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Completed

NCT Number: NCT02136810

Perioperative Blood Pressures and Chronic Hypertension

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale-New Haven Hospital PreAdmission Testing Clinic

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Performance of Blood Pressure Referral Threshold

    Time frame: 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 outcomes

  1. Patient Perspectives and Beliefs Regarding Blood Pressure Status as They Relate to Actual Home Blood Pressures.

    Time frame: 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.

  2. Preidentified Subgroups

    Time frame: 1 year

    The investigators will examine the correlation between blood pressure and heart rate in the subset of patients with hypertension diagnosis.

  3. Patient Perspectives

    Time frame: 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.

  4. Patient Adherence

    Time frame: 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.

  5. Preidentified Subgroup Analysis

    Time frame: 1 year

    The investigators will examine the correlation between blood pressure and heart rate in the subset of patients without hypertension diagnosis.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

The Association Between Home Blood Pressures and Clinic Blood Pressures in Patients Presenting for Surgery.

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
May 13, 2014
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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