Comparison of School-Based Supervised Versus Parental Supervised Asthma Therapy

• ClinicalTrials.gov Identifier: NCT00110383
• Recruitment Status: Completed
• First Posted: May 9, 2005
• Last Update Posted: March 4, 2014
• Sponsor: University of Alabama at Birmingham
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by: University of Alabama at Birmingham

Tracking Information

• First Submitted Date: May 6, 2005
• First Posted Date: May 9, 2005
• Last Update Posted Date: March 4, 2014
• Study Start Date: May 2004
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: December 11, 2007): Asthma exacerbations [ Time Frame: Measured at 15 months ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of School-Based Supervised Versus Parental Supervised Asthma Therapy
• Official Title: Effectiveness of School Based Supervised Asthma Therapy

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Asthma

Intervention

Behavioral: School-Based Supervised Asthma Therapy

Child's inhaled steroid use supervised daily at school

Study Arms

• Experimental: 1
  Supervised therapy
  Intervention: Behavioral: School-Based Supervised Asthma Therapy
• No Intervention: 2
  Inhaled steroid use as usual care

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 11, 2007): 295
• Original Enrollment: Not Provided
• Actual Study Completion Date: May 2007
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 12 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00110383
• Other Study ID Numbers: 174; R01HL075043 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Lynn B. Gerald, PhD, MSPH, University of Alabama at Birmingham
• Original Responsible Party: Not Provided
• Current Study Sponsor: University of Alabama at Birmingham
• Original Study Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Study Chair: Lynn B. Gerald, PhD, MSPH; University of Alabama Birmingham Lung Health Center

• PRS Account: University of Alabama at Birmingham
• Verification Date: December 2007