Trial Outcomes & Findings for BREATHE-Peds Pilot- II III Trial and Post Trial (NCT NCT05832437)
NCT ID: NCT05832437
Last Updated: 2025-11-17
Results Overview
Asthma control as measured by improvements in Asthma Control Questionnaire (ACQ) score, a 6-item validated and widely used measure of asthma control. Each question is rated from 0 to 6. A score of 0 indicates well controlled asthma and a score of 6 indicates extremely poorly controlled asthma. The overall ACQ score is the mean score of all 6 items with scores ranging from 0 to 6. Lower mean scores indicate greater asthma control (better outcome), higher mean scores indicate lesser asthma control.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
Up to 3 months post intervention
Results posted on
2025-11-17
Participant Flow
30 dyads (30 pediatric patients + 30 caregivers) were randomized to the intervention and 30 dyads (30 pediatric patients + 30 caregivers) were randomized to the control group.
Participant milestones
| Measure |
BREATHE-Peds Intervention (PCPs)
Providers which delivered the intervention were considered participants.
|
BREATHE-Peds Intervention (Dyads)
The patient's primary care provider (PCP) will deliver a brief intervention using motivational interviewing and shared decision making, in a one time 9-minute intervention integrated into an office visit for asthma. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit.
BREATHE-Peds Intervention: BREATHE-Peds utilizes Primary Care Providers (PCPs) to deliver a 4-step script that was created by and tailored to Black adults' asthma and inhaled corticosteroid beliefs, as well as their Asthma Control Questionnaire (ACQ) score, measured just prior to the medical visit. Step 1: Raise the subject (1½ minute). Step 2: Provide feedback (1½ minutes). Step 3: Enhance engagement (3 minutes). Step 4: Shared decision-making (3 minutes).
|
Control Intervention (PCPs)
Providers which delivered the control intervention were considered participants.
|
Control Intervention (Dyads)
The patient's primary care provider (PCP) will deliver a 9-minute scripted intervention on credible nutrition and lifestyle information. The control intervention is designed to not be specific enough to change strategies related to asthma control.
Control Intervention: The control intervention will be a 9-minute scripted discussion tailored to living a health lifestyle. Step 1: Review of BMI, current diet and exercise (3 minutes). Step 2: Diet/exercise counseling (3 minutes). Step 3: Plan for goal attainment (3 minutes).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
30
|
4
|
30
|
|
Overall Study
COMPLETED
|
2
|
30
|
4
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
BREATHE-Peds Intervention (PCPs)
Providers which delivered the intervention were considered participants.
|
BREATHE-Peds Intervention (Dyads)
The patient's primary care provider (PCP) will deliver a brief intervention using motivational interviewing and shared decision making, in a one time 9-minute intervention integrated into an office visit for asthma. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit.
BREATHE-Peds Intervention: BREATHE-Peds utilizes Primary Care Providers (PCPs) to deliver a 4-step script that was created by and tailored to Black adults' asthma and inhaled corticosteroid beliefs, as well as their Asthma Control Questionnaire (ACQ) score, measured just prior to the medical visit. Step 1: Raise the subject (1½ minute). Step 2: Provide feedback (1½ minutes). Step 3: Enhance engagement (3 minutes). Step 4: Shared decision-making (3 minutes).
|
Control Intervention (PCPs)
Providers which delivered the control intervention were considered participants.
|
Control Intervention (Dyads)
The patient's primary care provider (PCP) will deliver a 9-minute scripted intervention on credible nutrition and lifestyle information. The control intervention is designed to not be specific enough to change strategies related to asthma control.
Control Intervention: The control intervention will be a 9-minute scripted discussion tailored to living a health lifestyle. Step 1: Review of BMI, current diet and exercise (3 minutes). Step 2: Diet/exercise counseling (3 minutes). Step 3: Plan for goal attainment (3 minutes).
|
|---|---|---|---|---|
|
Overall Study
time off work
|
1
|
0
|
0
|
0
|
Baseline Characteristics
One participant in control group did not report sex.
Baseline characteristics by cohort
| Measure |
BREATHE-Peds Intervention (PCPs)
n=3 Participants
Providers which delivered the intervention were considered participants.
|
BREATHE-Peds Intervention (Child in Dyads)
n=30 Participants
The patient's primary care provider (PCP) will deliver a brief intervention using motivational interviewing and shared decision making, in a one time 9-minute intervention integrated into an office visit for asthma. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit.
