Emergency Department Home Blood Pressure Monitoring and BpTRU Study

November 27, 2017 updated by: Rhode Island Hospital

Congruence of Emergency Department Attendings' Predictions of Hypertension With Results of Home Blood Pressure Monitoring

The purpose of this study is to evaluate the Congruence of Emergency Department (ED) Attendings' Predictions of Hypertension with Results of Home Blood Pressure Monitoring.

Study Overview

Status

Completed

Conditions

Detailed Description

Evaluate the Congruence of Emergency Department (ED) Attendings' Predictions of Hypertension with Results of Home Blood Pressure Monitoring & evaluate reliability of ED measured elevated blood pressure compared to the BpTRU

Study Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Emergency Department

Description

Inclusion Criteria:

  • One elevated blood pressure greater than 120 systolic and/or 80 diastolic
  • BpTRU device blood pressure greater than 120 systolic and/or 80 diastolic while in ED

Exclusion Criteria:

  • Prior history of hypertension
  • Currently on antihypertensives or receiving prescription on discharge
  • Pregnancy
  • History of atrial fibrillation
  • Dialysis patient
  • Nursing home or rehabilitation center resident
  • Admitted
  • Moving out of the area in next 30 days
  • Substance abuse
  • Prisoner
  • Presenting for psychiatric complaint requiring constant observation
  • Inability to give informed consent (intoxicated, altered, non-English speaking)
  • Presenting with symptoms of hypertensive emergency
  • Inability to demonstrate adequate use of the home blood pressure device in the ED
  • Arm circumference less than 9 inches or greater than 17 inches

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Prehypertension
Using the JNC7 definition
Stage I Hypertension
Using the JNC7 definition
Stage II Hypertension
Using the JNC7 definition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percentage of emergency department attendings that accurately predict which patients meet criteria for hypertension in two week follow-up using home blood pressure monitoring.
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The predictive value of the emergency department measured blood pressure by the standard ED blood pressure device, BpTRU device, and home blood pressure device for hypertension in follow-up
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

August 7, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 15, 2014

Study Record Updates

Last Update Posted (Actual)

November 29, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UEMF0000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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