An interventional study of BREATHE Intervention and Control Intervention in Asthma, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-28.
Sponsored by Columbia University · Not applicable, Interventional, and Supportive care
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).
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.
PROVIDER RECRUITMENT
Inclusion Criteria:
Exclusion Criteria:
PATIENT RECRUITMENT
Inclusion Criteria:
Patients must be
Exclusion Criteria:
The patient's primary care provider (PCP) will deliver the active intervention (shared decision-making discussion of asthma control status and treatment) - BREATHE Intervention.
Behavioral: BREATHE Intervention
The patient's primary care provider (PCP) will deliver the control intervention (discussion of healthy lifestyles).
Behavioral: Control Intervention
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.
PCP will provide discussion of healthy lifestyles.
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
Time frame: Baseline, 1 Month, 2 Months, 3 Months (post-intervention)
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)
Time frame: Baseline, 1 Month, 2 Months, 3 Months (post-intervention)
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)
Time frame: Baseline, 1 Month, 2 Months, 3 Months (post-intervention)
| Milestone | BREATHE Intervention | Control Intervention |
|---|---|---|
| Started | 40 | 40 |
| Completed | 38 | 38 |
| Not completed | 2 | 2 |
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 | BREATHE Intervention | Control Intervention |
|---|---|---|
| Baseline | 2.94 ± 0.15 | 2.63 ± 0.15 |
| 1-month post | 2.17 ± 0.17 | 2.16 ± 0.16 |
| 2-month post | 2.22 ± 0.16 | 2.35 ± 0.16 |
| 3-month post | 2.40 ± 0.15 | 2.24 ± 0.15 |
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)
| score on a scale | BREATHE Intervention | Control Intervention |
|---|---|---|
| Baseline | 3.50 ± 0.18 | 3.65 ± 0.18 |
| 1-month post | 4.03 ± 0.20 | 4.07 ± 0.19 |
| 2-month post | 3.97 ± 0.19 | 4.18 ± 0.19 |
| 3-month post | 4.02 ± 0.18 | 4.22 ± 0.18 |
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)
| score on a scale | BREATHE Intervention | Control Intervention |
|---|---|---|
| Baseline | 3.95 ± 0.12 | 3.88 ± 0.12 |
| 1-month post | 4.07 ± 0.13 | 4.12 ± 0.12 |
| 2- month post | 4.28 ± 0.12 | 4.18 ± 0.12 |
| 3-month post | 4.08 ± 0.12 | 4.03 ± 0.12 |
Collected over Up to 3 months post-intervention. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BREATHE Intervention | 1/40 (2.5%) | 1/40 (2.5%) | 5/40 (12.5%) |
| Control Intervention | 1/40 (2.5%) | 0/40 (0%) | 2/40 (5%) |
| Event | BREATHE Intervention | Control Intervention |
|---|---|---|
| presumed myocardial infarctionCardiac disorders | 1/40 | 0/40 |
| Event | BREATHE Intervention | Control Intervention |
|---|---|---|
| emergency department visitRespiratory, thoracic and mediastinal disorders | 5/40 | 2/40 |
| Age, Continuous(years) | BREATHE Intervention | Control Intervention | Total |
|---|---|---|---|
| Mean | 47.35 ± 12.80 | 42.9 ± 13.06 | 45.1 ± 13.1 |
| Sex: Female, Male(Participants) | BREATHE Intervention | Control Intervention | Total |
|---|---|---|---|
| Female | 30 | 36 | 66 |
| Male | 10 | 4 | 14 |
| Race (NIH/OMB)(Participants) | BREATHE Intervention | Control Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 38 | 35 | 73 |
| White | 0 | 0 | 0 |
| More than one race | 2 | 5 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | BREATHE Intervention | Control Intervention | Total |
|---|---|---|---|
| United States | 40 | 40 | 80 |
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Columbia University