Clinical trial NCT04089046: Telemedicine Enhanced Asthma Management - Uniting Providers for Teens (TEAM-UP for Teens)
Official title: Telemedicine Enhanced Asthma Management - Uniting Providers for Teens
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma in Children
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: University of Arkansas
First posted: 2019-09-13
Enrollment: 360
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Low-income, minority teenagers have disproportionately high rates of asthma morbidity, including excess risk of emergency department visits, hospitalizations, and death from asthma. Despite well established guidelines, under-treatment for asthma is common, particularly for poor urban teens. This study aims to test a novel, developmentally appropriate and scalable model of care to ensure optimal guideline-based treatment for urban teens with difficult to control asthma. The Telemedicine Enhanced Asthma Management-Uniting Providers for Teens (TEAM-UP for Teens) program includes 3 core components: 1- An individualized asthma management plan developed at the start of the school year via a real-time, synchronous school-based telemedicine visit that directly connects the teen to an asthma specialist, 2- School-based or video supported directly observed therapy (DOT) to implement the medication plan and allow for teens to experience the benefits of consistent therapy, 3- Follow-up telehealth visits with a nurse asthma educator to facilitate ongoing care and provide developmentally appropriate self-management support. This study is a randomized trial of TEAM-UP for Teens vs an enhanced care (EC) control group (n=360, 12-16 years). We will assess the effectiveness of the program in reducing morbidity and improving guideline-based asthma care. Our main hypothesis is that Teens receiving the TEAM-UP for Teens intervention will have more symptom-free days at 3, 5, 7, and 12-months compared to EC. We will assess a number of secondary outcomes, including additional clinical outcomes, functional outcomes, airway inflammation, and receipt of specific care measures including medication adjustments and treatment of and other comorbidities. We will also identify potential mediators and moderators of the intervention effect, and will evaluate the process of intervention implementation. At the completion of the study, the program will be better defined as a sustainable means to improve care and reduce morbidity for high risk teens with difficult to control asthma.


Eligibility criteria: Inclusion Criteria:

1. Physician-diagnosed asthma (based on caregiver report with validation from teen's physician).
2. Moderate-severe persistent severity (requiring Step 3 or higher care) or asthma that is uncontrolled despite therapy
3. Age \>=12 and =\<17 years
4. Residence in the City of Rochester and surrounding metro area.

Exclusion Criteria:

1. Inability to speak and understand either English or Spanish. (\*Participants unable to read will be eligible, and all instruments will be given verbally.)
2. Current participation in an asthma study
3. Planning to move outside of Rochester in less than 6 months
4. If they have received asthma specialist care in the prior 3 months, they will be asked if they would be comfortable seeing an additional asthma specialist for our study if their current specialist is unable to participate in the study. If the family is not comfortable with seeing an additional asthma specialist for the study, they will be excluded.
5. Having other significant medical conditions (congenital heart disease, cystic fibrosis, 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

Primary outcomes:
measure: Mean Symptom Free Days in prior 14 days
timeFrame: 12-month
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Department of Pediatrics, University of Rochester
state: New York
Study officials:
References: