Dataset Information

Smartwatch monitoring for atrial fibrillation after stroke-The Pulsewatch Study: Protocol for a multiphase randomized controlled trial.

ABSTRACT:

Background

Atrial fibrillation (AF) is a common heart rhythm disorder that elevates stroke risk. Stroke survivors undergo routine heart rhythm monitoring for AF. Smartwatches are capable of AF detection and potentially can replace traditional cardiac monitoring in stroke patients.

Objective

The goal of Pulsewatch is to assess the accuracy, usability, and adherence of a smartwatch-based AF detection system in stroke patients.

Methods

The study will consist of two parts. Part I will have 6 focus groups with stroke patients, caretakers, and physicians, and a Hack-a-thon, to inform development of the Pulsewatch system. Part II is a randomized clinical trial with 2 phases designed to assess the accuracy and usability in the first phase (14 days) and adherence in the second phase (30 days). Participants will be randomized in a 3:1 ratio (intervention to control) for the first phase, and both arms will receive gold-standard electrocardiographic (ECG) monitoring. The intervention group additionally will receive a smartphone/smartwatch dyad with the Pulsewatch applications. Upon completion of 14 days, participants will be re-randomized in a 1:1 ratio. The intervention group will receive the Pulsewatch system and a handheld ECG device, while the control group will be passively monitored. Participants will complete questionnaires at enrollment and at 14- and 44-day follow-up visits to assess various psychosocial measures and health behaviors.

Results

Part I was completed in August 2019. Enrollment for Part II began September 2019, with expected completion by the end of 2021.

Conclusion

Pulsewatch aims to demonstrate that a smartwatch can be accurate for real-time AF detection, and that older stroke patients will find the system usable and will adhere to monitoring.

SUBMITTER: Dickson EL

PROVIDER: S-EPMC8890084 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature

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Publications

Smartwatch monitoring for atrial fibrillation after stroke-The Pulsewatch Study: Protocol for a multiphase randomized controlled trial.

Dickson Emily L EL Ding Eric Y EY Saczynski Jane S JS Han Dong D Moonis Majaz M Fitzgibbons Timothy P TP Barton Bruce B Chon Ki K McManus David D DD

Cardiovascular digital health journal 20210713 4

<h4>Background</h4>Atrial fibrillation (AF) is a common heart rhythm disorder that elevates stroke risk. Stroke survivors undergo routine heart rhythm monitoring for AF. Smartwatches are capable of AF detection and potentially can replace traditional cardiac monitoring in stroke patients.<h4>Objective</h4>The goal of Pulsewatch is to assess the accuracy, usability, and adherence of a smartwatch-based AF detection system in stroke patients.<h4>Methods</h4>The study will consist of two parts. Part ...[more]

PMID: 35265913

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Project description:BackgroundNonvalvular atrial fibrillation (AF) is a common ongoing health problem that places patients at risk of stroke. Whether and how a patient addresses this risk depends on each patient's goals, context, and values. Consequently, leading cardiovascular societies recommend using shared decision making (SDM) to individualize antithrombotic treatment in patients with AF. The aim of this study is to assess the extent to which the ANTICOAGULATION CHOICE conversation tool promotes high-quality SDM and influences anticoagulation uptake and adherence in patients with AF at risk of strokes.MethodsThis study protocol describes a multicenter, encounter-level, randomized trial to assess the effect of using the ANTICOAGULATION CHOICE conversation tool in the clinical encounter, compared to usual care. The participating centers include an academic hospital system, a suburban community group practice, and an urban safety net hospital, all in Minnesota, USA. Patients with ongoing nonvalvular AF at risk of strokes (CHA2DS2-VASc score ≥ 1 in men, or ≥ 2 in women) will be eligible for participation. We aim to include 999 patients and their clinicians. The primary outcome is the quality of SDM as perceived by participants, and as assessed by a post-encounter survey that ascertains (a) knowledge transfer, (b) concordance of the decision made, (c) quality of communication, and (d) satisfaction with the decision-making process. Recordings of encounters will be reviewed to assess the extent of patient involvement and how participants use the tool (fidelity). Anticoagulant use, choice of agent, and adherence will be drawn from patients' medical and pharmacy records. Strokes and bleeding events will be drawn from patient records.DiscussionThis study will provide a valid and precise measure of the effect of the ANTICOAGULATION CHOICE conversation tool on SDM quality and processes, and on the treatment choices and adherence to therapy among AF patients at risk of stroke.Trial registrationClinicalTrials.gov, NCT02905032 . Registered on 9 September 2016.

