Trial Outcomes & Findings for Telemedicine Enhanced Asthma Management - Uniting Providers (NCT NCT03545906)
NCT ID: NCT03545906
Last Updated: 2025-09-17
Results Overview
Mean number of symptom-free days in the prior 14 days (range 0-14)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
326 participants
Primary outcome timeframe
3 months after baseline
Results posted on
2025-09-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
163
|
163
|
|
Overall Study
COMPLETED
|
139
|
137
|
|
Overall Study
NOT COMPLETED
|
24
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Telemedicine Enhanced Asthma Management - Uniting Providers
Baseline characteristics by cohort
| Measure |
TEAM-UP Intervention Group
n=162 Participants
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.
|
Enhanced Care Comparison Group
n=163 Participants
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.
|
Total
n=325 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.2 years
STANDARD_DEVIATION 2.3 • n=99 Participants
|
8.5 years
STANDARD_DEVIATION 2.5 • n=107 Participants
|
8.35 years
STANDARD_DEVIATION 2.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
195 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
54 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
108 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
212 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
96 Participants
n=99 Participants
|
91 Participants
n=107 Participants
|
187 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
22 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
36 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
162 participants
n=99 Participants
|
163 participants
n=107 Participants
|
325 participants
n=206 Participants
|
|
Public Insurance
|
128 Participants
n=99 Participants
|
132 Participants
n=107 Participants
|
260 Participants
n=206 Participants
|
|
Symptom-free days over 2 weeks
|
6.36 days
STANDARD_DEVIATION 5.1 • n=99 Participants
|
6.84 days
STANDARD_DEVIATION 5.3 • n=107 Participants
|
6.6 days
STANDARD_DEVIATION 5.2 • n=206 Participants
|
PRIMARY outcome
Timeframe: 3 months after baselineMean number of symptom-free days in the prior 14 days (range 0-14)
Outcome measures
| Measure |
TEAM-UP Intervention Group
n=154 Participants
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.
|
Enhanced Care Comparison Group
n=149 Participants
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.
|
|---|---|---|
|
Mean Symptom-Free Days in Prior 14 Days
|
9.21 days
Standard Deviation 4.8
|
8.21 days
Standard Deviation 5.0
|
PRIMARY outcome
Timeframe: 5 months after baselineMean number of symptom-free days in the prior 14 days (range 0-14)
Outcome measures
| Measure |
TEAM-UP Intervention Group
n=147 Participants
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.
|
Enhanced Care Comparison Group
n=150 Participants
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.
|
|---|---|---|
|
Mean Symptom-Free Days in Prior 14 Days
|
10.4 days
Standard Deviation 4.5
|
9.1 days
Standard Deviation 4.8
|
PRIMARY outcome
Timeframe: 7 months after baselineMean number of symptom-free days in the prior 14 days (range 0-14)
Outcome measures
| Measure |
TEAM-UP Intervention Group
n=143 Participants
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.
|
Enhanced Care Comparison Group
n=142 Participants
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.
|
|---|---|---|
|
Mean Symptom-Free Days in Prior 14 Days
|
10.1 days
Standard Deviation 4.9
|
8.9 days
Standard Deviation 5.0
|
PRIMARY outcome
Timeframe: 12 months after baselineMean number of symptom-free days in the prior 14 days (range 0-14)
Outcome measures
| Measure |
TEAM-UP Intervention Group
n=139 Participants
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.
|
Enhanced Care Comparison Group
n=137 Participants
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.
|
|---|---|---|
|
Mean Symptom-Free Days in Prior 14 Days
|
9.6 days
Standard Deviation 5.1
|
8.9 days
Standard Deviation 5.4
|
Adverse Events
TEAM-UP Intervention Group
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Care Comparison Group
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TEAM-UP Intervention Group
n=163 participants at risk
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.
|
Enhanced Care Comparison Group
n=163 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hospitalizations due to asthma
|
7.4%
12/163 • 1 year
|
6.1%
10/163 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place