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Clinical Trials/NCT03634813
NCT03634813
Completed
N/A

Perioperative Blood Pressure Screening to Improve Long-term Cardiovascular Health

Yale University1 site in 1 country100 target enrollmentAugust 31, 2018
ConditionsBlood Pressure

Overview

Phase
N/A
Intervention
Not specified
Conditions
Blood Pressure
Sponsor
Yale University
Enrollment
100
Locations
1
Primary Endpoint
Patients Reporting Primary Care Follow-up
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 31, 2018
End Date
April 17, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

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

  • Patient Acceptance/Satisfaction With Blood Pressure Care(60 days)

Study Sites (1)

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