NCT02217059

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

November 29, 2017

Status Verified

March 1, 2016

Enrollment Period

2.9 years

First QC Date

August 7, 2014

Last Update Submit

November 27, 2017

Conditions

Hypertension

Keywords

Emergency Medical ServicesEmergency CareHypertensionBpTRUBlood pressure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (3)

Prehypertension

Using the JNC7 definition

Stage I Hypertension

Using the JNC7 definition

Stage II Hypertension

Using the JNC7 definition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Emergency Department

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2014

First Posted

August 15, 2014

Study Start

August 1, 2014

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

November 29, 2017

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)