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

NCT05341726 | Recruiting DMC

• 2 other identifiers: AAAT0939 - trial & post-trialR01NR019275
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

This study is an efficacy-implementation trial to:

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

Conditions

Asthma

Keywords

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Outcome Measures

Primary Outcomes (1)

• Mean Asthma Control Questionnaire Score

  Asthma control as measured by improvements in Asthma Control Questionnaire (ACQ) score, a 6-item validated and widely used measure of asthma control. Each question is rated from 0 to 6. A score of 0 indicates well controlled asthma and a score of 6 indicates extremely poorly controlled asthma. The overall ACQ score is the mean score of all 6 items. Lower mean scores indicate greater asthma control, higher mean scores indicate lesser asthma control.

  Baseline, 1 month, 2 months, 3 months, 6 months, 9 months, 12 Months (post-intervention)

Secondary Outcomes (4)

• Mean Shared Decision Making-Questionnaire-9 Score

  Baseline (immediately post-intervention)

• Mean Medication Adherence Report Scale - Asthma Score

  Baseline, 1 month, 2 months, 3 months, 6 months, 9 months, 12 Months (post-intervention)

• Mean Asthma Quality of Life Questionnaire Score

  Baseline, 1 month, 3 months, 6 months, 12 Months (post-intervention)

• Mean Asthma Impairment and Risk Questionnaire Score

  Baseline, 1 month, 3 months, 6 months, 12 Months (post-intervention)

Other Outcomes (1)

• Number of participants who completed post-trial interviews

  up to 3 months (post-trial)

Study Arms (2)

BREATHE intervention

EXPERIMENTAL

The patient's primary care provider (PCP) will deliver a brief intervention using motivational interviewing and shared decision making, in a one time 9-minute intervention integrated into an office visit for asthma. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit.

Behavioral: BREATHE Intervention

Control Intervention

ACTIVE COMPARATOR

The patient's primary care provider (PCP) will deliver a 9-minute scripted intervention on credible nutrition and lifestyle information. The control intervention is designed to not be specific enough to change strategies related to asthma control.

Behavioral: Control Intervention

Interventions

BREATHE Intervention BEHAVIORAL

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).

BREATHE intervention

Control Intervention BEHAVIORAL

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).

Control Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients participants will
• be adults (\> or = 18 years of age)
• self-report race as 'Black' race (African American, African, Caribbean, West Indian, multi-racial \[Black AND one or more additional races\]); identify their ethnicity as Hispanic OR non-Hispanic
• have clinician-diagnosed persistent asthma (defined as being prescribed inhaled corticosteroids in the last 48 months) or have had an asthma exacerbation (e.g., ER visit, course of Prednisone) regardless of controller medicine use
• receive asthma care at a partner FQHC and
• screen positive for uncontrolled asthma as measured by the Asthma Control Questionnaire- 6 items (ACQ-6) and erroneous beliefs as measured by the Conventional and Alternative Management for Asthma (CAM-A) survey.

You may not qualify if:

• non-English speaking
• serious mental health conditions that preclude completion of study procedures or confound analyses or
• participation in a listening session
• \. those who manage a panel of adult asthma patients
• must be identified by patient participant as a loved one and
• loved one must be a family member or friend of the patient participant.
• non-English speaking or
• serious mental health conditions that preclude completion of study procedures or confound analyses

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

Sun River Health

Beacon, New York, 12508, United States

RECRUITING

Bedford Stuyvesant Family Health Center

Brooklyn, New York, 11216, United States

RECRUITING

MeSH Terms

Conditions

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Maureen George, PhD

  Columbia University School of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maureen George, PhD

CONTACT

2123051175; mg3656@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patient participants, data collectors, and the statistician will be blinded to assignment. Consent materials will inform patient participants that the focus of the trial is on the communication they have with their clinician about asthma management and control. Immediately after the intervention, patient participants will be asked to guess the condition to which their clinician had been randomized. At the end of participants' final data collection visit, data collectors will be asked to guess whether participants had received the active or control intervention at the visit. These data will provide some measurement of the success of masking.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nursing at the Columbia University Irving Medical Center

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 22, 2022
• Study Start: January 19, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)