HypertensionBLESSEDNCT06133322
Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED)
A study testing Behavioral: Evidence-based interventions recommended by the 2017 ACC/AHA hypertension clinical guideline in people with Hypertension, run by Tulane University at 1 site in United States.
Trial summary
The burden of hypertension and related cardiovascular diseases, stroke, and end-stage kidney disease is disproportionately high in Black populations, especially in the South. The Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED) cluster randomized trial aims to test the effectiveness… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Behavioral: Evidence-based interventions recommended by the 2017 ACC/AHA hypertension clinical guideline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,176 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged ≥18 years
- Community members associated with the participating churches (church members and their families and friends)
- Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mm Hg
- Willing and able to participate in the intervention.
- Willing and able to sign written informed consent.
Who cannot join
- Prior hospitalization in the last 3 months for chronic heart failure or heart attack
- Current diagnosis of cancer requiring chemotherapy or radiation therapy
- Stage-5 chronic kidney disease requiring chronic dialysis or transplant
- Pregnant or planning to become pregnant in the next 18 months
- Planning to move out of the Greater New Orleans area during the next year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Tulane University
New Orleans, Louisiana, 70112
Allison N Marshall, PhD MPH MSSW, 5049886454, amarshall@tulane.edu
Jodie Laurent, MPH, 504-988-5432, jlaurent@tulane.edu
About this study
Official title: Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities
The burden of hypertension and related cardiovascular diseases, stroke, and end-stage kidney disease is disproportionately high in Black populations, especially in the South. The Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED) cluster randomized trial aims to test the effectiveness, implementation, and sustainability of a community health worker (CHW)-led multifaceted intervention compared to enhanced usual care for hypertension control in Black communities. In the BLESSED trial, the investigators plan to recruit 1,176 adults with hypertension (approximately 28 per church) from 42 predominantly Black churches in the Greater New Orleans area. The multifaceted intervention will last for 18 months, followed by a post-intervention follow-up visit at 24 months. The BLESSED trial aims to generate evidence regarding the effectiveness, implementation, and sustainability of this CHW-led church-based multifaceted intervention in eliminating hypertension disparities in the United States (US) general population.
Read the detailed description
Louisiana residents, especially African Americans, bear a disproportionately high burden of hypertension and cardiovascular disease (CVD). In the Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED) cluster randomized trial, the investigators will compare the impact of two implementation strategies - a CHW-led multifaceted strategy and a group-based education strategy - for delivering interventions recommended by the 2017 American College of Cardiology (ACC) and the American Heart Association (AHA) hypertension clinical guidelines on implementation and clinical effectiveness outcomes in predominantly Black community members over 18 months. The BLESSED study utilizes an effectiveness-implementation hybrid design to: (1). test the effectiveness of a CHW-led church-based multifaceted implementation strategy for reducing estimated CVD risk over 18 months among African American church community members at high risk for CVD, and (2). assess the implementation outcomes (acceptability, adaptation, adoption, feasibility, fidelity, penetrance, cost-effectiveness, and sustainability) simultaneously. The Exploration, Preparation, Implementation, Sustainment (EPIS) framework has guided the development and evaluation of the multifaceted implementation strategy, which includes CHW-led health coaching on lifestyle changes and medication adherence; healthcare delivery in community; church-based exercise and weight loss programs; self-monitoring of blood pressure (BP); and provider education and engagement. The CHW-led church-based intervention will provide strong social support and tackle multiple social determinants of CVD disparities. The primary clinical effectiveness outcome is the difference in mean change of systolic blood pressure (SBP) from baseline to 18 months between intervention and control groups. The primary implementation outcome is a fidelity summary score for key implementation strategy components to the CHW-led church-based multifaceted implementation strategy assessed at the participant levels. This study has 90% statistical power to detect group differences in mean SBP change of 5.8 mm Hg over 18 months using a 2-sided significance level of 0.05. The investigators will recruit 1,176 participants (28 per church) who are aged ≥18 years with systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mm Hg, and randomly assign 21 churches to intervention and 21 to control; the investigators will implement the multifaceted intervention program; the investigators will follow-up participants and collect data on effectiveness and implementation outcomes at 6, 12, and 18 months; the investigators will evaluate the sustainability of the intervention at 6 months post-intervention; and the investigators will perform intention-to-treat analyses and disseminate and scale-up the proven-effective implementation strategy. The proposed study will generate evidence on the effectiveness, implementation, and sustainability of the multifaceted intervention aimed at eliminating CVD disparities in African American populations in the US.
