Comparison of School-Based Supervised Versus Parental Supervised Asthma Therapy

NCT ID: NCT00110383

Last Updated: 2014-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 295 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2007-05-31

Brief Summary

1. Develop a simple school-based intervention using school-based supervised asthma therapy to increase adherence to asthma medication.

2. Implement a school-based internet monitoring system within both the school-based supervised asthma therapy and parent supervised asthma therapy groups to record asthma symptoms, peak flow meter readings, school absences, and usage of rescue medications at school.

3. Randomly assign 250 children from inner-city school systems to either school-based supervised asthma therapy or parental supervised asthma therapy.

4. Compare children assigned to school-based supervised asthma therapy with children assigned to parent supervised asthma therapy, in regards to time-averaged proportion having at least one exacerbation per month, rescue medication use, peak flow meter readings, asthma symptoms, school absences, and asthma self-management knowledge.

Detailed Description

BACKGROUND:

Pediatric asthma is a well-documented public health issue in the United States. The impact of pediatric asthma can be measured by both health care costs and morbidity. Whereas many factors contribute to the high health care costs of asthma, much of the morbidity can be directly attributed to lack of adherence to medical treatments. The consequence of non-adherence for most individuals with ashtma is exacerbations. Greater numbers of exacerbations lead to increased school absenteeism, greater activity limitations, decreased quality of life for both parent and child, increased urgent health care use and costs, and increased parental days missed at work. Therefore, adherence to treatment is essential for proper asthma management and ultimate reductions in morbidity.

Asthma morbidity, as measured by the number of exacerbations, is largely preventable with patient education and optimal treatment. However, it has been demonstrated that patient education alone is insufficient to decrease asthma morbidity. Optimal treatment is essential to control asthma morbidity. Inhaled corticosteroids offer considerable protection against asthma exacerbations. However, only a minority of asthma patients take their inhaled steroids as recommended by the National Asthma Education and Prevention Program (NAEPP) guidelines. Therefore, the Pediatric Asthma Guidelines recommend development and testing of programs (including school-based programs) to increase adherence with therapy.

Because morbidity is higher in inner-city, low-income, minority children, this study will collaborate with several inner-city, low-income, minority school districts to examine the effects of school-based supervised asthma therapy.

DESIGN NARRATIVE:

This study is a longitudinal two-group trial of the effectiveness of a school-based supervised asthma therapy program. Two hundred and fifty children will be randomly assigned to one of two groups: school-based supervised asthma therapy or parental supervised asthma therapy. The children will be followed for 16 months.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Supervised therapy

Group Type: EXPERIMENTAL

School-Based Supervised Asthma Therapy

Intervention Type: BEHAVIORAL

Child's inhaled steroid use supervised daily at school

2

Inhaled steroid use as usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

School-Based Supervised Asthma Therapy

Child's inhaled steroid use supervised daily at school

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Persistent asthma requiring daily controller medication
• Enrolled at a participating elementary school

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

University of Alabama at Birmingham

Principal Investigators

Lynn B. Gerald, PhD, MSPH

Role: STUDY_CHAIR

University of Alabama Birmingham Lung Health Center

Locations

University of Alabama Birmingham Lung Health Center

Birmingham, Alabama, United States

Countries

United States

References

Gerald LB, Gerald JK, Gibson L, Patel K, Zhang S, McClure LA. Changes in environmental tobacco smoke exposure and asthma morbidity among urban school children. Chest. 2009 Apr;135(4):911-916. doi: 10.1378/chest.08-1869. Epub 2008 Nov 18.

Reference Type: DERIVED

PMID: 19017893 (View on PubMed)

Other Identifiers

R01HL075043

Identifier Type: NIH

Identifier Source: secondary_id

View Link

174

Identifier Type: -

Identifier Source: org_study_id