Asthma in Central Texas Project

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT01676896
First received: August 24, 2012
Last updated: April 2, 2015
Last verified: April 2015
  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, End of Study [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    (Days absent/days enrolled)x100 = absenteeism. Using data provided by the school district at the end of the study year.

  • Quality of Life, End of Study [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Number of Days Hospitalized, During Study Year [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Emergency Department Visits, Study Year [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Number of Asthma Hospitalizations Pre-Study Year [ Time Frame: 12 months before baseline ] [ Designated as safety issue: No ]
    Number of times hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.

  • Absenteeism Pre-study Year [ Time Frame: 12 months before baseline ] [ Designated as safety issue: No ]
    (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.

  • Number of Days in Hospital for Asthma, Pre-Study Year [ Time Frame: 12 months before baseline ] [ Designated as safety issue: No ]
    Number of days hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.

  • Number of Asthma Hospital Stays, During Study Year [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Emergency Department Visits, Pre-study Year [ Time Frame: 12 months before baseline ] [ Designated as safety issue: No ]
    Number of visits to Emergency Department for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.

  • Quality of Life, Pre-study Year [ Time Frame: 12 months before baseline ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Asthma Self-management, Time 4 [ Time Frame: Time 4, at 12 months ] [ Designated as safety issue: No ]
    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.

  • Home Asthma Management, Time 4, End of Study [ Time Frame: Time 4 at 12 months ] [ Designated as safety issue: No ]
    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.

  • Metered Dose Inhaler Skill, Time 4 [ Time Frame: Time 4 at 12 months ] [ Designated as safety issue: No ]
    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.

  • Medication Adherence, Time 4 [ Time Frame: Time 4 at 12 months ] [ Designated as safety issue: No ]
    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.

  • Asthma Self-management, Time 3 [ Time Frame: Time 3 at 9 months ] [ Designated as safety issue: No ]
    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.

  • Asthma Self-management, Time 2 [ Time Frame: Time 2 at 5 months ] [ Designated as safety issue: No ]
    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.

  • Asthma Self-management, Time 1, Baseline [ Time Frame: Time 1, baseline ] [ Designated as safety issue: No ]
    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.

  • Home Asthma Management, Time 1, Baseline [ Time Frame: Time 1, baseline ] [ Designated as safety issue: No ]
    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.

  • Home Asthma Management, Time 2. [ Time Frame: Time 2 at 5 months ] [ Designated as safety issue: No ]
    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.

  • Home Asthma Management, Time 3 [ Time Frame: Time 3 at 9 months ] [ Designated as safety issue: No ]
    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.

  • Metered Dose Inhaler Skill, Time 3 [ Time Frame: Time 3 at 9 months ] [ Designated as safety issue: No ]
    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.

  • Metered Dose Inhaler Skill, Time 2 [ Time Frame: Time 2 at 5 months ] [ Designated as safety issue: No ]
    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.

  • Metered Dose Inhaler Skill, Time 1 [ Time Frame: Time 1 at baseline ] [ Designated as safety issue: No ]
    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.

  • Medication Adherence, Time 1 [ Time Frame: Time 1 at baseline ] [ Designated as safety issue: No ]
    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.

  • Medication Adherence, Time 2 [ Time Frame: Time 2 at 5 months ] [ Designated as safety issue: No ]
    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.

  • Medication Adherence, Time 3 [ Time Frame: Time 3 at 9 months ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Lung Inflammation, Time 4 [ Time Frame: Time 4 at 12 months ] [ Designated as safety issue: No ]
    Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 4 visit. Higher values represent greater airway inflammation.

  • Lung Inflammation, Time 1 [ Time Frame: Time 1 at baseline ] [ Designated as safety issue: No ]
    Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 1 visit. Higher values represent greater airway inflammation.

  • Lung Inflammation, Time 2 [ Time Frame: Time 2 at 5 months ] [ Designated as safety issue: No ]
    Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 2 visit. Higher values represent greater airway inflammation.

  • Lung Inflammation, Time 3 [ Time Frame: Time 3 at 9 months ] [ Designated as safety issue: No ]
    Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 3 visit. Higher values represent greater airway inflammation.


Enrollment: 292
Study Start Date: December 2008
Study Completion Date: November 2014
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
Results First Received: December 3, 2014
Last Updated: April 2, 2015
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
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 03, 2015