Asthma
Conditions
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALBREATHE 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.
BEHAVIORALControl Intervention
PCP will provide discussion of healthy lifestyles.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
PROVIDER RECRUITMENT Inclusion Criteria: * PCPs (MDs and Nurse Practitioners (NPs)/Physician Assistants (PAs)) working in family, primary or internal medicine care services * Who have at least 40 adult patients with persistent asthma (defined as having been prescribed ICS) on their patient panel
Exclusion criteria
* PCPs whose primary focus is outside of adult health services (family, primary or internal medicine), such as behavioral health, pediatrics and Obstetrics and Gynaecology (OB-GYN) PATIENT RECRUITMENT Inclusion Criteria: Patients must be 1. adults (\> or = 18 years of age) who self-report race as Black or African American 2. with PCP-diagnosed persistent asthma 3. prescribed ICS 4. receiving asthma care at participating FQHCs 5. who have uncontrolled asthma 6. have erroneous personal health and/or negative ICS beliefs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Questionnaire (ACQ) Score | Baseline, 1 Month, 2 Months, 3 Months (post-intervention) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Quality of Life Questionnaire (AQLQ) Score | Baseline, 1 Month, 2 Months, 3 Months (post-intervention) | 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) |
| Medication Adherence Record Scale-Asthma (MARS-A) Score | Baseline, 1 Month, 2 Months, 3 Months (post-intervention) | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BREATHE Intervention The patient's primary care provider (PCP) will deliver the active intervention (shared decision-making discussion of asthma control status and treatment) - BREATHE Intervention.
BREATHE 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. | 40 |
| Control Intervention The patient's primary care provider (PCP) will deliver the control intervention (discussion of healthy lifestyles).
Control Intervention: PCP will provide discussion of healthy lifestyles. | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | BREATHE Intervention | Total | Control Intervention |
|---|---|---|---|
| Age, Continuous | 47.35 years STANDARD_DEVIATION 12.8 | 45.1 years STANDARD_DEVIATION 13.1 | 42.9 years STANDARD_DEVIATION 13.06 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 38 Participants | 73 Participants | 35 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 40 participants | 80 participants | 40 participants |
| Sex: Female, Male Female | 30 Participants | 66 Participants | 36 Participants |
| Sex: Female, Male Male | 10 Participants | 14 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 40 | 1 / 40 |
| other Total, other adverse events | 5 / 40 | 2 / 40 |
| serious Total, serious adverse events | 1 / 40 | 0 / 40 |
Outcome results
Primary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BREATHE Intervention | Asthma Control Questionnaire (ACQ) Score | Baseline | 2.94 score on a scale | Standard Error 0.15 |
| BREATHE Intervention | Asthma Control Questionnaire (ACQ) Score | 1-month post | 2.17 score on a scale | Standard Error 0.17 |
| BREATHE Intervention | Asthma Control Questionnaire (ACQ) Score | 2-month post | 2.22 score on a scale | Standard Error 0.16 |
| BREATHE Intervention | Asthma Control Questionnaire (ACQ) Score | 3-month post | 2.40 score on a scale | Standard Error 0.15 |
| Control Intervention | Asthma Control Questionnaire (ACQ) Score | 3-month post | 2.24 score on a scale | Standard Error 0.15 |
| Control Intervention | Asthma Control Questionnaire (ACQ) Score | Baseline | 2.63 score on a scale | Standard Error 0.15 |
| Control Intervention | Asthma Control Questionnaire (ACQ) Score | 2-month post | 2.35 score on a scale | Standard Error 0.16 |
| Control Intervention | Asthma Control Questionnaire (ACQ) Score | 1-month post | 2.16 score on a scale | Standard Error 0.16 |
Secondary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BREATHE Intervention | Asthma Quality of Life Questionnaire (AQLQ) Score | Baseline | 3.50 score on a scale | Standard Error 0.18 |
| BREATHE Intervention | Asthma Quality of Life Questionnaire (AQLQ) Score | 1-month post | 4.03 score on a scale | Standard Error 0.2 |
| BREATHE Intervention | Asthma Quality of Life Questionnaire (AQLQ) Score | 2-month post | 3.97 score on a scale | Standard Error 0.19 |
| BREATHE Intervention | Asthma Quality of Life Questionnaire (AQLQ) Score | 3-month post | 4.02 score on a scale | Standard Error 0.18 |
| Control Intervention | Asthma Quality of Life Questionnaire (AQLQ) Score | 3-month post | 4.22 score on a scale | Standard Error 0.18 |
| Control Intervention | Asthma Quality of Life Questionnaire (AQLQ) Score | Baseline | 3.65 score on a scale | Standard Error 0.18 |
| Control Intervention | Asthma Quality of Life Questionnaire (AQLQ) Score | 2-month post | 4.18 score on a scale | Standard Error 0.19 |
| Control Intervention | Asthma Quality of Life Questionnaire (AQLQ) Score | 1-month post | 4.07 score on a scale | Standard Error 0.19 |
Secondary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BREATHE Intervention | Medication Adherence Record Scale-Asthma (MARS-A) Score | Baseline | 3.95 score on a scale | Standard Error 0.12 |
| BREATHE Intervention | Medication Adherence Record Scale-Asthma (MARS-A) Score | 1-month post | 4.07 score on a scale | Standard Error 0.13 |
| BREATHE Intervention | Medication Adherence Record Scale-Asthma (MARS-A) Score | 2- month post | 4.28 score on a scale | Standard Error 0.12 |
| BREATHE Intervention | Medication Adherence Record Scale-Asthma (MARS-A) Score | 3-month post | 4.08 score on a scale | Standard Error 0.12 |
| Control Intervention | Medication Adherence Record Scale-Asthma (MARS-A) Score | 3-month post | 4.03 score on a scale | Standard Error 0.12 |
| Control Intervention | Medication Adherence Record Scale-Asthma (MARS-A) Score | Baseline | 3.88 score on a scale | Standard Error 0.12 |
| Control Intervention | Medication Adherence Record Scale-Asthma (MARS-A) Score | 2- month post | 4.18 score on a scale | Standard Error 0.12 |
| Control Intervention | Medication Adherence Record Scale-Asthma (MARS-A) Score | 1-month post | 4.12 score on a scale | Standard Error 0.12 |