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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR007770 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asthma in-school class | Experimental | 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. |
|
| Asthma Day Camp | Experimental | 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. |
|
| Health Promotion in-school class | Sham Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asthma in-school class | Behavioral |
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| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Lung Inflammation, Time 1 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas at Austin | Austin | Texas | 78712 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Asthma in-school class |
| FG001 | 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. Asthma Day Camp |
| FG002 | 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. Health Promotion in-school class |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Asthma in-school class |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data for days enrolled and days absent was obtained from the school districts. Two school districts declined to provide the requested information, therefore there was substantial missing data for this variable. | Posted | Mean | Standard Deviation | percentage of days enrolled | 12 months |
|
Every 3 months for up to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Asthma in-school class |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital stay > 24 hours | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | child was hospitalized for greater than 24 hours to manage asthma episode |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharon Horner | UTexasAustin | 512-471-7951 | shorner@mail.nur.utexas.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
| Asthma Day Camp |
| Behavioral |
|
| Health Promotion in-school class | Behavioral |
|
| 12 months before baseline |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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 |
| 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 |
| 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 |
| BG001 | 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. Asthma Day Camp |
| BG002 | 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. Health Promotion in-school class |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. Asthma Day Camp |
| OG002 | 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. Health Promotion in-school class |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
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| 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. | Posted | Mean | Standard Deviation | days hospitalized | 12 months |
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| 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. | Posted | Mean | Standard Deviation | number of visits | 12 months |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Time 4, at 12 months |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Time 4 at 12 months |
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| 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. | Posted | Mean | Standard Deviation | number of correct steps | Time 4 at 12 months |
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| 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. | Posted | Mean | Standard Deviation | number of yes responses | Time 4 at 12 months |
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | uM | Time 4 at 12 months |
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| 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. | Posted | Mean | Standard Deviation | number of hospitalizations | 12 months before baseline |
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| 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. | Data for days enrolled and days absent for the pre-study year was obtained from the school districts. Two school districts declined to provide the requested information, therefore there was substantial missing data for this variable. | Posted | Mean | Standard Deviation | percentage of days enrolled | 12 months before baseline |
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| 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. | Posted | Mean | Standard Deviation | days hospitalized | 12 months before baseline |
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| 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. | Posted | Mean | Standard Deviation | number of hospital stays | 12 months |
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| 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. | Posted | Mean | Standard Deviation | number of visits | 12 months before baseline |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months before baseline |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Time 3 at 9 months |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Time 2 at 5 months |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Time 1, baseline |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Time 1, baseline |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Time 2 at 5 months |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Time 3 at 9 months |
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| 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. | Posted | Mean | Standard Deviation | number of correct steps | Time 3 at 9 months |
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| 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. | Posted | Mean | Standard Deviation | number of correct steps | Time 2 at 5 months |
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| 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. | Posted | Mean | Standard Deviation | number of correct steps | Time 1 at baseline |
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| 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. | Posted | Mean | Standard Deviation | number of yes responses | Time 1 at baseline |
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| 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. | Posted | Mean | Standard Deviation | number of yes responses | Time 2 at 5 months |
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| 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. | Posted | Mean | Standard Deviation | number of yes responses | Time 3 at 9 months |
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | uM | Time 1 at baseline |
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | uM | Time 2 at 5 months |
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | uM | Time 3 at 9 months |
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|
|
| 1 |
| 96 |
| 0 |
| 96 |
| EG001 | 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. Asthma Day Camp | 0 | 96 | 0 | 96 |
| EG002 | 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. Health Promotion in-school class | 1 | 100 | 0 | 100 |
|
Not provided
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |