reduction was seen between the 2 teams, regardless of affected person training on the worth of weight reduction to enhance their AF signs.
Introduction
Atrial fibrillation (AF) is a standard arrhythmia chargeable for vital affected person morbidity, together with stroke, coronary heart failure and intrusive palpitations.1 Weight problems is nicely recognised as a contributor to AF incidence and symptom burden.2 Weight reduction has been proven to scale back incidence of AF and improve the probability of sustaining sinus rhythm after cardioversion or catheter ablation for AF.3–5
Though it has been demonstrated that weight reduction can scale back AF burden in a trial setting, it’s nicely recognised that motivation for sustained weight reduction is low in a real-world inhabitants, and infrequently any weight reduction achieved is short-term.6 It’s, subsequently, important that efficient methods are utilised to make sure sufferers are motivated and educated to attain sustained weight reduction; to not solely enhance signs of AF, but in addition to scale back hospital admissions and the necessity for invasive procedures, akin to AF ablation.
App-based digital well being options are more and more standard and, with the ubiquity of smartphones, supply an necessary potential avenue for sufferers to obtain ongoing motivation and training to maintain weight reduction. AVATR is a smartphone-based app that permits an individual to create a digital illustration of themselves, which they personal and management. The app collects uncooked well being/life-style information from smartphones and wearable medical units, and may share this with medical professionals to obtain personalised healthcare. The app doesn’t require giant information units or inferencing from inhabitants information, and so is nicely positioned to assist inhabitants teams vulnerable to exclusion and machine bias, akin to girls, older individuals and the economically deprived.
Our examine got down to study the efficacy of this smartphone-based expertise to coach sufferers round AF and weight reduction, and by offering continued assist, make sure the affected person remained centered on attaining sustained weight reduction.
Methodology
People have been screened for enrolment following outpatient referral to Leeds Educating Hospitals NHS Belief for symptomatic AF. Inclusion standards included: age ≥18 years; physique mass index (BMI) >27 kg/m2; symptomatic AF; dedication to make use of the AVATR app and attend follow-up appointments. Exclusion standards included: life-expectancy <1 12 months; lack of ability to decide to follow-up; prior recruitment to ongoing weight-loss research; lack of smartphone app compatibility; and never offering expressed knowledgeable consent to utilizing the app.
Every participant’s understanding of the influence of weight reduction on AF signs was assessed. Steering was supplied to the participant advising that for each improve of 1 unit in BMI there will probably be an elevated danger of AF by 5%, whereas a discount of 1 unit might present as much as 10% discount in signs.7 Motivation and confidence to vary was assessed by a subjective scoring of 0 to 10, 0 being not motivated and 10 being extremely motivated. Any rating lower than seven was mentioned to establish the reason for the decrease rating. High quality of life was assessed utilizing the EQ-5D-5L questionnaire. The participant selected their favoured weight-loss methodology from a number of totally different programmes, and have been requested to set a weight-loss objective.
Block randomisation with sealed envelopes was carried out to allocate the therapy teams to both medical phone follow-up or AVATR follow-up. Envelopes have been opened on the time of enrolment and the randomisation sequence was hid from each medical workers and sufferers. Sufferers randomised to medical follow-up acquired nurse-led phone calls each two weeks, whereas these within the AVATR arm acquired automated reminder messages each two weeks to remind individuals to report weight and exercise throughout the app, with any medical points communicated through the app. Ultimate follow-up at six months included medical and weight information and a quality-of-life questionnaire.
The first end result was weight reduction at six month follow-up in contrast with baseline. Secondary outcomes included enchancment in high quality of life and discount of signs (EQ-5D-5L), affected person satisfaction, time saved by digital follow-up and compliance.
Outcomes
Desk 1. Baseline traits
Attribute
AVATRfollow-up(n=22)
Phonefollow-up(n=32)
Imply age ± SD, years
63 ± 7.7
60 ± 9.5
Feminine individuals, n (%)
11 (50)
15 (47)
Imply BMI ± SD, kg/m2
38.3 ± 4.6
37.9 ± 6.6
Sinus rhythm at baseline, n (%)
4 (18)
9 (28)
Imply SBP ± SD, mmHg
133.1 ± 13.4
127.3 ± 16.7
Imply DBP ± SD, mmHg
81.3 ± 9.5
77.5 ± 13.5
Imply coronary heart fee ± SD, bpm
71.9 ± 14.3
77.4 ± 14.1
Hypertension, n (%)
14 (64)
12 (38)
Diabetes, n (%)
5 (23)
6 (19)
Ischaemic coronary heart illness, n (%)
2 (9)
1 (3)
Congestive coronary heart failure, n (%)
4 (18)
7 (22)
Key: BMI = physique mass index; DBP = diastolic blood strain; SBP = systolic blood strain; SD = customary deviation
A complete of 148 eligible referrals have been acquired, 84 sufferers declined to consent and 64 underwent randomisation. Thirty-three have been randomised to phone name, 28 have been randomised to AVATR, and three sufferers couldn’t be contacted. Six sufferers from the AVATR arm and one affected person from the phone follow-up arm withdrew from the examine previous to the preliminary go to. Baseline traits are offered in desk 1.
