Viewing Study NCT01625364



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Study NCT ID: NCT01625364
Status: COMPLETED
Last Update Posted: 2015-11-09
First Post: 2012-06-19

Brief Title: Comparison of Asthma Programs for Schools
Sponsor: University of Texas at Austin
Organization: University of Texas at Austin

Study Overview

Official Title: Comparison of Asthma Programs for Schools
Status: COMPLETED
Status Verified Date: 2015-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CAPS
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
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 freereduced lunch eligibility and racialethnic 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None