Clinical trial NCT05341726: BREATHE: An Efficacy-implementation Trial Among Black Adults With Uncontrolled Asthma
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma
Keywords: Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2022-04-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Asthma Control Questionnaire Score
timeFrame: Baseline, 1 month, 2 months, 3 months, 6 months, 9 months, 12 Months (post-intervention)
Secondary outcomes:
measure: Mean Shared Decision Making-Questionnaire-9 Score
timeFrame: Baseline (immediately post-intervention)
measure: Mean Medication Adherence Report Scale - Asthma Score
timeFrame: Baseline, 1 month, 2 months, 3 months, 6 months, 9 months, 12 Months (post-intervention)
measure: Mean Asthma Quality of Life Questionnaire Score
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 Months (post-intervention)
measure: Mean Asthma Impairment and Risk Questionnaire Score
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 Months (post-intervention)
Other outcomes:
measure: Number of participants who completed post-trial interviews
timeFrame: up to 3 months (post-trial)
Locations:
city: Beacon
country: United States
facility: Sun River Health
state: New York
city: Brooklyn
country: United States
facility: Bedford Stuyvesant Family Health Center
state: New York
Study officials:
affiliation: Columbia University School of Nursing
name: Maureen George, PhD
role: PRINCIPAL_INVESTIGATOR
References: