Mobile Health Program for Rural Hypertension
Recruiting · NCT05546931 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Pittsburgh
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- Heart failure necessitating hospital admission ≤3 months prior to study inclusion;
- 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;
- 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.
Where it is running
1 location listed across 1 US state.
- University of Pittsburgh Medical Center - Pittsburgh, Pennsylvania, United States