- Conditions
- Hypertension
- Being tested
- Behavioral: Evidence-based interventions recommended by the 2017 ACC/AHA hypertension clinical guideline
- Keywords
- church-based, Black, African American, Community-based Intervention, health disparities, cardiovascular disease prevention
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Evidence-based interventions recommended by the 2017 ACC/AHA hypertension clinical guidelineBehavioural
The recommended evidence-based interventions include therapeutic lifestyle change and medical treatment of hypertension
| Study group | Role | What they receive |
|---|---|---|
| Community health worker-led implementation strategy | Experimental | CHW-led church-based multifaceted implementation strategy: CHWs will conduct individualized health coaching and healthcare navigation, organize church-based health promotion programs (e.g., nutrition education and exercise sessions), and train and assist the study participants in self-monitoring of BP. Nurse practitioners will see study participants at church settings, and community pharmacies will deliver antihypertensive medications to patients' homes. Receives: Behavioral: Behavioral: Evidence-based interventions recommended by the 2017 ACC/AHA hypertension clinical guideline |
| Group-based Education Strategy | Experimental | The investigator team will work with church leadership and wellness coordinators to organize group-based education sessions. Health education will be delivered by local primary care providers, dieticians, and health educators. Contact information for primary care providers and information on self-monitoring of BP will also be given at group sessions. Receives: Behavioral: Behavioral: Evidence-based interventions recommended by the 2017 ACC/AHA hypertension clinical guideline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean change of systolic blood pressure
Difference in mean change of systolic blood pressure from baseline to 18 months between intervention and control groups
Measured: Measured from baseline to 18 months
Implementation fidelity summary score
The fidelity summary score is composed of the following key implementation strategy components: proportion of assigned health education sessions attended in all participants, proportion of assigned discussion sessions attended in all participants, proportion of recommended minutes of physical activity completed in all participants, proportion of days per week that fruits/vegetables are eaten as recommended in all participants, proportion of recommended home blood pressure (BP) monitoring completed in patients with hypertension, proportion of required provider visits attended in all patients, and proportion of antihypertensive medications taken in patients with hypertension. The score ranged from zero to six with a higher score indicates greater fidelity.
Measured: Measured at 6, 12, and 18 months
Secondary outcomes (23)
Difference in the proportion of patients with controlled BP between intervention and control groups
Difference in the proportion of patients with controlled BP (<130/80 mm Hg) between intervention and control groups at 18 months
Measured: Measured from baseline to 18 months
Difference in mean change of diastolic BP
Difference in mean change of diastolic BP (DBP) from baseline to 18 months between intervention and control groups
Measured: Measured from baseline to 18 months
Side effects of medications and adverse events
Change in side effects of medications and adverse events from baseline to 18 months
Measured: Measured from baseline to 18 months
Cost-effectiveness
Cost-effectiveness assessed as incremental direct costs per additional percentage of hypertension control
Measured: Measured from baseline to 18 months
Acceptability
Percentage of participants, community health worker, providers, and church administrators who reply that the intervention is acceptable (satisfactory). Measured by survey.
Measured: Measured from baseline to 18 months
Adoption (Churches)
% of churches adopting the intervention program
Measured: Measured from baseline to 18 months
Adoption (Providers)
% of invited providers attending training sessions
Measured: Measured from baseline to 18 months
Appropriateness
Percentage of participants, community health workers, providers, and church administrators who reply that the intervention is appropriate (good perceived fit). The outcome will be measured by survey question.
