Recruiting

Mobile Health Program

Sponsor:

University of Pittsburgh

Code:

NCT05546931

Conditions

Hypertension,Essential

Adherence, Medication

Quality of Life

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Coaching application

WebMD

Home-based blood pressure monitoring

Study Details

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).

Conditions

Hypertension,Essential

Adherence, Medication

Quality of Life

Study ID

NCT05546931

Start date

Sep 4, 2023

Status verified date

Nov, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

334 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

Coaching application

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

WebMD

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

Home-based blood pressure monitoring

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

Primary outcome measure

  • Change in systolic and diastolic blood pressure from baseline to 6 months [ Time Frame: Baseline, 6 months ]

Central Contacts and Locations

Central contacts

Jared W Magnani, MD

4123830611magnanij@pitt.edu

Locations

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

More Information

Sponsor

University of Pittsburgh

Last update posted

Nov 19, 2025

Last verified

Nov, 2025

Keywords

  • hypertension
  • adherence
  • rurality

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2025-11-19.