Validation and Acceptability of a Cuffless Wrist-Worn Wearable Blood Pressure Monitoring Device Among Users and Health Care Professionals: Mixed Methods Study
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Abstract
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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In a small study, mean biases between cuff-less wearable and ambulatory devices over 24 h were 0.5 mmHg for systolic BP and 2.24 mmHg for diastolic BP, with mean bias widening over 7 days to -12.7 mmHg for systolic BP and -5.6 mmHg for diastolic BP.
“Mean biases between the wearable and ambulatory devices over 24 h were 0.5 mmHg (–10.1 mmHg to 11.1 mmHg) for systolic BP and 2.24 mmHg (–17.6 mmHg to 13.1 mmHg) for diastolic BP, with the mean bias widening over 7 days to –12.7 mmHg for systolic BP and –5.6 mmHg for diastolic BP.”
From Smart wearable devices in cardiovascular care: Where we are and how to move forward (2021) · cites this paper as [28]
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Smart wearable devices in cardiovascular care: Where we are and how to move forward
Bayoumy, K., Gaber, M., Elshafeey, A., Mhaimeed, O., Dineen, E. H., Marvel, F. A., Martin, S. S., Muse, E. D., Turakhia, M. P., Tarakji, K. G., et al. (2021) · Nature Reviews Cardiology · doi:10.1038/s41569-021-00522-7 · Cited by 829 · see citing works
Wearable health devices in health care: narrative systematic review
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- Authors
- Islam, S. M. S., Cartledge, S., Karmakar, C., Rawstorn, J. C., Fraser, S. F., Chow, C., & Maddison, R.
- Affiliations
- Deakin University (AU)
- The University of Sydney (AU)
- Corresponding author
- Islam, Sheikh Mohammed Shariful
- ORCID
- Venue
- JMIR mHealth and uHealth
- Publisher
- JMIR Publications Inc.
- Published
- 2019-09-14
- Volume
- 7
- Issue
- 10
- Pages
- e14706
- ISSN
- 2291-5222 (ISSN-L)
- PMC
- PMC6827985
- OpenAlex
- W2954015722
- Cited by
- 57
- References
- 23
- Citations by year
- 2026: 5 · 2025: 9 · 2024: 5 · 2023: 9 · 2022: 14 · 2021: 7 · 2020: 8
- FWCI
- 2.64
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- JMIR mhealth and uhealth (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Figshare (submittedVersion, cc-by)
- Topics
- Physical Sciences › Engineering › Biomedical Engineering › Non-Invasive Vital Sign Monitoring
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Health and Disease Prevention
- Keywords
- cuffless blood pressure measurement, ambulatory blood pressure monitoring, home blood pressure monitoring, device validation, measurement bias, limits of agreement, acceptability, user experience, healthcare professionals' perceptions, cardiovascular risk, long-term blood pressure monitoring
- MeSH terms
- Wearable Electronic Devices, Adolescent, Adult, Blood Pressure, Blood Pressure Determination, Female, Health Personnel, Humans, Male, Patients
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