Telemedicine Enhanced Asthma Management - Uniting Providers (TEAM-UP)
Primary Purpose
Asthma in Children
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TEAM-UP Intervention Group
Enhanced Care Comparison
Sponsored by
About this trial
This is an interventional health services research trial for Asthma in Children
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, 14626.
- 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.
Sites / Locations
- University of RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TEAM-UP Intervention Group
Enhanced Care Comparison Group
Arm Description
Outcomes
Primary Outcome Measures
Mean Symptom-Free Days in prior 14 days
Mean number of symptom-free days in the prior 14 days (range 0-14)
Mean Symptom-Free Days in prior 14 days
Mean number of symptom-free days in the prior 14 days (range 0-14)
Mean Symptom-Free Days in prior 14 days
Mean number of symptom-free days in the prior 14 days (range 0-14)
Mean Symptom-Free Days in prior 14 days
Mean number of symptom-free days in the prior 14 days (range 0-14)
Secondary Outcome Measures
Full Information
NCT ID
NCT03545906
First Posted
May 17, 2018
Last Updated
April 4, 2023
Sponsor
University of Rochester
Collaborators
University of Arkansas, University at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT03545906
Brief Title
Telemedicine Enhanced Asthma Management - Uniting Providers
Acronym
TEAM-UP
Official Title
Telemedicine Enhanced Asthma Management - Uniting Providers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2018 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
University of Arkansas, University at Buffalo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
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 Intervention Group
Arm Type
Experimental
Arm Title
Enhanced Care Comparison Group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
TEAM-UP Intervention Group
Intervention Description
Children randomly assigned to TEAM-UP will have a telemedicine assisted specialist visit scheduled after 4 weeks of initiating DOT at school, as well as 2 subsequent follow-up visits. The visits will be performed by a specialist in pediatric asthma, to implement guideline-based care. Prescriptions for asthma medications will be prescribed to be delivered as directly observed therapy in school.
Intervention Type
Other
Intervention Name(s)
Enhanced Care Comparison
Intervention Description
Similar to the TEAM-UP group, children in the Enhanced Care group will receive a symptom assessment and asthma education materials at baseline, and we will contact the PCP by facsimile or email and will recommend DOT of preventive asthma medication through school as well as a referral to specialist. However specialist visits will not be facilitated via telemedicine.
Primary Outcome Measure Information:
Title
Mean Symptom-Free Days in prior 14 days
Description
Mean number of symptom-free days in the prior 14 days (range 0-14)
Time Frame
3 months after baseline
Title
Mean Symptom-Free Days in prior 14 days
Description
Mean number of symptom-free days in the prior 14 days (range 0-14)
Time Frame
6 months after baseline
Title
Mean Symptom-Free Days in prior 14 days
Description
Mean number of symptom-free days in the prior 14 days (range 0-14)
Time Frame
9 months after baseline
Title
Mean Symptom-Free Days in prior 14 days
Description
Mean number of symptom-free days in the prior 14 days (range 0-14)
Time Frame
12 months after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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, 14626.
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.
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
First Name & Middle Initial & Last Name or Official Title & Degree
Reynaldo Tajon
Phone
585-276-5141
Email
reynaldo_tajon@urmc.rochester.edu
Facility Information:
Facility Name
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
Jill S Halterman, MD, MPH
Phone
585-275-5798
Email
jill_halterman@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Jill S. Halterman, MD, MPH
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Telemedicine Enhanced Asthma Management - Uniting Providers
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