Asthma
Conditions
Keywords
Asthma
Brief summary
The goal of this new translational project is to test the feasibility and effectiveness of implementing school-based directly observed therapy of preventive asthma medications in a real-world setting, using state-of-the-art web-based technology for systematic screening, electronic report generation, and communication between nurses, caregivers, and primary care providers. With the use of a novel method to improve adherence and subsequently reduce morbidity, the investigators hypothesize that this novel adaptation of school-based asthma care will; 1) be feasible and acceptable among this population and among school and community stakeholders, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and emergency room / urgent care use for asthma care). The investigators anticipate that enhancing preventive healthcare for young urban children with asthma through partnerships with the schools using a novel technology will yield improved health, prevention of suffering, decreased absenteeism from school, and reduced healthcare costs.
Interventions
OTHERSchool-Based Medication Delivery
For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
(all 4 criteria must be met): 1. Physician-diagnosed asthma (based on parent report). 2. Persistent asthma (criteria based on NHLBI guidelines). Any 1 of the following: 1. An average of \>2 days per week with asthma symptoms 2. \>2 days per week with rescue medication use 3. \>2 days per month with nighttime symptoms 4. ≥2 episodes of asthma during the past year that have required systemic corticosteroids 3. Age ≥3 and ≤10 years. 4. Attending school in participating Rochester City School District preschools or elementary schools.
Exclusion criteria
1. Inability to speak and understand English. (\*Parents unable to read will be eligible, and all instruments will be given verbally.) 2. No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible alternate phone number). 3. Family planning to leave the school district within fewer than 6 months. 4. The child having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures. 5. Children in foster care or other situations in which consent cannot be obtained from a guardian.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Number of Symptom-free Days Over 14 Days; (Symptom-free Days Are Averaged Over 4 Bi-monthly Follow-ups) | Average number of days, over 2 weeks, throughout the school year | The primary outcome is asthma morbidity between groups. We will measure asthma morbidity by looking at the average number of symptom-free days, over 2 weeks, at each bi-monthly follow-up time point over the school year. Number of days without asthma symptoms will be reported by the child's caregiver. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost Effectiveness | one year | We will evaluate the cost effectiveness to implement and sustain the web-based system in schools. We will review the cost of the intervention using three main categories of costs; programmatic costs (costs of initiating and running the program), productivity costs, and medical costs estimated at the individual child level. |
| Feasibility and Acceptability | one year | We will conduct interviews with parents and school nurses to evaluate whether this new program is feasible and acceptable among this population. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| School-Based Medication Group For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year. | 48 |
| Usual Care Group Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians. | 51 |
| Total | 99 |
Baseline characteristics
| Characteristic | Usual Care Group | School-Based Medication Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 51 Participants | 48 Participants | 99 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 6.98 years STANDARD_DEVIATION 1.8 | 7.48 years STANDARD_DEVIATION 1.7 | 7.2 years STANDARD_DEVIATION 1.8 |
| Region of Enrollment United States | 51 participants | 48 participants | 99 participants |
| Sex: Female, Male Female | 19 Participants | 23 Participants | 42 Participants |
| Sex: Female, Male Male | 32 Participants | 25 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 0 / 51 |
| serious Total, serious adverse events | 0 / 48 | 0 / 51 |
Outcome results
Primary
Average Number of Symptom-free Days Over 14 Days; (Symptom-free Days Are Averaged Over 4 Bi-monthly Follow-ups)
The primary outcome is asthma morbidity between groups. We will measure asthma morbidity by looking at the average number of symptom-free days, over 2 weeks, at each bi-monthly follow-up time point over the school year. Number of days without asthma symptoms will be reported by the child's caregiver.
Time frame: Average number of days, over 2 weeks, throughout the school year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| School-Based Medication Group | Average Number of Symptom-free Days Over 14 Days; (Symptom-free Days Are Averaged Over 4 Bi-monthly Follow-ups) | 11.33 Days | Standard Deviation 2.6 |
| Usual Care Group | Average Number of Symptom-free Days Over 14 Days; (Symptom-free Days Are Averaged Over 4 Bi-monthly Follow-ups) | 10.40 Days | Standard Deviation 3.4 |
Secondary
Cost Effectiveness
We will evaluate the cost effectiveness to implement and sustain the web-based system in schools. We will review the cost of the intervention using three main categories of costs; programmatic costs (costs of initiating and running the program), productivity costs, and medical costs estimated at the individual child level.
Time frame: one year
Secondary
Feasibility and Acceptability
We will conduct interviews with parents and school nurses to evaluate whether this new program is feasible and acceptable among this population.
Time frame: one year