Measured: Measured from baseline to 18 months
Feasibility to participant, community health worker, provider and churches
Percentage of participants, community health worker, providers, and church administrators who reply that the intervention is feasible (actual fit, suitability). Measured by survey and study administrative data.
Measured: Measured from baseline to 18 months
Exercise Session Fidelity (community health worker-led strategy group)
Percentage of exercise sessions organized. Measured by study administrative data.
Measured: Measured at 6, 12, and 18 months
Fidelity of Group Health Education Session
Percentage of group health education sessions conducted out of health educated sessions planned per study protocol.
Measured: Measured at 6, 12, and 18 months
Nutrition Education Session Fidelity (community health worker-led strategy group)
Percentage of nutrition education sessions organized. Measured by study administrative data.
Measured: Measured at 6, 12, and 18 months
Health Care Appointment Fidelity (community health worker-led strategy group)
Percentage of health care visit appointments made. Measured by study administrative data.
Measured: Measured at 6, 12, and 18 months
Percentage of enrolled participants receiving assigned intervention. Measured by study administrative data. Reach (Participants)
Percentage of enrolled participants receiving assigned intervention. Measured by study administrative data.
Measured: Measured at baseline, 6, 12, and 18 months
Reach (Participants)
The percentage of eligible/screened/contacted participants enrolled. Measured by study data, administrative data.
Measured: Measured at baseline
Penetrance (Participants)
Percentage of enrolled participants receiving assigned intervention. Measured by intervention monitoring data.
Measured: Measured at baseline, 6, 12, and 18 months
Penetrance (Providers)
Percentage of trained providers delivering protocol-based care. Measured by intervention monitoring data.
Measured: Measured at baseline, 6, 12, and 18 months
Penetrance (educators)
Percentage of trained CHWs or providers and health educators delivering health coaching. Measured by intervention monitoring data.
Measured: Measured at baseline, 6, 12, and 18 months
Sustainability (Churches)
Percentage of churches continuing the intervention program and individual components. Measured by 6-month post-intervention survey.
Measured: Measured at baseline, 6, 12, and 18 months
Sustainability (Participants)
Percentage of participants maintaining ideal cardiovascular health metrics, healthy lifestyle components, and adherence to medications. Measured by 6-month post-intervention survey and examination.
Measured: Measured at 24 months
Sustainability Effectiveness Outcome: Differences in mean change of SBP and DBP
Differences in mean change of SBP and DBP from baseline to 24 months (6 months post-intervention) between intervention and control groups
Measured: Measured at baseline and 24 months
Sustainability Effectiveness Outcome: Difference in the proportion of patients with controlled BP
Difference in the proportion of patients with controlled BP (<130/80 mm Hg) between intervention and control groups at 24 months.
Measured: Measured at baseline and 24 months
Sustainability of Fidelity
A fidelity summary score for key implementation strategy components at 6 months post-intervention (24 months overall). The fidelity summary score is composed of the following key implementation strategy components: proportion of assigned health education sessions attended in all participants, proportion of assigned discussion sessions attended in all participants, proportion of recommended minutes of physical activity completed in all participants, proportion of days per week that fruits/vegetables are eaten as recommended in all participants, proportion of recommended home BP monitoring completed in patients with hypertension, proportion of required provider visits attended in all patients, and proportion of antihypertensive medications taken in patients with hypertension. Fidelity score ranges from zero to six with a higher score indicates greater fidelity.
Measured: Measured at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start1 Nov 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
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 HypertensionStudies of the same condition, open and under way.
- 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
- Cluster randomization of 42 churches in New Orleans, Louisiana to 2 arms
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Jiang He, MD, PhD, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133322
- Sponsor's protocol ID
- 2022-1081-SPHTM
- Other IDs
- R01MD018193
- Acronym
- BLESSED
- Status last verified
- Sep 2026
- First submitted
- 1 Nov 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study data sharing plan will comply with all NIH policies for data sharing. Data sharing will be executed through the centralized NIH data repository and will be implemented in a timely manner. The study data, including data from baseline and follow-up visits, will be prepared for transmission to the NHLBI data repository - the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC). The datasets will be submitted to the NHLBI no later than three years after the end of the final participant follow-up or two years after the main paper of the trial has been published, whichever comes first. The NHLBI will review the submitted data prior to release. These data will be free of identifiers that allow identification of individual research participants either directly or through "deductive disclosure." In addition, the investigators will offer, through a publicly accessible website, opportunities for outside investigators to collaborate using complete study data.
