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Trial record 1 of 1 for:    NCT04371614
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PTSC: Improving Hypertension Control Among Poor Midlife African American Women (PTSC-RCT)

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ClinicalTrials.gov Identifier: NCT04371614
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : May 1, 2020
Sponsor:
Collaborators:
American Institutes for Research
The Gaston & Porter Health Improvement Center, Inc.
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

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.


Condition or disease Intervention/treatment Phase
Uncontrolled Hypertension BMI Stress Medication Adherence Behavioral: Prime Time Sister Circle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 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
Estimated Primary Completion Date : December 20, 2021
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.



Primary Outcome Measures :
  1. Blood Pressure [ Time Frame: Baseline ]
    Systolic and Diastolic Blood Pressure

  2. Blood Pressure [ Time Frame: 3 months ]
    Systolic and Diastolic Blood Pressure

  3. Blood Pressure [ Time Frame: 9 months ]
    Systolic and Diastolic Blood Pressure

  4. Blood Pressure [ Time Frame: 15 months ]
    Systolic and Diastolic Blood Pressure

  5. Body Mass Index [ Time Frame: Baseline ]
    Calculation based on height and weight

  6. Body Mass Index [ Time Frame: 3 months ]
    Calculation based on height and weight

  7. Body Mass Index [ Time Frame: 9 months ]
    Calculation based on height and weight

  8. Body Mass Index [ Time Frame: 15 months ]
    Calculation based on height and weight

  9. Waist Circumference [ Time Frame: Baseline ]
    Measured in centimeters

  10. Waist Circumference [ Time Frame: 3 months ]
    Measured in centimeters

  11. Waist Circumference [ Time Frame: 9 months ]
    Measured in centimeters

  12. Waist Circumference [ Time Frame: 15 months ]
    Measured in centimeters


Secondary Outcome Measures :
  1. 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,"

  2. 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,"

  3. 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,"

  4. 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,"

  5. Medication Adherence [ Time Frame: Baseline ]

    Hill-Bone High Blood Pressure Compliance Scale

    This is a scale based on 14 questions where respondents answer

    1. Not at all
    2. Some of the time
    3. Most of the time
    4. All of the time

    The items are additive. The minimum score is 14 indicating most compliance and the maximum is 56 indicating least compliance.


  6. Medication Adherence [ Time Frame: 3 months ]

    Hill-Bone High Blood Pressure Compliance Scale

    This is a scale based on 14 questions where respondents answer

    1. Not at all
    2. Some of the time
    3. Most of the time
    4. All of the time

    The items are additive. The minimum score is 14 indicating most compliance and the maximum is 56 indicating least compliance.


  7. Medication Adherence [ Time Frame: 9 months ]

    Hill-Bone High Blood Pressure Compliance Scale

    This is a scale based on 14 questions where respondents answer

    1. Not at all
    2. Some of the time
    3. Most of the time
    4. All of the time

    The items are additive. The minimum score is 14 indicating most compliance and the maximum is 56 indicating least compliance.


  8. Medication Adherence [ Time Frame: 15 months ]

    Hill-Bone High Blood Pressure Compliance Scale

    This is a scale based on 14 questions where respondents answer

    1. Not at all
    2. Some of the time
    3. Most of the time
    4. All of the time

    The items are additive. The minimum score is 14 indicating most compliance and the maximum is 56 indicating least compliance.


  9. 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.


  10. 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.


  11. 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.


  12. 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.


  13. 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.


  14. 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.




Information from the National Library of Medicine

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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
Criteria

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)

Information from the National Library of Medicine

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


Contacts
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Contact: Darrell J Gaskin, PhD 443-287-0306 dgaskin1@jh.edu

Locations
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United States, Maryland
Baltimore Medical System Recruiting
Baltimore, Maryland, United States, 21213
Contact: Felicia Roane    410-614-5983    froane1@jhu.edu   
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
American Institutes for Research
The Gaston & Porter Health Improvement Center, Inc.
Investigators
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Principal Investigator: Darrell J Gaskin, PhD Johns Hopkins University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Hypertension
African American women
Lifestyle Modification
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases