Mobile Health Program for 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).
Conditions:
🦠 Hypertension,Essential 🦠 Adherence, Medication 🦠 Quality of Life
🗓️ Study Start (Actual) 4 September 2023
🗓️ Primary Completion (Estimated) December 2026
✅ Study Completion (Estimated) June 2027
👥 Enrollment (Estimated) 334
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Pittsburgh, Pennsylvania, United States

📋 Eligibility Criteria

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. 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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 September 2022
  • First Submitted that Met QC Criteria 15 September 2022
  • First Posted 21 September 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 7 May 2024
  • Last Update Posted 8 May 2024
  • Last Verified May 2024