Feasibility of the BREATHE Asthma Intervention Trial

NCT03036267 | Completed Results DMC

• 1 other identifier: AAAR0605
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

Asthma rates are high and asthma control is greatly reduced in Black, Medicaid-insured adults, due in part to their poor adherence to inhaled corticosteroids (ICS), which in turn may be due to erroneous health beliefs about asthma and negative beliefs regarding ICS. A brief shared decision-making intervention for use by primary care providers in Federally Qualified Health Centers (FQHCs) has the potential to be a novel avenue to greatly improve asthma control in this high-risk patient group.

Conditions

Asthma Chronic; Health Behavior

Keywords

health disparity; motivational interviewing; African American adults; Federally Qualified Health Centers; adherence; health beliefs; self-management; asthma control

Outcome Measures

Primary Outcomes (1)

• Asthma Control Questionnaire

  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 - for descriptive purposes only

Study Arms (2)

BREATHE

EXPERIMENTAL

7-minute brief shared decision-making intervention using a 4-step motivational interviewing approach

Behavioral: BREATHE

Attention Control Condition

ACTIVE COMPARATOR

7-minute diet and exercise discussion

Other: Attention Control Condition

Interventions

BREATHE BEHAVIORAL

Primary care providers (PCPs) randomized to BREATHE will be trained to deliver the 7-minute brief shared decision-making intervention using a 4-step motivational interviewing approach.

Also known as: Shared decision-making using motivational interviewing

BREATHE

Attention Control Condition OTHER

PCPs randomized to the control intervention will not receive any specific training. To control for contact, they will be instructed to engage in a 7-minute diet and exercise discussion as this will not confound results.

Attention Control Condition

Eligibility Criteria

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

You may qualify if:

• \- Adult patients with persistent asthma or loved ones of adult patients with persistent asthma (prescribed ICS regardless of whether they are using ICS or not) receiving care at the participating FQHCs

You may not qualify if:

• \- Patients with persistent asthma or loved ones of patients with persistent asthma under they age of 18 OR NOT prescribed ICS or NOT receiving care at the participating FQHCs
• Patients must be:
• Adults (18 years of age or older)
• PCP-diagnosed persistent asthma
• Currently prescribed ICS
• Receiving asthma care at participating FQHCs
• Who screen positive for uncontrolled asthma
• Have erroneous personal health and/or negative ICS beliefs
• Participation in focus groups during the development phase
• Non-English speaking
• Serious mental health conditions (e.g., psychosis) that preclude completion of study procedures or confound analyses

Sponsors & Collaborators

• Columbia University: lead
• University of Pennsylvania: collaborator

Study Sites (2)

Spectrum Health Services

Philadelphia, Pennsylvania, 19139, United States

Location

Greater Philadelphia Health Action

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (2)

• George M, Arcia A, Chung A, Coleman D, Bruzzese JM. African Americans Want a Focus on Shared Decision-Making in Asthma Adherence Interventions. Patient. 2020 Feb;13(1):71-81. doi: 10.1007/s40271-019-00382-x.

  PMID: 31414396 BACKGROUND

• 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 DERIVED

MeSH Terms

Conditions

Health Behavior

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Results Point of Contact

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

mg3656@cumc.columbia.edu

2123051175

Study Officials

• Maureen George, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nursing

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: January 30, 2017
• Study Start: April 4, 2017
• Primary Completion: September 22, 2017
• Study Completion: September 22, 2017
• Last Updated: December 6, 2021
• Results First Posted: December 6, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)