Asthma
Conditions
Keywords
children, asthma, quality of life, self-management
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).
Interventions
BEHAVIORALAsthma in-school class
BEHAVIORALAsthma Day Camp
BEHAVIORALHealth Promotion in-school class
Sponsors
National Institute of Nursing Research (NINR)
University of Texas at Austin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Asthma Hospital Stays, During Study Year | 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. |
| Quality of Life, Pre-study Year | 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. |
| Emergency Department Visits, Pre-study Year | 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. |
| Number of Days in Hospital for Asthma, Pre-Study Year | 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. |
| Absenteeism, End of Study | 12 months | (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 | 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. |
| Number of Days Hospitalized, During Study Year | 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. |
| Emergency Department Visits, Study Year | 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. |
| Number of Asthma Hospitalizations Pre-Study Year | 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. |
| Absenteeism Pre-study Year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Home Asthma Management, Time 3 | 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. |
| Metered Dose Inhaler Skill, Time 3 | 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. |
| Metered Dose Inhaler Skill, Time 1 | 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. |
| Medication Adherence, Time 1 | 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. |
| Medication Adherence, Time 2 | 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. |
| Medication Adherence, Time 3 | 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. |
| Metered Dose Inhaler Skill, Time 2 | 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. |
| Asthma Self-management, Time 4 | 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. |
| Home Asthma Management, Time 4, End of Study | 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. |
| Metered Dose Inhaler Skill, Time 4 | 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. |
| Medication Adherence, Time 4 | 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. |
| Asthma Self-management, Time 3 | 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. |
| Asthma Self-management, Time 2 | 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. |
| Asthma Self-management, Time 1, Baseline | 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. |
| Home Asthma Management, Time 1, Baseline | 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. |
| Home Asthma Management, Time 2. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Lung Inflammation, Time 4 | 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. |
| Lung Inflammation, Time 3 | 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. |
| Lung Inflammation, Time 2 | 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. |
| Lung Inflammation, Time 1 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 96 |
| 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 | 96 |
| 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 | 100 |
| Total | 292 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 12 | 7 | 19 |
Baseline characteristics
| Characteristic | Asthma Day Camp | Health Promotion In-school Class | Asthma In-school Class | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 96 Participants | 100 Participants | 96 Participants | 292 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.83 years STANDARD_DEVIATION 1.21 | 8.86 years STANDARD_DEVIATION 1.29 | 8.77 years STANDARD_DEVIATION 1.25 | 8.82 years STANDARD_DEVIATION 1.25 |
| Region of Enrollment United States | 96 participants | 100 participants | 96 participants | 292 participants |
| Sex: Female, Male Female | 37 Participants | 26 Participants | 43 Participants | 106 Participants |
| Sex: Female, Male Male | 59 Participants | 74 Participants | 53 Participants | 186 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 96 | 0 / 96 | 0 / 100 |
| serious Total, serious adverse events | 1 / 96 | 0 / 96 | 1 / 100 |
Outcome results
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Absenteeism, End of Study | 3.83 percentage of days enrolled | Standard Deviation 3.53 |
| Asthma Day Camp | Absenteeism, End of Study | 4.41 percentage of days enrolled | Standard Deviation 4.04 |
| Health Promotion In-school Class | Absenteeism, End of Study | 3.68 percentage of days enrolled | Standard Deviation 3.17 |
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.
Time frame: 12 months before baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Absenteeism Pre-study Year | 3.17 percentage of days enrolled | Standard Deviation 2.73 |
| Asthma Day Camp | Absenteeism Pre-study Year | 4.34 percentage of days enrolled | Standard Deviation 3.2 |
| Health Promotion In-school Class | Absenteeism Pre-study Year | 4.00 percentage of days enrolled | Standard Deviation 4.14 |
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.
Time frame: 12 months before baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Emergency Department Visits, Pre-study Year | 0.42 number of visits | Standard Deviation 0.97 |
| Asthma Day Camp | Emergency Department Visits, Pre-study Year | 0.49 number of visits | Standard Deviation 1.13 |
| Health Promotion In-school Class | Emergency Department Visits, Pre-study Year | 0.76 number of visits | Standard Deviation 1.42 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Emergency Department Visits, Study Year | .22 number of visits | Standard Deviation 0.96 |
| Asthma Day Camp | Emergency Department Visits, Study Year | .09 number of visits | Standard Deviation 0.51 |
| Health Promotion In-school Class | Emergency Department Visits, Study Year | .29 number of visits | Standard Deviation 0.76 |
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.