Project description:BackgroundSmartwatches can be used for atrial fibrillation (AF) detection, but little is known about how older adults at risk for AF perceive their usability.MethodsWe employed a mixed-methods study design using data from the ongoing Pulsewatch study, a randomized clinical trial (NCT03761394) examining the accuracy of a smartwatch-smartphone app dyad (Samsung/Android) compared to usual care with a patch monitor (Cardea SOLO™ ECG System) for detection of AF among older stroke survivors. To be eligible to participate in Pulsewatch, participants needed to be at least 50 years of age, have had an ischemic stroke, and have no major contraindications to anticoagulation therapy should AF be detected. After 14 days of use, usability was measured by the System Usability Scale (SUS) and investigator-generated questions. Qualitative interviews were conducted, transcribed, and coded via thematic analysis.ResultsNinety participants in the Pulsewatch trial were randomized to use a smartwatch-smartphone app dyad for 14 days (average age: 65 years, 41% female, 87% White), and 46% found it to be highly usable (SUS ≥68). In quantitative surveys, participants who used an assistive device (eg, wheelchair) and those with history of anxiety or depression were more likely to report anxiety associated with watch use. In qualitative interviews, study participants reported wanting a streamlined system that was more focused on rhythm monitoring and a smartwatch with a longer battery life. In-person training and support greatly improved their experience, and participants overwhelmingly preferred use of a smartwatch over traditional cardiac monitoring owing to its comfort, appearance, and convenience.ConclusionOlder adults at high risk for AF who were randomized to use a smartwatch-app dyad for AF monitoring over 14 days found it to be usable for AF detection and preferred their use to the use of a patch monitor. However, participants reported that a simpler device interface and longer smartwatch battery life would increase the system's usability.

Project description:BackgroundThe prevalence of atrial fibrillation (AF) increases with age and can lead to stroke. Therefore, older adults may benefit the most from AF screening. However, older adult populations tend to lag more than younger groups in the adoption of, and comfort with, the use of mobile health (mHealth) apps. Furthermore, although mobile apps that can detect AF are available to the public, most are designed for intermittent AF detection and for younger users. No app designed for long-term AF monitoring has released detailed system design specifications that can handle large data collections, especially in this age group.ObjectiveThis study aimed to design an innovative smartwatch-based AF monitoring mHealth solution in collaboration with older adult participants and clinicians.MethodsThe Pulsewatch system is designed to link smartwatches and smartphone apps, a website for data verification, and user data organization on a cloud server. The smartwatch in the Pulsewatch system is designed to continuously monitor the pulse rate with embedded AF detection algorithms, and the smartphone in the Pulsewatch system is designed to serve as the data-transferring hub to the cloud storage server.ResultsWe implemented the Pulsewatch system based on the functionality that patients and caregivers recommended. The user interfaces of the smartwatch and smartphone apps were specifically designed for older adults at risk for AF. We improved our Pulsewatch system based on feedback from focus groups consisting of patients with stroke and clinicians. The Pulsewatch system was used by the intervention group for up to 6 weeks in the 2 phases of our randomized clinical trial. At the conclusion of phase 1, 90 trial participants who had used the Pulsewatch app and smartwatch for 14 days completed a System Usability Scale to assess the usability of the Pulsewatch system; of 88 participants, 56 (64%) endorsed that the smartwatch app is "easy to use." For phases 1 and 2 of the study, we collected 9224.4 hours of smartwatch recordings from the participants. The longest recording streak in phase 2 was 21 days of consecutive recordings out of the 30 days of data collection.ConclusionsThis is one of the first studies to provide a detailed design for a smartphone-smartwatch dyad for ambulatory AF monitoring. In this paper, we report on the system's usability and opportunities to increase the acceptability of mHealth solutions among older patients with cognitive impairment.Trial registrationClinicalTrials.gov NCT03761394; https://www.clinicaltrials.gov/ct2/show/NCT03761394.International registered report identifier (irrid)RR2-10.1016/j.cvdhj.2021.07.002.

