Trial Outcomes & Findings for Asthma Express: Bridging the Emergency to Primary Care in Underserved Children (NCT NCT01981564)
NCT ID: NCT01981564
Last Updated: 2019-03-06
Results Overview
Symptom days for asthma during past 14 days
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
222 participants
Primary outcome timeframe
3 months
Results posted on
2019-03-06
Participant Flow
Participant milestones
| Measure |
Asthma Express Intervention
Clinic visit for asthma education + nurse home visits
Asthma Express Intervention: Asthma Express clinic visit for asthma education + nurse home visit
Asthma Express Control Arm: Asthma Express home nurse visits for asthma education
|
Standard ASthma Education Control Group
STandard asthma education delivered in home by nurse
Asthma Express Intervention: Asthma Express clinic visit for asthma education + nurse home visit
Asthma Express Control Arm: Asthma Express home nurse visits for asthma education
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
115
|
|
Overall Study
COMPLETED
|
98
|
106
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
3 caregivers did not report number of ED visits over past 3 months at the baseline survey.
Baseline characteristics by cohort
| Measure |
Asthma Express Intervention
n=107 Participants
Clinic visit for asthma education + nurse home visits
Asthma Express Intervention: Asthma Express clinic visit for asthma education + nurse home visit
Asthma Express Control Arm: Asthma Express home nurse visits for asthma education
|
Standard ASthma Education Control Group
n=115 Participants
STandard asthma education delivered in home by nurse
Asthma Express Intervention: Asthma Express clinic visit for asthma education + nurse home visit
Asthma Express Control Arm: Asthma Express home nurse visits for asthma education
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
107 Participants
n=107 Participants
|
115 Participants
n=115 Participants
|
222 Participants
n=222 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=107 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=222 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=107 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=222 Participants
|
|
Age, Continuous
|
6.2 years
STANDARD_DEVIATION 2.7 • n=107 Participants
|
6.5 years
STANDARD_DEVIATION 2.6 • n=115 Participants
|
6.3 years
STANDARD_DEVIATION 2.7 • n=222 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=107 Participants
|
35 Participants
n=115 Participants
|
80 Participants
n=222 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=107 Participants
|
80 Participants
n=115 Participants
|
142 Participants
n=222 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=107 Participants
|
3 Participants
n=115 Participants
|
7 Participants
n=222 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=107 Participants
|
112 Participants
n=115 Participants
|
215 Participants
n=222 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=107 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=222 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=107 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=222 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=107 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=222 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=107 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=222 Participants
|
|
Race (NIH/OMB)
Black or African American
|
101 Participants
n=107 Participants
|
107 Participants
n=115 Participants
|
208 Participants
n=222 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=107 Participants
|
3 Participants
n=115 Participants
|
7 Participants
n=222 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=107 Participants
|
5 Participants
n=115 Participants
|
7 Participants
n=222 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=107 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=222 Participants
|
|
Region of Enrollment
United States
|
107 participants
n=107 Participants
|
115 participants
n=115 Participants
|
222 participants
n=222 Participants
|
|
Symptoms days past 14 days
|
5.55 symptom days
STANDARD_DEVIATION 4.6 • n=107 Participants
|
6.17 symptom days
STANDARD_DEVIATION 4.9 • n=115 Participants
|
5.88 symptom days
STANDARD_DEVIATION 4.8 • n=222 Participants
|
|
Emergency Department visits over past 3 months
|
1.02 Number of ED visits over past 3 months
STANDARD_DEVIATION 1.1 • n=105 Participants • 3 caregivers did not report number of ED visits over past 3 months at the baseline survey.
|
1.48 Number of ED visits over past 3 months
STANDARD_DEVIATION 1.6 • n=114 Participants • 3 caregivers did not report number of ED visits over past 3 months at the baseline survey.
|
1.26 Number of ED visits over past 3 months
STANDARD_DEVIATION 1.4 • n=219 Participants • 3 caregivers did not report number of ED visits over past 3 months at the baseline survey.
|
PRIMARY outcome
Timeframe: 3 monthsSymptom days for asthma during past 14 days
Outcome measures
| Measure |
Asthma Express Intervention
n=98 Participants
Asthma Express clinic visit for asthma education + nurse home visit
|
Standard ASthma Education Control Group
n=106 Participants
Asthma Express home nurse visits for asthma education
|
|---|---|---|
|
Symptom Days
|
6.24 symptom days over past 14 days
Standard Deviation 5.7
|
4.82 symptom days over past 14 days
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: No data for one participant in the control group for this outcome
Number of emergency department visits for asthma in the past 3 months
Outcome measures
| Measure |
Asthma Express Intervention
n=98 Participants
Asthma Express clinic visit for asthma education + nurse home visit
|
Standard ASthma Education Control Group
n=105 Participants
Asthma Express home nurse visits for asthma education
|
|---|---|---|
|
Emergency Department (ED) Visits for Asthma
|
0.64 visits
Standard Deviation 2.26
|
0.62 visits
Standard Deviation 1.02
|
Adverse Events
Asthma Express Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard ASthma Education Control Group
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
Dr. Arlene Butz
Johns Hopkins University School of Medicine, Department of Pediatrics
Phone: 410-614-5963
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place