Telemedicine for Childhood Asthma
(TEAM-UP Trial)

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Rochester

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for urban children aged 4-12 with moderate to severe asthma or difficult-to-control asthma, living in specific areas of Rochester. They must not be currently in another asthma study, planning to move soon, have seen an asthma specialist recently, be in foster care without guardian consent, or have other major health issues like heart disease.

Inclusion Criteria

My asthma is severe and hard to control despite treatment.

My child's doctor has diagnosed them with asthma.

I am between 4 and 12 years old.

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Exclusion Criteria

I do not have major health issues like heart or severe lung diseases that could affect asthma evaluation.

I have seen an asthma specialist in the last 3 months.

Inability to speak and understand English or Spanish (*Parents unable to read will be eligible, and all instruments will be given verbally)

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Treatment Details

Interventions

Enhanced Care Comparison (Behavioural Intervention)
Telemedicine Enhanced Asthma Management-Uniting Providers (TEAM-UP) program (Behavioural Intervention)

Trial OverviewThe TEAM-UP program is being tested against enhanced care. It includes a school-based system where primary care doctors start treatment and refer kids to specialists who then use telemedicine for check-ups. The goal is to see if this improves the number of symptom-free days over a year.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: TEAM-UP Intervention GroupExperimental Treatment1 Intervention

Group II: Enhanced Care Comparison GroupActive Control1 Intervention