REACH OUT: to Reduce High Blood Pressure in the Emergency Department

February 7, 2018 updated by: Lesli E. Skolarus, MD, University of Michigan

One of the most powerful predictors of stroke is hypertension, with estimates of approximately 33% of adults in the United States experiencing this condition.

Hypertension is very prevalent in the emergency department (ED), but significantly undertreated. The overall goal of this project is to develop a text messaging intervention to improve hypertension care in the ED. This will first be done by testing the feasibility of identifying hypertensive patients in the ED, and the response rate to text messages.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

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

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult (≥18 y/o)
  • At least one BP of systolic blood pressure (SBP) ≥160 or a diastolic blood pressure (DBP) ≥100 or only BP performed prior to enrollment is SBP ≥160 or a DBP ≥100 (If the patient has repeated measurements after achieving Criteria 1, but prior to being enrolled, at least one of the repeat BP remains SBP ≥140 or a DBP ≥90)
  • Must have mobile phones with text-messaging capability
  • Likely to be discharged from the ED

Exclusion Criteria:

  • Adult who is in an urgent condition
  • Unable to read
  • Non-English speaking
  • Incarcerated/ institutionalized resident
  • Pregnant, or has a pre-existing condition that makes follow-up for 4 months unlikely.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control, Not hypertensive
Participants who after 3 weeks do not have high blood pressure or are not responsive to text messages.
Experimental: Text messages, hypertensive
Participants who after 3 weeks have high blood pressure and are responsive to text messages, who are then randomized to receive text messages.
Behavioral: Text messaging
persistently hypertensive participants will be randomized to receive these tailored, motivational text messages
No Intervention: No text messages, hypertensive
Participants who after 3 weeks have high blood pressure and are responsive to text messages, who are then randomized to not receive text messages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of people who respond to text messages and are persistently hypertensive
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in systolic and diastolic blood pressure
Time Frame: 4 months
4 months
Feasibility of a screening algorithm
Time Frame: 4 months
Proportion of subjects recruited compared to proportion of subjects approached. Subject eligibility identified by screening algorithm.
4 months
Feasibility of subject follow-up mechanism
Time Frame: 4 months
Proportion of subjects responding to follow-up text messages
4 months
Mean group differences and standard deviations for systolic blood pressure
Time Frame: 4 months
4 months

Collaborators and Investigators

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

Sponsor

University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

October 23, 2014

First Submitted That Met QC Criteria

November 24, 2014

First Posted (Estimate)

November 26, 2014

Study Record Updates

Last Update Posted (Actual)

February 9, 2018

Last Update Submitted That Met QC Criteria

February 7, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00091668

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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