Evaluation of Integrating Self Blood Pressure Monitoring Into Urban Primary Care Practices to Improve Ethnic/ Racial Disparities in Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 899
- 试验地点
- 6
- 主要终点
- Absolute and relative changes in systolic and diastolic BP in the intervention and control groups.
研究概览
简要总结
Background:
Hypertension (HTN) is a major risk factor for cardiovascular disease (CVD), the leading cause of death in the United States and New York City (NYC). One in 4 NYC adults has hypertension, with higher prevalence in both Blacks and Latinos compared to Whites (Angell 2008). In NYC, only 65% of all adults with HTN and on treatment are controlled (Angell 2008).
Self-blood pressure monitoring (SBPM) is associated with reduced blood pressure in patients with hypertension (Cappuccio 2004). Studies suggest that SBPM may increase control either by inducing clinicians to titrate medication more actively, (Agency for Healthcare Research and Quality 2002) by engaging patients to participate in their own health care, (Taylor 2007) or a combination of the two.
However, minimal research has been done to evaluate the effectiveness of SBPM in different racial and/or ethnic groups or in low income populations or to discern effective patterns of SBPM use by patients. Best practices for integration of self monitoring into HTN into regular treatment have also yet to be established.
Objectives:
The goal of this study is to assess the impact of SBPM under conditions consistent with existing community health clinic resources and infrastructure in NYC's medically underserved neighborhoods using commonly available automated home BP monitors. By using a community clinic's electronic health record (EHR) and automated BP monitors with the capability to transmit readings to a research database, we can facilitate a more rigorous evaluation of a pilot SBPM intervention and assess patterns of home monitor use and clinical management and their association with outcomes.
The three specific aims of this intervention are to:
- Assess whether use of SBPM reduces elevated BP and increases HTN control to similar levels in two historically understudied minority populations, Blacks and Latinos.
- Confirm pilot findings by assessing the impact of SBPM on BP and HTN control compared to usual care using randomized controlled trial methodology.
- Develop standards and refine guidance for the effective use of SBPM that can be easily communicated to key stakeholders.
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
- •Adult patients attending one of the participating primary care clinics
- •Diagnosis of hypertension for at least 6 months
- •Ethnicity or Race of Latino, Black or White
- •Physically and mentally able to monitor BP at home
- •*Uncontrolled BP at last office visit
- •*Uncontrolled BP at current office visit
- •Note: *Uncontrolled BP is defined as systolic BP ≥ 140 and/or diastolic BP ≥ 90, or systolic BP ≥ 130 and/or diastolic BP ≥ 80 mm Hg for participants with chronic kidney disease or diabetes.
排除标准
- •Arm circumference greater than 17.5 inches (maximum size of large BP cuff)
- •Already monitoring BP at home at request of health care provider
- •No access to a land line telephone line (to upload home readings)
结局指标
主要结局
Absolute and relative changes in systolic and diastolic BP in the intervention and control groups.
时间窗: 9 months
Proportion of intervention participants achieving BP control compared to control participants
时间窗: 9 months
Trajectory of BP changes over time.
时间窗: 9 months
次要结局
未报告次要终点
研究者
Stella Yi
Principal Investigator
New York City Department of Health and Mental Hygiene