Psychosocial measures in relation to smartwatch alerts for atrial fibrillation detection

Abstract

Key findings•Receipt of atrial fibrillation (AF) alerts generated by smartwatches in older poststroke adults may be associated with a lower perception of physical health.•AF smartwatch alerts in our poststroke cohort were not related to changes in self-reported anxiety, patient activation or mental health perception.Atrial fibrillation (AF) is the most common arrhythmia and is a common cause of mortality and cerebrovascular events.1Kalantarian S. Ay H. Gollub R.L. et al.Association between atrial fibrillation and silent cerebral infarctions: a systematic review and meta-analysis.Ann Intern Med. 2014; 161: 650-658Crossref PubMed Scopus (109) Google Scholar Therefore, AF detection after a stroke is vital. Algorithms for analysis of pulse data from smartwatches have been approved by the Food and Drug Administration (FDA) for AF detection and are being increasingly recommended for AF screening.2Perez M.V. Mahaffey K.W. Hedlin H. et al.Large-scale assessment of a smartwatch to identify atrial fibrillation.N Engl J Med. 2019; 381: 1909-1917Crossref PubMed Scopus (606) Google Scholar At the same time, ownership of wearable devices has shown a steady annual increase among adults ≥50 years of age, with approximately 42% reporting almost daily use of the technology, thus highlighting the potential of wearable devices for AF monitoring.3American Association of Retired Persons (AARP)2022 Tech Trends and the 50-Plus. December 2021.https://www.aarp.org/content/dam/aarp/research/surveys_statistics/technology/2021/2022-technology-trends-older-americans.doi.10.26419-2Fres.00493.001.pdfDate accessed: March 16, 2022Google Scholar The impact of AF screening on older adults with regard to key outcomes, including psychological well-being, has not been well explored.4Ding E.Y. Svennberg E. Wurster C. et al.Survey of current perspectives on consumer-available digital health devices for detecting atrial fibrillation.Cardiovasc Digit Health J. 2020; 1: 21-29Abstract Full Text Full Text PDF PubMed Scopus (11) Google Scholar Historically, AF has been associated with worse health-related quality of life,5Goren A. Liu X. Gupta S. Simon T.A. Phatak H. Quality of life, activity impairment, and healthcare resource utilization associated with atrial fibrillation in the US National Health and Wellness Survey.PLoS One. 2013; 8e71264Crossref Scopus (24) Google Scholar especially among older adults. Additionally, anxiety among smartwatch users, possibly driven by receipt of alerts for possible rhythm abnormalities, has been reported.6Rosman L. Gehi A. Lampert R. When smartwatches contribute to health anxiety in patients with atrial fibrillation.Cardiovasc Digit Health J. 2020; 1: 9-10Abstract Full Text Full Text PDF PubMed Scopus (4) Google ScholarTo examine the associations between smartwatch alerts for possible AF and psychological health, we analyzed data from the Pulsewatch study,7Dickson E.L. Ding E.Y. Saczynski J.S. et al.Smartwatch monitoring for atrial fibrillation after stroke—the Pulsewatch study: protocol for a multiphase randomized controlled trial.Cardiovasc Digit Health J. 2021; 2: 231-241Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar a multiphase, randomized controlled trial (ClinicalTrials.gov Identifier: NCT03761394) of smartwatches for AF detection among survivors of stroke/transient ischemic attack (TIA). The study enrolled older adult (age ≥50 years) survivors of stroke/TIA with no contraindications to anticoagulation therapy. Phase I intended to assess the accuracy of the smartwatch system and phase II assessed the adherence to it. In phase I, participants were randomized 3:1 (intervention: control) to either receive a smartwatch/smartphone dyad capable of alerting the participant of possible AF and an FDA-approved mobile cardiac outpatient telemetry (MCOT) patch monitor (Cardiac Insight, Bellevue, WA) or receive only the MCOT patch (control) and monitor for AF for 14 days. In phase II, participants were re-randomized (1:1) following a permuted block randomization, to ensure adequate representation of phase I control group participants in the intervention group, who were offered continued use of the smartphone/smartwatch dyad for an additional 30 days. In this analysis, we included participants who received a smartwatch/smartphone dyad and grouped them into those receiving one or more alerts of possible