Trial Outcomes & Findings for Validation of the BREATHE Asthma Intervention Trial (NCT NCT03300752)
NCT ID: NCT03300752
Last Updated: 2021-09-28
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Baseline, 1 Month, 2 Months, 3 Months (post-intervention)
Results posted on
2021-09-28
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
38
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Validation of the BREATHE Asthma Intervention Trial
Baseline characteristics by cohort
| Measure |
BREATHE Intervention
n=40 Participants
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.
|
Control Intervention
n=40 Participants
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.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.35 years
STANDARD_DEVIATION 12.80 • n=5 Participants
|
42.9 years
STANDARD_DEVIATION 13.06 • n=7 Participants
|
45.1 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
38 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
BREATHE Intervention
n=40 Participants
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.
|
Control Intervention
n=40 Participants
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.
|
|---|---|---|
|
Asthma Control Questionnaire (ACQ) Score
Baseline
|
2.94 score on a scale
Standard Error 0.15
|
2.63 score on a scale
Standard Error 0.15
|
|
Asthma Control Questionnaire (ACQ) Score
1-month post
|
2.17 score on a scale
Standard Error 0.17
|
2.16 score on a scale
Standard Error 0.16
|
|
Asthma Control Questionnaire (ACQ) Score
2-month post
|
2.22 score on a scale
Standard Error 0.16
|
2.35 score on a scale
Standard Error 0.16
|
|
Asthma Control Questionnaire (ACQ) Score
3-month post
|
2.40 score on a scale
Standard Error 0.15
|
2.24 score on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
BREATHE Intervention
n=40 Participants
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.
|
Control Intervention
n=40 Participants
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.
|
|---|---|---|
|
Asthma Quality of Life Questionnaire (AQLQ) Score
2-month post
|
3.97 score on a scale
Standard Error 0.19
|
4.18 score on a scale
Standard Error 0.19
|
|
Asthma Quality of Life Questionnaire (AQLQ) Score
Baseline
|
3.50 score on a scale
Standard Error 0.18
|
3.65 score on a scale
Standard Error 0.18
|
|
Asthma Quality of Life Questionnaire (AQLQ) Score
1-month post
|
4.03 score on a scale
Standard Error 0.20
|
4.07 score on a scale
Standard Error 0.19
|
|
Asthma Quality of Life Questionnaire (AQLQ) Score
3-month post
|
4.02 score on a scale
Standard Error 0.18
|
4.22 score on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
BREATHE Intervention
n=40 Participants
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.
|
Control Intervention
n=40 Participants
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.
|
|---|---|---|
|
Medication Adherence Record Scale-Asthma (MARS-A) Score
2- month post
|
4.28 score on a scale
Standard Error 0.12
|
4.18 score on a scale
Standard Error 0.12
|
|
Medication Adherence Record Scale-Asthma (MARS-A) Score
3-month post
|
4.08 score on a scale
Standard Error 0.12
|
4.03 score on a scale
Standard Error 0.12
|
|
Medication Adherence Record Scale-Asthma (MARS-A) Score
Baseline
|
3.95 score on a scale
Standard Error 0.12
|
3.88 score on a scale
Standard Error 0.12
|
|
Medication Adherence Record Scale-Asthma (MARS-A) Score
1-month post
|
4.07 score on a scale
Standard Error 0.13
|
4.12 score on a scale
Standard Error 0.12
|
Adverse Events
BREATHE Intervention
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Control Intervention
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
BREATHE Intervention
n=40 participants at risk
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.
|
Control Intervention
n=40 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
presumed myocardial infarction
|
2.5%
1/40 • Number of events 1 • Up to 3 months post-intervention
|
0.00%
0/40 • Up to 3 months post-intervention
|
Other adverse events
| Measure |
BREATHE Intervention
n=40 participants at risk
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.
|
Control Intervention
n=40 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
emergency department visit
|
12.5%
5/40 • Up to 3 months post-intervention
|
5.0%
2/40 • Up to 3 months post-intervention
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place