Mobile Health Program for Rural Hypertension

NCT ID: NCT05546931

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 334 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-04
• Study Completion Date: 2027-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

A smartphone-based, interactive coaching application designed to enhance adherence to home-based blood pressure monitoring, provided guidance on blood pressure management, patient-facing education, and assistance with modifying behaviors associated with poor blood pressure control; connected to a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform. All participants in the experimental arm receive a smartphone for the 6-month intervention duration and the home-based blood pressure cuff.

Group Type: EXPERIMENTAL

Coaching application

Intervention Type: BEHAVIORAL

A digital application for providing education and support for home-based blood pressure monitoring.

Home-based blood pressure monitoring

Intervention Type: BEHAVIORAL

Device for measuring blood pressure at home with blue tooth connectivity for automated collection.

Enhanced usual care

WebMD, a smartphone-based tool for learning about blood pressure and other health conditions. Enhanced usual care participants receive a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform. All participants in the experimental arm receive a smartphone for the 6-month intervention duration and the home-based blood pressure cuff.

Group Type: ACTIVE_COMPARATOR

WebMD

Intervention Type: OTHER

Smartphone-based application for health education and/or monitoring.

Home-based blood pressure monitoring

Intervention Type: BEHAVIORAL

Device for measuring blood pressure at home with blue tooth connectivity for automated collection.

Interventions

Coaching application

A digital application for providing education and support for home-based blood pressure monitoring.

Intervention Type: BEHAVIORAL

WebMD

Smartphone-based application for health education and/or monitoring.

Intervention Type: OTHER

Home-based blood pressure monitoring

Device for measuring blood pressure at home with blue tooth connectivity for automated collection.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. History of uncontrolled hypertension, identified from the electronic health record problem list and an average systolic BP 140-199 or diastolic BP 90-119 mm Hg at 2 ambulatory visits, one of which is within 6 months of study entry

2. Residence in one of 48 counties categorized as rural by the Center for Rural Pennsylvania;

3. English-speaking at level appropriate for informed consent and study participation;

4. No plans to relocate from the area within 12 months of enrollment.

Exclusion Criteria

1. Heart failure necessitating hospital admission ≤3 months prior to study inclusion;

2. Acute coronary syndrome (defined as at least 2 of the following: chest pain, ischemic electrocardiographic changes, or troponin ≥0.1 ng/mL) ≤3 months prior to study inclusion;

3. Planned major surgery, cardiovascular or non-cardiovascular;

4. Pregnancy or planned pregnancy within 12 months;

5. Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer);

6. Inability to comprehend the study protocol, defined by failing 3 times to answer correctly a set of questions during consent;

7. Institutionalized status (e.g., nursing home, incarceration);

8. Inability to operate a smartphone or HBPM device due to sensory or neurocognitive deficit.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Jared W Magnani, MD, MSc

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jared W Magnani, MD

Role: CONTACT

magnanij@pitt.edu

4123830611

Facility Contacts

Jared W Magnani, MD

Role: primary

magnanij@pitt.edu

412 383 0611

Other Identifiers

R01HL160749

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY21120151

Identifier Type: -

Identifier Source: org_study_id