Mobile health program to manage hypertension in rural areas
Multilevel Mobile Health Program to Improve Rural Hypertension
This study tests a home-based program that helps people in rural areas with high blood pressure by providing personalized coaching and health education to see if it improves their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 334 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05546931 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a home-based blood pressure monitoring program designed for individuals living in rural areas with uncontrolled hypertension. Participants will be randomized to receive either the intervention, which includes personalized coaching and health education, or a control group that receives basic health information through a smartphone application. The program aims to improve medication adherence and overall health outcomes by addressing the unique challenges faced by rural populations, such as limited access to healthcare and low health literacy. The trial will last for 12 months, with assessments at baseline, 6 months, and 12 months.
Who should consider this trial
Good fit: Ideal candidates are rural individuals with a history of uncontrolled hypertension and the ability to engage with a mobile health platform.
Not a fit: Patients with recent heart failure, acute coronary syndrome, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve blood pressure control and quality of life for rural patients with hypertension.
How similar studies have performed: Other studies have shown promise in using mobile health interventions for hypertension management, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Jared W Magnani, MD
- Email: magnanij@pitt.edu
- Phone: 4123830611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.