Publications
Maroney K, Laurent J, Alvarado F, Gabor A, Bell C, Ferdinand K, He J, Mills KT. Systematic review and meta-analysis of church-based interventions to improve cardiovascular disease risk factors. Am J Med Sci. 2023 Sep;366(3):199-208. doi: 10.1016/j.amjms.2023.05.010. Epub 2023 May 25.
PubMed 37244637He J, Bundy JD, Geng S, Tian L, He H, Li X, Ferdinand KC, Anderson AH, Dorans KS, Vasan RS, Mills KT, Chen J. Social, Behavioral, and Metabolic Risk Factors and Racial Disparities in Cardiovascular Disease Mortality in U.S. Adults : An Observational Study. Ann Intern Med. 2023 Sep;176(9):1200-1208. doi: 10.7326/M23-0507. Epub 2023 Aug 15.
PubMed 37579311Bundy JD, Mills KT, He H, LaVeist TA, Ferdinand KC, Chen J, He J. Social determinants of health and premature death among adults in the USA from 1999 to 2018: a national cohort study. Lancet Public Health. 2023 Jun;8(6):e422-e431. doi: 10.1016/S2468-2667(23)00081-6.
PubMed 37244672
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities
- ClinicalTrials.gov ID
- NCT06133322
- Acronym / sponsor ID
- BLESSED / 2022-1081-SPHTM
- Conditions
- Hypertension
- Keywords
- church-based, Black, African American, Community-based Intervention, health disparities, cardiovascular disease prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,176 participants (estimated)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Nov 2023 (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.
The burden of hypertension and related cardiovascular diseases, stroke, and end-stage kidney disease is disproportionately high in Black populations, especially in the South. The Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED) cluster randomized trial aims to test the effectiveness, implementation, and sustainability of a community health worker (CHW)-led multifaceted intervention compared to enhanced usual care for hypertension control in Black communities. In the BLESSED trial, the investigators plan to recruit 1,176 adults with hypertension (approximately 28 per church) from 42 predominantly Black churches in the Greater New Orleans area. The multifaceted intervention will last for 18 months, followed by a post-intervention follow-up visit at 24 months. The BLESSED trial aims to generate evidence regarding the effectiveness, implementation, and sustainability of this CHW-led church-based multifaceted intervention in eliminating hypertension disparities in the United States (US) general population.
Detailed description
Louisiana residents, especially African Americans, bear a disproportionately high burden of hypertension and cardiovascular disease (CVD). In the Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED) cluster randomized trial, the investigators will compare the impact of two implementation strategies - a CHW-led multifaceted strategy and a group-based education strategy - for delivering interventions recommended by the 2017 American College of Cardiology (ACC) and the American Heart Association (AHA) hypertension clinical guidelines on implementation and clinical effectiveness outcomes in predominantly Black community members over 18 months. The BLESSED study utilizes an effectiveness-implementation hybrid design to: (1). test the effectiveness of a CHW-led church-based multifaceted implementation strategy for reducing estimated CVD risk over 18 months among African American church community members at high risk for CVD, and (2). assess the implementation outcomes (acceptability, adaptation, adoption, feasibility, fidelity, penetrance, cost-effectiveness, and sustainability) simultaneously. The Exploration, Preparation, Implementation, Sustainment (EPIS) framework has guided the development and evaluation of the multifaceted implementation strategy, which includes CHW-led health coaching on lifestyle changes and medication adherence; healthcare delivery in community; church-based exercise and weight loss programs; self-monitoring of blood pressure (BP); and provider education and engagement. The CHW-led church-based intervention will provide strong social support and tackle multiple social determinants of CVD disparities. The primary clinical effectiveness outcome is the difference in mean change of systolic blood pressure (SBP) from baseline to 18 months between intervention and control groups. The primary implementation outcome is a fidelity summary score for key implementation strategy components to the CHW-led church-based multifaceted implementation strategy assessed at the participant levels. This study has 90% statistical