An interventional study of BREATHE and Attention Control Condition in Asthma Chronic and Health Behavior, sponsored by Columbia University. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-06.
Sponsored by Columbia University · Not applicable, Interventional, and Other
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.
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).
3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's enrollment of 46 is below the median of 83 across 2,751 interventional studies indexed under Asthma.
Browse Asthma studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
The intervention trial will be informed by focus groups
Focus Group Inclusion Criteria:
Focus Group Exclusion Criteria:
Intervention Inclusion Criteria:
Patients must be:
Intervention Exclusion Criteria:
7-minute brief shared decision-making intervention using a 4-step motivational interviewing approach
Behavioral: BREATHE
7-minute diet and exercise discussion
Other: Attention Control Condition
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
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.
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
| Milestone | Focus Groups |
|---|---|
| Started | 46 |
| Completed | 46 |
| Not completed | 0 |
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
| score on a scale | Focus Groups |
|---|---|
| Asthma Control Questionnaire | 2.34 ± 1.06 |
Collected over All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Focus Groups | — | — | — |
| Age, Continuous(years) | Focus Groups |
|---|---|
| Mean | 47.7 ± 11.26 |
| Sex: Female, Male(Participants) | Focus Groups |
|---|---|
| Female | 31 |
| Male | 15 |
| Ethnicity (NIH/OMB)(Participants) | Focus Groups |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 45 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Focus Groups |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 44 |
| White | 0 |
| More than one race | 1 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | Focus Groups |
|---|---|
| United States | 46 |
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Plan to share: No
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Columbia University