Comparison of Asthma Programs for Schools

Asthma Clinical Trial

— CAPS  

Official title:

Comparison of Asthma Programs for Schools

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625364
• Other study ID #: 5R01NR010544-05
• Status: Completed
• Phase: N/A
• First received: June 19, 2012
• Last updated: November 6, 2015
• Start date: September 2009
• Est. completion date: September 2014

Study information

• Verified date: November 2015
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 432
• Est. completion date: September 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years and older

Eligibility

Inclusion Criteria:

• Student eligibility inclusion criteria included (a) a diagnosis of asthma, (b) availability to participate in scheduled classes or make-up sessions, and (c) verbal and written assent to participate in the study. Caregiver eligibility inclusion criteria included (a) being a caregiver of a student with asthma, (b) ability to understand English, and (c) expressed availability to attend and participate in the community program.

Exclusion Criteria:

• Exclusion criteria included student's expressed unwillingness to participate or lack of consent from parent/legal guardian. Severity of symptoms was not a criterion for eligibility. Exclusion criteria included expressed unwillingness to participate or lack of consent.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Bronchial Hyperreactivity
• Reactive Airway Disease

Intervention

Behavioral:
• SHARP program
Staying 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.
• Open Airways for Schools
OAS is a non-academic asthma health education program for elementary students with asthma and their parents.

Locations

Country	Name	City	State
United States	The University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reasoning about Asthma Management	Evidence of statistically significant increase in older school-age student reasoning about managing symptom exacerbation during an acute asthma episode.	24 months or 2 years post-intervention	No
Secondary	Participation in Life Activities	Evidence of statistically significant improvement in quality of life as evidenced by increase in participation in life activities score.	24 months or 2 years post-intervention	No