Multilevel Mobile Health Program to Improve Rural Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 334
- 试验地点
- 2
- 主要终点
- Change in systolic and diastolic blood pressure from baseline to 6 months
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in systolic and diastolic blood pressure from baseline to 6 months
时间窗: Baseline, 6 months
Change in home-based systolic and diastolic blood pressure from baseline to 6 months between the intervention and usual care arms.
次要结局
- Self-efficacy for managing medications and treatment(Baseline, 6 months)
- Patient-Reported Outcomes(Baseline, 12 months)
- Self-efficacy or managing medications and treatment(Baseline, 12 months)
- Adherence to antihypertensive medications(Baseline, 12 months)
- Adherence to antihypertensive medications(Baseline, 12 months)
- Patient-Reported Outcomes(Baseline, 12 months)
- Self-efficacy or managing medications and treatment(Baseline, 12 months)
- Self-efficacy for managing medications and treatment(Baseline, 6 months)
- Adherence to home blood pressure monitoring(From enrollment to the end of the intervention phase at 6 months.)
研究者
Jared W Magnani, MD, MSc
Associate Professor
University of Pittsburgh