RecruitingNot ApplicableNCT05341726

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

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)

Sponsor

Columbia University

Enrollment

400 participants

Start Date

Jan 19, 2023

Study Type

INTERVENTIONAL

Conditions

Asthma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a culturally tailored asthma education and support program called BREATHE to help Black adults with poorly controlled asthma better manage their condition, in partnership with community health centers. **You may be eligible if...** - You are 18 years or older - You self-identify as Black (African American, African, Caribbean, West Indian, or multiracial including Black) - You have a doctor's diagnosis of persistent asthma (prescribed inhaled corticosteroids in the last 4 years, or had a recent asthma attack) - You receive asthma care at a participating community health center (FQHC) - Your asthma is currently uncontrolled based on a screening questionnaire **You may NOT be eligible if...** - Your asthma is well-controlled - You do not receive care at a partnering health center - You do not self-identify as Black Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALBREATHE Intervention

BREATHE utilizes Primary Care Providers (PCPs) to deliver a 4-step script that was created by and tailored to Black adults' asthma and inhaled corticosteroid beliefs, as well as their Asthma Control Questionnaire (ACQ) score, measured just prior to the medical visit. Step 1: Raise the subject (1½ minute). Step 2: Provide feedback (1½ minutes). Step 3: Enhance engagement (3 minutes). Step 4: Shared decision-making (3 minutes).

BEHAVIORALControl Intervention

The control intervention will be a 9-minute scripted discussion tailored to living a health lifestyle. Step 1: Review of BMI, current diet and exercise (3 minutes). Step 2: Diet/exercise counseling (3 minutes). Step 3: Plan for goal attainment (3 minutes).