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Feasibility of the BREATHE Asthma Intervention Trial

Self-care Decision-making: Feasibility of the BREATHE Asthma Intervention Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03036267
Enrollment
46
Registered
2017-01-30
Start date
2017-04-04
Completion date
2017-09-22
Last updated
2021-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma Chronic, Health Behavior

Keywords

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

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.

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).

Interventions

BEHAVIORALBREATHE

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.

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.

Sponsors

University of Pennsylvania
CollaboratorOTHER
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Asthma Control QuestionnaireBaseline - for descriptive purposes onlyFull 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

Countries

United States

Participant flow

Participants by arm

ArmCount
Focus Groups
Six focus group were held with adults with asthma and their (adult) loved ones
46
Total46

Baseline characteristics

CharacteristicFocus Groups
Age, Continuous47.7 years
STANDARD_DEVIATION 11.26
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
45 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
44 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
0 Participants
Region of Enrollment
United States
46 Participants
Sex: Female, Male
Female
31 Participants
Sex: Female, Male
Male
15 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

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

Time frame: Baseline - for descriptive purposes only

Population: only those with asthma completed the survey

ArmMeasureValue (MEAN)Dispersion
Focus GroupsAsthma Control Questionnaire2.34 score on a scaleStandard Deviation 1.06

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026