Role of Wrist Based Blood Pressure Monitoring in Clinical Practice

Withdrawn

• Conditions: Blood Pressure; Transitions of Care

• Registration Number: NCT03862742
• Lead Sponsor: Scripps Translational Science Institute

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.

Study Timeline

• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-05
• Study Start: 2019-05-22
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood pressure	Pts 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 hours	blood pressure measured by the wrist watch like blood pressure device

Secondary Outcome Measures

Name	Time	Method
Survey of healthcare providers	A 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 patients	A 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

Trial Locations

Locations (1)

Scripps Green Hospital; 🇺🇸 La Jolla, California, United States