power to detect group differences in mean SBP change of 5.8 mm Hg over 18 months using a 2-sided significance level of 0.05. The investigators will recruit 1,176 participants (28 per church) who are aged ≥18 years with systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mm Hg, and randomly assign 21 churches to intervention and 21 to control; the investigators will implement the multifaceted intervention program; the investigators will follow-up participants and collect data on effectiveness and implementation outcomes at 6, 12, and 18 months; the investigators will evaluate the sustainability of the intervention at 6 months post-intervention; and the investigators will perform intention-to-treat analyses and disseminate and scale-up the proven-effective implementation strategy. The proposed study will generate evidence on the effectiveness, implementation, and sustainability of the multifaceted intervention aimed at eliminating CVD disparities in African American populations in the US.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomization of 42 churches in New Orleans, Louisiana to 2 arms
| Arm | Type | Receives |
|---|---|---|
| Community health worker-led implementation strategy | Experimental | Behavioral: Behavioral: Evidence-based interventions recommended by the 2017 ACC/AHA hypertension clinical guidelineCHW-led church-based multifaceted implementation strategy: CHWs will conduct individualized health coaching and healthcare navigation, organize church-based health promotion programs (e.g., nutrition education and exercise sessions), and train and assist the study participants in self-monitoring of BP. Nurse practitioners will see study participants at church settings, and community pharmacies will deliver antihypertensive medications to patients' homes. |
| Group-based Education Strategy | Experimental | Behavioral: Behavioral: Evidence-based interventions recommended by the 2017 ACC/AHA hypertension clinical guidelineThe investigator team will work with church leadership and wellness coordinators to organize group-based education sessions. Health education will be delivered by local primary care providers, dieticians, and health educators. Contact information for primary care providers and information on self-monitoring of BP will also be given at group sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women aged ≥18 years
- Community members associated with the participating churches (church members and their families and friends)
- Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mm Hg
- Willing and able to participate in the intervention.
- Willing and able to sign written informed consent.
Key exclusion criteria (5 listed)
- Prior hospitalization in the last 3 months for chronic heart failure or heart attack
- Current diagnosis of cancer requiring chemotherapy or radiation therapy
- Stage-5 chronic kidney disease requiring chronic dialysis or transplant
- Pregnant or planning to become pregnant in the next 18 months
- Planning to move out of the Greater New Orleans area during the next year
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 |
|---|---|---|
| Behavioral: Evidence-based interventions recommended by the 2017 ACC/AHA hypertension clinical guidelineThe recommended evidence-based interventions include therapeutic lifestyle change and medical treatment of hypertension | Behavioural | Community health worker-led implementation strategy, Group-based Education Strategy |
Primary outcome
Difference in mean change of systolic blood pressure
Time frame: Measured from baseline to 18 months
Difference in mean change of systolic blood pressure from baseline to 18 months between intervention and control groups
Implementation fidelity summary score
Time frame: Measured at 6, 12, and 18 months
The fidelity summary score is composed of the following key implementation strategy components: proportion of assigned health education sessions attended in all participants, proportion of assigned discussion sessions attended in all participants, proportion of recommended minutes of physical activity completed in all participants, proportion of days per week that fruits/vegetables are eaten as recommended in all participants, proportion of recommended home blood pressure (BP) monitoring completed in patients with hypertension, proportion of required provider visits attended in all patients, and proportion of antihypertensive medications taken in patients with hypertension. The score ranged from zero to six with a higher score indicates greater fidelity.