Median weight reduction was 3.95 kg (median lack of 1.6% preliminary body weight) within the telephone follow-up arm versus 2.25 kg (median lack of 3.6% preliminary body weight) within the app follow-up arm. No vital distinction in weight reduction was seen when assessed on an intention-to-treat foundation utilizing Mann-Whitney U check (determine 1).
Affected person engagement was much more constant within the phone follow-up group, with a last weight obtainable on the finish of the 26-week follow-up interval from 31 out of the 32 sufferers (97%) in that arm, and a median 13 contacts out of a attainable 13. Conversely, as indicated in determine 1B, simply 5 of the 22 sufferers (23%) within the app follow-up arm had a weight measurement within the last week, with a median of two.5 contacts per affected person out of 13. Completion of ultimate follow-up questionnaires was inadequate within the AVATR app group to find out any significant outcomes.
Particular person sufferers are represented by particular person traces. No vital variations in weight reduction have been seen.Key: B = baseline
Dialogue
This examine of weight reduction guided by phone follow-up or smartphone-based app expertise demonstrated no vital distinction in weight reduction between the 2 teams. A excessive proportion of eligible sufferers declined to participate within the examine in any respect, doubtlessly reflecting preliminary motivation on this affected person group as a complete.
Ongoing motivation was assessed on a realistic foundation by whether or not the affected person engaged with follow-up visits, relatively than utilizing particular motivation evaluation instruments. This can be thought-about a limitation of the examine. Non-compliance with the weight loss plan, in addition to an lack of ability to train have been widespread causes for sufferers to report why they didn’t drop pounds.
Affected person engagement with the app was poor, with restricted obtainable follow-up information and few affected person contacts, regardless of common automated reminders. Further options to assist affected person engagement throughout the app weren’t used on this trial, and because of the COVID pandemic there was no face-to-face coaching in easy methods to use the app. Usability of the AVATR app could, subsequently, have restricted information assortment and lowered compliance, however the interface of the app itself can’t be commented on, as suggestions for this was not collected.
The perceived social strain of a healthcare skilled personally amassing and monitoring information could have been a motivating issue for these sufferers within the telephone follow-up arm to stay engaged in contrast with automated reminders. This stage of medical enter to help weight-loss motivation exceeds what is feasible for ‘real-world’ sufferers, and was meant to reflect the app capabilities. There was a numerically increased variety of sufferers in sinus rhythm at baseline evaluation on this arm, which can result in improved train capability. Nonetheless, this baseline distinction and continued affected person engagement was nonetheless not enough to result in sustained, vital weight reduction on this group.
Though this examine didn’t present improved weight-loss outcomes with app-based expertise, the usage of data expertise and apps in healthcare is a area that’s frequently rising and growing. It could nonetheless have a pivotal position, along side healthcare skilled enter, to encourage weight reduction sooner or later. Nonetheless, probably the most frequent customers of digital well being applied sciences are sometimes these with least want for them, and technological enhancements alone are unlikely to resolve the issue of easy methods to join with these sufferers who will profit most, and encourage sustainable change.
Key messages
Weight problems is a danger issue for atrial fibrillation, and weight reduction improves signs
Digital well being applied sciences are more and more standard, and should assist enhance weight-loss motivation
A smartphone app designed to enhance affected person engagement and motivation didn’t have an effect on weight reduction in our randomised examine
Affected person engagement was poor with the app, and weight-loss motivation stays tough to attain
Conflicts of curiosity
MHT has acquired fellowship funding and proctoring charges from Biosense Webster and analysis grants from AliveCor. MW is CEO and founding father of Inavya Ventures Ltd. TAS, EM, LL: none declared.
Funding
This analysis was supported by Inavya Ventures Ltd., who supplied the app and {hardware}. Further funding was supplied by the Leeds Electrophysiology Analysis fund. The examine was adopted by the NIHR medical analysis community portfolio.
Examine approval
Moral approval was supplied by North of Scotland Analysis Ethics Committee – reference 20/NS/0045. Written knowledgeable consent was obtained from all individuals in concordance with the Declaration of Helsinki.
References
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