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

Asthma Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05341726
• Other study ID #: AAAT0939 - trial & post-trial
• Secondary ID: R01NR019275
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2023
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Columbia University
• Contact: Maureen George, PhD
• Phone: 2123051175
• Email: mg3656[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
United States	Sun River Health	Beacon	New York
United States	Bedford Stuyvesant Family Health Center	Brooklyn	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants who completed post-trial interviews	Qualitative post-trial interviews will be conducted with patient participants, their loved ones, and primary care providers to determine the satisfaction with, and acceptability of the intervention. The interviews will be analyzed using a directed content analysis to determine themes within the interviews.	up to 3 months (post-trial)
Primary	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	Mean Shared Decision Making-Questionnaire-9 Score	The Shared Decision Making (SDM) Questionnaire-9, is a patient reported, 9-item validated instrument that consists of nine statements that measure the decisional process in medical visits from both patients' and physicians' perspectives. Each statement is rated on a six-point scale from "completely disagree" (0) to "completely agree" (5). The raw total score of all items range from 0-45. Lower scores indicate lower levels of shared decision making between provider and patient (in this study as it pertains to asthma treatment) and higher scores indicate higher levels of shared decision making.	Baseline (immediately post-intervention)
Secondary	Mean Medication Adherence Report Scale - Asthma Score	Inhaled corticosteroid adherence as measured by the Medication Adherence Report Scale - Asthma (MARS-A). Participants are asked to rate the frequency with which they engage in each of the adherence-related behaviors on a five-point scale, where 5 = never, 4 = rarely, 3 = sometimes, 2 = often and 1 = always. Scores for each item are summed to give a total score, with higher scores indicating higher levels of reported adherence.	Baseline, 1 month, 2 months, 3 months, 6 months, 9 months, 12 Months (post-intervention)
Secondary	Mean Asthma Quality of Life Questionnaire Score	Asthma quality of life improvements as measured by the Asthma Quality of Life Questionnaire (AQLQ), a 32-item validated and widely-used measure consisting of 4 domains: symptoms (11 items), emotions (5 items), environment (4 items), and activities (12 items). Each item is measured on a 7-point Likert scale (7 = not impaired at all, 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains. Lower mean scores indicate lower quality of life due to asthma.	Baseline, 1 month, 3 months, 6 months, 12 Months (post-intervention)
Secondary	Mean Asthma Impairment and Risk Questionnaire Score	Asthma Impairment and Risk Questionnaire (AIRQ) is a 10-item valid and reliable survey that measures bot domains of control: symptom impairments and risk for uncontrolled asthma. AIRQ™ score ranges from 0-10, measured by total number of YES answers. Score tally of 0-1 indicates well controlled asthma, scores 2-4 indicate not well controlled asthma, and scores 5-10 indicate very poorly controlled asthma.	Baseline, 1 month, 3 months, 6 months, 12 Months (post-intervention)