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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

August 24, 2012
July 5, 2013
December 2008
September 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01676896 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
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).
Same as current
 
Asthma in Central Texas Project
Enhancing Children's and Parents' Asthma Management

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Asthma
  • Behavioral: Asthma in-school class
    Other Name: Asthma Plan for Kids
  • Behavioral: Asthma Day Camp
  • Behavioral: Health Promotion in-school class
  • 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.
    Intervention: Behavioral: Asthma in-school class
  • 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.
    Intervention: 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.
    Intervention: Behavioral: Health Promotion in-school class
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
320
November 2013
September 2013   (final data collection date for primary outcome measure)

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)
Both
6 Years to 13 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01676896
R01NR007770, R01NR007770
Yes
University of Texas at Austin
University of Texas at Austin
National Institute of Nursing Research (NINR)
Not Provided
University of Texas at Austin
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP