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Telemedicine Enhanced Asthma Management - Uniting Providers for Teens (TEAM-UP for Teens)

Primary Purpose

Asthma in Children

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TEAM-UP for Teens
Enhanced Care (EC)
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma in Children

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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 =<16 years
  4. Residence in the City of Rochester

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. Received specialist care in prior 3 months
  4. Planning to move outside of Rochester in less than 6 months
  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

Sites / Locations

  • Department of Pediatrics, University of RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TEAM-UP for Teens Intervention

Enhanced Care Comparison

Arm Description

TEAM-UP for Teens pairs school-based and video-supported directly observed therapy (DOT) of daily preventive asthma medications with specialist care and ongoing self-management support using live, real-time telemedicine through school.

Teens in the EC group will receive a symptom assessment and asthma education materials at baseline, and their PCPs will be contacted by facsimile or email to recommend DOT of preventive asthma medication through school as well as referral to an asthma specialist. Systematic reminders will be sent to the family and PCPs to schedule recommended healthcare visits and consider specialist referral at the same intervals as the TEAM-UP group's virtual visits.

Outcomes

Primary Outcome Measures

Mean Symptom Free Days in prior 14 days
Mean Symptom Free Days will be calculated as a mean using data collected at 3-, 5-, 7- and 12-months post baseline. Caregivers and teens will report the number of days the teen experienced no symptoms of asthma (defined as 24 hrs with no coughing, wheezing, shortness of breath, and no need for rescue medicine) in the past 2 weeks (range 0-14).

Secondary Outcome Measures

Full Information

First Posted
September 10, 2019
Last Updated
March 29, 2023
Sponsor
University of Rochester
Collaborators
Johns Hopkins University, University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT04089046
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2021 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Johns Hopkins University, University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TEAM-UP for Teens Intervention
Arm Type
Experimental
Arm Description
TEAM-UP for Teens pairs school-based and video-supported directly observed therapy (DOT) of daily preventive asthma medications with specialist care and ongoing self-management support using live, real-time telemedicine through school.
Arm Title
Enhanced Care Comparison
Arm Type
Active Comparator
Arm Description
Teens in the EC group will receive a symptom assessment and asthma education materials at baseline, and their PCPs will be contacted by facsimile or email to recommend DOT of preventive asthma medication through school as well as referral to an asthma specialist. Systematic reminders will be sent to the family and PCPs to schedule recommended healthcare visits and consider specialist referral at the same intervals as the TEAM-UP group's virtual visits.
Intervention Type
Behavioral
Intervention Name(s)
TEAM-UP for Teens
Intervention Description
TEAM-UP for Teens pairs school-based directly observed therapy (DOT) of daily preventive asthma medications with specialist care and ongoing self-management support using live, real-time telemedicine through school.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Care (EC)
Intervention Description
Teens in the EC group will receive a symptom assessment and asthma education materials at baseline, and their PCPs will be contacted by facsimile or email to recommend DOT of preventive asthma medication through school as well as referral to an asthma specialist. Systematic reminders will be sent to the family and PCPs to schedule recommended healthcare visits and consider specialist referral at the same intervals as the TEAM-UP group's virtual visits.
Primary Outcome Measure Information:
Title
Mean Symptom Free Days in prior 14 days
Description
Mean Symptom Free Days will be calculated as a mean using data collected at 3-, 5-, 7- and 12-months post baseline. Caregivers and teens will report the number of days the teen experienced no symptoms of asthma (defined as 24 hrs with no coughing, wheezing, shortness of breath, and no need for rescue medicine) in the past 2 weeks (range 0-14).
Time Frame
12-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Physician-diagnosed asthma (based on caregiver report with validation from teen's physician). Moderate-severe persistent severity (requiring Step 3 or higher care) or asthma that is uncontrolled despite therapy Age >=12 and =<17 years Residence in the City of Rochester and surrounding metro area. Exclusion Criteria: Inability to speak and understand either English or Spanish. (*Participants unable to read will be eligible, and all instruments will be given verbally.) Current participation in an asthma study Planning to move outside of Rochester in less than 6 months 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. Having other significant medical conditions (congenital heart disease, cystic fibrosis, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Fagnano, MPH
Phone
585-275-8220
Email
maria_fagnano@urmc.rochester.edu
Facility Information:
Facility Name
Department of Pediatrics, University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Fagnano, MPH
Phone
585-275-8220
Email
maria_fagnano@urmc.rochester.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data sets to be submitted to the NHLBI Data Repository will include baseline, follow up visit, procedural based data, and outcome data. Prior to providing data, patient identifiers will be deleted, original identification numbers will be replaced with new, randomized identification numbers, dates will be coded relative to date of enrollment, and identifiers will be removed. Variables such as socioeconomic and demographic data, household and family composition, anthropometric measures, prior medical conditions, and parent and teen medical history will be grouped or recoded.

Learn more about this trial

Telemedicine Enhanced Asthma Management - Uniting Providers for Teens (TEAM-UP for Teens)

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