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Completed

NCT Number: NCT03634813

Perioperative Blood Pressure Screening to Improve Long-term Cardiovascular Health

To explore in a pilot randomized clinical trial, the impact of Home Blood Pressure Monitoring with patient directed information as compared to usual care on the postoperative management of blood pressure.

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Key information

Conditions

Blood Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale-New Haven Hospital PreAdmission Testing Clinic

New Haven, Connecticut, 06520, United States

About this study

The intervention and control groups will be defined by, 1) preoperative home blood pressure monitoring with a detailed report sent to the patient, and 2) usual standard of care including a suggestion during the pre-operative clinic appointment to follow up with Primary Care. Both groups will receive a brief questionnaire about their blood pressure treatment and medication adherence. We will examine the rate of primary care follow-up and changes in hypertension treatment at 60 days post-operative, through a telephone call. This information, along with information regarding patient acceptance of the intervention will be used to inform the design of a future clinical trial powered to outcomes, including follow-up visits and blood pressure management.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • We propose to recruit patients who present for ambulatory surgery, aged >18 years, with a preoperative blood pressure > 140/90 mmHg taken as the mean of two readings during the pre-admission testing visit.

Exclusion criteria

  • Patients who are unable or unwilling to be contacted by telephone, are non-English speaking, or are unable to operate an automated home blood pressure monitor will also be excluded.
  • Healthy patients with blood pressure readings that fall within the American Heart Association (AHA) guidelines.

Treatment and study plan

High Blood Pressure Monitor

Device

High Blood Pressure Monitoring device (Omron MX3 model BP742, Omron, Shaumberg, IL)

usual care

Procedure

Usual Care

Primary outcomes

  1. Patients Reporting Primary Care Follow-up

    Time frame: 60 days

    For the primary analysis, we will estimate the proportion of subjects that had a primary care follow-up visit within 60 days

  2. Patients Reporting New/Adjusted Hypertension Treatment.

    Time frame: 60 days

    For the primary analysis, we will estimate the proportion reporting new/adjusted hypertension treatment within 60 days. The count of participants is the number of patients for whom it was determined that they had new or adjusted hypertension treatment.

Secondary outcomes

  1. Patient Acceptance/Satisfaction With Blood Pressure Care

    Time frame: 60 days

    Patient Acceptance/Satisfaction With Blood Pressure Care. A questionnaire was provided to all participants, these data were not intended to be compared between treatment arms. The count of participants is the number of participants that reported they were moderately to very satisfied with their care.

Other outcomes

  1. Patients Demonstrating HBPM Elevation.

    Time frame: 1 year

    The proportion of patients demonstrating HBPM elevation was measured. Specific cut-offs for the interpretation of home blood pressure are controversial. The mean home blood pressure threshold was > 135/85 mmHg as indicating hypertension, in-line with recommendations from the American Heart Association.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Aug 16, 2018
Registry last updated
Nov 17, 2022

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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