BREATHE-Peds Intervention: BREATHE-Peds utilizes Primary Care Providers (PCPs) to deliver a 4-step script that was created by and tailored to Black adults' asthma and inhaled corticosteroid beliefs, as well as their Asthma Control Questionnaire (ACQ) score, measured just prior to the medical visit. Step 1: Raise the subject (1½ minute). Step 2: Provide feedback (1½ minutes). Step 3: Enhance engagement (3 minutes). Step 4: Shared decision-making (3 minutes).
|
BREATHE-Peds Intervention (Caregiver in Dyads)
n=30 Participants
The patient's primary care provider (PCP) will deliver a brief intervention using motivational interviewing and shared decision making, in a one time 9-minute intervention integrated into an office visit for asthma. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit.
BREATHE-Peds Intervention: BREATHE-Peds utilizes Primary Care Providers (PCPs) to deliver a 4-step script that was created by and tailored to Black adults' asthma and inhaled corticosteroid beliefs, as well as their Asthma Control Questionnaire (ACQ) score, measured just prior to the medical visit. Step 1: Raise the subject (1½ minute). Step 2: Provide feedback (1½ minutes). Step 3: Enhance engagement (3 minutes). Step 4: Shared decision-making (3 minutes).
|
Control Intervention (PCPs)
n=4 Participants
Providers which delivered the control intervention were considered participants.
|
Control Intervention (Child in Dyads)
n=30 Participants
The patient's primary care provider (PCP) will deliver a 9-minute scripted intervention on credible nutrition and lifestyle information. The control intervention is designed to not be specific enough to change strategies related to asthma control.
Control Intervention: The control intervention will be a 9-minute scripted discussion tailored to living a health lifestyle. Step 1: Review of BMI, current diet and exercise (3 minutes). Step 2: Diet/exercise counseling (3 minutes). Step 3: Plan for goal attainment (3 minutes).
|
Control Intervention (Caregivers in Dyad)
n=30 Participants
The patient's primary care provider (PCP) will deliver a 9-minute scripted intervention on credible nutrition and lifestyle information. The control intervention is designed to not be specific enough to change strategies related to asthma control.
Control Intervention: The control intervention will be a 9-minute scripted discussion tailored to living a health lifestyle. Step 1: Review of BMI, current diet and exercise (3 minutes). Step 2: Diet/exercise counseling (3 minutes). Step 3: Plan for goal attainment (3 minutes).
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
30 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=4 Participants
|
30 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
60 Participants
n=127 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=3 Participants
|
0 Participants
n=30 Participants
|
29 Participants
n=30 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
65 Participants
n=127 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=3 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=127 Participants
|
|
Age, Continuous
|
53.33 years
STANDARD_DEVIATION 13.50 • n=3 Participants
|
11.3 years
STANDARD_DEVIATION 0.99 • n=30 Participants
|
39.43 years
STANDARD_DEVIATION 8.92 • n=30 Participants
|
43.75 years
STANDARD_DEVIATION 13.64 • n=4 Participants
|
11.1 years
STANDARD_DEVIATION 0.92 • n=30 Participants
|
36.86 years
STANDARD_DEVIATION 6.45 • n=30 Participants
|
15.03 years
STANDARD_DEVIATION 12.03 • n=127 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants • One participant in control group did not report sex.
|
16 Participants
n=30 Participants • One participant in control group did not report sex.
|
27 Participants
n=30 Participants • One participant in control group did not report sex.
|
4 Participants
n=4 Participants • One participant in control group did not report sex.
|
13 Participants
n=29 Participants • One participant in control group did not report sex.
|
29 Participants
n=30 Participants • One participant in control group did not report sex.
|
91 Participants
n=126 Participants • One participant in control group did not report sex.
