Remote Hypertension Tracking, Help, and Management to Reduce Disparities in Black Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 864
- 试验地点
- 1
- 主要终点
- Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 12
研究概览
简要总结
This study will compare two approaches for managing hypertension in Black patients with uncontrolled blood pressure (BP). One approach will include home BP telemonitoring supported by a pharmacist and a community health worker. The other approach will include usual clinic-based care along with a home BP monitor and routine care.
详细描述
This study is a pragmatic effectiveness-implementation hybrid type 2 trial with two study arms. One arm will include home BP telemonitoring supported by a pharmacist and a community health worker providing centralized self-management support. The other arm will include enhanced usual clinic-based care with a home BP monitor and routine care from providers trained on evidence-based guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Black or African American race
- •Hypertension diagnosis
- •aged 21 to 85 years
- •Uncontrolled blood pressure as defined by [a] most recent SBP ≥140 mmHg and an additional SBP≥140 mmHg within the past 12 months in an outpatient setting (excluding urgent care, emergency department or surgery clinic), or [b] most recent SBP>160mmHg in an outpatient setting (excluding urgent care, emergency department or surgery clinic), or [c] referral by PCP for uncontrolled hypertension with at least one documented SBP≥140 mmHg (in clinic or at home) in the past 12 months; and (v) primary care provided at a participating clinic.
- •Able to speak English
- •Primary care provided at a participating clinic
排除标准
- •currently pregnant or planning to get pregnant during the study period
- •residence in a long-term care facility, hospice or with a terminal illness with less than 1 year life expectancy as determined by the Primary Care Physician or study team. Stable chronic illness such as compensated cirrhosis, chronic obstructive pulmonary disease, congestive heart failure etc. will not be excluded.
- •estimated Glomerular Filtration Rate (eGFR) <30 ml/min or on dialysis. Patients with a functioning kidney transplant will not be excluded.
- •inability to provide informed consent or participate in study procedures. For example, conditions that limit ability to participate in phone visits or check BPs in at least one arm.
- •currently participating in another BP management program.
- •plan to move out of the area within the next 12 months.
- •Hispanic ethnicity.
研究组 & 干预措施
RHYTHM (Remote Hypertension Tracking Help Management)
home blood pressure telemonitoring with remote medication management and social support, lifestyle education and connection to community resources to address social needs
干预措施: RHYTHM (Remote Hypertension Tracking Help Management) (Behavioral)
Enhanced usual care (UC)
standardized packet with evidence-based hypertension education material and a blood pressure monitor to complete blood pressure measurements at home
干预措施: Enhanced usual care (UC) (Behavioral)
结局指标
主要结局
Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 12
时间窗: Month 12
Percent of patients achieving BP control (i.e., SBP\<130mmHg)
次要结局
- Systolic blood pressure (mmHg) - Month 12(Month 12)
- Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Baseline(Baseline)
- Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 18(Month 18)
- Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 6(Month 6)
- 20-Item Short Form Health Survey (SF-20) - Baseline(Baseline)
- Systolic blood pressure (mmHg) - Baseline(Baseline)
- Systolic blood pressure (mmHg) - Month 6(Month 6)
- Healthcare Utilization - Number of Acute Care Days - Baseline(Baseline)
- Healthcare Utilization - Number of Acute Care Days - Month 12(Month 12)
- Systolic blood pressure (mmHg) - Month 18(Month 18)
- Self-Management - Hypertension Self-Care Profile Score - Baseline(Baseline)
- Self-Management - Hypertension Self-Care Profile Score - Month 12(Month 12)
- Medication adherence - Hill-Bone medication adherence scale survey score - Baseline(Baseline)
- Medication adherence - Hill-Bone medication adherence scale survey score - Month 12(Month 12)
- Patient assessment of chronic illness care (PACIC) survey score - Baseline(Baseline)
- Patient assessment of chronic illness care (PACIC) survey score - Month 12(Month 12)
- 20-Item Short Form Health Survey (SF-20) - Month 12(Month 12)
- Healthcare Utilization - Number of Acute Care Days - Month 24(Month 24)