Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: May 13, 2019
Open Peer Review Period: May 16, 2019 - Jun 16, 2019
Date Accepted: Jun 28, 2019
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Validation and Acceptability of a Cuffless Wrist-Worn Wearable Blood Pressure Monitoring Device Among Users and Health Care Professionals: Mixed Methods Study
Background:
Blood pressure (BP) is an important modifiable cardiovascular risk factor, yet its long-term monitoring remains problematic. Wearable cuffless devices enable the capture of multiple BP measures during everyday activities and could improve BP monitoring, but little is known about their validity or acceptability.
Objective:
This study aimed to validate a wrist-worn cuffless wearable BP device (Model T2; TMART Technologies Limited) and assess its acceptability among users and health care professionals.
Methods:
A mixed methods study was conducted to examine the validity and comparability of a wearable cuffless BP device against ambulatory and home devices. BP was measured simultaneously over 24 hours using wearable and ambulatory devices and over 7 days using wearable and home devices. Pearson correlation coefficients compared the degree of association between the measures, and limits of agreement (LOA; Bland-Altman plots) were generated to assess measurement bias. Semistructured interviews were conducted with users and 10 health care professionals to assess acceptability, facilitators, and barriers to using the wearable device. Interviews were audio recorded, transcribed, and analyzed.
Results:
A total of 9090 BP measurements were collected from 20 healthy volunteers (mean 20.3 years, SD 5.4; N=10 females). Mean (SD) systolic BP (SBP)/diastolic BP (DBP) measured using the ambulatory (24 hours), home (7 days), and wearable (7 days) devices were 126 (SD 10)/75 (SD 6) mm Hg, 112 (SD 10)/71 (SD 9) mm Hg and 125 (SD 4)/77 (SD 3) mm Hg, respectively. Mean (LOA) biases and precision between the wearable and ambulatory devices over 24 hours were 0.5 (−10.1 to 11.1) mm Hg for SBP and 2.24 (−17.6 to 13.1) mm Hg for DBP. The mean biases (LOA) and precision between the wearable and home device over 7 days were −12.7 (−28.7 to 3.4) mm Hg for SBP and −5.6 (−20.5 to 9.2) mm Hg for DBP. The wearable BP device was well accepted by participants who found the device easy to wear and use. Both participants and health care providers agreed that the wearable cuffless devices were easy to use and that they could be used to improve BP monitoring.
Conclusions:
Wearable BP measures compared well against a gold-standard ambulatory device, indicating potential for this user-friendly method to augment BP management, particularly by enabling long-term monitoring that could improve treatment titration and increase understanding of users’ BP response during daily activity and stressors.
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.