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Role of Wrist Based Blood Pressure Monitoring in Clinical Practice

Role of Wrist Based Blood Pressure Monitoring in Clinical Practice

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03862742
Enrollment
0
Registered
2019-03-05
Start date
2019-05-22
Completion date
2020-03-31
Last updated
2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Transitions of Care

Brief summary

This is a pilot clinical study to test the overarching hypothesis that frequent and longitudinal blood pressure monitoring with FDA approved consumer wrist based device during the patient transition from inpatient to home to the first clinic visit will elicit valuable BP data that can assist in physician treatment of hypertension

Detailed description

Wrist based health devices, often with mobile connectivity, that continuously or near continuously track heart rate, blood pressure, temperature, activity and sleep are growing in everyday popularity and beginning to enter the sphere of clinical relevance. However, their accuracy and utility for clinical use is largely unstudied. As these consumer devices, some of which are FDA approved, become more commonplace, it is paramount to understand their function, know their limitations, and be able to interpret results appropriately before incorporating them into our clinical practice. The AHA/ACC 2017 guideline makes a 1A recommendation for clinical use of out of office BP measurements(1). This recommendation is based on evidence that out of office BP and frequent and longitudinal BP measurements are important in predicting cardiovascular risk and monitoring treatment efficacy(2-5). This trend towards consumer driven digital health monitoring and the new AHA/ACC guideline are essentially advancing a consumer based precision medicine strategy for diagnosis and monitoring of hypertension. As this becomes commonplace in our patient population, we need rigorous clinical study of wrist base BP monitoring to better understand its role patient care.

Interventions

None listed

Sponsors

Scripps Translational Science Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* ≥18 years of age * Own an iOS or Android device

Exclusion criteria

* Inability to give informed consent * \<18 years of age * Inability to understand written English language * Hypertensive urgency or emergency as an admission diagnosis

Design outcomes

Primary

MeasureTime frameDescription
Blood pressurePts will monitor BP during the transition from inpatient to home to the first clinic visit. BP measurements will be performed several times during the day and several times at night. The estimated time frame when data will be collected is 24 to 48 hoursblood pressure measured by the wrist watch like blood pressure device

Secondary

MeasureTime frameDescription
Survey of healthcare providersA survey to measure how easy it is to use the device will be obtained at the completion of data collection. The estimated timeframe when the survey will be completed is 24 to 48 hours.Survey to measure ease of use to the device in measuring blood pressure
Survey of patientsA survey to measure how easy it is to use the device will be obtained at the completion of data collection. The estimated timeframe when the survey will be completed is 24 to 48 hours.Survey to measure ease of use to the device in measuring blood pressure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026