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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Uncontrolled Hypertension, BMI, Stress, Medication Adherence
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Systolic and Diastolic Blood Pressure
Measured: Baseline
Blood Pressure
Systolic and Diastolic Blood Pressure
Measured: 3 months
Blood Pressure
Systolic and Diastolic Blood Pressure
Measured: 9 months
Blood Pressure
Systolic and Diastolic Blood Pressure
Measured: 15 months
Body Mass Index
Calculation based on height and weight
Measured: Baseline
Body Mass Index
Calculation based on height and weight
Measured: 3 months
Body Mass Index
Calculation based on height and weight
Measured: 9 months
Body Mass Index
Calculation based on height and weight
Measured: 15 months
Waist Circumference
Measured in centimeters
Measured: Baseline
Waist Circumference
Measured in centimeters
Measured: 3 months
Waist Circumference
Measured in centimeters
Measured: 9 months
Waist Circumference
Measured in centimeters
Measured: 15 months
Secondary outcomes (14)
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
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
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
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
Medication Adherence
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.
Measured: Baseline
Medication Adherence
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.
Measured: 3 months
Medication Adherence
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.
Measured: 9 months
Medication Adherence
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.
Measured: 15 months
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
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
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
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
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
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.
- First posted1 May 2020
- Study start14 Jul 2016
- Primary completion19 Mar 2019
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- American Institutes for Research, The Gaston & Porter Health Improvement Center, Inc.
- Responsible party
- Sponsor
- Investigators
- Darrell J Gaskin, PhD, Principal investigator, Johns Hopkins University
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 37500950Ibe 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 33781228Gabriel 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTSC: Improving Hypertension Control Among Poor Midlife African American Women
- ClinicalTrials.gov ID
- NCT04371614
- Acronym / sponsor ID
- PTSC-RCT / R01MD010462
- Conditions
- Uncontrolled Hypertension, BMI, Stress, Medication Adherence
- Keywords
- Hypertension, African American women, Lifestyle Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- American Institutes for Research, The Gaston & Porter Health Improvement Center, Inc.
- Study start
- 14 Jul 2016 (actual)
- Primary completion
- 19 Mar 2019 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Prime Time Sister Circle Intervention | Active comparator | Behavioral: Prime Time Sister CircleThe 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. |
| 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prime Time Sister CircleThe PTSC is a multi-faceted, facilitated, curriculum- and community-based, intensive, support group intervention with 25-30 mid-life African American women per group. | Behavioural | Prime Time Sister Circle Intervention |
Primary outcome
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
14 secondary outcomes
Stress
Time frame: Baseline
Stress
Time frame: 3 months
Stress
Time frame: 9 months
Stress
Time frame: 15 months
Medication Adherence
Time frame: Baseline
Medication Adherence
Time frame: 3 months
Medication Adherence
Time frame: 9 months
Medication Adherence
Time frame: 15 months
Hypertension Knowledge
Time frame: Baseline
Hypertension Knowledge
Time frame: 3 months
Hypertension Knowledge
Time frame: 9 months
Hypertension Knowledge
Time frame: 15 months
Functional Status
Time frame: Baseline
Functional Status
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Derived from this study: PubMed 37500950Zare 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.
- Derived from this study: PubMed 33781228Ibe 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.
- Derived from this study: PubMed 33566072Gabriel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darrell J Gaskin, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
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.