Feasibility of the BREATHE Asthma Intervention Trial

• Sponsor: Columbia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03036267
• Collaborator: University of Pennsylvania (Other)
• Enrollment: 46
• Locations: 2
• Arms: 2
• Actual Duration (Months): 5.6
• Patients Per Site: 23
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma Chronic; Health Behavior	Behavioral: BREATHE; Other: Attention Control Condition	N/A

Detailed Description

Uncontrolled asthma disproportionally impacts Black and poor adults. Adherence to inhaled corticosteroids (ICS), which plays a significant role in asthma control, is relatively low in poor and minority populations. Non-adherence to ICS is associated with erroneous personal health beliefs regarding asthma care and with negative beliefs regarding ICS. Despite this, no intervention concurrently addresses beliefs regarding asthma self-care and ICS. Shared decision-making interventions have not been tested in underserved Black adults, despite this model's success in pediatric populations and in White, privately insured patients with asthma. Federally Qualified Health Centers (FQHCs) have unique challenges to helping patients achieve asthma control but are overlooked in asthma intervention research. Process evaluations are often lacking during intervention development. We will address these treatment and methodological gaps.

Objectives: This pilot study will (1) develop a brief shared decision-making intervention delivered by primary care providers (PCPs) to improve asthma control in Black adults receiving care in FQHCs; (2) evaluate the intervention's feasibility and acceptability; and (3) assess preliminary evidence of intervention effects on asthma control, ICS adherence, forced expiratory volume in one second (FEV1) - an objective lung function measure - and asthma quality of life (QOL) over a 3-month follow-up period.

Hypotheses: (1) The intervention will be feasible and acceptable, and (2) over 3 months, relative to controls, patients whose PCPs are trained in the intervention will have significant improvement on asthma control (primary outcome), ICS adherence, FEV1 and asthma QOL (secondary outcomes).

Methods: Using community-based participatory research and including a Patient Advocate, we will develop the intervention, Brief Evaluation of Asthma Therapy (BREATHE). Intervention development is guided by patient and family/support persons of asthma patients input, as well as PCP feedback. We will then conduct a randomized trial of the intervention with 8 PCPs from 2 FQHCs in Philadelphia, PA; for each PCP we will enroll 10 Black adults (N=80) with uncontrolled asthma, and with erroneous asthma care beliefs and negative ICS beliefs. PCPs will be randomized within FQHC to intervention and control; patients will be followed for 3 months. Process evaluation interviews with patients and PCPs will obtain feedback regarding intervention procedures.

Significance: This study has high public health significance because it (1) targets a highly vulnerable population for poor asthma control - Black poor adults with erroneous asthma care beliefs and with negative ICS beliefs; (2) adapts a model-based intervention to develop a novel intervention delivered by PCPs that simultaneously targets erroneous asthma beliefs and negative ICS beliefs, and which has the potential to amplify intervention effects and increase the likelihood of sustainability; and (3) includes a process evaluation, bridging the gap between science and practice, and aiding in the design of a full-scale randomized controlled trial (RCT).

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Self-care Decision-making: Feasibility of the BREATHE Asthma Intervention Trial
• Actual Study Start Date: Apr 4, 2017
• Actual Primary Completion Date: Sep 22, 2017
• Actual Study Completion Date: Sep 22, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BREATHE 7-minute brief shared decision-making intervention using a 4-step motivational interviewing approach	Behavioral: BREATHE; 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.; Other Names: Shared decision-making using motivational interviewing
Active Comparator: Attention Control Condition 7-minute diet and exercise discussion	Other: Attention Control Condition; 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.

Outcome Measures

Primary Outcome Measures

1. Asthma Control Questionnaire [Baseline - for descriptive purposes only]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

The intervention trial will be informed by focus groups

Focus Group Inclusion Criteria:

• 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

Focus Group Exclusion Criteria:

• 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

Intervention Inclusion Criteria:

Patients must be:

1. Adults (18 years of age or older)

2. PCP-diagnosed persistent asthma

3. Currently prescribed ICS

4. Receiving asthma care at participating FQHCs

5. Who screen positive for uncontrolled asthma

6. Have erroneous personal health and/or negative ICS beliefs

Intervention Exclusion Criteria:

1. Participation in focus groups during the development phase

2. Non-English speaking

3. Serious mental health conditions (e.g., psychosis) that preclude completion of study procedures or confound analyses

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Spectrum Health Services	Philadelphia	Pennsylvania	United States	19139
2	Greater Philadelphia Health Action	Philadelphia	Pennsylvania	United States	19146

Sponsors and Collaborators

• Columbia University
• University of Pennsylvania

Investigators

• Principal Investigator: Maureen George, PhD, Columbia University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 21, 2016

More Information

Publications

• 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.

• Responsible Party: Maureen George, Associate Professor of Nursing, Columbia University
• ClinicalTrials.gov Identifier: NCT03036267
• Other Study ID Numbers: AAAR0605
• First Posted: Jan 30, 2017
• Last Update Posted: Dec 6, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Maureen George, Associate Professor of Nursing, Columbia University: health disparity; motivational interviewing; African American adults; Federally Qualified Health Centers; adherence; health beliefs; self-management; asthma control
• Additional relevant MeSH terms: Asthma

Study Results

Participant Flow

Arm/Group Title	Focus Groups
Arm/Group Description	Six focus group were held with adults with asthma and their (adult) loved ones
Period Title: Overall Study
STARTED	46
COMPLETED	46
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Focus Groups
Arm/Group Description	Six focus group were held with adults with asthma and their (adult) loved ones
Overall Participants	46
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.7 (11.26)
Sex: Female, Male (Count of Participants)
Female	31 67.4%
Male	15 32.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2.2%
Not Hispanic or Latino	45 97.8%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	44 95.7%
White	0 0%
More than one race	1 2.2%
Unknown or Not Reported	1 2.2%
Region of Enrollment (Count of Participants)
United States	46 100%

Outcome Measures

1. Primary Outcome

Title	Asthma Control Questionnaire
Description	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
Time Frame	Baseline - for descriptive purposes only

Outcome Measure Data

Analysis Population Description

only those with asthma completed the survey

Arm/Group Title	Focus Groups
Arm/Group Description	Six focus group were held with adults with asthma and their (adult) loved ones
Measure Participants	32
Mean (Standard Deviation) [score on a scale]	2.34 (1.06)

Adverse Events

Time Frame	All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
Adverse Event Reporting Description	All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
Arm/Group Title	Focus Groups
Arm/Group Description	Six focus group were held with adults with asthma and their (adult) loved ones
All Cause Mortality
	Focus Groups
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Focus Groups
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Focus Groups
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.