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants • One participant in control group did not report sex.
|
14 Participants
n=30 Participants • One participant in control group did not report sex.
|
3 Participants
n=30 Participants • One participant in control group did not report sex.
|
0 Participants
n=4 Participants • One participant in control group did not report sex.
|
16 Participants
n=29 Participants • One participant in control group did not report sex.
|
1 Participants
n=30 Participants • One participant in control group did not report sex.
|
35 Participants
n=126 Participants • One participant in control group did not report sex.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=3 Participants
|
23 Participants
n=30 Participants
|
23 Participants
n=30 Participants
|
1 Participants
n=4 Participants
|
27 Participants
n=30 Participants
|
27 Participants
n=30 Participants
|
102 Participants
n=127 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=3 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=30 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
23 Participants
n=127 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=127 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=3 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=3 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=3 Participants
|
8 Participants
n=30 Participants
|
7 Participants
n=30 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=30 Participants
|
6 Participants
n=30 Participants
|
28 Participants
n=127 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=3 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=127 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
21 Participants
n=30 Participants
|
22 Participants
n=30 Participants
|
0 Participants
n=4 Participants
|
26 Participants
n=30 Participants
|
24 Participants
n=30 Participants
|
93 Participants
n=127 Participants
|
PRIMARY outcome
Timeframe: Up to 3 months post interventionPopulation: Pediatric patient participants only
Asthma control as measured by improvements in Asthma Control Questionnaire (ACQ) score, a 6-item validated and widely used measure of asthma control. Each question is rated from 0 to 6. A score of 0 indicates well controlled asthma and a score of 6 indicates extremely poorly controlled asthma. The overall ACQ score is the mean score of all 6 items with scores ranging from 0 to 6. Lower mean scores indicate greater asthma control (better outcome), higher mean scores indicate lesser asthma control.
Outcome measures
| Measure |
BREATHE-Peds Intervention
n=30 Participants
The patient's primary care provider (PCP) will deliver a brief intervention using motivational interviewing and shared decision making, in a one time 9-minute intervention integrated into an office visit for asthma. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit.
BREATHE-Peds Intervention: BREATHE-Peds utilizes Primary Care Providers (PCPs) to deliver a 4-step script that was created by and tailored to Black adults' asthma and inhaled corticosteroid beliefs, as well as their Asthma Control Questionnaire (ACQ) score, measured just prior to the medical visit. Step 1: Raise the subject (1½ minute). Step 2: Provide feedback (1½ minutes). Step 3: Enhance engagement (3 minutes). Step 4: Shared decision-making (3 minutes).
|
Control Intervention
n=30 Participants
The patient's primary care provider (PCP) will deliver a 9-minute scripted intervention on credible nutrition and lifestyle information. The control intervention is designed to not be specific enough to change strategies related to asthma control.
Control Intervention: The control intervention will be a 9-minute scripted discussion tailored to living a health lifestyle. Step 1: Review of BMI, current diet and exercise (3 minutes). Step 2: Diet/exercise counseling (3 minutes). Step 3: Plan for goal attainment (3 minutes).
|
|---|---|---|
|
Mean Asthma Control Questionnaire Score
Baseline
|
2.7 score on a scale
Standard Deviation 0.57
|
2.63 score on a scale
Standard Deviation 0.62
|
|
Mean Asthma Control Questionnaire Score
Month 2
|
0.80 score on a scale
Standard Deviation 0.85
|
0.58 score on a scale
Standard Deviation 0.64
|
|
Mean Asthma Control Questionnaire Score
Month 3
|
0.95 score on a scale
Standard Deviation 1.05
|
0.68 score on a scale
Standard Deviation 0.76
|
|
Mean Asthma Control Questionnaire Score
Month 1
|
0.98 score on a scale
Standard Deviation 0.98
|
0.82 score on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Baseline (immediately post-intervention)Population: Pediatric patient participants only
The Shared Decision Making (SDM) Questionnaire-9, is a patient reported, 9-item validated instrument that consists of nine statements that measure the decisional process in medical visits from both patients' and physicians' perspectives. Each statement is rated on a six-point scale from "completely disagree" (0) to "completely agree" (5). The raw total score of all items range from 0-45. Lower scores indicate lower levels of shared decision making between provider and patient (in this study as it pertains to asthma treatment) and higher scores indicate higher levels of shared decision making (better outcome).
Outcome measures
| Measure |
BREATHE-Peds Intervention
n=30 Participants
The patient's primary care provider (PCP) will deliver a brief intervention using motivational interviewing and shared decision making, in a one time 9-minute intervention integrated into an office visit for asthma. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit.
