Asthma in Central Texas Project

NCT01676896 | Completed Results DMC

• 1 other identifier: R01NR007770
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is the most common chronic childhood illness and disproportionately affects children who are ethnic minorities and poor. Few studies of childhood asthma have been conducted with children who live in rural areas or have included Mexican American children in their samples. This study builds on the original R01NR007770 with findings that demonstrated the intervention could improve children's asthma self-management, asthma knowledge, metered dose inhaler skill, asthma severity, and parents' asthma management and access to care. In this competing continuation, the investigators added a third arm to the current research design with schools randomized into either an in-school asthma intervention, an in-school attention-control intervention, or an alternate intervention-delivery format of a single 5.5-hour asthma day camp. The tri-ethnic sample will be composed of 320 Mexican-American, African-American, and White rural school-aged children (grades 2-5) who have asthma and their parents. In addition, the investigators propose adding a non-invasive measure of chronic airway inflammation (exhaled nitric oxide) to assess the impact of changes in asthma management on airway inflammation. Families will be followed for a full year with data collection at baseline and at 1-month, 4-months, and 7-months after the intervention to assess improvement in children's asthma morbidity, asthma severity, airway inflammation, family asthma management and quality of life. Hypotheses (H): Children in the Camp-Workshop group and the School-Home group will demonstrate equivalent improvements, but greater improvements than the Attention-Control group in:(H1.1) their asthma severity and airway inflammation from the Time 1 assessment when compared to Time 4 assessment; (H1.2) office visits, ED visits, and hospitalizations for asthma, and absenteeism for the study year (Time 4) when compared to the pre-study year (Time 1); and (H1.4) Parents in the intervention arms will demonstrate sustained improvements in asthma caregiver's quality of life (QOL0 from the pre-study year (Time 1) to the end of the study year (Time 4) measurement, when compared to the Attention-Control group.

Conditions

Asthma

Keywords

children; asthma; quality of life; self-management

Outcome Measures

Primary Outcomes (10)

• Absenteeism, End of Study

  (Days absent/days enrolled)x100 = absenteeism. Using data provided by the school district at the end of the study year.

  12 months

• Quality of Life, End of Study

  Self reported asthma-related quality of life. Outcome data were collected at end of study (Time 4). The Pediatric Asthma Quality of Life scale. Minimum score 23 to maximum score of 115. A higher score indicates worse quality of life. Mean scale scores are computed.

  12 months

• Number of Days Hospitalized, During Study Year

  Number of days hospitalized for asthma. Data were obtained from parent report at the second, third, and fourth data collection point. The number of hospitalization days were summed for a total number at the end of the 12 months.

  12 months

• Emergency Department Visits, Study Year

  Number of visits to Emergency Department for asthma. Data is obtained from parents at three time points (time 2, 3, and 4) and summed for total number of visits to the emergency department for asthma during the study year.

  12 months

• Number of Asthma Hospitalizations Pre-Study Year

  Number of times hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.

  12 months before baseline

• Absenteeism Pre-study Year

  (Days absent/days enrolled)x100 = absenteeism. Using data for the 12 months prior to study enrollment as the pre-study year. Data is provided by the participating school districts.

  12 months before baseline

• Number of Days in Hospital for Asthma, Pre-Study Year

  Number of days hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.

  12 months before baseline

• Number of Asthma Hospital Stays, During Study Year

  Number of hospital admissions for asthma. Data were obtained from parent report at the second, third, and fourth data collection point. The number of hospitalizations were summed for a total number at the end of the 12 months.

  12 months

• Emergency Department Visits, Pre-study Year

  Number of visits to Emergency Department for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.

  12 months before baseline

• Quality of Life, Pre-study Year

  Self reported asthma-related quality of life. Data were collected at study enrollment (time 1). The Pediatric Asthma Quality of Life scale. Minimum score 23 to maximum score of 115. A higher score indicates worse quality of life. Mean scale scores are computed.

  12 months before baseline

Secondary Outcomes (16)

• Asthma Self-management, Time 4

  Time 4, at 12 months

• Home Asthma Management, Time 4, End of Study

  Time 4 at 12 months

• Metered Dose Inhaler Skill, Time 4

  Time 4 at 12 months

• Medication Adherence, Time 4

  Time 4 at 12 months

• Asthma Self-management, Time 3

  Time 3 at 9 months

Other Outcomes (4)

• Lung Inflammation, Time 4

  Time 4 at 12 months

• Lung Inflammation, Time 1

  Time 1 at baseline

• Lung Inflammation, Time 2

  Time 2 at 5 months

Study Arms (3)

Asthma in-school class

EXPERIMENTAL

Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.

Behavioral: Asthma in-school class

Asthma Day Camp

EXPERIMENTAL

The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics \[a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner\] are covered as those in the asthma in-school classes.

Behavioral: Asthma Day Camp

Health Promotion in-school class

SHAM COMPARATOR

The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.

Behavioral: Health Promotion in-school class

Interventions

Asthma in-school class BEHAVIORAL

Also known as: Asthma Plan for Kids

Asthma in-school class

Asthma Day Camp BEHAVIORAL

Asthma Day Camp

Health Promotion in-school class BEHAVIORAL

Health Promotion in-school class

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• parent reports the child has a diagnosis of asthma made by a medical provider;
• has had asthma symptoms in the previous 12 months;
• speaks either English or Spanish.

You may not qualify if:

• has a significant co-morbidity that would preclude participation in classes (e.g., severe cerebral palsy, oxygen dependent conditions)

Sponsors & Collaborators

• University of Texas at Austin: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Sharon Horner
• Organization: UTexasAustin

shorner@mail.nur.utexas.edu

512-471-7951

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: August 31, 2012
• Study Start: December 1, 2008
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2014
• Last Updated: April 24, 2015
• Results First Posted: April 2, 2015

Record last verified: 2015-04

Locations

US (1)