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Trial Outcomes & Findings for Academic Achievement in Children With Asthma (NCT NCT02228499)

NCT ID: NCT02228499

Last Updated: 2019-05-07

Results Overview

To determine the association between asthma and school performance by comparing grade point averages (GPA) in school aged children with and without asthma. We will enroll 200 children in grades 3-8 with asthma (cases) from the ED/IMPACT DC and compare them with a group of 200 children in grades 3-8 without asthma (controls) recruited from the ED. Report cards will be collected between June 2014 and November 1, 2014 or until 200 cases and 200 controls have been recruited, and GPAs will be compared. We expect children with asthma will have lower GPAs . GPAs are unweighted 0-4 scale.

Recruitment status

COMPLETED

Target enrollment

66 participants

Primary outcome timeframe

single time point

Results posted on

2019-05-07

Participant Flow

After participant enrollment the lead author of the study called to obtain report cards. Those participants for which a report card was unable to be obtained was not included in the GPA analysis.

Participant milestones

Participant milestones
Measure
Asthma
children with asthma who were in middle school for the 2013-2014 school year will take surveys on health and quality of life Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group.
Controls
Children with no history of asthma who were in middle school for the 2013-2014 school year will take surveys on health and quality of life Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group.
Overall Study
STARTED
30
36
Overall Study
COMPLETED
7
10
Overall Study
NOT COMPLETED
23
26

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Academic Achievement in Children With Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Asthma
n=30 Participants
children with asthma who were in middle school for the 2013-2014 school year will take surveys on health and quality of life Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group.
Controls
n=36 Participants
Children with no history of asthma who were in middle school for the 2013-2014 school year will take surveys on health and quality of life Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group.
Total
n=66 Participants
Total of all reporting groups
Age, Categorical
<=18 years
30 Participants
n=93 Participants
36 Participants
n=4 Participants
66 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Sex: Female, Male
Female
14 Participants
n=93 Participants
12 Participants
n=4 Participants
26 Participants
n=27 Participants
Sex: Female, Male
Male
16 Participants
n=93 Participants
24 Participants
n=4 Participants
40 Participants
n=27 Participants
Race/Ethnicity, Customized
Black/African American
23 Participants
n=93 Participants
26 Participants
n=4 Participants
49 Participants
n=27 Participants
Race/Ethnicity, Customized
White/Caucasian
0 Participants
n=93 Participants
2 Participants
n=4 Participants
2 Participants
n=27 Participants
Race/Ethnicity, Customized
Asian
0 Participants
n=93 Participants
1 Participants
n=4 Participants
1 Participants
n=27 Participants
Race/Ethnicity, Customized
Other
7 Participants
n=93 Participants
7 Participants
n=4 Participants
14 Participants
n=27 Participants

PRIMARY outcome

Timeframe: single time point

To determine the association between asthma and school performance by comparing grade point averages (GPA) in school aged children with and without asthma. We will enroll 200 children in grades 3-8 with asthma (cases) from the ED/IMPACT DC and compare them with a group of 200 children in grades 3-8 without asthma (controls) recruited from the ED. Report cards will be collected between June 2014 and November 1, 2014 or until 200 cases and 200 controls have been recruited, and GPAs will be compared. We expect children with asthma will have lower GPAs . GPAs are unweighted 0-4 scale.

Outcome measures

Outcome measures
Measure
Asthma
n=7 Participants
Children with asthma who were in school for the 2013-2014 school year will take surveys on health and quality of life Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group.
Controls
n=10 Participants
Children with no history of asthma who were in school for the 2013-2014 school year will take surveys on health and quality of life Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group.
GPA
Mathematics Grade
2.75 GPA(unweighted)
Standard Deviation 0.61
2.61 GPA(unweighted)
Standard Deviation 0.84
GPA
Reading Grade
3.25 GPA(unweighted)
Standard Deviation 0.76
2.50 GPA(unweighted)
Standard Deviation 0.65

Adverse Events

Asthma

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Controls

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. Seema Agrawal

The George Washington University

Phone: 202 699 1648

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place