AF detection vs those not receiving any alerts. The smartwatch would alert a participant to “hold still” to minimize motion artifact during the detection of a possible abnormal rhythm, followed by another alert of “abnormality detected” when AF was indeed captured (Figure 1). Trained research staff abstracted data from participants’ medical records, including demographic, clinical, and psychosocial characteristics. The study protocol was approved by the University of Massachusetts Medical School Institutional Review Board (H00016067).The GAD (Generalized Anxiety Disorder)-7 Scale, a standardized 7-item questionnaire (range 0–21), was used to assess anxiety.8Spitzer R.L. Kroenke K. Williams J.B.W. et al.A brief measure for assessing generalized anxiety disorder: the GAD-7.Arch Intern Med. 2016; 166: 1092-1097Crossref Scopus (11954) Google Scholar Presence of anxiety was defined as GAD-7 score ≥5. The Consumer Health Activation Index (CHAI), a validated 10-item scale (range 0–100), was used to evaluate patient activation,9Wolf M.S. Smith S.G. Pandit A.U. et al.Development and validation of the Consumer Health Activation Index.Med Decis Making. 2018; 38: 334-343Crossref PubMed Scopus (23) Google Scholar with CHAI score ≥95 indicative of high activation level. The Physical Component Summary and Mental Component Summary of the Short-Form Health Survey (SF-12), an established 12-item survey (range 0–100), were used to assess health-related quality of life, with higher scores indicative of higher-quality health status.10Brazier J.E. Roberts J. The estimation of a preference-based measure of health from the SF-12.Med Care. 2004; 42: 851-859Crossref PubMed Scopus (955) Google Scholar Questionnaires were delivered to all participants at baseline, 14 days, and 44 days.Baseline participant characteristics were compared using Student t tests for continuous variables and χ2 tests for categorical variables. Approximately one-third of participants demonstrated low anxiety levels at baseline in both groups (receiving alerts vs no alerts). Health status and patient activation were not different between the groups. Mixed-effects repeated measures linear regression models with anxiety, patient activation, and physical and mental health status as outcomes were used to examine their association with receiving alerts. Individual participants were included as the random effect to account for correlation among repeated measures from the same participant. Age, race, sex, baseline depression, cognitive impairment, as well as history of congestive heart failure, history of cardiac arrhythmias, and history of myocardial infarction were included as fixed effects.A total of 94 participants (age 64.6 ± 9.1 years; 44% female; 87 % non-Hispanic white) were included in the analysis. Among participants who received alerts, 12 received 1–3 alerts, 3 received 11–18 alerts, and 1 received 226 alerts. Adjusting for confounders, receiving alerts was not significantly associated with change in self-reported anxiety (β = –0.78; P = .33), patient activation (β = –1.70; P = .60), or mental health status (β 2.85; P = .09), but receipt of an alert was associated with a statistically significant reduction in self-rated physical health status (β = –4.67; P = .04), over the study period.Clinicians are increasingly recommending the use of wearable devices approved for AF detection to patients at risk for the arrhythmia, including older adults with stroke. Our study findings suggest that AF alerts generated by wearable devices are unlikely to lead to significant anxiety among older adults, but an alert may be associated with a lower perception of physical health. Our observation may be explained by the fact that an individual's perception of his or her well-being may be changed because of an alert for AF or, conversely, because of the symptoms from AF. Generalizability of our findings is limited by the small sample size, short observation time, and inclusion of only poststroke adults. Further studies are needed to examine any potential harms of AF screening using wearable devices to assist with their optimal clinical integration and to better inform clinicians and public health guidelines. Key findings•Receipt of atrial fibrillation (AF) alerts generated by smartwatches in older poststroke adults may be associated with a lower perception of physical health.