PTSC: Improving Hypertension Control Among Poor Midlife African American Women

NCT04371614 | Completed

• 1 other identifier: R01MD010462
• Study Type: interventional
• Target: 359
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uncontrolled Hypertension; BMI; Stress; Medication Adherence

Keywords

Hypertension; African American women; Lifestyle Modification

Outcome Measures

Primary Outcomes (12)

• Blood Pressure

  Systolic and Diastolic Blood Pressure

  Baseline

• Blood Pressure

  Systolic and Diastolic Blood Pressure

  3 months

• Blood Pressure

  Systolic and Diastolic Blood Pressure

  9 months

• Blood Pressure

  Systolic and Diastolic Blood Pressure

  15 months

• Body Mass Index

  Calculation based on height and weight

  Baseline

• Body Mass Index

  Calculation based on height and weight

  3 months

• Body Mass Index

  Calculation based on height and weight

  9 months

• Body Mass Index

  Calculation based on height and weight

  15 months

• Waist Circumference

  Measured in centimeters

  Baseline

• Waist Circumference

  Measured in centimeters

  3 months

• Waist Circumference

  Measured in centimeters

  9 months

• Waist Circumference

  Measured in centimeters

  15 months

Secondary Outcomes (14)

• Stress

  Baseline

• Stress

  3 months

• Stress

  9 months

• Stress

  15 months

• Medication Adherence

  Baseline

Study Arms (2)

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.

Behavioral: Prime Time Sister Circle

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.

Interventions

Prime Time Sister Circle BEHAVIORAL

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.

Prime Time Sister Circle Intervention

Eligibility Criteria

• Age: 40 Years - 75 Years
• Gender Eligibility Details: Participate must self identify as female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• American Institutes for Research: collaborator
• The Gaston & Porter Health Improvement Center, Inc.: collaborator

Study Sites (1)

Baltimore Medical System

Baltimore, Maryland, 21213, United States

Location

Related Publications (3)

• Zare H, Ibe CA, Yang M, Porter G, Gaston M, Jones N, Jones W, Rose V, Balamani M, Woods DL, Gaskin DJ. Evaluating the Impact of the Prime Time Sister Circles(R) Intervention on Reducing Depressive Symptoms Among African American Women with Uncontrolled Hypertension. J Gen Intern Med. 2023 Oct;38(13):2879-2887. doi: 10.1007/s11606-023-08288-z. Epub 2023 Jul 27.

  PMID: 37500950 DERIVED

• Ibe CA, Haywood DR, Creighton C, Cao Y, Gabriel A, Zare H, Jones W, Yang M, Balamani M, Gaston M, Porter G, Woods DL, Gaskin DJ. Study protocol of a randomized controlled trial evaluating the Prime Time Sister Circles (PTSC) program's impact on hypertension among midlife African American women. BMC Public Health. 2021 Mar 29;21(1):610. doi: 10.1186/s12889-021-10459-8.

  PMID: 33781228 DERIVED

• Gabriel A, Zare H, Jones W, Yang M, Ibe CA, Cao Y, Balamani M, Gaston M, Porter G, Woods DL, Gaskin DJ. Evaluating Depressive Symptoms Among Low-Socioeconomic-Status African American Women Aged 40 to 75 Years With Uncontrolled Hypertension: A Secondary Analysis of a Randomized Clinical Trial. JAMA Psychiatry. 2021 Apr 1;78(4):426-432. doi: 10.1001/jamapsychiatry.2020.4622.

  PMID: 33566072 DERIVED

MeSH Terms

Conditions

Medication Adherence; Hypertension

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Darrell J Gaskin, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 1, 2020
• Study Start: July 14, 2016
• Primary Completion: March 19, 2019
• Study Completion: July 31, 2020
• Last Updated: October 5, 2022

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)