Clinical trial NCT06133322: Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED)
Official title: Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: church-based
Black
African American
Community-based Intervention
health disparities
cardiovascular disease prevention
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-11-15
Enrollment: 1176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomization of 42 churches in New Orleans, Louisiana to 2 arms
Primary purpose: PREVENTION

Brief 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, 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.

Eligibility criteria: Inclusion Criteria:

1. Men or women aged ≥18 years
2. Community members associated with the participating churches (church members and their families and friends)
3. Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mm Hg
4. Willing and able to participate in the intervention.
5. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Prior hospitalization in the last 3 months for chronic heart failure or heart attack
2. Current diagnosis of cancer requiring chemotherapy or radiation therapy
3. Stage-5 chronic kidney disease requiring chronic dialysis or transplant
4. Pregnant or planning to become pregnant in the next 18 months
5. Planning to move out of the Greater New Orleans area during the next year

Primary outcomes:
measure: Difference in mean change of systolic blood pressure
timeFrame: Measured from baseline to 18 months
measure: Implementation fidelity summary score
timeFrame: Measured at 6, 12, and 18 months
Secondary outcomes:
measure: Difference in the proportion of patients with controlled BP between intervention and control groups
timeFrame: Measured from baseline to 18 months
measure: Difference in mean change of diastolic BP
timeFrame: Measured from baseline to 18 months
measure: Side effects of medications and adverse events
timeFrame: Measured from baseline to 18 months
measure: Cost-effectiveness
timeFrame: Measured from baseline to 18 months
measure: Acceptability
timeFrame: Measured from baseline to 18 months
measure: Adoption (Churches)
timeFrame: Measured from baseline to 18 months
measure: Adoption (Providers)
timeFrame: Measured from baseline to 18 months
measure: Appropriateness
timeFrame: Measured from baseline to 18 months
measure: Feasibility to participant, community health worker, provider and churches
timeFrame: Measured from baseline to 18 months
measure: Exercise Session Fidelity (community health worker-led strategy group)
timeFrame: Measured at 6, 12, and 18 months
measure: Fidelity of Group Health Education Session
timeFrame: Measured at 6, 12, and 18 months
measure: Nutrition Education Session Fidelity (community health worker-led strategy group)
timeFrame: Measured at 6, 12, and 18 months
measure: Health Care Appointment Fidelity (community health worker-led strategy group)
timeFrame: Measured at 6, 12, and 18 months
measure: Percentage of enrolled participants receiving assigned intervention. Measured by study administrative data. Reach (Participants)
timeFrame: Measured at baseline, 6, 12, and 18 months
measure: Reach (Participants)
timeFrame: Measured at baseline
measure: Penetrance (Participants)
timeFrame: Measured at baseline, 6, 12, and 18 months
measure: Penetrance (Providers)
timeFrame: Measured at baseline, 6, 12, and 18 months
measure: Penetrance (educators)
timeFrame: Measured at baseline, 6, 12, and 18 months
measure: Sustainability (Churches)
timeFrame: Measured at baseline, 6, 12, and 18 months
measure: Sustainability (Participants)
timeFrame: Measured at 24 months
measure: Sustainability Effectiveness Outcome: Differences in mean change of SBP and DBP
timeFrame: Measured at baseline and 24 months
measure: Sustainability Effectiveness Outcome: Difference in the proportion of patients with controlled BP
timeFrame: Measured at baseline and 24 months
measure: Sustainability of Fidelity
timeFrame: Measured at 24 months
Other outcomes:
measure: Change in quality of life
timeFrame: Measured from baseline to 18 months
Locations:
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
Study officials:
References:
citation: 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.
citation: He 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.
citation: Bundy 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.