PTSC: Improving Hypertension Control Among Poor Midlife African American Women (PTSC-RCT)
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ClinicalTrials.gov Identifier: NCT04371614 |
Recruitment Status :
Completed
First Posted : May 1, 2020
Last Update Posted : October 5, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
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Uncontrolled Hypertension BMI Stress Medication Adherence | Behavioral: Prime Time Sister Circle | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 359 participants |
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 |
Official Title: | PTSC: Improving Hypertension Control Among Poor Midlife African American Women |
Actual Study Start Date : | July 14, 2016 |
Actual Primary Completion Date : | March 19, 2019 |
Actual Study Completion Date : | July 31, 2020 |

Arm | Intervention/treatment |
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Active Comparator: Prime Time Sister Circle Intervention
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.
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Behavioral: Prime Time Sister Circle
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. |
No Intervention: Usual Care
The women in the arm do not receive the intervention but provide data at baseline, 3 months, 9 months and 15 months.
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- Blood Pressure [ Time Frame: Baseline ]Systolic and Diastolic Blood Pressure
- Blood Pressure [ Time Frame: 3 months ]Systolic and Diastolic Blood Pressure
- Blood Pressure [ Time Frame: 9 months ]Systolic and Diastolic Blood Pressure
- Blood Pressure [ Time Frame: 15 months ]Systolic and Diastolic Blood Pressure
- Body Mass Index [ Time Frame: Baseline ]Calculation based on height and weight
- Body Mass Index [ Time Frame: 3 months ]Calculation based on height and weight
- Body Mass Index [ Time Frame: 9 months ]Calculation based on height and weight
- Body Mass Index [ Time Frame: 15 months ]Calculation based on height and weight
- Waist Circumference [ Time Frame: Baseline ]Measured in centimeters
- Waist Circumference [ Time Frame: 3 months ]Measured in centimeters
- Waist Circumference [ Time Frame: 9 months ]Measured in centimeters
- Waist Circumference [ Time Frame: 15 months ]Measured in centimeters
- Stress [ Time Frame: Baseline ]Perceived Stress Scale Respondents are asked to rate their current stress level on a scale from 1 to 7, where 1 means "not at all stressed," and 7 means "extremely stressed,"
- Stress [ Time Frame: 3 months ]Perceived Stress Scale Respondents are asked to rate their current stress level on a scale from 1 to 7, where 1 means "not at all stressed," and 7 means "extremely stressed,"
- Stress [ Time Frame: 9 months ]Perceived Stress Scale Respondents are asked to rate their current stress level on a scale from 1 to 7, where 1 means "not at all stressed," and 7 means "extremely stressed,"
- Stress [ Time Frame: 15 months ]Perceived Stress Scale Respondents are asked to rate their current stress level on a scale from 1 to 7, where 1 means "not at all stressed," and 7 means "extremely stressed,"
- Medication Adherence [ Time Frame: Baseline ]
Hill-Bone High Blood Pressure Compliance Scale
This is a scale based on 14 questions where respondents answer
- Not at all
- Some of the time
- Most of the time
- All of the time
The items are additive. The minimum score is 14 indicating most compliance and the maximum is 56 indicating least compliance.
- Medication Adherence [ Time Frame: 3 months ]
Hill-Bone High Blood Pressure Compliance Scale
This is a scale based on 14 questions where respondents answer
- Not at all
- Some of the time
- Most of the time
- All of the time
The items are additive. The minimum score is 14 indicating most compliance and the maximum is 56 indicating least compliance.
- Medication Adherence [ Time Frame: 9 months ]
Hill-Bone High Blood Pressure Compliance Scale
This is a scale based on 14 questions where respondents answer
- Not at all
- Some of the time
- Most of the time
- All of the time
The items are additive. The minimum score is 14 indicating most compliance and the maximum is 56 indicating least compliance.
- Medication Adherence [ Time Frame: 15 months ]
Hill-Bone High Blood Pressure Compliance Scale
This is a scale based on 14 questions where respondents answer
- Not at all
- Some of the time
- Most of the time
- All of the time
The items are additive. The minimum score is 14 indicating most compliance and the maximum is 56 indicating least compliance.
- Hypertension Knowledge [ Time Frame: Baseline ]
COUNSELING AFRICAN AMERICANS TO CONTROL HYPERTENSION (CAATCH)
This is a 17 item scale where respondents answer True or False to questions about hypertension. The scale has a minimum value of 0 which indicates the respondent is not very knowledgeable about hypertension to 17 which indicates the respondent is very knowledgeable about hypertension.
- Hypertension Knowledge [ Time Frame: 3 months ]
COUNSELING AFRICAN AMERICANS TO CONTROL HYPERTENSION (CAATCH)
This is a 17 item scale where respondents answer True or False to questions about hypertension. The scale has a minimum value of 0 which indicates the respondent is not very knowledgeable about hypertension to 17 which indicates the respondent is very knowledgeable about hypertension.
- Hypertension Knowledge [ Time Frame: 9 months ]
COUNSELING AFRICAN AMERICANS TO CONTROL HYPERTENSION (CAATCH)
This is a 17 item scale where respondents answer True or False to questions about hypertension. The scale has a minimum value of 0 which indicates the respondent is not very knowledgeable about hypertension to 17 which indicates the respondent is very knowledgeable about hypertension.
- Hypertension Knowledge [ Time Frame: 15 months ]
COUNSELING AFRICAN AMERICANS TO CONTROL HYPERTENSION (CAATCH)
This is a 17 item scale where respondents answer True or False to questions about hypertension. The scale has a minimum value of 0 which indicates the respondent is not very knowledgeable about hypertension to 17 which indicates the respondent is very knowledgeable about hypertension.
- Functional Status [ Time Frame: Baseline ]
EuroQol 5
This is a 5 item scale where respondent are asked whether have problems along five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondent rate each item based on five point scale: (1) no, (2) slight, (3) some, (4) moderate, or (5) extreme. The scale is scored based on a country and population specific valuation that is proprietary. Each dimension make up a digit in a five digit code: 1,1,1,1,1 indicate most healthy state while 5,5,5,5,5 indicates the most unhealthy state.
- Functional Status [ Time Frame: 15 months ]
EuroQol 5
This is a 5 item scale where respondent are asked whether have problems along five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondent rate each item based on five point scale: (1) no, (2) slight, (3) some, (4) moderate, or (5) extreme. The scale is scored based on a country and population specific valuation that is proprietary. Each dimension make up a digit in a five digit code: 1,1,1,1,1 indicate most healthy state while 5,5,5,5,5 indicates the most unhealthy state.

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Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Participate must self identify as female. |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371614
United States, Maryland | |
Baltimore Medical System | |
Baltimore, Maryland, United States, 21213 |
Principal Investigator: | Darrell J Gaskin, PhD | Johns Hopkins University |
Responsible Party: | Johns Hopkins Bloomberg School of Public Health |
ClinicalTrials.gov Identifier: | NCT04371614 |
Other Study ID Numbers: |
R01MD010462 ( U.S. NIH Grant/Contract ) |
First Posted: | May 1, 2020 Key Record Dates |
Last Update Posted: | October 5, 2022 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hypertension African American women Lifestyle Modification |
Hypertension Vascular Diseases Cardiovascular Diseases |