PTSC: Improving Hypertension Control Among Poor Midlife African American Women
Condition: Uncontrolled Hypertension; BMI; Stress; Medication Adherence
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).

      Aim 2. Estimate the effectiveness of PTSC on health knowledge, health self-efficacy, and
      health behaviors that contribute to risks associated with hypertension.

      Hypothesis 2.1 Patients randomized to PTSC will demonstrate a greater increase in knowledge
      of the causes and consequences of high blood pressure than patients receiving usual care.

      Hypothesis 2.2 Patients randomized to PTSC will demonstrate a greater increase in
      health-related self-efficacy than patients receiving usual care.

      Hypothesis 2.3 Patients randomized to PTSC will practice more adaptive stress management
      techniques, increase their level of physical activity, and improve their diets more than
      patients receiving usual care.

      Hypothesis 2.4 Patients randomized to PTSC will monitor their own blood pressure more
      regularly than patients receiving usual care.

      Hypothesis 2.5: Patients randomized to PTSC will be more compliant with taking prescribed
      hypertension medications than patients receiving usual care.

      Aim 3. Test whether there is a cost offset of PTSC for society. Hypothesis 3.1 Patients
      randomized to PTSC will have fewer unnecessary hospitalizations and emergency rooms visits
      for cardiovascular related problems than patients receiving usual care.

      Hypothesis 3.2 Patients randomized to PTSC will have fewer hospital admissions for
      cardiovascular related problems than patients receiving usual care.

      Hypothesis 3.3 The costs of providing PTSC will be offset by reductions in healthcare costs
      associated with health improvements for patients randomized to PTSC compared to patients
      receiving usual care.

      FQHCs and other safety net providers are challenged to effectively manage the hypertension of
      their midlife African American female patients. PTSC may be a viable low-cost,
      community-based intervention that physicians can use as a resource for their patients to
      support necessary lifestyle changes and improve their health.
    

Intervention name(s): Prime Time Sister Circle
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The women are randomly assigned to receive the PTSC intervention or usual care from the FQHC. The intervention last for 3 months. The women are followed for 1 year after receiving the intervention
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hypertension; African American women; Lifestyle Modification