Comparison of Asthma Programs for Schools

NCT01625364 | Completed DMC

• 1 other identifier: 5R01NR010544-05
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

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).

Conditions

Asthma; Reactive Airway Disease

Keywords

Health Education; Health Counseling; Patient Education

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Participation in Life Activities

  24 months or 2 years post-intervention

Study Arms (2)

Open Airways for Schools

EXPERIMENTAL

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

Behavioral: Open Airways for Schools

SHARP program

EXPERIMENTAL

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

Interventions

SHARP program 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.

Also known as: Staying Healthy-Asthma Responsible and Prepared

SHARP program

Open Airways for Schools BEHAVIORAL

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

Also known as: OAS

Open Airways for Schools

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78701-1499, United States

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Health Education

Interventions

Schools

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities

Study Officials

• Eileen K Kintner, PhD

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 21, 2012
• Study Start: September 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2014
• Last Updated: November 9, 2015

Record last verified: 2015-11

Locations

US (1)