Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06133322
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-11-01
Brief Title:
Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities BLESSED
Sponsor:
Tulane University
Organization:
Tulane University
Study Overview
Official Title:
Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BLESSED
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 1176 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
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 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 58 mm Hg over 18 months using a 2-sided significance level of 005 The investigators will recruit 1176 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MD018193 | NIH | None | httpsreporternihgovquickSearchR01MD018193 |