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Feasibility of the BREATHE Asthma Intervention Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03036267
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : October 3, 2017
University of Pennsylvania
Information provided by (Responsible Party):
Maureen George, Columbia University

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 Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
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 : April 4, 2017
Actual Primary Completion Date : September 22, 2017
Actual Study Completion Date : September 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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 Name: 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.

Primary Outcome Measures :
  1. Asthma Control Questionnaire Score [ Time Frame: Up to 3 months post-intervention ]
    Asthma Control Questionnaire (ACQ) score: The ACQ includes 6 items about asthma symptoms and one objective measure of pulmonary function: the forced expiratory volume 1 (FEV1). Self-report items and FEV1 are used to calculate a summary ACQ score. ACQ scores >1.5 have a positive predictive value of 88% in identifying uncontrolled asthma in clinical trials.

Secondary Outcome Measures :
  1. Score on the Medication Adherence Record Scale-Asthma (MARS-A) [ Time Frame: Up to 3 months post-intervention ]
    The Medication Adherence Record Scale-Asthma (MARS-A) will be used to measure Inhaled corticosteroids (ICS) adherence. The MARS-A correlates with objective ICS adherence as measured by electronic monitoring and ICS fill/refill claims data.

  2. Score on the Asthma Quality of Life Questionnaire [ Time Frame: Baseline, 1-, 2- and 3-months post-intervention ]
    Asthma Quality of Life will be measured by the Asthma Quality of Life Questionnaire.

  3. Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Up to 3 months post-intervention ]
    The FEV1 is a physiologic measurement of airflow obstruction.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03036267

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United States, Pennsylvania
Spectrum Health Services
Philadelphia, Pennsylvania, United States, 19139
Greater Philadelphia Health Action
Philadelphia, Pennsylvania, United States, 19146
Sponsors and Collaborators
Columbia University
University of Pennsylvania
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Principal Investigator: Maureen George, PhD Columbia University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Maureen George, Associate Professor of Nursing, Columbia University Identifier: NCT03036267    
Other Study ID Numbers: AAAR0605
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maureen George, Columbia University:
health disparity
motivational interviewing
African American adults
Federally Qualified Health Centers
health beliefs
asthma control
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases