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Validation of the BREATHE Asthma Intervention Trial

Primary Purpose

Asthma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BREATHE Intervention

Control Intervention

About this trial

This is an interventional supportive care trial for Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

Exclusion Criteria:

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

Sites / Locations

Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BREATHE Intervention

Control Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Asthma Quality of Life Questionnaire (AQLQ) Score

Full title: Asthma Quality of Life Questionnaire Construct: quality of life for patients with asthma Scoring: 32 items, each scored 1-7. The total score is calculated as a mean of all 32 items (1= low quality of life/ worse outcome, 7= high quality of life/ best outcome)

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

Full title: Medication Adherence Record Scale- Asthma Construct: Adherence to inhaled corticosteroid medications Scoring: Total score is calculated as a mean of the 10 items, scores range from 1-5 (1= low adherence/ worse outcome, 5= high adherence/ best outcome)

Full Information

NCT ID

NCT03300752

First Posted

September 29, 2017

Last Updated

September 1, 2021

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT03300752

Brief Title

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

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

October 1, 2017 (Actual)

Primary Completion Date

May 29, 2019 (Actual)

Study Completion Date

May 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BREATHE Intervention

Arm Type

Experimental

Arm Description

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

Arm Title

Control Intervention

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

BREATHE Intervention

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Control Intervention

Intervention Description

PCP will provide discussion of healthy lifestyles.

Primary Outcome Measure Information:

Title

Asthma Control Questionnaire (ACQ) Score

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Asthma Quality of Life Questionnaire (AQLQ) Score

Description

Time Frame

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

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maureen George, PhD

Organizational Affiliation

Associate Professor of Nursing at Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30479020

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.

Results Reference

background

PubMed Identifier

33249632

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.

Results Reference

derived

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Validation of the BREATHE Asthma Intervention Trial

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