Asthma in Central Texas Project

Asthma Clinical Trial

Official title:

Enhancing Children's and Parents' Asthma Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01676896
• Other study ID #: R01NR007770
• Secondary ID: R01NR007770
• Status: Completed
• Phase: N/A
• First received: August 24, 2012
• Last updated: April 2, 2015
• Start date: December 2008
• Est. completion date: November 2014

Study information

• Verified date: April 2015
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: November 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 13 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Asthma in-school class

• Asthma Day Camp

• Health Promotion in-school class

Locations

Country	Name	City	State
United States	The University of Texas at Austin	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lung Inflammation, Time 4	Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 4 visit. Higher values represent greater airway inflammation.	Time 4 at 12 months	No
Other	Lung Inflammation, Time 1	Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 1 visit. Higher values represent greater airway inflammation.	Time 1 at baseline	No
Other	Lung Inflammation, Time 2	Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 2 visit. Higher values represent greater airway inflammation.	Time 2 at 5 months	No
Other	Lung Inflammation, Time 3	Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 3 visit. Higher values represent greater airway inflammation.	Time 3 at 9 months	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Asthma Self-management, Time 4	Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the Time 4, final measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.	Time 4, at 12 months	No
Secondary	Home Asthma Management, Time 4, End of Study	Parent report of asthma preventive and treatment activities. Data collected at final study visit, Time 4. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.	Time 4 at 12 months	No
Secondary	Metered Dose Inhaler Skill, Time 4	Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at final, time 4 data visit.	Time 4 at 12 months	No
Secondary	Medication Adherence, Time 4	Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at final data point, Time 4.	Time 4 at 12 months	No
Secondary	Asthma Self-management, Time 3	Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the Time 3 measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.	Time 3 at 9 months	No
Secondary	Asthma Self-management, Time 2	Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the Time 2 measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.	Time 2 at 5 months	No
Secondary	Asthma Self-management, Time 1, Baseline	Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the baseline, Time 1 measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.	Time 1, baseline	No
Secondary	Home Asthma Management, Time 1, Baseline	Parent report of asthma preventive and treatment activities. Data are collected at study enrollment, Time 1, baseline visit. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.	Time 1, baseline	No
Secondary	Home Asthma Management, Time 2.	Parent report of asthma preventive and treatment activities. Data collected at the time 2 visit. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.	Time 2 at 5 months	No
Secondary	Home Asthma Management, Time 3	Parent report of asthma preventive and treatment activities. Data collected at third time point (Time 3). Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.	Time 3 at 9 months	No
Secondary	Metered Dose Inhaler Skill, Time 3	Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at time 3 data visit.	Time 3 at 9 months	No
Secondary	Metered Dose Inhaler Skill, Time 2	Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at final, time 2 data visit.	Time 2 at 5 months	No
Secondary	Metered Dose Inhaler Skill, Time 1	Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at enrollment visit, Time 1 data visit.	Time 1 at baseline	No
Secondary	Medication Adherence, Time 1	Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at study enrollment, Time 1.	Time 1 at baseline	No
Secondary	Medication Adherence, Time 2	Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at Time 2 visit.	Time 2 at 5 months	No
Secondary	Medication Adherence, Time 3	Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at Time 3 visit.	Time 3 at 9 months	No