Overview

This trial is active, not recruiting.

Conditions hypertension, stroke
Treatment text messaging
Phase phase 1
Sponsor University of Michigan
Start date February 2014
End date April 2015
Trial size 94 participants
Trial identifier NCT02664610, GO13884

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
Participants who have high blood pressure, who are randomized to health information (do not receive text messages).
(Experimental)
Participants who have high blood pressure, who are randomized to receive text messages.
text messaging
hypertensive participants will be randomized to receive tailored, motivational text messages

Primary Outcomes

Measure
Change in systolic and diastolic blood pressure
time frame: 6 months

Secondary Outcomes

Measure
Proportion of persistently hypertensive participants who respond to text messages
time frame: 6 months
Feasibility of subject follow-up mechanism (Proportion of subjects responding to follow-up text messages)
time frame: 6 months
Mean group differences for systolic blood pressure
time frame: 6 months
Mean group differences for medication adherence
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title REACH OUT: to Reduce High Blood Pressure
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Michigan.