Clinical Trials Directory

Trials / Completed

CompletedNCT01625364

Comparison of Asthma Programs for Schools

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
432 (actual)
Sponsor
University of Texas at Austin · Academic / Other
Sex
All
Age
9 Years
Healthy volunteers
Accepted

Summary

The purpose was to evaluate effectiveness and impact of an academic and counseling asthma health education program (SHARP) for fourth- and fifth-grade students diagnosed with asthma. Students attending schools randomized to the low-dose control condition received Open Airways for Schools (OAS). The first aim was to evaluate the effectiveness of SHARP, compared to the low-dose group, for students on cognitive, psychosocial, and behavioral aspects of asthma management at 1, 12, and 24 months post-intervention. We hypothesized that compared to students enrolled in elementary schools who received the low-dose program, students in elementary schools that received SHARP would increase asthma knowledge (cognition) and logical reasoning abilities for managing acute episodes (cognition), acceptance of asthma as a chronic condition (psychosocial), and use of effective asthma health behaviors (behavior). The second aim was to evaluate the long-term impact of SHARP, compared to the low-dose group, for students on condition characteristics, use of healthcare services, and quality of life at 12 and 24 months post intervention. We hypothesized that compared to students enrolled in elementary schools who received the low-dose program; students in elementary schools who received SHARP would decrease asthma severity, use of healthcare services, and school absenteeism due to asthma, and increase participation in life activities (quality of life).

Detailed description

Over 7 million US children younger than age 18 years are currently diagnosed with asthma, and approximately 4 million children experience exacerbation of asthma symptoms annually. The NIH National Guidelines for the Diagnosis and Management of Asthma specify that part of a successful management program includes educating students with asthma and their caregivers about the condition. The guidelines recommend expanding education of students and families to schools and community settings. An academic and counseling program was developed for older school-age students with asthma and their family caregivers titled Staying Healthy-Asthma Responsible \& Prepared™ (SHARP). A two-group prospective randomized single-blinded design was used. The sample consisted of two cohorts of students diagnosed aged 9-12 years with asthma and their caregivers from varying socioeconomic, racial, and ethnic backgrounds. Cohort dyads were drawn from 23 elementary schools that were located in a diverse, moderately sized, medically underserved, inner-city community. The schools were matched based on projected enrollment numbers, standardized reading and math scores, free/reduced lunch eligibility, and racial/ethnic proportions prior to randomization. Recently retired certified elementary schoolteachers, identified by the district, were trained to serve as interveners to deliver both programs in the schools during instructional time.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSHARP programStaying Healthy-Asthma Responsible and Prepared is an academic and counseling asthma health education program for older school-age students with asthma and members of their social networks including their family caregivers.
BEHAVIORALOpen Airways for SchoolsOAS is a non-academic asthma health education program for elementary students with asthma and their parents.

Timeline

Start date
2009-09-01
Primary completion
2013-07-01
Completion
2014-09-01
First posted
2012-06-21
Last updated
2015-11-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01625364. Inclusion in this directory is not an endorsement.