Comparison of Asthma Programs for Schools (CAPS)
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Purpose
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 | Intervention |
|---|---|
|
Asthma Reactive Airway Disease |
Behavioral: SHARP program Behavioral: Open Airways for Schools |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparison of Asthma Programs for Schools |
- Reasoning about Asthma Management [ Time Frame: 24 months or 2 years post-intervention ] [ Designated as safety issue: No ]Evidence of statistically significant increase in older school-age student reasoning about managing symptom exacerbation during an acute asthma episode.
- Participation in Life Activities [ Time Frame: 24 months or 2 years post-intervention ] [ Designated as safety issue: No ]Evidence of statistically significant improvement in quality of life as evidenced by increase in participation in life activities score.
| Enrollment: | 432 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: Staying Healthy-Asthma Responsible and Prepared
|
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.
Eligibility| Ages Eligible for Study: | 9 Years and older |
| Genders Eligible for Study: | Both |
| 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| United States, Texas | |
| The University of Texas at Austin | |
| Austin, Texas, United States, 78701-1499 | |
| Principal Investigator: | Eileen K Kintner, PhD | The University of Texas at Austin |
More Information
No publications provided
| Responsible Party: | University of Texas at Austin |
| ClinicalTrials.gov Identifier: | NCT01625364 History of Changes |
| Other Study ID Numbers: | 5R01NR010544-05 |
| Study First Received: | June 19, 2012 |
| Last Updated: | June 19, 2012 |
| Health Authority: | United States: Data and Safety Monitoring Board |
Keywords provided by University of Texas at Austin:
|
Health Education Health Counseling Patient Education |
Additional relevant MeSH terms:
|
Asthma Bronchial Hyperreactivity Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive |
Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013