Time frame: 12 months before baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Number of Asthma Hospitalizations Pre-Study Year | 0.32 number of hospitalizations | Standard Deviation 1.53 |
| Asthma Day Camp | Number of Asthma Hospitalizations Pre-Study Year | 0.15 number of hospitalizations | Standard Deviation 0.67 |
| Health Promotion In-school Class | Number of Asthma Hospitalizations Pre-Study Year | 0.26 number of hospitalizations | Standard Deviation 0.84 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Number of Asthma Hospital Stays, During Study Year | 0.04 number of hospital stays | Standard Deviation 0.19 |
| Asthma Day Camp | Number of Asthma Hospital Stays, During Study Year | 0.06 number of hospital stays | Standard Deviation 0.28 |
| Health Promotion In-school Class | Number of Asthma Hospital Stays, During Study Year | 0.10 number of hospital stays | Standard Deviation 0.3 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Number of Days Hospitalized, During Study Year | .04 days hospitalized | Standard Deviation 0.19 |
| Asthma Day Camp | Number of Days Hospitalized, During Study Year | .09 days hospitalized | Standard Deviation 0.51 |
| Health Promotion In-school Class | Number of Days Hospitalized, During Study Year | .26 days hospitalized | Standard Deviation 1.19 |
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.
Time frame: 12 months before baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Number of Days in Hospital for Asthma, Pre-Study Year | 0.32 days hospitalized | Standard Deviation 1.53 |
| Asthma Day Camp | Number of Days in Hospital for Asthma, Pre-Study Year | 0.15 days hospitalized | Standard Deviation 0.67 |
| Health Promotion In-school Class | Number of Days in Hospital for Asthma, Pre-Study Year | 0.26 days hospitalized | Standard Deviation 0.84 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Quality of Life, End of Study | 43.57 units on a scale | Standard Deviation 15.4 |
| Asthma Day Camp | Quality of Life, End of Study | 43.87 units on a scale | Standard Deviation 16.83 |
| Health Promotion In-school Class | Quality of Life, End of Study | 50.24 units on a scale | Standard Deviation 20.76 |
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.
Time frame: 12 months before baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Quality of Life, Pre-study Year | 51.16 units on a scale | Standard Deviation 18.98 |
| Asthma Day Camp | Quality of Life, Pre-study Year | 53.57 units on a scale | Standard Deviation 18.59 |
| Health Promotion In-school Class | Quality of Life, Pre-study Year | 55.06 units on a scale | Standard Deviation 21.65 |
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 frame: Time 1, baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Asthma Self-management, Time 1, Baseline | 48.57 units on a scale | Standard Deviation 9.65 |
| Asthma Day Camp | Asthma Self-management, Time 1, Baseline | 48.12 units on a scale | Standard Deviation 8.95 |
| Health Promotion In-school Class | Asthma Self-management, Time 1, Baseline | 50.45 units on a scale | Standard Deviation 9.23 |
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 frame: Time 2 at 5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Asthma Self-management, Time 2 | 50.46 units on a scale | Standard Deviation 10.44 |
| Asthma Day Camp | Asthma Self-management, Time 2 | 51.01 units on a scale | Standard Deviation 9.17 |
| Health Promotion In-school Class | Asthma Self-management, Time 2 | 51.70 units on a scale | Standard Deviation 9.11 |
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 frame: Time 3 at 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Asthma Self-management, Time 3 | 51.60 units on a scale | Standard Deviation 10.45 |
| Asthma Day Camp | Asthma Self-management, Time 3 | 51.84 units on a scale | Standard Deviation 9.27 |
| Health Promotion In-school Class | Asthma Self-management, Time 3 | 52.58 units on a scale | Standard Deviation 10.02 |
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 frame: Time 4, at 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Asthma Self-management, Time 4 | 51.84 units on a scale | Standard Deviation 10.29 |
| Asthma Day Camp | Asthma Self-management, Time 4 | 51.65 units on a scale | Standard Deviation 9.09 |
| Health Promotion In-school Class | Asthma Self-management, Time 4 | 51.44 units on a scale | Standard Deviation 10.25 |
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 frame: Time 1, baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Home Asthma Management, Time 1, Baseline | 53.39 units on a scale | Standard Deviation 10.96 |
| Asthma Day Camp | Home Asthma Management, Time 1, Baseline | 53.07 units on a scale | Standard Deviation 10.11 |
| Health Promotion In-school Class | Home Asthma Management, Time 1, Baseline | 55.37 units on a scale | Standard Deviation 9.18 |
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 frame: Time 2 at 5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Home Asthma Management, Time 2. | 61.08 units on a scale | Standard Deviation 21.37 |
| Asthma Day Camp | Home Asthma Management, Time 2. | 61.60 units on a scale | Standard Deviation 11.6 |
| Health Promotion In-school Class | Home Asthma Management, Time 2. | 64.57 units on a scale | Standard Deviation 18.06 |
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 frame: Time 3 at 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Home Asthma Management, Time 3 | 60.82 units on a scale | Standard Deviation 12.56 |
| Asthma Day Camp | Home Asthma Management, Time 3 | 64.41 units on a scale | Standard Deviation 10.79 |
| Health Promotion In-school Class | Home Asthma Management, Time 3 | 64.16 units on a scale | Standard Deviation 11.5 |
