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NCT Number: NCT06133322

Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED)

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Behavioral: Evidence-based interventions recommended by the 2017 ACC/AHA hypertension clinical guideline

Behavioral

The recommended evidence-based interventions include therapeutic lifestyle change and medical treatment of hypertension

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. Difference in the proportion of patients with controlled BP between intervention and control groups

    Time frame: Measured from baseline to 18 months

    Difference in the proportion of patients with controlled BP (<130/80 mm Hg) between intervention and control groups at 18 months

  2. Difference in mean change of diastolic BP

    Time frame: Measured from baseline to 18 months

    Difference in mean change of diastolic BP (DBP) from baseline to 18 months between intervention and control groups

  3. Side effects of medications and adverse events

    Time frame: Measured from baseline to 18 months

    Change in side effects of medications and adverse events from baseline to 18 months

  4. Cost-effectiveness

    Time frame: Measured from baseline to 18 months

    Cost-effectiveness assessed as incremental direct costs per additional percentage of hypertension control

  5. Acceptability

    Time frame: Measured from baseline to 18 months

    Percentage of participants, community health worker, providers, and church administrators who reply that the intervention is acceptable (satisfactory). Measured by survey.

  6. Adoption (Churches)

    Time frame: Measured from baseline to 18 months

    % of churches adopting the intervention program

  7. Adoption (Providers)

    Time frame: Measured from baseline to 18 months

    % of invited providers attending training sessions

  8. Appropriateness

    Time frame: Measured from baseline to 18 months

    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.

  9. Feasibility to participant, community health worker, provider and churches

    Time frame: Measured from baseline to 18 months

    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.

  10. Exercise Session Fidelity (community health worker-led strategy group)

    Time frame: Measured at 6, 12, and 18 months

    Percentage of exercise sessions organized. Measured by study administrative data.

  11. Fidelity of Group Health Education Session

    Time frame: Measured at 6, 12, and 18 months

    Percentage of group health education sessions conducted out of health educated sessions planned per study protocol.

  12. Nutrition Education Session Fidelity (community health worker-led strategy group)

    Time frame: Measured at 6, 12, and 18 months

    Percentage of nutrition education sessions organized. Measured by study administrative data.

  13. Health Care Appointment Fidelity (community health worker-led strategy group)

    Time frame: Measured at 6, 12, and 18 months

    Percentage of health care visit appointments made. Measured by study administrative data.

  14. Percentage of enrolled participants receiving assigned intervention. Measured by study administrative data. Reach (Participants)

    Time frame: Measured at baseline, 6, 12, and 18 months

    Percentage of enrolled participants receiving assigned intervention. Measured by study administrative data.

  15. Reach (Participants)

    Time frame: Measured at baseline

    The percentage of eligible/screened/contacted participants enrolled. Measured by study data, administrative data.

  16. Penetrance (Participants)

    Time frame: Measured at baseline, 6, 12, and 18 months

    Percentage of enrolled participants receiving assigned intervention. Measured by intervention monitoring data.

  17. Penetrance (Providers)

    Time frame: Measured at baseline, 6, 12, and 18 months

    Percentage of trained providers delivering protocol-based care. Measured by intervention monitoring data.

  18. Penetrance (educators)

    Time frame: Measured at baseline, 6, 12, and 18 months

    Percentage of trained CHWs or providers and health educators delivering health coaching. Measured by intervention monitoring data.

  19. Sustainability (Churches)

    Time frame: Measured at baseline, 6, 12, and 18 months

    Percentage of churches continuing the intervention program and individual components. Measured by 6-month post-intervention survey.

  20. Sustainability (Participants)

    Time frame: Measured at 24 months

    Percentage of participants maintaining ideal cardiovascular health metrics, healthy lifestyle components, and adherence to medications. Measured by 6-month post-intervention survey and examination.

  21. Sustainability Effectiveness Outcome: Differences in mean change of SBP and DBP

    Time frame: Measured at baseline and 24 months

    Differences in mean change of SBP and DBP from baseline to 24 months (6 months post-intervention) between intervention and control groups

  22. Sustainability Effectiveness Outcome: Difference in the proportion of patients with controlled BP

    Time frame: Measured at baseline and 24 months

    Difference in the proportion of patients with controlled BP (<130/80 mm Hg) between intervention and control groups at 24 months.

  23. Sustainability of Fidelity

    Time frame: Measured at 24 months

    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.

Other outcomes

  1. Change in quality of life

    Time frame: Measured from baseline to 18 months

    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.

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • National Institutes of Health (NIH)

Registry information

Official study title

Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities

Acronym: BLESSED

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 15, 2023
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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