Validation of the BREATHE Asthma Intervention Trial

NCT03300752 | Completed Results DMC

• 1 other identifier: AAAR5216
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this study to preliminarily validate a novel intervention delivered by primary care providers (PCPs) to their Black adult patients with uncontrolled asthma in federally qualified health centers (FQHCs).

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Asthma Control Questionnaire (ACQ) Score

  Full title: Asthma Control Questionnaire Construct measured: self-reported asthma control Scoring: 0 points = total asthma control/ best outcome, 6 points = completely uncontrolled asthma/ worst outcome

  Baseline, 1 Month, 2 Months, 3 Months (post-intervention)

Secondary Outcomes (2)

• Asthma Quality of Life Questionnaire (AQLQ) Score

  Baseline, 1 Month, 2 Months, 3 Months (post-intervention)

• Medication Adherence Record Scale-Asthma (MARS-A) Score

  Baseline, 1 Month, 2 Months, 3 Months (post-intervention)

Study Arms (2)

BREATHE Intervention

EXPERIMENTAL

The patient's primary care provider (PCP) will deliver the active intervention (shared decision-making discussion of asthma control status and treatment) - BREATHE Intervention.

Behavioral: BREATHE Intervention

Control Intervention

ACTIVE COMPARATOR

The patient's primary care provider (PCP) will deliver the control intervention (discussion of healthy lifestyles).

Behavioral: Control Intervention

Interventions

BREATHE Intervention BEHAVIORAL

PCPs randomized to BREATHE will receive the tablet which, when the screen is advanced by the PCP, will prompt the PCP through a 7-minute, 4-step brief intervention tailored to respond to the patient's specific beliefs, and shared decision-making discussion of asthma control status and treatment.

BREATHE Intervention

Control Intervention BEHAVIORAL

PCP will provide discussion of healthy lifestyles.

Control Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PCPs (MDs and Nurse Practitioners (NPs)/Physician Assistants (PAs)) working in family, primary or internal medicine care services
• Who have at least 40 adult patients with persistent asthma (defined as having been prescribed ICS) on their patient panel

You may not qualify if:

• PCPs whose primary focus is outside of adult health services (family, primary or internal medicine), such as behavioral health, pediatrics and Obstetrics and Gynaecology (OB-GYN)
• PATIENT RECRUITMENT
• Patients must be
• adults (\> or = 18 years of age) who self-report race as Black or African American
• with PCP-diagnosed persistent asthma
• prescribed ICS
• receiving asthma care at participating FQHCs
• who have uncontrolled asthma
• have erroneous personal health and/or negative ICS beliefs
• participation in Phase 1 (Part 1) of the BREATHE trial (focus groups)
• non-English speaking
• serious mental health conditions (e.g., psychosis) that preclude completion of study procedures or confound analyses

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

• George M, Pantalon MV, Sommers MLS, Glanz K, Jia H, Chung A, Norful AA, Poghosyan L, Coleman D, Bruzzese JM. Shared decision-making in the BREATHE asthma intervention trial: A research protocol. J Adv Nurs. 2019 Apr;75(4):876-887. doi: 10.1111/jan.13916. Epub 2019 Jan 24.

  PMID: 30479020 BACKGROUND

• George M, Bruzzese JM, Lynn S Sommers M, Pantalon MV, Jia H, Rhodes J, Norful AA, Chung A, Chittams J, Coleman D, Glanz K. Group-randomized trial of tailored brief shared decision-making to improve asthma control in urban black adults. J Adv Nurs. 2021 Mar;77(3):1501-1517. doi: 10.1111/jan.14646. Epub 2020 Nov 29.

  PMID: 33249632 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Maureen George
• Organization: Columbia University School of Nursing

mg3656@cumc.columbia.edu

2123051175

Study Officials

• Maureen George, PhD

  Associate Professor of Nursing at Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nursing at the Columbia University Medical Center, Nursing Scholarship & Research

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 3, 2017
• Study Start: October 1, 2017
• Primary Completion: May 29, 2019
• Study Completion: May 30, 2019
• Last Updated: September 28, 2021
• Results First Posted: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)