Perioperative Blood Pressures and Chronic Hypertension

Completed

• Conditions: Hypertension

• Registration Number: NCT02136810
• Lead Sponsor: Yale University

Brief Summary

This study aims to assess the performance of presurgical clinic blood pressure measurements in predicting home blood pressure readings among surgical patients. It also aims to measure the association between home blood pressures and patient perspectives on blood pressure control.

Detailed Description

A convenience sample of presurgical patients seen in a preadmission testing clinic were enrolled and sent home with a home blood pressure monitor that stored up to 50 readings. Participants were asked to return the BP cuff on the day of their surgery.

Study Timeline

• Study First Submitted: 2014-05-06
• Study First Submitted QC: 2014-05-08
• Study First Posted: 2014-05-13
• Study Start: 2015-11-09
• Primary Completion: 2017-01-11
• Study Completion: 2018-01-16
• Results First Submitted: 2018-11-20
• Results First Submitted QC: 2018-11-20
• Results First Posted: 2018-12-14
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-01
• Last Update Posted: 2023-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Ambulatory patients >= 21 years of age presenting for surgery to a tertiary care preadmission testing clinic.

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Exclusion Criteria

• Inability or unwillingness to independently operate a home blood pressure monitor.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance of Blood Pressure Referral Threshold	Subjects followed for approximately 1 year	The positive predictive value of preadmission testing-measured blood pressure to predict mean home blood pressure \>135/85mmHg will be calculated.

Secondary Outcome Measures

Name	Time	Method
Preidentified Subgroup Analysis	1 year	The investigators will examine the correlation between blood pressure and heart rate in the subset of patients without hypertension diagnosis.
Patient Perspectives and Beliefs Regarding Blood Pressure Status as They Relate to Actual Home Blood Pressures.	Approximately 60 days	In secondary analyses, the agreement between patients' self-reported blood pressure control (binary outcome) and home blood pressure monitor-determined blood pressure status (binary outcome) will we assessed via Cohen's kappa and raw indices of agreement.
Preidentified Subgroups	1 year	The investigators will examine the correlation between blood pressure and heart rate in the subset of patients with hypertension diagnosis.
Patient Perspectives	60 days	The possible association of self-reported availability of primary care (5 point LIKERT scale) with home blood pressure monitor-status will be examined by the Mantel-Haenszel Chi-Square Test.
Patient Adherence	60 days	The possible association of medication adherence (Morisky scale) with home blood pressure monitor-status will be examined by the Mantel-Haenszel Chi-Square Test.

Trial Locations

Locations (1)

Yale-New Haven Hospital PreAdmission Testing Clinic; 🇺🇸 New Haven, Connecticut, United States