23 secondary outcomes
Difference in the proportion of patients with controlled BP between intervention and control groups
Time frame: Measured from baseline to 18 months
Difference in mean change of diastolic BP
Time frame: Measured from baseline to 18 months
Side effects of medications and adverse events
Time frame: Measured from baseline to 18 months
Cost-effectiveness
Time frame: Measured from baseline to 18 months
Acceptability
Time frame: Measured from baseline to 18 months
Adoption (Churches)
Time frame: Measured from baseline to 18 months
Adoption (Providers)
Time frame: Measured from baseline to 18 months
Appropriateness
Time frame: Measured from baseline to 18 months
Feasibility to participant, community health worker, provider and churches
Time frame: Measured from baseline to 18 months
Exercise Session Fidelity (community health worker-led strategy group)
Time frame: Measured at 6, 12, and 18 months
Fidelity of Group Health Education Session
Time frame: Measured at 6, 12, and 18 months
Nutrition Education Session Fidelity (community health worker-led strategy group)
Time frame: Measured at 6, 12, and 18 months
Health Care Appointment Fidelity (community health worker-led strategy group)
Time frame: Measured at 6, 12, and 18 months
Percentage of enrolled participants receiving assigned intervention. Measured by study administrative data. Reach (Participants)
Time frame: Measured at baseline, 6, 12, and 18 months
Reach (Participants)
Time frame: Measured at baseline
Penetrance (Participants)
Time frame: Measured at baseline, 6, 12, and 18 months
Penetrance (Providers)
Time frame: Measured at baseline, 6, 12, and 18 months
Penetrance (educators)
Time frame: Measured at baseline, 6, 12, and 18 months
Sustainability (Churches)
Time frame: Measured at baseline, 6, 12, and 18 months
Sustainability (Participants)
Time frame: Measured at 24 months
Sustainability Effectiveness Outcome: Differences in mean change of SBP and DBP
Time frame: Measured at baseline and 24 months
Sustainability Effectiveness Outcome: Difference in the proportion of patients with controlled BP
Time frame: Measured at baseline and 24 months
Sustainability of Fidelity
Time frame: Measured at 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 37244637Maroney K, Laurent J, Alvarado F, Gabor A, Bell C, Ferdinand K, He J, Mills KT. Systematic review and meta-analysis of church-based interventions to improve cardiovascular disease risk factors. Am J Med Sci. 2023 Sep;366(3):199-208. doi: 10.1016/j.amjms.2023.05.010. Epub 2023 May 25.
- Background: PubMed 37579311He J, Bundy JD, Geng S, Tian L, He H, Li X, Ferdinand KC, Anderson AH, Dorans KS, Vasan RS, Mills KT, Chen J. Social, Behavioral, and Metabolic Risk Factors and Racial Disparities in Cardiovascular Disease Mortality in U.S. Adults : An Observational Study. Ann Intern Med. 2023 Sep;176(9):1200-1208. doi: 10.7326/M23-0507. Epub 2023 Aug 15.
- Background: PubMed 37244672Bundy JD, Mills KT, He H, LaVeist TA, Ferdinand KC, Chen J, He J. Social determinants of health and premature death among adults in the USA from 1999 to 2018: a national cohort study. Lancet Public Health. 2023 Jun;8(6):e422-e431. doi: 10.1016/S2468-2667(23)00081-6.
- Individual participant dataSharing planned: Yes. The study data sharing plan will comply with all NIH policies for data sharing. Data sharing will be executed through the centralized NIH data repository and will be implemented in a timely manner. The study data, including data from baseline and follow-up visits, will be prepared for transmission to the NHLBI data repository - the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC). The datasets will be submitted to the NHLBI no later than three years after the end of the final participant follow-up or two years after the main paper of the trial has been published, whichever comes first. The NHLBI will review the submitted data prior to release. These data will be free of identifiers that allow identification of individual research participants either directly or through "deductive disclosure." In addition, the investigators will offer, through a publicly accessible website, opportunities for outside investigators to collaborate using complete study data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: Evidence-based interventions recommended by the 2017 ACC/AHA hypertension clinical guideline in people with Hypertension, run by Tulane University 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 5 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: looking for participants now, as of the sponsor's last update on 1 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean change of systolic blood pressure (time frame: Measured from baseline to 18 months). The study lists 2 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 NCT06133322, 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 1 Oct 2026.