Clinical trial NCT03300752: Validation of the BREATHE Asthma Intervention Trial
Official title: Self-care Decision-making: Feasibility of the BREATHE Asthma Intervention Trial - Phase II (Part 2 - a Pilot Randomized Trial Phase)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 80
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: 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).

Detailed description: Nearly every asthma related hospitalization and death could be prevented with appropriate self-management that achieves and maintains disease control. However, as many as 64% of adults have uncontrolled asthma; minorities are disproportionately represented within that population. While inhaled corticosteroids (ICS) are a safe and effective treatment for uncontrolled asthma, relative to Whites, Blacks have lower rates of ICS adherence.

Black adults with uncontrolled asthma experience profound health disparities. Despite data that point to the critical need for enhanced asthma self-management, rates of controlled asthma are well below Healthy People 2020 targets, particularly among vulnerable populations. This Brief Evaluation of Asthma Therapy (BREATHE) intervention has the potential to offer a new avenue to asthma control via shared decision-making that supports ICS adherence.

Eligibility criteria: PROVIDER RECRUITMENT

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Inclusion Criteria:

Patients must be

1. adults (\> or = 18 years of age) who self-report race as Black or African American
2. with PCP-diagnosed persistent asthma
3. prescribed ICS
4. receiving asthma care at participating FQHCs
5. who have uncontrolled asthma
6. have erroneous personal health and/or negative ICS beliefs

Exclusion Criteria:

1. participation in Phase 1 (Part 1) of the BREATHE trial (focus groups)
2. non-English speaking
3. serious mental health conditions (e.g., psychosis) that preclude completion of study procedures or confound analyses

Primary outcomes:
measure: Asthma Control Questionnaire (ACQ) Score
timeFrame: Baseline, 1 Month, 2 Months, 3 Months (post-intervention)
Secondary outcomes:
measure: Asthma Quality of Life Questionnaire (AQLQ) Score
timeFrame: Baseline, 1 Month, 2 Months, 3 Months (post-intervention)
measure: Medication Adherence Record Scale-Asthma (MARS-A) Score
timeFrame: Baseline, 1 Month, 2 Months, 3 Months (post-intervention)
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Associate Professor of Nursing at Columbia University
name: Maureen George, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.