Clinical trial NCT01676896: Asthma in Central Texas Project
Official title: Enhancing Children's and Parents' Asthma Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: children
asthma
quality of life
self-management
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2012-08-31
Enrollment: 292
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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)

Primary outcomes:
measure: Absenteeism, End of Study
timeFrame: 12 months
measure: Quality of Life, End of Study
timeFrame: 12 months
measure: Number of Days Hospitalized, During Study Year
timeFrame: 12 months
measure: Emergency Department Visits, Study Year
timeFrame: 12 months
measure: Number of Asthma Hospitalizations Pre-Study Year
timeFrame: 12 months before baseline
measure: Absenteeism Pre-study Year
timeFrame: 12 months before baseline
measure: Number of Days in Hospital for Asthma, Pre-Study Year
timeFrame: 12 months before baseline
measure: Number of Asthma Hospital Stays, During Study Year
timeFrame: 12 months
measure: Emergency Department Visits, Pre-study Year
timeFrame: 12 months before baseline
measure: Quality of Life, Pre-study Year
timeFrame: 12 months before baseline
Secondary outcomes:
measure: Asthma Self-management, Time 4
timeFrame: Time 4, at 12 months
measure: Home Asthma Management, Time 4, End of Study
timeFrame: Time 4 at 12 months
measure: Metered Dose Inhaler Skill, Time 4
timeFrame: Time 4 at 12 months
measure: Medication Adherence, Time 4
timeFrame: Time 4 at 12 months
measure: Asthma Self-management, Time 3
timeFrame: Time 3 at 9 months
measure: Asthma Self-management, Time 2
timeFrame: Time 2 at 5 months
measure: Asthma Self-management, Time 1, Baseline
timeFrame: Time 1, baseline
measure: Home Asthma Management, Time 1, Baseline
timeFrame: Time 1, baseline
measure: Home Asthma Management, Time 2.
timeFrame: Time 2 at 5 months
measure: Home Asthma Management, Time 3
timeFrame: Time 3 at 9 months
measure: Metered Dose Inhaler Skill, Time 3
timeFrame: Time 3 at 9 months
measure: Metered Dose Inhaler Skill, Time 2
timeFrame: Time 2 at 5 months
measure: Metered Dose Inhaler Skill, Time 1
timeFrame: Time 1 at baseline
measure: Medication Adherence, Time 1
timeFrame: Time 1 at baseline
measure: Medication Adherence, Time 2
timeFrame: Time 2 at 5 months
measure: Medication Adherence, Time 3
timeFrame: Time 3 at 9 months
Other outcomes:
measure: Lung Inflammation, Time 4
timeFrame: Time 4 at 12 months
measure: Lung Inflammation, Time 1
timeFrame: Time 1 at baseline
measure: Lung Inflammation, Time 2
timeFrame: Time 2 at 5 months
measure: Lung Inflammation, Time 3
timeFrame: Time 3 at 9 months
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
References: