NCT05546931

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
334

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Sep 2023Jun 2027

First Submitted

Initial submission to the registry

September 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

September 4, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

3.2 years

First QC Date

September 15, 2022

Last Update Submit

November 16, 2025

Conditions

Hypertension,EssentialAdherence, MedicationQuality of Life

Keywords

hypertensionadherencerurality

Outcome Measures

Primary Outcomes (1)

  • Change in systolic and diastolic blood pressure from baseline to 6 months

    Change in home-based systolic and diastolic blood pressure from baseline to 6 months between the intervention and usual care arms.

    Baseline, 6 months

Secondary Outcomes (7)

  • Adherence to antihypertensive medications

    Baseline, 6 months

  • Adherence to antihypertensive medications

    Baseline, 12 months

  • Patient-Reported Outcomes

    Baseline, 6 months

  • Patient-Reported Outcomes

    Baseline, 12 months

  • Self-efficacy for managing medications and treatment

    Baseline, 6 months

  • +2 more secondary outcomes

Other Outcomes (1)

  • Change in systolic and diastolic blood pressure from baseline to 6 months, stratified by home-supervised blood pressure at baseline visit.

    Baseline, 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Coaching applicationBehavioral: Home-based blood pressure monitoring

Enhanced usual care

ACTIVE COMPARATOR

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.

Other: WebMDBehavioral: Home-based blood pressure monitoring

Interventions

Coaching applicationBEHAVIORAL

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

Intervention
WebMDOTHER

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

Enhanced usual care
Home-based blood pressure monitoringBEHAVIORAL

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

Enhanced usual careIntervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Residence in one of 48 counties categorized as rural by the Center for Rural Pennsylvania;
  • English-speaking at level appropriate for informed consent and study participation;
  • No plans to relocate from the area within 12 months of enrollment.

You may not qualify if:

  • Planned major surgery, cardiovascular or non-cardiovascular;
  • Pregnancy or planned pregnancy within 12 months;
  • Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer);
  • Inability to comprehend the study protocol, defined by failing 3 times to answer correctly a set of questions during consent;
  • Institutionalized status (e.g., nursing home, incarceration);
  • Inability to operate a smartphone or HBPM device due to sensory or neurocognitive deficit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Essential HypertensionMedication AdherenceHypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Jared W Magnani, MD

CONTACT

4123830611magnanij@pitt.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel-arm, randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 21, 2022

Study Start

September 4, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

The study team will share all of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The data will be available 12 months following publication of the primary results of this trial.
Access Criteria
Researchers who provide a methodologically sound proposal. Proposals should be directed to the Principal Investigator at magnanij@pittt.edu. To gain access, data requestors will need to sign a data access agreement. Data will be provided directly by the study investigators. Costs associated with producing datasets and analysis will be the responsibility of investigators seeking the data.

Locations

US(1)