Community Study to Reduce High Blood Pressure Through Text Messaging (REACH OUT)

May 8, 2023 updated by: Lesli E. Skolarus, MD, University of Michigan

REACH OUT: to Reduce High Blood Pressure

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 significantly more prevalent in African Americans compared to European Americans. Importantly, hypertension is a modifiable stroke risk factor.

This proposal will use a community-based participatory research approach to perform a randomized trial of a mobile phone text-messaging intervention to reduce high blood pressure in an urban African American community in Flint, Michigan.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized controlled trial of text messaging and blood pressure self-monitoring to reduce blood pressure.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

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

No

Description

Inclusion Criteria:

  • Adult (>18 y/o) participants with BP ≥140/90 who have mobile phones with text-messaging capability.

Exclusion Criteria:

  • Adult who is illiterate, non-English speaking, pregnant, incarcerated/ institutionalized resident, or has a pre-existing condition that makes follow-up for 6 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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No text messages, hypertensive
Participants who have high blood pressure, who are randomized to health information (do not receive text messages).
Experimental: Text messages, hypertensive
Participants who have high blood pressure, who are randomized to receive text messages.
Behavioral: Text Messaging
hypertensive participants will be randomized to receive tailored, motivational text messages

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Change in Systolic Blood Pressure
Time Frame: Baseline to 6 months
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean Change in Diastolic Blood Pressure
Time Frame: Baseline to 6 months
Baseline to 6 months

Collaborators and Investigators

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

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Lesli Skolarus, University of Michigan

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 (Actual)

February 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

October 6, 2015

First Submitted That Met QC Criteria

January 22, 2016

First Posted (Estimated)

January 27, 2016

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO13884

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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