BREATHE-Peds Intervention: BREATHE-Peds utilizes Primary Care Providers (PCPs) to deliver a 4-step script that was created by and tailored to Black adults' asthma and inhaled corticosteroid beliefs, as well as their Asthma Control Questionnaire (ACQ) score, measured just prior to the medical visit. Step 1: Raise the subject (1½ minute). Step 2: Provide feedback (1½ minutes). Step 3: Enhance engagement (3 minutes). Step 4: Shared decision-making (3 minutes).
|
Control Intervention
n=29 Participants
The patient's primary care provider (PCP) will deliver a 9-minute scripted intervention on credible nutrition and lifestyle information. The control intervention is designed to not be specific enough to change strategies related to asthma control.
Control Intervention: The control intervention will be a 9-minute scripted discussion tailored to living a health lifestyle. Step 1: Review of BMI, current diet and exercise (3 minutes). Step 2: Diet/exercise counseling (3 minutes). Step 3: Plan for goal attainment (3 minutes).
|
|---|---|---|
|
Mean Shared Decision Making-Questionnaire-9 Score
|
42.9 score on a scale
Standard Deviation 8.10
|
39.55 score on a scale
Standard Deviation 8.89
|
SECONDARY outcome
Timeframe: Up to 3 months post interventionPopulation: Pediatric patient participants who were prescribed ICS at baseline
Inhaled corticosteroid adherence as measured by the Medication Adherence Report Scale - Asthma (MARS-A). Participants are asked to rate the frequency with which they engage in each of the adherence-related behaviors on a five-point scale, where 5 = never, 4 = rarely, 3 = sometimes, 2 = often and 1 = always. Scores for each item are summed to give a total score ranging from 1 to 5, with higher scores indicating higher levels of reported adherence.
Outcome measures
| Measure |
BREATHE-Peds Intervention
n=23 Participants
The patient's primary care provider (PCP) will deliver a brief intervention using motivational interviewing and shared decision making, in a one time 9-minute intervention integrated into an office visit for asthma. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit.
BREATHE-Peds Intervention: BREATHE-Peds utilizes Primary Care Providers (PCPs) to deliver a 4-step script that was created by and tailored to Black adults' asthma and inhaled corticosteroid beliefs, as well as their Asthma Control Questionnaire (ACQ) score, measured just prior to the medical visit. Step 1: Raise the subject (1½ minute). Step 2: Provide feedback (1½ minutes). Step 3: Enhance engagement (3 minutes). Step 4: Shared decision-making (3 minutes).
|
Control Intervention
n=20 Participants
The patient's primary care provider (PCP) will deliver a 9-minute scripted intervention on credible nutrition and lifestyle information. The control intervention is designed to not be specific enough to change strategies related to asthma control.
Control Intervention: The control intervention will be a 9-minute scripted discussion tailored to living a health lifestyle. Step 1: Review of BMI, current diet and exercise (3 minutes). Step 2: Diet/exercise counseling (3 minutes). Step 3: Plan for goal attainment (3 minutes).
|
|---|---|---|
|
Mean Medication Adherence Report Scale - Asthma Score
Baseline
|
4.13 score on a scale
Standard Deviation 0.81
|
3.87 score on a scale
Standard Deviation 0.80
|
|
Mean Medication Adherence Report Scale - Asthma Score
Month 1
|
4.13 score on a scale
Standard Deviation 0.88
|
4.05 score on a scale
Standard Deviation 0.77
|
|
Mean Medication Adherence Report Scale - Asthma Score
Month 2
|
4.34 score on a scale
Standard Deviation 0.68
|
4.26 score on a scale
Standard Deviation 0.87
|
|
Mean Medication Adherence Report Scale - Asthma Score
Month 3
|
4.45 score on a scale
Standard Deviation 0.683
|
4.48 score on a scale
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: Up to 3 months post interventionPopulation: Pediatric patient participants only
Asthma quality of life improvements as measured by the Asthma Quality of Life Questionnaire (AQLQ), a 32-item validated and widely-used measure consisting of 4 domains: symptoms (11 items), emotions (5 items), environment (4 items), and activities (12 items). Each item is measured on a 7-point Likert scale (7 = not impaired at all, 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains. The overall score ranges from 1 to 7, where lower mean scores indicate lower quality of life due to asthma (worse outcome).
Outcome measures
| Measure |
BREATHE-Peds Intervention
n=30 Participants
The patient's primary care provider (PCP) will deliver a brief intervention using motivational interviewing and shared decision making, in a one time 9-minute intervention integrated into an office visit for asthma. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit.
