Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05341726

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)

Led by Columbia University · Updated on 2026-01-30

400

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

N

National Institute of Nursing Research (NINR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the BREATHE intervention, a brief shared decision-making program designed specifically for Black adults with uncontrolled asthma who receive care at urban federally qualified health centers. This study aims to test the effectiveness of BREATHE in improving asthma control and to explore the factors that affect how widely this intervention can be adopted and implemented in these healthcare settings. The intervention was developed with patient input to address inaccurate beliefs that impact asthma management in this population. The BREATHE intervention involves a one-time, 9-minute session delivered by the patient's primary care provider during a routine office visit. The provider follows a 4-step script tailored to each patient's asthma control score and beliefs about asthma and inhaled corticosteroids. Participants are randomly assigned either to receive this tailored BREATHE intervention or to a control group that receives a 9-minute scripted discussion on nutrition and lifestyle, which is not specific to asthma management. Participants will be involved in multiple assessments over 12 months, including the Asthma Control Questionnaire at baseline and several follow-up points, as well as questionnaires on shared decision making, medication adherence, quality of life, and asthma impairment. The study also includes post-trial interviews with patients, their loved ones, and providers to gather feedback on the interventions. This comprehensive monitoring helps researchers understand the impact of BREATHE on asthma outcomes and its acceptability among participants and clinicians.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Be an adult aged 18 years or older
  • Self-report as Black race (including African American, African, Caribbean, West Indian, or multi-racial including Black)
  • Have clinician-diagnosed persistent asthma or have had an asthma exacerbation within the last 48 months
  • Receive asthma care at a partner federally qualified health center
  • Screen positive for uncontrolled asthma using the Asthma Control Questionnaire and have erroneous asthma beliefs measured by a survey
Not Eligible

You will not qualify if you...

  • Unable to speak English
  • Have serious mental health conditions that prevent completing study procedures or interfere with analysis
  • Currently participating in a listening session
  • Loved ones must also be English speaking and free of serious mental health conditions to participate

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Single session

Participants receive a one-time 9-minute behavioral intervention delivered by their primary care provider during an office visit. This intervention is tailored either to asthma self-management beliefs and asthma control (BREATHE intervention) or to general health lifestyle information (control intervention).

1 visit (in-person)

Post-trial Follow-up

Duration - 12 months

Participants are followed for up to 12 months after the intervention to assess asthma control, medication adherence, quality of life, and shared decision-making outcomes through scheduled assessments.

Visits at baseline, 1 month, 2 months, 3 months, 6 months, 9 months, and 12 months post-intervention

Trial Site Locations

Total: 2 locations

1

Sun River Health

Beacon, New York, United States, 12508

Actively Recruiting

2

Bedford Stuyvesant Family Health Center

Brooklyn, New York, United States, 11216

Actively Recruiting

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Research Team

M

Maureen George, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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