Asthma in Central Texas Project

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT01676896
First received: August 24, 2012
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Asthma
Behavioral: Asthma in-school class
Behavioral: Asthma Day Camp
Behavioral: Health Promotion in-school class

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Enhancing Children's and Parents' Asthma Management

Resource links provided by NLM:


Further study details as provided by University of Texas at Austin:

Primary Outcome Measures:
  • Absenteeism [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    (Days absent/days enrolled)x100 = absenteeism. Using data from pre-enrollment school year for first 12 months and the data from the enrolled study year as months 13-24.

  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Self reported asthma-related quality of life. Data is collected at baseline (Time 1) and at end of study (Time 4)

  • Hospitalization [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Number of times hospitalized for asthma, how many days hospitalized. Data is obtained for the pre-study year for first 12 months and over the study year for months 13-24.

  • Emergency Department Visits [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Number of visits to Emergency Department for asthma. Data is obtained for the pre-study year for first 12 months and over the study year for months 13-24.


Secondary Outcome Measures:
  • Asthma self-management [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Child self-report of asthma preventive and management activities. Data is collected at each time point, Time 1, 2, 3, and 4.

  • Home Asthma Management [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Parent report of asthma preventive and treatment activities. Data are collected at each time point (Time 1, 2, 3, 4).

  • Metered dose inhaler skill [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Data are collected at each time point (Time 1, 2, 3, 4).

  • Medication Adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Parent report of their child remembering/forgetting to take medications. Data are collected at each time point (Time 1, 2, 3, 4).


Other Outcome Measures:
  • lung inflammation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Exhaled breath condensation collected and sent for lab analysis of NO3. Data are collected at each time point (Time 1, 2, 3, 4).


Estimated Enrollment: 320
Study Start Date: December 2008
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asthma in-school class
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
Other Name: Asthma Plan for Kids
Experimental: Asthma Day Camp
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
Sham Comparator: Health Promotion in-school class
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

Detailed Description:

Families are recruited at the beginning of the school year (Time 1, October-November); parents consent and child assent obtained and baseline data collected in fall. The intervention is provided in December-January. Follow-up data are collected at February (Time 2), April (Time 3), and August (Time 4).

  Eligibility

Ages Eligible for Study:   6 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • has a significant co-morbidity that would preclude participation in classes (e.g., severe cerebral palsy, oxygen dependent conditions)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676896

Locations
United States, Texas
The University of Texas at Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
  More Information

No publications provided

Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT01676896     History of Changes
Other Study ID Numbers: R01NR007770, R01NR007770
Study First Received: August 24, 2012
Last Updated: July 5, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Texas at Austin:
children
asthma
quality of life
self-management

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 27, 2014