BREATHE-Peds Intervention: BREATHE-Peds utilizes Primary Care Providers (PCPs) to deliver a 4-step script that was created by and tailored to Black adults' asthma and inhaled corticosteroid beliefs, as well as their Asthma Control Questionnaire (ACQ) score, measured just prior to the medical visit. Step 1: Raise the subject (1½ minute). Step 2: Provide feedback (1½ minutes). Step 3: Enhance engagement (3 minutes). Step 4: Shared decision-making (3 minutes).
|
Control Intervention
n=30 Participants
The patient's primary care provider (PCP) will deliver a 9-minute scripted intervention on credible nutrition and lifestyle information. The control intervention is designed to not be specific enough to change strategies related to asthma control.
Control Intervention: The control intervention will be a 9-minute scripted discussion tailored to living a health lifestyle. Step 1: Review of BMI, current diet and exercise (3 minutes). Step 2: Diet/exercise counseling (3 minutes). Step 3: Plan for goal attainment (3 minutes).
|
|---|---|---|
|
Mean Asthma Quality of Life Questionnaire Score
Baseline
|
5.37 score on a scale
Standard Deviation 1.32
|
5.72 score on a scale
Standard Deviation 1.05
|
|
Mean Asthma Quality of Life Questionnaire Score
Month 1
|
5.78 score on a scale
Standard Deviation 1.24
|
6.44 score on a scale
Standard Deviation 0.80
|
|
Mean Asthma Quality of Life Questionnaire Score
Month 3
|
5.89 score on a scale
Standard Deviation 1.19
|
6.17 score on a scale
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: Up to 3 months post interventionPopulation: Pediatric patient participants 12 years of age and older
Asthma Impairment and Risk Questionnaire (AIRQ) is a 10-item valid and reliable survey that measures bot domains of control: symptom impairments and risk for uncontrolled asthma. AIRQ™ score ranges from 0-10, measured by total number of YES answers. Score tally of 0-1 indicates well controlled asthma, scores 2-4 indicate not well controlled asthma, and scores 5-10 indicate very poorly controlled asthma.
Outcome measures
| Measure |
BREATHE-Peds Intervention
n=14 Participants
The patient's primary care provider (PCP) will deliver a brief intervention using motivational interviewing and shared decision making, in a one time 9-minute intervention integrated into an office visit for asthma. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit.
BREATHE-Peds Intervention: BREATHE-Peds utilizes Primary Care Providers (PCPs) to deliver a 4-step script that was created by and tailored to Black adults' asthma and inhaled corticosteroid beliefs, as well as their Asthma Control Questionnaire (ACQ) score, measured just prior to the medical visit. Step 1: Raise the subject (1½ minute). Step 2: Provide feedback (1½ minutes). Step 3: Enhance engagement (3 minutes). Step 4: Shared decision-making (3 minutes).
|
Control Intervention
n=11 Participants
The patient's primary care provider (PCP) will deliver a 9-minute scripted intervention on credible nutrition and lifestyle information. The control intervention is designed to not be specific enough to change strategies related to asthma control.
Control Intervention: The control intervention will be a 9-minute scripted discussion tailored to living a health lifestyle. Step 1: Review of BMI, current diet and exercise (3 minutes). Step 2: Diet/exercise counseling (3 minutes). Step 3: Plan for goal attainment (3 minutes).
|
|---|---|---|
|
Mean Asthma Impairment and Risk Questionnaire Score
Month 2
|
1.08 score on a scale
Standard Deviation 1.31
|
1.45 score on a scale
Standard Deviation 2.21
|
|
Mean Asthma Impairment and Risk Questionnaire Score
Month 3
|
1.75 score on a scale
Standard Deviation 1.71
|
1.82 score on a scale
Standard Deviation 1.94
|
|
Mean Asthma Impairment and Risk Questionnaire Score
Baseline
|
2.79 score on a scale
Standard Deviation 2.55
|
3.00 score on a scale
Standard Deviation 2.10
|
|
Mean Asthma Impairment and Risk Questionnaire Score
Month 1
|
1.46 score on a scale
Standard Deviation 1.98
|
1.64 score on a scale
Standard Deviation 2.46
|
Adverse Events
BREATHE-Peds Intervention (PCPs)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BREATHE-Peds Intervention (Dyads)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Intervention (Dyads)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Intervention (PCPs)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place