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Uncontrolled HypertensionPTSC-RCTNCT04371614

PTSC: Improving Hypertension Control Among Poor Midlife African American Women

A study testing Prime Time Sister Circle in people with Uncontrolled Hypertension and BMI, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for
Uncontrolled Hypertension, BMI, Stress
What is being tested?
Prime Time Sister Circle
Could I receive a placebo?
No, everyone receives an active treatment
How many people
359 participants
Where
1 siteUnited States
Study dates
14 Jul 2016to 31 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Baltimore Medical System

    Baltimore, Maryland, 21213

Other trials in United States

About this study

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.

Read the 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.

Being tested
Prime Time Sister Circle
Keywords
Hypertension, African American women, Lifestyle Modification
Medical subject headings
Medication Adherence, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prime Time Sister CircleBehavioural

    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.

Study groups in NCT04371614
Study groupRoleWhat they receive
Prime Time Sister Circle InterventionActive comparatorThe 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.
Receives: Behavioral: Prime Time Sister Circle
Usual CareNo interventionThe women in the arm do not receive the intervention but provide data at baseline, 3 months, 9 months and 15 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Pressure

    Systolic and Diastolic Blood Pressure

    Measured: Baseline

  2. Blood Pressure

    Systolic and Diastolic Blood Pressure

    Measured: 3 months

  3. Blood Pressure

    Systolic and Diastolic Blood Pressure

    Measured: 9 months

  4. Blood Pressure

    Systolic and Diastolic Blood Pressure

    Measured: 15 months

  5. Body Mass Index

    Calculation based on height and weight

    Measured: Baseline

  6. Body Mass Index

    Calculation based on height and weight

    Measured: 3 months

  7. Body Mass Index

    Calculation based on height and weight

    Measured: 9 months

  8. Body Mass Index

    Calculation based on height and weight

    Measured: 15 months

  9. Waist Circumference

    Measured in centimeters

    Measured: Baseline

  10. Waist Circumference

    Measured in centimeters

    Measured: 3 months

  11. Waist Circumference

    Measured in centimeters

    Measured: 9 months

  12. Waist Circumference

    Measured in centimeters

    Measured: 15 months

Secondary outcomes (14)
  1. Stress

    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,"

    Measured: Baseline

  2. Stress

    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,"

    Measured: 3 months

  3. Stress

    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,"

    Measured: 9 months

  4. Stress

    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,"

    Measured: 15 months

  5. Medication Adherence

    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.

    Measured: Baseline

  6. Medication Adherence

    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.

    Measured: 3 months

  7. Medication Adherence

    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.

    Measured: 9 months

  8. Medication Adherence

    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.

    Measured: 15 months

  9. Hypertension Knowledge

    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.

    Measured: Baseline

  10. Hypertension Knowledge

    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.

    Measured: 3 months

  11. Hypertension Knowledge

    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.

    Measured: 9 months

  12. Hypertension Knowledge

    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.

    Measured: 15 months

  13. Functional Status

    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.

    Measured: Baseline

  14. Functional Status

    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.

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2020
  2. Study start14 Jul 2016
  3. Primary completion19 Mar 2019
  4. Study completion31 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
359 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04371614
Sponsor's protocol ID
R01MD010462
Acronym
PTSC-RCT
Status last verified
Apr 2020
First submitted
28 Apr 2020
Last updated
5 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37500950
  • 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.

    PubMed 33781228
  • 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.

    PubMed 33566072

Questions about this trial

What is this clinical trial studying?

A study testing Prime Time Sister Circle in people with Uncontrolled Hypertension and BMI, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Pressure (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04371614, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.

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