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临床试验/NCT04371614
NCT04371614已完成不适用

PTSC: Improving Hypertension Control Among Poor Midlife African American Women

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 359 人开始时间: 2016年7月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
359
试验地点
1
主要终点
Waist Circumference

研究概览

简要总结

African American women are more likely to suffer higher rates of uncontrolled hypertension than non-Hispanic white women. Prime Time Sister Circles® (PTSC) empowers women to proactively manage their blood pressure by promoting the effective use of preventive health care; encouraging self monitoring of blood pressure, and teaching strategies for managing stress, increasing physical activity, and improving nutrition. The 12-week community-based, holistic lifestyle intervention aims to improve blood pressure control by improving health knowledge, health efficacy, and health behaviors. PTSC potentially reduces health care costs through prevention, earlier detection, and improved management of hypertension through a culturally tailored program addressing specific barriers experienced by midlife and late life African American women.

This 5-year study is a collaboration between The Johns Hopkins Center for Health Disparities Solutions (HCHDS), The Gaston & Porter Health Improvement Center, Inc. (GPHIC), and the American Institutes for Research (AIR). The investigators seek to determine the impact and cost-effectiveness of the PTSC intervention among low-income African American women with uncontrolled hypertension. To do this, the investigators will randomly assign 600 women between the ages of 40 and 75 who receive their care from an federally qualified health center (FQHC) to either PTSC (n=300) or a comparison group (n=300) who will receive the PTSC intervention after they have been observed for 15 month. Using data from in person surveys and clinical measures conducted during in-person data collection meetings, the investigative team will determine if PTSC help low-income African American women effectively manage their blood pressure.

详细描述

African American women suffer significantly higher rates of hypertension than non-Hispanic white women. Forty-six to fifty percent of African American women have hypertension, compared with 31 percent of White women making it a major contributor to disparities in cardiovascular morbidity and mortality in this population from higher rates of complications, i.e., ischemic heart disease, stroke, and end-stage renal disease. Despite these statistics, African American women are less often aware of their diagnosis, less likely to have their blood pressure controlled, and less likely to be treated. From a societal perspective, high blood pressure was estimated to cost the United States approximately $93.5 billion in health care services, medications, and missed work days in 2010.

Public and private health plans, employers, and health care providers are seeking cost-effective approaches to preventing and improving management of uncontrolled hypertension (140/90 and above). Prime Time Sister Circles® (PTSC) empowers women to proactively manage their health by promoting the effective use of preventive health care; providing screening and monitoring of blood pressure and weight, and teaching strategies for managing stress, increasing physical activity, and improving nutrition. The 13-week community-based, holistic lifestyle intervention aims to improve blood pressure control and reduce health care costs through prevention, earlier detection, and improved management of hypertension through a culturally tailored program addressing specific risk factors and barriers experienced by mid to late life African American women.

The primary objective of this research project is to determine the impact and cost-effectiveness of the PTSC intervention among low-income African American women with uncontrolled hypertension. This 5-year study is a collaboration between The Johns Hopkins Center for Health Disparities Solutions (HCHDS), The Gaston & Porter Health Improvement Center, Inc. (GPHIC), and the American Institutes for Research (AIR). Study participants will be recruited from FQHCs in Washington, DC and Baltimore, MD. These FQHCs were chosen because they are medical homes to a large number of low income midlife African American women who have hypertension. The sample, 480 African American women between the ages of 40 and 75 who receive their primary care from a FQHC, will be randomly assigned to receive the PTSC intervention (n=240) or usual care for a FQHC (n=240). Data on blood pressure, health status, health behaviors, and health care utilization will be collected through participant surveys and administrative records from the FQHCs. Blood pressure measurements and surveys will be collected at baseline, 13 weeks (end of program), 9 months (6 months after the end of the program), and 15 months (a year after the end of the program). Administrative records to track health services use and costs will be collected on an ongoing basis over the same time period. These data will be used to address the following specific aims:

Aim 1. Estimate the effectiveness of PTSC compared with usual care on blood pressure control among hypertensive, low-income, mid-to-late life African American women.

Hypothesis 1.1 Patients randomized to PTSC will have better controlled blood pressure than patients who receive usual care at the end of the intervention (13 weeks) and up to one year post intervention (15 months).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •diagnosed with hypertension (401)
  • •had a visit to the FQHC within the prior 24 months
  • •had an elevated blood pressure (140/90 or above) at their last visit
  • •able to speak English

排除标准

  • •diagnosed with psychotic disorders (295.42, 295.90)
  • •diagnosed with dementia (290)
  • •diagnosed with other nutritional deficiencies (269.9)
  • •diagnosed with congestive heart failure (428)
  • •diagnosed with blindness (369.3)

研究组 & 干预措施

Prime Time Sister Circle Intervention

Active Comparator

The women in this arm participate in a Prime Time Sister Circle (PTSC). The PTSC is a multi-faceted, facilitated, curriculum- and community-based, intensive, support group intervention with 25-30 mid-life African American women per group. PTSC addresses three key modifiable health risk factors for chronic disease: unmanaged stress, physical inactivity, and unhealthy nutritional choices. It also addresses additional risk factors that contribute to unhealthy lifestyles: lack of knowledge or misinformation about major illnesses-cardiovascular disease (CVD), hypertension, diabetes, cancer, stress and depression-and the failure of African American women to prioritize their health and take proactive steps to manage their health and health outcomes. PTSC gives African American women the information, motivation, tools, skills, and consultative support they need to improve and maintain their health.

干预措施: Prime Time Sister Circle (Behavioral)

Usual Care

No Intervention

The women in the arm do not receive the intervention but provide data at baseline, 3 months, 9 months and 15 months.

结局指标

主要结局

Waist Circumference

时间窗: 15 months

Measured in centimeters

Blood Pressure

时间窗: 15 months

Systolic and Diastolic Blood Pressure

Body Mass Index

时间窗: 15 months

Calculation based on height and weight

Body Mass Index

时间窗: Baseline

Calculation based on height and weight

Blood Pressure

时间窗: Baseline

Systolic and Diastolic Blood Pressure

Blood Pressure

时间窗: 3 months

Systolic and Diastolic Blood Pressure

Blood Pressure

时间窗: 9 months

Systolic and Diastolic Blood Pressure

Body Mass Index

时间窗: 3 months

Calculation based on height and weight

Body Mass Index

时间窗: 9 months

Calculation based on height and weight

Waist Circumference

时间窗: Baseline

Measured in centimeters

Waist Circumference

时间窗: 3 months

Measured in centimeters

Waist Circumference

时间窗: 9 months

Measured in centimeters

次要结局

  • Stress(15 months)
  • Hypertension Knowledge(15 months)
  • Medication Adherence(15 months)
  • Functional Status(15 months)
  • Stress(Baseline)
  • Stress(3 months)
  • Stress(9 months)
  • Medication Adherence(Baseline)
  • Medication Adherence(3 months)
  • Medication Adherence(9 months)
  • Hypertension Knowledge(Baseline)
  • Hypertension Knowledge(3 months)
  • Hypertension Knowledge(9 months)
  • Functional Status(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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