Investigating Behavior Change Methods for the Management of Hypertension

Part of paid clinical trials in College Station, Texas.

Sponsor
Texas A&M University
Study ID
NCT07631546
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Digital Coaching Plan — BEHAVIORAL
    The participants will have the opportunity to establish their own personal health goals for blood pressure, resting heart rate, weight, and step count in HyperCoach. At the end of every week, participants will have the opportunity to have a progress report available to them to demonstrate their current trends regarding their weight, blood pressure, resting heart rate, and step count. The progress report will also allow users to change their current goals to more appropriate ones according to their health and knowledge development. The participants will be provided with a Bluetooth-enabled blood pressure cuff and weight scale. The devices will be used alongside the participants' IOS phones to collect their blood pressure and weight readings through the use of the iPhone Application - HyperCoach. The application will provide the participants with American Heart Association (AHA) approved content in the form of flyers, messages, and videos.
  • Health Awareness — BEHAVIORAL
    Daily reminders to monitor bloodp pressure and weight , mobile platform functions are disabled except for biofeedback and trend graphs.

Study Details

This project aims to promote general wellness using a mobile health intervention that incorporates health coaching to help manage hypertension. The mobile application (HyperCoach) does not intend to cure, mitigate, or prevent hypertension. The main questions it aims to answer are: 1. Does digital mobile health coaching impact hypertension management outcomes, including blood pressure and adherence? 2. How does adherence to mobile health intervention influence the long-term man-agement and outcomes of hypertension? 3. How are health beliefs and QOL affected by digital coaching and health tracking for hypertension management? Participants will be required to complete the following: Blood pressure reading every day Weight reading every day Take hypertension medication as prescribed by their physician Complete educational content (if on coaching group) Belief and Attitudes Survey (before and after study) Personality Assessment Survey Demographic Information Survey Hypertension Health Literacy Survey (before and after study) Two General Health Literacy Surveys (before and after study) Quality of Life Survey

Key Dates

Start date
Aug 31, 2023
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
37 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Digital Coaching
    A study will be conducted where participants will be guided through a 90-day hypertension AHA-approved care plan, and 180-days later, will be checked for self-sustainability. The coaching plan that has been developed was created through AHA-approved content and guidelines. The participants will be provided with a blood pressure cuff and a weight scale. The iPhone application will provide the coaching group participants with a combination of educational content and motivational messages.
  • Active Comparator: Health Awareness
    The Health Awareness group will only receive daily reminders to complete their measurements, the ability to track, and display their data trends in a graph.

Primary Outcome Measure

Change in Baseline Systolic Blood Pressure [ Time Frame: From enrollment to Day 90 and 270 of the intervention. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Texas A&M UniversityCollege StationTexas77843-

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