NCT02228499

Brief Summary

Background: Asthma is the most common chronic disease of childhood with a prevalence that is 1.6 times greater in African American children than in Non-Hispanic White children.1 Nationally, 700,000 children are seen for asthma in Emergency Departments every year, 1% of which are seen at Children's National Health System in Washington, District of Columbia. School performance and school attendance has not been well studied in urban children with asthma, especially at the middle school level. Objective: Our purpose is to test the hypothesis that middle school children with asthma have worse school performance than middle school children without asthma in Washington DC and Prince George's county schools. Methods: The investigators will conduct a cross-sectional observational study of middle-school (grades 6-8 in the 2013-2014 school year) aged children with and without asthma recruited from the Emergency Departments and the IMPACT DC asthma clinic at CN. The investigators will collect demographic information, asthma severity information (for cases), and request that parents mail report cards and standardized test scores directly to the investigators. The investigators will use multivariable linear and logistic regression to determine if the presence of asthma is associated with school performance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2014

Completed
2.3 years until next milestone

Study Start

First participant enrolled

December 15, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
2 years until next milestone

Results Posted

Study results publicly available

May 7, 2019

Completed
Last Updated

May 7, 2019

Status Verified

February 1, 2019

Enrollment Period

4 months

First QC Date

August 26, 2014

Results QC Date

April 3, 2018

Last Update Submit

February 2, 2019

Conditions

Keywords

asthmaacademicsGPAattendance

Outcome Measures

Primary Outcomes (1)

  • GPA

    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.

    single time point

Study Arms (2)

Asthma

children with asthma who were in middle school for the 2013-2014 school year will take surveys on health and quality of life

Other: Survey

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

Other: Survey

Interventions

SurveyOTHER

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.

AsthmaControls

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

We are proposing a cross-sectional case-control observational study of middle school (grades 6-8) children to compare academic achievement and school attendance between children with and without asthma. 200 children with asthma (cases) will be recruited from the IMPACT DC clinic and/or ED and 200 children without asthma (controls) will be recruited from the ED.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's National Health Systems

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Limitations and Caveats

Data for this study was analyzed used a mixed methods approach. The quality of life scores were examined quantitatively and the report card data was analyzed qualitatively. Not all families mailed report cards to the IMPACT DC clinic.

Results Point of Contact

Title
Dr. Seema Agrawal
Organization
The George Washington University

Study Officials

  • Shilpa Patel, MD

    Children's National Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
5 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 26, 2014

First Posted

August 29, 2014

Study Start

December 15, 2016

Primary Completion

March 31, 2017

Study Completion

May 1, 2017

Last Updated

May 7, 2019

Results First Posted

May 7, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations