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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02217059
Other study ID # UEMF0000
Secondary ID
Status Completed
Phase N/A
First received August 7, 2014
Last updated November 27, 2017
Start date August 2014
Est. completion date July 2017

Study information

Verified date March 2016
Source Rhode Island Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Rhode Island Hospital Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 18 months
Secondary 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 18 months
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