Mobile Health Program for Rural Hypertension

Multilevel Mobile Health Program to Improve Rural Hypertension

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).

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Adherence, Medication; Hypertension,Essential
• Intervention / Treatment: Behavioral: Coaching application; Behavioral: Home-based blood pressure monitoring; Other: 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.

• Study Type: Interventional
• Enrollment (Estimated): 334
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jared W Magnani, MD; Phone Number: 4123830611; Email: magnanij@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh Medical Center
      • Contact: Jared W Magnani, MD; Phone Number: 412-383-0611; Email: magnanij@pitt.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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. Prescribed use of one or more antihypertensive agents as identified by the International Society of Hypertension core drug-treatment strategy;
3. Residence in one of 48 counties categorized as rural by the Center for Rural Pennsylvania;
4. English-speaking at level appropriate for informed consent and study participation;
5. No plans to relocate from the area within 12 months of enrollment.

Exclusion Criteria:

1. History of malignant HTN (defined by BP >200/120 mm Hg) with or without clinical sequelae;
2. Heart failure necessitating hospital admission ≤3 months prior to study inclusion;
3. 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;
4. Planned major surgery, cardiovascular or non-cardiovascular;
5. Pregnancy or planned pregnancy within 12 months;
6. Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer);
7. Inability to comprehend the study protocol, defined by failing 3 times to answer correctly a set of questions during consent;
8. Institutionalized status (e.g., nursing home, incarceration);
9. Inability to operate a smartphone or HBPM device due to sensory or neurocognitive deficit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Coaching application; A digital application for providing education and support for home-based blood pressure monitoring.; Behavioral: Home-based blood pressure monitoring; Device for measuring blood pressure at home with blue tooth connectivity for automated collection.
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.	Behavioral: Home-based blood pressure monitoring; Device for measuring blood pressure at home with blue tooth connectivity for automated collection.; Other: WebMD; Smartphone-based application for health education and/or monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to antihypertensive medications	Adherence to antihypertensive medication from baseline to 6 months between the intervention and usual care arms using Proportion of Days Covered, ranging from 0 to 100%, where higher values indicate superior medication adherence.	Baseline, 6 months
Adherence to antihypertensive medications	Adherence to antihypertensive medication from baseline to 12 months between the intervention and usual care arms using Proportion of Days Covered, ranging from 0 to 100%, where higher values indicate superior medication adherence.	Baseline, 12 months
Patient-Reported Outcomes	Patient-reported outcomes between the intervention and usual care arms at 6 months measured with the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) with distinct assessments of the following: (1) physical function, (2) anxiety, (3) depression, (4) fatigue, (5) sleep, (6) ability to participate in social roles, (7) social role satisfaction, and (8) interference in functioning by pain. Each domain is scored separately, such that scores for each domain range from 4 (lowest score) to 20 (highest score), where higher scores indicate greater impairment.	Baseline, 6 months
Patient-Reported Outcomes	Patient-reported outcomes between the intervention and usual care arms at 12 months measured with the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) with distinct assessments of the following: (1) physical function, (2) anxiety, (3) depression, (4) fatigue, (5) sleep, (6) ability to participate in social roles, (7) social role satisfaction, and (8) interference in functioning by pain. Each domain is scored separately, such that scores for each domain range from 4 (lowest score) to 20 (highest score), where higher scores indicate greater impairment.	Baseline, 12 months
Self-efficacy for managing medications and treatment	Patient-reported outcomes between the intervention and usual care arms at 6 months measured with the Patient-Reported Outcomes Measurement Information System Self-efficacy for managing medications and treatment, a 10-item instrument, scored from 10 (minimum) to 40 (maximum), where higher scores indicate superior self-efficacy.	Baseline, 6 months
Self-efficacy or managing medications and treatment	Patient-reported outcomes between the intervention and usual care arms at 12 months measured with the Patient-Reported Outcomes Measurement Information System Self-efficacy for managing medications and treatment, a 10-item instrument, scored from 10 (minimum) to 40 (maximum), where higher scores indicate superior self-efficacy.	Baseline, 12 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: adherence; hypertension; rurality
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: STUDY21120151; R01HL160749 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study team will share all of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: The data will be available 12 months following publication of the primary results of this trial.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No