•AF smartwatch alerts in our poststroke cohort were not related to changes in self-reported anxiety, patient activation or mental health perception. •Receipt of atrial fibrillation (AF) alerts generated by smartwatches in older poststroke adults may be associated with a lower perception of physical health.•AF smartwatch alerts in our poststroke cohort were not related to changes in self-reported anxiety, patient activation or mental health perception. •Receipt of atrial fibrillation (AF) alerts generated by smartwatches in older poststroke adults may be associated with a lower perception of physical health.•AF smartwatch alerts in our poststroke cohort were not related to changes in self-reported anxiety, patient activation or mental health perception. Atrial fibrillation (AF) is the most common arrhythmia and is a common cause of mortality and cerebrovascular events.1Kalantarian S. Ay H. Gollub R.L. et al.Association between atrial fibrillation and silent cerebral infarctions: a systematic review and meta-analysis.Ann Intern Med. 2014; 161: 650-658Crossref PubMed Scopus (109) Google Scholar Therefore, AF detection after a stroke is vital. Algorithms for analysis of pulse data from smartwatches have been approved by the Food and Drug Administration (FDA) for AF detection and are being increasingly recommended for AF screening.2Perez M.V. Mahaffey K.W. Hedlin H. et al.Large-scale assessment of a smartwatch to identify atrial fibrillation.N Engl J Med. 2019; 381: 1909-1917Crossref PubMed Scopus (606) Google Scholar At the same time, ownership of wearable devices has shown a steady annual increase among adults ≥50 years of age, with approximately 42% reporting almost daily use of the technology, thus highlighting the potential of wearable devices for AF monitoring.3American Association of Retired Persons (AARP)2022 Tech Trends and the 50-Plus. December 2021.https://www.aarp.org/content/dam/aarp/research/surveys_statistics/technology/2021/2022-technology-trends-older-americans.doi.10.26419-2Fres.00493.001.pdfDate accessed: March 16, 2022Google Scholar The impact of AF screening on older adults with regard to key outcomes, including psychological well-being, has not been well explored.4Ding E.Y. Svennberg E. Wurster C. et al.Survey of current perspectives on consumer-available digital health devices for detecting atrial fibrillation.Cardiovasc Digit Health J. 2020; 1: 21-29Abstract Full Text Full Text PDF PubMed Scopus (11) Google Scholar Historically, AF has been associated with worse health-related quality of life,5Goren A. Liu X. Gupta S. Simon T.A. Phatak H. Quality of life, activity impairment, and healthcare resource utilization associated with atrial fibrillation in the US National Health and Wellness Survey.PLoS One. 2013; 8e71264Crossref Scopus (24) Google Scholar especially among older adults. Additionally, anxiety among smartwatch users, possibly driven by receipt of alerts for possible rhythm abnormalities, has been reported.6Rosman L. Gehi A. Lampert R. When smartwatches contribute to health anxiety in patients with atrial fibrillation.Cardiovasc Digit Health J. 2020; 1: 9-10Abstract Full Text Full Text PDF PubMed Scopus (4) Google Scholar To examine the associations between smartwatch alerts for possible AF and psychological health, we analyzed data from the Pulsewatch study,7Dickson E.L. Ding E.Y. Saczynski J.S. et al.Smartwatch monitoring for atrial fibrillation after stroke—the Pulsewatch study: protocol for a multiphase randomized controlled trial.Cardiovasc Digit Health J. 2021; 2: 231-241Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar a multiphase, randomized controlled trial (ClinicalTrials.gov Identifier: NCT03761394) of smartwatches for AF detection among survivors of stroke/transient ischemic attack (TIA). The study enrolled older adult (age ≥50 years) survivors of stroke/TIA with no contraindications to anticoagulation therapy. Phase I intended to assess the accuracy of the smartwatch system and phase II assessed the adherence to it. In phase I, participants were randomized 3:1 (intervention: control) to either receive a smartwatch/smartphone dyad capable of alerting the participant of possible AF and an FDA-approved mobile cardiac outpatient telemetry (MCOT) patch monitor (Cardiac Insight, Bellevue, WA) or receive only the MCOT patch (control) and monitor for AF for 14 days. In phase II, participants were re-randomized (1:1) following a permuted block randomization, to ensure adequate representation of phase I control group participants in the intervention