Comparison of Asthma Programs for Schools

NCT ID: NCT01625364

Last Updated: 2015-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 432 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2014-09-30

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, 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

Asthma; Reactive Airway Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Open Airways for Schools

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

Group Type: EXPERIMENTAL

Open Airways for Schools

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

SHARP program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Open Airways for Schools

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Staying Healthy-Asthma Responsible and Prepared; OAS

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Eileen K. Kintner

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eileen K Kintner, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at Austin

Locations

The University of Texas at Austin

Austin, Texas, United States

Countries

United States

Other Identifiers

5R01NR010544-05

Identifier Type: NIH

Identifier Source: org_study_id

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