Telemedicine Enhanced Asthma Management - Uniting Providers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Asthma in Children
- Sponsor
- University of Rochester
- Enrollment
- 326
- Locations
- 1
- Primary Endpoint
- Mean Symptom-Free Days in Prior 14 Days
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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.
Investigators
Jill Halterman
Professor
University of Rochester
Eligibility Criteria
Inclusion Criteria
- •Physician-diagnosed asthma (based on parent report with validation from the child's physician).
- •Age \>=4 and =\<12 years.
- •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,
- •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
- •Inability to speak and understand English or Spanish. (\*Parents unable to read will be eligible, and all instruments will be given verbally.)
- •Current participation in an asthma study.
- •Planning to leave the Rochester city school district area in fewer than 6 months.
- •Having received asthma specialist care in the prior 3 months.
- •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.
- •In foster care or other situations in which consent cannot be obtained from a guardian.
Outcomes
Primary Outcomes
Mean Symptom-Free Days in Prior 14 Days
Time Frame: 12 months after baseline
Mean number of symptom-free days in the prior 14 days (range 0-14)