group, who were offered continued use of the smartphone/smartwatch dyad for an additional 30 days. In this analysis, we included participants who received a smartwatch/smartphone dyad and grouped them into those receiving one or more alerts of possible AF detection vs those not receiving any alerts. The smartwatch would alert a participant to “hold still” to minimize motion artifact during the detection of a possible abnormal rhythm, followed by another alert of “abnormality detected” when AF was indeed captured (Figure 1). Trained research staff abstracted data from participants’ medical records, including demographic, clinical, and psychosocial characteristics. The study protocol was approved by the University of Massachusetts Medical School Institutional Review Board (H00016067). The GAD (Generalized Anxiety Disorder)-7 Scale, a standardized 7-item questionnaire (range 0–21), was used to assess anxiety.8Spitzer R.L. Kroenke K. Williams J.B.W. et al.A brief measure for assessing generalized anxiety disorder: the GAD-7.Arch Intern Med. 2016; 166: 1092-1097Crossref Scopus (11954) Google Scholar Presence of anxiety was defined as GAD-7 score ≥5. The Consumer Health Activation Index (CHAI), a validated 10-item scale (range 0–100), was used to evaluate patient activation,9Wolf M.S. Smith S.G. Pandit A.U. et al.Development and validation of the Consumer Health Activation Index.Med Decis Making. 2018; 38: 334-343Crossref PubMed Scopus (23) Google Scholar with CHAI score ≥95 indicative of high activation level. The Physical Component Summary and Mental Component Summary of the Short-Form Health Survey (SF-12), an established 12-item survey (range 0–100), were used to assess health-related quality of life, with higher scores indicative of higher-quality health status.10Brazier J.E. Roberts J. The estimation of a preference-based measure of health from the SF-12.Med Care. 2004; 42: 851-859Crossref PubMed Scopus (955) Google Scholar Questionnaires were delivered to all participants at baseline, 14 days, and 44 days. Baseline participant characteristics were compared using Student t tests for continuous variables and χ2 tests for categorical variables. Approximately one-third of participants demonstrated low anxiety levels at baseline in both groups (receiving alerts vs no alerts). Health status and patient activation were not different between the groups. Mixed-effects repeated measures linear regression models with anxiety, patient activation, and physical and mental health status as outcomes were used to examine their association with receiving alerts. Individual participants were included as the random effect to account for correlation among repeated measures from the same participant. Age, race, sex, baseline depression, cognitive impairment, as well as history of congestive heart failure, history of cardiac arrhythmias, and history of myocardial infarction were included as fixed effects. A total of 94 participants (age 64.6 ± 9.1 years; 44% female; 87 % non-Hispanic white) were included in the analysis. Among participants who received alerts, 12 received 1–3 alerts, 3 received 11–18 alerts, and 1 received 226 alerts. Adjusting for confounders, receiving alerts was not significantly associated with change in self-reported anxiety (β = –0.78; P = .33), patient activation (β = –1.70; P = .60), or mental health status (β 2.85; P = .09), but receipt of an alert was associated with a statistically significant reduction in self-rated physical health status (β = –4.67; P = .04), over the study period. Clinicians are increasingly recommending the use of wearable devices approved for AF detection to patients at risk for the arrhythmia, including older adults with stroke. Our study findings suggest that AF alerts generated by wearable devices are unlikely to lead to significant anxiety among older adults, but an alert may be associated with a lower perception of physical health. Our observation may be explained by the fact that an individual's perception of his or her well-being may be changed because of an alert for AF or, conversely, because of the symptoms from AF. Generalizability of our findings is limited by the small sample size, short observation time, and inclusion of only poststroke adults. Further studies are needed to examine any potential harms of AF screening using wearable devices to assist with their optimal clinical integration and to better inform clinicians and public health guidelines.