CAPS: Comparison of Asthma Programs for Schools

Sponsor
University of Texas at Austin (Other)
Overall Status
Completed
CT.gov ID
NCT01625364
Collaborator
(none)
432
1
2
60
7.2

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: SHARP program
  • Behavioral: Open Airways for Schools
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
432 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Asthma Programs for Schools
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Sep 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Open Airways for Schools

OAS is a school-based non-academic asthma health education program for elementary students with asthma and their parents.

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

    The Staying Health-Asthma Responsible & Prepared (SHARP) program 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 caregiver.

    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.
    Other Names:
  • Staying Healthy-Asthma Responsible and Prepared
  • Outcome Measures

    Primary Outcome Measures

    1. Reasoning about Asthma Management [24 months or 2 years post-intervention]

      Evidence of statistically significant increase in older school-age student reasoning about managing symptom exacerbation during an acute asthma episode.

    Secondary Outcome Measures

    1. Participation in Life Activities [24 months or 2 years post-intervention]

      Evidence of statistically significant improvement in quality of life as evidenced by increase in participation in life activities score.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    9 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Texas at Austin Austin Texas United States 78701-1499

    Sponsors and Collaborators

    • University of Texas at Austin

    Investigators

    • Principal Investigator: Eileen K Kintner, PhD, The University of Texas at Austin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eileen K. Kintner, Principal Investigator, University of Texas at Austin
    ClinicalTrials.gov Identifier:
    NCT01625364
    Other Study ID Numbers:
    • 5R01NR010544-05
    First Posted:
    Jun 21, 2012
    Last Update Posted:
    Nov 9, 2015
    Last Verified:
    Nov 1, 2015
    Keywords provided by Eileen K. Kintner, Principal Investigator, University of Texas at Austin
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 9, 2015