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Completed

NCT Number: NCT01676896

Asthma in Central Texas Project

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas at Austin

Austin, Texas, 78712, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Asthma in-school class

Behavioral

Other names: Asthma Plan for Kids

Asthma Day Camp

Behavioral

Health Promotion in-school class

Behavioral

Primary outcomes

  1. Absenteeism, End of Study

    Time frame: 12 months

    (Days absent/days enrolled)x100 = absenteeism. Using data provided by the school district at the end of the study year.

  2. Quality of Life, End of Study

    Time frame: 12 months

    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.

  3. Number of Days Hospitalized, During Study Year

    Time frame: 12 months

    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.

  4. Emergency Department Visits, Study Year

    Time frame: 12 months

    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.

  5. Number of Asthma Hospitalizations Pre-Study Year

    Time frame: 12 months before baseline

    Number of times hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.

  6. Absenteeism Pre-study Year

    Time frame: 12 months before baseline

    (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.

  7. Number of Days in Hospital for Asthma, Pre-Study Year

    Time frame: 12 months before baseline

    Number of days hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.

  8. Number of Asthma Hospital Stays, During Study Year

    Time frame: 12 months

    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.

  9. Emergency Department Visits, Pre-study Year

    Time frame: 12 months before baseline

    Number of visits to Emergency Department for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.

  10. Quality of Life, Pre-study Year

    Time frame: 12 months before baseline

    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 outcomes

  1. Asthma Self-management, Time 4

    Time frame: Time 4, at 12 months

    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.

  2. Home Asthma Management, Time 4, End of Study

    Time frame: Time 4 at 12 months

    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.

  3. Metered Dose Inhaler Skill, Time 4

    Time frame: Time 4 at 12 months

    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.

  4. Medication Adherence, Time 4

    Time frame: Time 4 at 12 months

    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.

  5. Asthma Self-management, Time 3

    Time frame: Time 3 at 9 months

    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.

  6. Asthma Self-management, Time 2

    Time frame: Time 2 at 5 months

    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.

  7. Asthma Self-management, Time 1, Baseline

    Time frame: 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.

  8. Home Asthma Management, Time 1, Baseline

    Time frame: 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.

  9. Home Asthma Management, Time 2.

    Time frame: Time 2 at 5 months

    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.

  10. Home Asthma Management, Time 3

    Time frame: Time 3 at 9 months

    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.

  11. Metered Dose Inhaler Skill, Time 3

    Time frame: Time 3 at 9 months

    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.

  12. Metered Dose Inhaler Skill, Time 2

    Time frame: Time 2 at 5 months

    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.

  13. Metered Dose Inhaler Skill, Time 1

    Time frame: Time 1 at baseline

    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.

  14. Medication Adherence, Time 1

    Time frame: Time 1 at baseline

    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.

  15. Medication Adherence, Time 2

    Time frame: Time 2 at 5 months

    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.

  16. Medication Adherence, Time 3

    Time frame: Time 3 at 9 months

    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 outcomes

  1. Lung Inflammation, Time 4

    Time frame: Time 4 at 12 months

    Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 4 visit. Higher values represent greater airway inflammation.

  2. Lung Inflammation, Time 1

    Time frame: Time 1 at baseline

    Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 1 visit. Higher values represent greater airway inflammation.

  3. Lung Inflammation, Time 2

    Time frame: Time 2 at 5 months

    Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 2 visit. Higher values represent greater airway inflammation.

  4. Lung Inflammation, Time 3

    Time frame: Time 3 at 9 months

    Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 3 visit. Higher values represent greater airway inflammation.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Enhancing Children's and Parents' Asthma Management

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Aug 31, 2012
Registry last updated
Apr 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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