Project description:BackgroundAtrial fibrillation (AF) is a common cause of stroke, and timely diagnosis is critical for secondary prevention. Little is known about smartwatches for AF detection among stroke survivors. We aimed to examine accuracy, usability, and adherence to a smartwatch-based AF monitoring system designed by older stroke survivors and their caregivers.ObjectiveThis study aims to examine the feasibility of smartwatches for AF detection in older stroke survivors.MethodsPulsewatch is a randomized controlled trial (RCT) in which stroke survivors received either a smartwatch-smartphone dyad for AF detection (Pulsewatch system) plus an electrocardiogram patch or the patch alone for 14 days to assess the accuracy and usability of the system (phase 1). Participants were subsequently rerandomized to potentially 30 additional days of system use to examine adherence to watch wear (phase 2). Participants were aged 50 years or older, had survived an ischemic stroke, and had no major contraindications to oral anticoagulants. The accuracy for AF detection was determined by comparing it to cardiologist-overread electrocardiogram patch, and the usability was assessed with the System Usability Scale (SUS). Adherence was operationalized as daily watch wear time over the 30-day monitoring period.ResultsA total of 120 participants were enrolled (mean age 65 years; 50/120, 41% female; 106/120, 88% White). The Pulsewatch system demonstrated 92.9% (95% CI 85.3%-97.4%) accuracy for AF detection. Mean usability score was 65 out of 100, and on average, participants wore the watch for 21.2 (SD 8.3) of the 30 days.ConclusionsOur findings demonstrate that a smartwatch system designed by and for stroke survivors is a viable option for long-term arrhythmia detection among older adults at risk for AF, though it may benefit from strategies to enhance adherence to watch wear.Trial registrationClinicalTrials.gov NCT03761394; https://clinicaltrials.gov/study/NCT03761394.International registered report identifier (irrid)RR2-10.1016/j.cvdhj.2021.07.002.

Project description:Background: Optimal timing to initiate anticoagulation after acute ischemic stroke (AIS) from atrial fibrillation (AF) is currently unknown. Compared to other stroke etiologies, AF typically provokes larger infarct volumes and greater concern of hemorrhagic transformation, so seminal randomized trials waited weeks to months to begin anticoagulation after initial stroke. Subsequent data are limited and non-randomized. Guidelines suggest anticoagulation initiation windows between 3 and 14 days post-stroke, with Class IIa recommendations, and level of evidence B in the USA and C in Europe. Aims: This open-label, parallel-group, multi-center, randomized controlled trial AREST (Apixaban for Early Prevention of Recurrent Embolic Stroke and Hemorrhagic Transformation) is designed to evaluate the safety and efficacy of early anticoagulation, based on stroke size, secondary prevention of ischemic stroke, and risks of subsequent hemorrhagic transformation. Methods: Subjects are randomly assigned in a 1:1 ratio to receive early apixaban at day 0-3 for transient ischemic attack (TIA), 3-5 for small-sized AIS (<1.5 cm), and 7-9 for medium-sized AIS (1.5 cm or greater but less than a full cortical territory), or warfarin at 1 week post-TIA or 2 weeks post-stroke. Large AISs are excluded. Study Outcomes: Primary: recurrent ischemic stroke, TIA, and fatal stroke; secondary: intracranial hemorrhage (ICH); hemorrhagic transformation (HT) of ischemic stroke; cerebral microbleeds (CMBs); neurologic disability [e.g., modified Rankin Scores (mRS), National Institutes of Health Stroke Scale (NIHSS), Stroke Specific Quality of Life scale (SS-QOL)]; and cardiac biomarkers [e.g., AF burden, transthoracic echo (TTE)/transesophageal echo (TEE) abnormalities]. Sample Size Estimates: Enrollment goal was 120 for 80% power (two-sided type I error rate of 0.05) to detect an absolute risk reduction of 16.5% postulated to occur with apixaban in the primary composite outcome of fatal stroke/recurrent ischemic stroke/TIA within 180 days. Enrollment was suspended at 91 subjects in 2019 after a focused guideline update recommended direct oral anticoagulants (DOACs) over warfarin in AF, excepting valvular disease (Class I, level of evidence A). Discussion: AREST will offer randomized controlled trial data about timeliness and safety of anticoagulation in AIS patients with AF. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02283294.

Dataset Information

Smartwatch monitoring for atrial fibrillation after stroke-The Pulsewatch Study: Protocol for a multiphase randomized controlled trial.

Background

Objective

Methods

Results

Conclusion

Publications

Smartwatch monitoring for atrial fibrillation after stroke-The Pulsewatch Study: Protocol for a multiphase randomized controlled trial.

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