Childhood Asthma
Conditions
Brief summary
The investigators hypothesize that school-based, direct supervision of daily controller therapy will result in more effective asthma control, as assessed by the Asthma Control Questionnaire than usual care. Additionally, as the result of enhanced asthma control and resulting decrease in health care utilization, school-based, direct supervision of daily controller therapy will result in lower cost per quality-adjusted life year (QALY) gained than usual care.
Detailed description
This research is being done to test if children with asthma will have fewer asthma symptoms if they are monitored at school to make sure they take their inhaled steroid medication (ICS) every day and take the medication the right way. All of the children with asthma in the school will be asked to participate. In the first year in one-half of the schools, children and school staff will participate in a standardized asthma education program presented by the American Lung Association (ALA). Children will have daily monitoring of their inhaled asthma medication. The other half of schools will continue with the usual treatment of children with asthma. In the second year of the study, all schools and children will have the asthma education program and monitoring. Parents will be queried quarterly for information about their child's asthma.
Interventions
Therapy observed daily in school. Asthma education by American Lung Association
Sponsors
Study design
Eligibility
Inclusion criteria
* A child with asthma attending a Tucson Unified School District elementary school selected for the study.
Exclusion criteria
* No asthma. * Not attending a Tucson Unified School District elementary school selected for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | 1 year | An ACQ score of \> 1.5 means asthma is not well controlled. An ACQ score of \<= 1.5 means asthma is well controlled. Missing ACQ score = number of participants not administered an ACQ |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Regular Therapy Regular Asthma Therapy | 192 |
| Supervised Therapy Supervised asthma therapy in schools
Supervised asthma therapy in schools: Therapy observed daily in school. Asthma education by American Lung Association | 250 |
| Total | 442 |
Baseline characteristics
| Characteristic | Regular Therapy | Supervised Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 192 Participants | 250 Participants | 442 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 128 Participants | 168 Participants | 296 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 57 Participants | 105 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants | 25 Participants | 41 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 12 Participants | 32 Participants | 44 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 24 Participants | 41 Participants |
| Race (NIH/OMB) More than one race | 62 Participants | 66 Participants | 128 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants | 34 Participants | 53 Participants |
| Race (NIH/OMB) White | 78 Participants | 92 Participants | 170 Participants |
| Sex: Female, Male Female | 72 Participants | 88 Participants | 160 Participants |
| Sex: Female, Male Male | 120 Participants | 162 Participants | 282 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 192 | 0 / 250 |
| serious Total, serious adverse events | 0 / 192 | 0 / 250 |
Outcome results
The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)
An ACQ score of \> 1.5 means asthma is not well controlled. An ACQ score of \<= 1.5 means asthma is well controlled. Missing ACQ score = number of participants not administered an ACQ
Time frame: 1 year
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Regular Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 1 | ACQ score >1.5 (not well controlled) | 54 Participants |
| Regular Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 1 | ACQ score <=1.5(well controlled) | 74 Participants |
| Regular Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 1 | missing ACQ score | 64 Participants |
| Regular Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 2 | ACQ score >1.5 (not well controlled) | 56 Participants |
| Regular Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 2 | ACQ score <=1.5(well controlled) | 75 Participants |
| Regular Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 2 | missing ACQ score | 61 Participants |
| Regular Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 3 | ACQ score >1.5 (not well controlled) | 55 Participants |
| Regular Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 3 | ACQ score <=1.5(well controlled) | 75 Participants |
| Regular Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 3 | missing ACQ score | 62 Participants |
| Regular Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 4 | ACQ score >1.5 (not well controlled) | 60 Participants |
| Regular Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 4 | ACQ score <=1.5(well controlled) | 77 Participants |
| Regular Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 4 | missing ACQ score | 55 Participants |
| Supervised Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 4 | ACQ score <=1.5(well controlled) | 123 Participants |
| Supervised Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 1 | ACQ score >1.5 (not well controlled) | 70 Participants |
| Supervised Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 3 | ACQ score >1.5 (not well controlled) | 65 Participants |
| Supervised Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 1 | ACQ score <=1.5(well controlled) | 95 Participants |
| Supervised Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 4 | ACQ score >1.5 (not well controlled) | 65 Participants |
| Supervised Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 1 | missing ACQ score | 85 Participants |
| Supervised Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 3 | ACQ score <=1.5(well controlled) | 116 Participants |
| Supervised Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 2 | ACQ score >1.5 (not well controlled) | 73 Participants |
| Supervised Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 4 | missing ACQ score | 62 Participants |
| Supervised Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 2 | ACQ score <=1.5(well controlled) | 99 Participants |
| Supervised Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 3 | missing ACQ score | 69 Participants |
| Supervised Therapy | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | Visit 2 | missing ACQ score | 78 Participants |