NCT05546931 Mobile Health Program for Rural Hypertension
| NCT ID | NCT05546931 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Hypertension,Essential |
| Study Type | INTERVENTIONAL |
| Enrollment | 334 participants |
| Start Date | 2023-09-04 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 334 participants in total. It began in 2023-09-04 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05546931 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypertension,Essential. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05546931 currently recruiting?
Yes, NCT05546931 is actively recruiting participants. Contact the research team at magnanij@pitt.edu for enrollment information.
Where is the NCT05546931 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT05546931 clinical trial?
NCT05546931 is sponsored by University of Pittsburgh. The trial plans to enroll 334 participants.