NCT05546931

Mobile Health Program for Rural Hypertension

Multilevel Mobile Health Program to Improve Rural Hypertension

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 334 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hypertension (HTN) is the leading modifiable cause of cardiovascular disease. Rural individuals experience challenges of the rural health divide: geographic distance from providers, social isolation, limited social resources, and high rates of low health literacy. This study evaluates a home-based blood pressure monitoring (HBPM) program that provides longitudinal health education, empathic guidance, monitoring, and adaptable patient-centered coaching to rural individuals. Participants in this study will be randomized to receive (1) HBPM with the intervention; or (2) the control, consisting of HBPM and a smartphone with a general health application (WebMD).

Detailed description

Hypertension (HTN) has increasing prevalence, is the leading cause of cardiovascular morbidity and mortality, and contributes significantly to health care utilization and costs. Social determinants of health (SDOH) exacerbate patients' access to therapies, adherence, and health outcomes. A robust literature demonstrates the effects of income, education, health literacy, and social resources on access to HTN treatment; medication adherence; and short- and long-term likelihood of clinical adversity. In the U.S., geographic obstacles to care further complicate HTN treatment and outcomes for rural individuals. This single-center, parallel group randomized clinical trial (RCT) evaluates a home-based blood pressure monitoring (HBPM) and cardiovascular mobile health platform in rural individuals with hypertension (HTN). The intervention uses a virtual coaching platform to provide health education, monitoring, guidance, and adaptable patient-centered coaching to rural individuals. The 6-month intervention provides a personalized curriculum to promote HBPM; medication adherence; HTN education; non-pharmacologic strategies for HTN management; preparation for the clinical encounter; and enhanced problem-solving and engagement for rural individuals. The trial is 12-month duration with visits at baseline, 6, and 12 months. Individuals with poorly controlled HTN (systolic BP 140-199 or diastolic BP 90-119 mm Hg at 2 ambulatory visits) will be randomized to: (1) intervention, the HBPM coaching intervention and HBPM; or (2) control, smartphone with a general health application (WebMD) and HBPM. For both intervention and control, summaries of BP measures are provided to clinicians in order to improve HTN management for rural patients. The primary study outcome is improvement in BP from baseline to 6 months. The secondary study outcomes are comparison of adherence to antihypertensive medications and patient-reported outcomes in the intervention and usual care arms at 6 and 12 months.

Conditions

• Hypertension,Essential
• Adherence, Medication
• Quality of Life

Interventions

Type	Name	Description
BEHAVIORAL	Coaching application	A digital application for providing education and support for home-based blood pressure monitoring.
OTHER	WebMD	Smartphone-based application for health education and/or monitoring.
BEHAVIORAL	Home-based blood pressure monitoring	Device for measuring blood pressure at home with blue tooth connectivity for automated collection.

Timeline

• Start date: 2023-09-04
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2022-09-21
• Last updated: 2025-11-19

Locations

1 site across 1 country: United States