Telemedicine Enhanced Asthma Management - Uniting Providers
| Status: | Recruiting |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 4 - 12 |
| Updated: | 4/6/2019 |
| Start Date: | November 9, 2018 |
| End Date: | July 2024 |
| Contact: | Maria Fagnano, MPH |
| Email: | maria_fagnano@urmc.rochester.edu |
| Phone: | 585-275-8220 |
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 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 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-, 6-, 9- and 12-months after
baseline, and the primary outcome is the comparison of symptom-free days (SFD) at each
follow-up time point.
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 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 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-, 6-, 9- and 12-months after
baseline, and the primary outcome is the comparison of symptom-free days (SFD) at each
follow-up time point.
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.
We found this trial at
1
site
60 Crittenden Blvd # 70
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Jill S. Halterman, MD, MPH
Phone: 585-275-5798
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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