Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED)

Hypertension Clinical Trial

— BLESSED  

Official title:

Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06133322
• Other study ID #: 2022-1081-SPHTM
• Secondary ID: R01MD018193
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: May 2024
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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 Black adults with hypertension (approximately 28 per church) from 42 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.

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 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 Americans 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 African American 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1176
• Est. completion date: June 30, 2027
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Black or African American 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

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Behavioral: Evidence-based interventions recommended by the 2017 ACC/AHA hypertension clinical guideline
The recommended evidence-based interventions include therapeutic lifestyle change and medical treatment of hypertension

Locations

Country	Name	City	State
United States	Tulane University	New Orleans	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Tulane University	National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in quality of life	The difference in QoL between the two arms over 18 months. QoL will be assessed using the SF-12 questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.	Measured from baseline to 18 months
Primary	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 from baseline to 18 months
Primary	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 at 6, 12, and 18 months
Secondary	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 from baseline to 18 months
Secondary	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 from baseline to 18 months
Secondary	Side effects of medications and adverse events	Change in side effects of medications and adverse events from baseline to 18 months	Measured from baseline to 18 months
Secondary	Cost-effectiveness	Cost-effectiveness assessed as incremental direct costs per additional percentage of hypertension control	Measured from baseline to 18 months
Secondary	Acceptability	Percentage of participants, community health worker, providers, and church administrators who reply that the intervention is acceptable (satisfactory). Measured by survey.	Measured from baseline to 18 months
Secondary	Adoption (Churches)	% of churches adopting the intervention program	Measured from baseline to 18 months
Secondary	Adoption (Providers)	% of invited providers attending training sessions	Measured from baseline to 18 months
Secondary	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 from baseline to 18 months
Secondary	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 from baseline to 18 months
Secondary	Exercise Session Fidelity (community health worker-led strategy group)	Percentage of exercise sessions organized. Measured by study administrative data.	Measured at 6, 12, and 18 months
Secondary	Fidelity of Group Health Education Session	Percentage of group health education sessions conducted out of health educated sessions planned per study protocol.	Measured at 6, 12, and 18 months
Secondary	Nutrition Education Session Fidelity (community health worker-led strategy group)	Percentage of nutrition education sessions organized. Measured by study administrative data.	Measured at 6, 12, and 18 months
Secondary	Health Care Appointment Fidelity (community health worker-led strategy group)	Percentage of health care visit appointments made. Measured by study administrative data.	Measured at 6, 12, and 18 months
Secondary	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 at baseline, 6, 12, and 18 months
Secondary	Reach (Participants)	The percentage of eligible/screened/contacted participants enrolled. Measured by study data, administrative data.	Measured at baseline
Secondary	Penetrance (Participants)	Percentage of enrolled participants receiving assigned intervention. Measured by intervention monitoring data.	Measured at baseline, 6, 12, and 18 months
Secondary	Penetrance (Providers)	Percentage of trained providers delivering protocol-based care. Measured by intervention monitoring data.	Measured at baseline, 6, 12, and 18 months
Secondary	Penetrance (educators)	Percentage of trained CHWs or providers and health educators delivering health coaching. Measured by intervention monitoring data.	Measured at baseline, 6, 12, and 18 months
Secondary	Sustainability (Churches)	Percentage of churches continuing the intervention program and individual components. Measured by 6-month post-intervention survey.	Measured at baseline, 6, 12, and 18 months
Secondary	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 at 24 months
Secondary	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 at baseline and 24 months
Secondary	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 at baseline and 24 months
Secondary	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 at 24 months