Investigating Behavior Change Methods for the Management of Hypertension

NCT07631546 | Active Not Recruiting

• 2 other identifiers: IRB2022-1153DCRM1800598
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Does digital mobile health coaching impact hypertension management outcomes, including blood pressure and adherence?
2. 2.How does adherence to mobile health intervention influence the long-term man-agement and outcomes of hypertension?
3. 3.How are health beliefs and QOL affected by digital coaching and health tracking for hypertension management?

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Change in Baseline Systolic Blood Pressure

  Blood pressure was measured by participants using a blood pressure cuff.

  From enrollment to Day 90 and 270 of the intervention.

• Change in Baseline Diastolic Blood Pressure

  Blood pressure was measured by the participants using blood pressure cuffs.

  From enrollment to the end of the treatment at Day 90 and 270.

Secondary Outcomes (10)

• Changes from Baseline Weight to Study Conclusion from Baseline to Day 90 and Day 270

  From enrollment to the end of treatment at 90 days and 270 days.

• Change from Quality of Life (SF-36) Score from Baseline to Day 90 and Day 270

  Surveys will be completed on enrollment, day 90, and day 270 of the study.

• Change in Health Belief Analysis Score from Baseline to Day 90 and Day 270

  Surveys will be completed at enrollment, on day 90, and on day 270 of the study.

• Changes in Technology Acceptance Model Score from Baseline to Day 90 and Day 270

  Surveys will be completed at enrollment, on day 90, and on day 270 of the study.

• Changes in Dual Factor Models from Baseline to Day 90 and Day 270

  Surveys will be completed at enrollment, on day 90, and on day 270 of the study.

Study Arms (2)

Digital Coaching

EXPERIMENTAL

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.

Behavioral: Digital Coaching Plan

Health Awareness

ACTIVE COMPARATOR

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.

Behavioral: Health Awareness

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.

Also known as: HyperCoach

Digital Coaching

Health Awareness BEHAVIORAL

Daily reminders to monitor bloodp pressure and weight , mobile platform functions are disabled except for biofeedback and trend graphs.

Health Awareness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Reliable internet access for mobile device (either WIFI or mobile data plan)
• iOS (14+) smarthphone (iPhone 6S or newer)
• Fluent in English or Spanish
• Participant is taking hypertension medication
• Diagnosis is hypertension
• + years of age

You may not qualify if:

• Diagnosed with resistant hypertension

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University

College Station, Texas, 77843, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To differentiate between the two participant groups: The non-coaching group will only have access to the daily reminders and trend graphs for the duration of the study. The coaching group will have access to all the app's functionalities, including daily reminders, trend graphs, educational content, knowledge assessment, and progress reports regarding their hypertension health behaviors.

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: June 8, 2026
• Study Start: August 31, 2023
• Primary Completion: June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-04

Locations

US (1)