N/A
N=292
Asthma in Central Texas Project
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01676896 ↗Enrolled (actual)
292
Serious AEs
0.7%
Results posted
Apr 2015
Primary outcome: Primary: Absenteeism, End of Study — 3.83; 4.41; 3.68 percentage of days enrolled
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Asthma in-school class (Behavioral); Asthma Day Camp (Behavioral); Health Promotion in-school class (Behavioral)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- University of Texas at Austin
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absenteeism, End of Study |
3.83; 4.41; 3.68 | — |
| PRIMARY Quality of Life, End of Study |
43.57; 43.87; 50.24 | — |
| PRIMARY Number of Days Hospitalized, During Study Year |
.04; .09; .26 | — |
| PRIMARY Emergency Department Visits, Study Year |
.22; .09; .29 | — |
| PRIMARY Number of Asthma Hospitalizations Pre-Study Year |
0.32; 0.15; 0.26 | — |
| PRIMARY Absenteeism Pre-study Year |
3.17; 4.34; 4.00 | — |
| PRIMARY Number of Days in Hospital for Asthma, Pre-Study Year |
0.32; 0.15; 0.26 | — |
| PRIMARY Number of Asthma Hospital Stays, During Study Year |
0.04; 0.06; 0.10 | — |
| PRIMARY Emergency Department Visits, Pre-study Year |
0.42; 0.49; 0.76 | — |
| PRIMARY Quality of Life, Pre-study Year |
51.16; 53.57; 55.06 | — |
| SECONDARY Asthma Self-management, Time 4 |
51.84; 51.65; 51.44 | — |
| SECONDARY Home Asthma Management, Time 4, End of Study |
61.16; 65.06; 62.34 | — |
| SECONDARY Metered Dose Inhaler Skill, Time 4 |
6.26; 6.30; 5.38 | — |
| SECONDARY Medication Adherence, Time 4 |
0.74; 0.72; 0.81 | — |
| SECONDARY Asthma Self-management, Time 3 |
51.60; 51.84; 52.58 | — |
| SECONDARY Asthma Self-management, Time 2 |
50.46; 51.01; 51.70 | — |
| SECONDARY Asthma Self-management, Time 1, Baseline |
48.57; 48.12; 50.45 | — |
| SECONDARY Home Asthma Management, Time 1, Baseline |
53.39; 53.07; 55.37 | — |
| SECONDARY Home Asthma Management, Time 2. |
61.08; 61.60; 64.57 | — |
| SECONDARY Home Asthma Management, Time 3 |
60.82; 64.41; 64.16 | — |
| SECONDARY Metered Dose Inhaler Skill, Time 3 |
6.16; 6.25; 5.63 | — |
| SECONDARY Metered Dose Inhaler Skill, Time 2 |
6.48; 6.20; 5.26 | — |
| SECONDARY Metered Dose Inhaler Skill, Time 1 |
4.84; 4.87; 5.02 | — |
| SECONDARY Medication Adherence, Time 1 |
1.07; 1.07; 1.19 | — |
| SECONDARY Medication Adherence, Time 2 |
1.01; 0.87; 1.06 | — |
| SECONDARY Medication Adherence, Time 3 |
1.03; 0.89; 0.81 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01676896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.