BREATHE: An Efficacy-implementation Trial Among Black Adults With Uncontrolled Asthma

Asthma Clinical Trial

Official title: BREATHE: An Efficacy-implementation Trial of a Brief Shared Decision Making Intervention Among Black Adults With Uncontrolled Asthma in Federally Qualified Health Centers (Trial and Post-trial)

Status Recruiting

Clinical Trial Summary

This study is an efficacy-implementation trial to:

1. evaluate systematically the efficacy of BREATHE in 200 Black adults receiving care at urban federally qualified health centers (FQHCs) for uncontrolled asthma; and

2. identify multi-level barriers and facilitators to the widespread adoption and implementation of BREATHE in FQHCs.

Clinical Trial Description

Black adults with asthma are an appropriate target for shared decision-making (SDM) interventions that support disease self-management as Black adults experience a higher asthma burden and worse clinical outcomes than non-Black adults and/or children with asthma of any racial-ethnic background. To date, the application of SDM and community-based interventions targeting Black adults have failed to address these disparities. Therefore, the investigator used patient input to develop BREATHE - BRief intervention to Evaluate Asthma THErapy - a 9-minute SDM intervention focused on reducing the impact of erroneous beliefs on asthma control - and established its efficacy in this health disparity population. This intervention is unique in that it is a one-time brief, tailored intervention integrated into office visits, using the patient's own provider as the interventionist (e.g. scalable). A previously conducted pilot trial demonstrated high fidelity to BREATHE delivery and improved asthma control and reduced symptoms among BREATHE participants compared to a dose-matched attention control condition.

We will conduct post-trial mixed-method interviews with patient participants, their loved ones, and PCPs using evaluation frameworks to determine satisfaction with, and acceptability of, the active and control interventions. ;

Related Conditions & MeSH terms

• Asthma

• NCT number: NCT05341726
• Study type: Interventional
• Source: Columbia University
• Contact: Maureen George, PhD
• Phone: 2123051175
• Email: mg3656@cumc.columbia.edu
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2023
• Completion date: January 2025