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

Primary Purpose

Hypertension, Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Text Messaging
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertension focused on measuring hypertension treatment, stroke prevention

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    No text messages, hypertensive

    Text messages, hypertensive

    Arm Description

    Participants who have high blood pressure, who are randomized to health information (do not receive text messages).

    Participants who have high blood pressure, who are randomized to receive text messages.

    Outcomes

    Primary Outcome Measures

    Mean Change in Systolic Blood Pressure

    Secondary Outcome Measures

    Mean Change in Diastolic Blood Pressure

    Full Information

    First Posted
    October 6, 2015
    Last Updated
    May 8, 2023
    Sponsor
    University of Michigan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02664610
    Brief Title
    Community Study to Reduce High Blood Pressure Through Text Messaging (REACH OUT)
    Official Title
    REACH OUT: to Reduce High Blood Pressure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (Actual)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Michigan

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Stroke
    Keywords
    hypertension treatment, stroke prevention

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    94 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    No text messages, hypertensive
    Arm Type
    No Intervention
    Arm Description
    Participants who have high blood pressure, who are randomized to health information (do not receive text messages).
    Arm Title
    Text messages, hypertensive
    Arm Type
    Experimental
    Arm Description
    Participants who have high blood pressure, who are randomized to receive text messages.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Text Messaging
    Intervention Description
    hypertensive participants will be randomized to receive tailored, motivational text messages
    Primary Outcome Measure Information:
    Title
    Mean Change in Systolic Blood Pressure
    Time Frame
    Baseline to 6 months
    Secondary Outcome Measure Information:
    Title
    Mean Change in Diastolic Blood Pressure
    Time Frame
    Baseline to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    110 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lesli Skolarus
    Organizational Affiliation
    University of Michigan
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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