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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,176
The recommended evidence-based interventions include therapeutic lifestyle change and medical treatment of hypertension
Tulane University
New Orleans, Louisiana, United States
RECRUITINGDifference 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
Time frame: 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.
Time frame: Measured at 6, 12, and 18 months
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
Time frame: 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
Time frame: 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
Time frame: Measured from baseline to 18 months
Cost-effectiveness
Cost-effectiveness assessed as incremental direct costs per additional percentage of hypertension control
Time frame: 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.
Time frame: Measured from baseline to 18 months
Adoption (Churches)
% of churches adopting the intervention program
Time frame: Measured from baseline to 18 months
Adoption (Providers)
% of invited providers attending training sessions
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured at baseline, 6, 12, and 18 months
Reach (Participants)
The percentage of eligible/screened/contacted participants enrolled. Measured by study data, administrative data.
Time frame: Measured at baseline
Penetrance (Participants)
Percentage of enrolled participants receiving assigned intervention. Measured by intervention monitoring data.
Time frame: Measured at baseline, 6, 12, and 18 months
Penetrance (Providers)
Percentage of trained providers delivering protocol-based care. Measured by intervention monitoring data.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Measured at 24 months
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