Trial Outcomes & Findings for School-Based Preventive Asthma Care Technology: A Trial Using a Novel Technology to Improve Adherence (NCT NCT01175434)
NCT ID: NCT01175434
Last Updated: 2014-02-17
Results Overview
The primary outcome is asthma morbidity between groups. We will measure asthma morbidity by looking at the average number of symptom-free days, over 2 weeks, at each bi-monthly follow-up time point over the school year. Number of days without asthma symptoms will be reported by the child's caregiver.
COMPLETED
NA
99 participants
Average number of days, over 2 weeks, throughout the school year
2014-02-17
Participant Flow
Participant milestones
| Measure |
School-Based Medication Group
For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
|
Usual Care Group
Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
51
|
|
Overall Study
COMPLETED
|
48
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
School-Based Preventive Asthma Care Technology: A Trial Using a Novel Technology to Improve Adherence
Baseline characteristics by cohort
| Measure |
School-Based Medication Group
n=48 Participants
For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
|
Usual Care Group
n=51 Participants
Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
48 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
7.48 years
STANDARD_DEVIATION 1.7 • n=99 Participants
|
6.98 years
STANDARD_DEVIATION 1.8 • n=107 Participants
|
7.2 years
STANDARD_DEVIATION 1.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=99 Participants
|
51 participants
n=107 Participants
|
99 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Average number of days, over 2 weeks, throughout the school yearThe primary outcome is asthma morbidity between groups. We will measure asthma morbidity by looking at the average number of symptom-free days, over 2 weeks, at each bi-monthly follow-up time point over the school year. Number of days without asthma symptoms will be reported by the child's caregiver.
Outcome measures
| Measure |
School-Based Medication Group
n=48 Participants
For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
|
Usual Care Group
n=51 Participants
Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
|
|---|---|---|
|
Average Number of Symptom-free Days Over 14 Days; (Symptom-free Days Are Averaged Over 4 Bi-monthly Follow-ups)
|
11.33 Days
Standard Deviation 2.6
|
10.40 Days
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: one yearWe will evaluate the cost effectiveness to implement and sustain the web-based system in schools. We will review the cost of the intervention using three main categories of costs; programmatic costs (costs of initiating and running the program), productivity costs, and medical costs estimated at the individual child level.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: one yearWe will conduct interviews with parents and school nurses to evaluate whether this new program is feasible and acceptable among this population.
Outcome measures
Outcome data not reported
Adverse Events
School-Based Medication Group
Usual Care Group
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