Clinical trial NCT05546931: Mobile Health Program for Rural Hypertension
Official title: Multilevel Mobile Health Program to Improve Rural Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension,Essential
Adherence, Medication
Quality of Life
Keywords: hypertension
adherence
rurality
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-09-21
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel-arm, randomized clinical trial
Primary purpose: TREATMENT

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).

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.

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.

Primary outcomes:
measure: Change in systolic and diastolic blood pressure from baseline to 6 months
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Adherence to antihypertensive medications
timeFrame: Baseline, 6 months
measure: Adherence to antihypertensive medications
timeFrame: Baseline, 12 months
measure: Patient-Reported Outcomes
timeFrame: Baseline, 6 months
measure: Patient-Reported Outcomes
timeFrame: Baseline, 12 months
measure: Self-efficacy for managing medications and treatment
timeFrame: Baseline, 6 months
measure: Self-efficacy or managing medications and treatment
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
References: