- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02664610
Community Study to Reduce High Blood Pressure Through Text Messaging (REACH OUT)
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
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
|
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
Sponsor
Investigators
- Principal Investigator: Lesli Skolarus, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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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