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 frame: Time 4 at 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Home Asthma Management, Time 4, End of Study | 61.16 units on a scale | Standard Deviation 13.11 |
| Asthma Day Camp | Home Asthma Management, Time 4, End of Study | 65.06 units on a scale | Standard Deviation 13.51 |
| Health Promotion In-school Class | Home Asthma Management, Time 4, End of Study | 62.34 units on a scale | Standard Deviation 13.31 |
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 frame: Time 1 at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Medication Adherence, Time 1 | 1.07 number of yes responses | Standard Deviation 1.04 |
| Asthma Day Camp | Medication Adherence, Time 1 | 1.07 number of yes responses | Standard Deviation 1.06 |
| Health Promotion In-school Class | Medication Adherence, Time 1 | 1.19 number of yes responses | Standard Deviation 1.13 |
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 frame: Time 2 at 5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Medication Adherence, Time 2 | 1.01 number of yes responses | Standard Deviation 1.07 |
| Asthma Day Camp | Medication Adherence, Time 2 | 0.87 number of yes responses | Standard Deviation 0.94 |
| Health Promotion In-school Class | Medication Adherence, Time 2 | 1.06 number of yes responses | Standard Deviation 1.1 |
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 frame: Time 3 at 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Medication Adherence, Time 3 | 1.03 number of yes responses | Standard Deviation 1.02 |
| Asthma Day Camp | Medication Adherence, Time 3 | 0.89 number of yes responses | Standard Deviation 0.91 |
| Health Promotion In-school Class | Medication Adherence, Time 3 | 0.81 number of yes responses | Standard Deviation 0.98 |
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 frame: Time 4 at 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Medication Adherence, Time 4 | 0.74 number of yes responses | Standard Deviation 0.82 |
| Asthma Day Camp | Medication Adherence, Time 4 | 0.72 number of yes responses | Standard Deviation 0.84 |
| Health Promotion In-school Class | Medication Adherence, Time 4 | 0.81 number of yes responses | Standard Deviation 0.9 |
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 frame: Time 1 at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Metered Dose Inhaler Skill, Time 1 | 4.84 number of correct steps | Standard Deviation 1.6 |
| Asthma Day Camp | Metered Dose Inhaler Skill, Time 1 | 4.87 number of correct steps | Standard Deviation 1.54 |
| Health Promotion In-school Class | Metered Dose Inhaler Skill, Time 1 | 5.02 number of correct steps | Standard Deviation 1.46 |
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 frame: Time 2 at 5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Metered Dose Inhaler Skill, Time 2 | 6.48 number of correct steps | Standard Deviation 1.18 |
| Asthma Day Camp | Metered Dose Inhaler Skill, Time 2 | 6.20 number of correct steps | Standard Deviation 1.25 |
| Health Promotion In-school Class | Metered Dose Inhaler Skill, Time 2 | 5.26 number of correct steps | Standard Deviation 1.39 |
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 frame: Time 3 at 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Metered Dose Inhaler Skill, Time 3 | 6.16 number of correct steps | Standard Deviation 1.55 |
| Asthma Day Camp | Metered Dose Inhaler Skill, Time 3 | 6.25 number of correct steps | Standard Deviation 1.24 |
| Health Promotion In-school Class | Metered Dose Inhaler Skill, Time 3 | 5.63 number of correct steps | Standard Deviation 1.55 |
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 frame: Time 4 at 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Metered Dose Inhaler Skill, Time 4 | 6.26 number of correct steps | Standard Deviation 1.37 |
| Asthma Day Camp | Metered Dose Inhaler Skill, Time 4 | 6.30 number of correct steps | Standard Deviation 1.1 |
| Health Promotion In-school Class | Metered Dose Inhaler Skill, Time 4 | 5.38 number of correct steps | Standard Deviation 1.34 |
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.
Time frame: Time 1 at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Lung Inflammation, Time 1 | 1.69 uM | Standard Deviation 2.11 |
| Asthma Day Camp | Lung Inflammation, Time 1 | 2.19 uM | Standard Deviation 2.5 |
| Health Promotion In-school Class | Lung Inflammation, Time 1 | 2.03 uM | Standard Deviation 3.63 |
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.
Time frame: Time 2 at 5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Lung Inflammation, Time 2 | 1.91 uM | Standard Deviation 2.25 |
| Asthma Day Camp | Lung Inflammation, Time 2 | 2.51 uM | Standard Deviation 3.2 |
| Health Promotion In-school Class | Lung Inflammation, Time 2 | 2.11 uM | Standard Deviation 2.56 |
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.
Time frame: Time 3 at 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Lung Inflammation, Time 3 | 1.83 uM | Standard Deviation 3.04 |
| Asthma Day Camp | Lung Inflammation, Time 3 | 2.50 uM | Standard Deviation 3.32 |
| Health Promotion In-school Class | Lung Inflammation, Time 3 | 2.61 uM | Standard Deviation 3.77 |
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.
Time frame: Time 4 at 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma In-school Class | Lung Inflammation, Time 4 | 1.93 uM | Standard Deviation 3.86 |
| Asthma Day Camp | Lung Inflammation, Time 4 | 2.05 uM | Standard Deviation 4.53 |
| Health Promotion In-school Class | Lung Inflammation, Time 4 | 1.97 uM | Standard Deviation 3.06 |