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

Part of paid clinical trials in Beacon, New York.

Sponsor
Columbia University
Study ID
NCT05341726
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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).
  • 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).

Study Details

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.

Key Dates

Start date
Jan 19, 2023
Status verified
Jan 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

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

Locations (2)

FacilityCityStateZIPSite coordinators
Sun River HealthBeaconNew York12508
Maureen George, PhD
[email protected]
212-305-1175
Bedford Stuyvesant Family Health CenterBrooklynNew York11216
Maureen George, PhD
[email protected]
212-305-1175

Find similar trials in Beacon, NY

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Sun River Health· Beacon, NYBedford Stuyvesant Family Health Center· Brooklyn, NY

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