Asthma in Children
Conditions
Brief summary
This research study is an innovative school-based program for urban children with moderate to severe persistent or difficult-to-control asthma. The Telemedicine Enhanced Asthma Management-Uniting Providers (TEAM-UP) program enhances a school-based, primary care directed asthma program with specialist-supported care to ensure optimal guideline based treatment. This study is a full-scale randomized trial of TEAM-UP versus an enhanced care comparison group. Primary care physicians (PCP) of all enrolled children (n=360, 4-12 yrs.) will be prompted to initiate directly observed therapy (DOT) of preventive asthma medication through school and to make a specialist referral. For children in the TEAM-UP group, the specialist visits will be facilitated via telemedicine at school. The telemedicine specialist visit will be scheduled after approximately 4 weeks of initiating DOT, in order to allow for accurate guideline-based assessments of medication and care needs once adherence with a daily controller medication is established. There will also be up to 2 telemedicine follow-up specialist visits to assess the child's response to treatment and make needed adjustments. The study will use the existing community infrastructure by implementing both telemedicine and DOT in school, and maintaining collaboration with PCPs. Blinded follow-ups will occur at 3-, 5-, 7- and 12-months after baseline, and the primary outcome is the comparison of symptom-free days (SFD) at each follow-up time point.
Interventions
OTHERTEAM-UP Intervention Group
Children randomly assigned to TEAM-UP will have a telemedicine assisted specialist visit scheduled after 4 weeks of initiating DOT at school, as well as 2 subsequent follow-up visits. The visits will be performed by a specialist in pediatric asthma, to implement guideline-based care. Prescriptions for asthma medications will be prescribed to be delivered as directly observed therapy in school.
OTHEREnhanced Care Comparison
Similar to the TEAM-UP group, children in the Enhanced Care group will receive a symptom assessment and asthma education materials at baseline, and we will contact the PCP by facsimile or email and will recommend DOT of preventive asthma medication through school as well as a referral to specialist. However specialist visits will not be facilitated via telemedicine.
Sponsors
University of Arkansas
University at Buffalo
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Physician-diagnosed asthma (based on parent report with validation from the child's physician). 2. Age \>=4 and =\<12 years. 3. Residence in the City of Rochester and surrounding suburbs, with a. primary residence within the following zip codes: 14445, 14604, 14605, 14606, 14607, 14608, 14609, 14610, 14611, 14612, 14613, 14614, 14615, 14616, 14617, 14618, 14619, 14620, 14621, 14622, 14623, 14624, 14625, 14626. 4. Moderate-severe persistent severity (requiring Step 3 or higher care) or difficult to control asthma despite therapy (based on age-specific NHLBI guidelines).
Exclusion criteria
1. Inability to speak and understand English or Spanish. (\*Parents unable to read will be eligible, and all instruments will be given verbally.) 2. Current participation in an asthma study. 3. Planning to leave the Rochester city school district area in fewer than 6 months. 4. Having received asthma specialist care in the prior 3 months. 5. 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. 6. In foster care or other situations in which consent cannot be obtained from a guardian.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Symptom-Free Days in Prior 14 Days | 3 months after baseline | Mean number of symptom-free days in the prior 14 days (range 0-14) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TEAM-UP Intervention Group TEAM-UP Intervention Group: Children randomly assigned to TEAM-UP will have a telemedicine assisted specialist visit scheduled after approximately 4 weeks of initiating DOT at school, as well as up to 2 subsequent follow-up visits. The visits will be performed by a specialist in pediatric asthma, to implement guideline-based care. Prescriptions for asthma medications will be prescribed to be delivered as directly observed therapy in school. | 162 |
| Enhanced Care Comparison Group Enhanced Care Comparison: Similar to the TEAM-UP group, children in the Enhanced Care group will receive a symptom assessment and asthma education materials at baseline, and we will contact the PCP by facsimile or email and will recommend DOT of preventive asthma medication through school as well as a referral to specialist. However specialist visits will not be facilitated via telemedicine. | 163 |
| Total | 325 |
Baseline characteristics
| Characteristic | Total | Enhanced Care Comparison Group | TEAM-UP Intervention Group |
|---|---|---|---|
| Age, Continuous | 8.35 years STANDARD_DEVIATION 2.4 | 8.5 years STANDARD_DEVIATION 2.5 | 8.2 years STANDARD_DEVIATION 2.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 113 Participants | 59 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 212 Participants | 104 Participants | 108 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Public Insurance | 260 Participants | 132 Participants | 128 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 187 Participants | 91 Participants | 96 Participants |
| Race (NIH/OMB) More than one race | 50 Participants | 28 Participants | 22 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 70 Participants | 34 Participants | 36 Participants |
| Race (NIH/OMB) White | 17 Participants | 9 Participants | 8 Participants |
| Region of Enrollment United States | 325 participants | 163 participants | 162 participants |
| Sex: Female, Male Female | 130 Participants | 68 Participants | 62 Participants |
| Sex: Female, Male Male | 195 Participants | 95 Participants | 100 Participants |
| Symptom-free days over 2 weeks | 6.6 days STANDARD_DEVIATION 5.2 | 6.84 days STANDARD_DEVIATION 5.3 | 6.36 days STANDARD_DEVIATION 5.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 163 | 0 / 163 |
| other Total, other adverse events | 0 / 163 | 0 / 163 |
| serious Total, serious adverse events | 12 / 163 | 10 / 163 |
Outcome results
Primary
Mean Symptom-Free Days in Prior 14 Days
Mean number of symptom-free days in the prior 14 days (range 0-14)
Time frame: 3 months after baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TEAM-UP Intervention Group | Mean Symptom-Free Days in Prior 14 Days | 9.21 days | Standard Deviation 4.8 |
| Enhanced Care Comparison Group | Mean Symptom-Free Days in Prior 14 Days | 8.21 days | Standard Deviation 5 |
p-value: 0.075t-test, 2 sided
Primary
Mean Symptom-Free Days in Prior 14 Days
Mean number of symptom-free days in the prior 14 days (range 0-14)
Time frame: 5 months after baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TEAM-UP Intervention Group | Mean Symptom-Free Days in Prior 14 Days | 10.4 days | Standard Deviation 4.5 |
| Enhanced Care Comparison Group | Mean Symptom-Free Days in Prior 14 Days | 9.1 days | Standard Deviation 4.8 |
p-value: 0.018t-test, 2 sided
Primary
Mean Symptom-Free Days in Prior 14 Days
Mean number of symptom-free days in the prior 14 days (range 0-14)
Time frame: 7 months after baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TEAM-UP Intervention Group | Mean Symptom-Free Days in Prior 14 Days | 10.1 days | Standard Deviation 4.9 |
| Enhanced Care Comparison Group | Mean Symptom-Free Days in Prior 14 Days | 8.9 days | Standard Deviation 5 |
p-value: 0.039t-test, 2 sided
Primary
Mean Symptom-Free Days in Prior 14 Days
Mean number of symptom-free days in the prior 14 days (range 0-14)
Time frame: 12 months after baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TEAM-UP Intervention Group | Mean Symptom-Free Days in Prior 14 Days | 9.6 days | Standard Deviation 5.1 |
| Enhanced Care Comparison Group | Mean Symptom-Free Days in Prior 14 Days | 8.9 days | Standard Deviation 5.4 |
p-value: 0.265t-test, 2 sided