Recruiting

Asthma

Sponsor:

Columbia University

Code:

NCT05341726

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

BREATHE Intervention

Control Intervention

Study Details

Brief 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.

Conditions

Asthma

Study ID

NCT05341726

Start date

Jan 19, 2023

Status verified date

Jan, 2026

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria (participants):

Patients participants will

1. be adults (> or = 18 years of age)
2. 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
3. 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
4. receive asthma care at a partner FQHC and
5. 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.

Exclusion Criteria (participants):

1. non-English speaking
2. serious mental health conditions that preclude completion of study procedures or confound analyses or
3. participation in a listening session

Inclusion Criterion (clinicians):

1\. those who manage a panel of adult asthma patients

Inclusion Criteria (loved ones):

1. must be identified by patient participant as a loved one and
2. loved one must be a family member or friend of the patient participant.

Exclusion Criteria (loved ones):

1. non-English speaking or
2. serious mental health conditions that preclude completion of study procedures or confound analyses

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: BREATHE intervention

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.

active comparator: Control Intervention

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.

Interventions

BREATHE 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).

Control 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).

Primary outcome measure

  • Mean Asthma Control Questionnaire Score [ Time Frame: Baseline, 1 month, 2 months, 3 months, 6 months, 9 months, 12 Months (post-intervention) ]

Central Contacts and Locations

Central contacts

Locations

Sun River Health

Recruiting

Beacon, New York, United States, 12508

Contacts

Bedford Stuyvesant Family Health Center

Recruiting

Brooklyn, New York, United States, 11216

Contacts

More Information

Sponsor

Columbia University

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-01-30.