School-Based Telemedicine Enhanced Asthma Management (SB-TEAM)

• ClinicalTrials.gov Identifier: NCT01650844
• Recruitment Status: Completed
• First Posted: July 26, 2012
• Results First Posted: April 17, 2018
• Last Update Posted: September 28, 2018
• Sponsor: University of Rochester
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Jill Halterman, University of Rochester

Study Description

Brief Summary:

This project aims to improve guideline-based asthma care using enhanced communication and screening tools, telemedicine and directly observed therapy of preventive medications in city schools. Web-based screening will be used to identify children with persistent or poorly controlled asthma and to send reports to the child's primary care doctor. Children in the SB-TEAM group will receive a telemedicine asthma assessment in school and be prescribed a daily preventive asthma medication to be taken through school-based directly observed therapy. The overall aim of this study is to evaluate the use of the SB-TEAM intervention for improving guideline based care, enhancing adherence to effective preventive medications and at reducing morbidity among young urban children with asthma.

Condition or disease	Intervention/treatment	Phase
Pediatric Asthma	Other: School-Based Telemedicine Enhanced Asthma Management; Other: Enhanced Usual Care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: School-Based Telemedicine Enhanced Asthma Management: A Randomized Control Trial Using Novel Technology to Improve Preventive Asthma Care
• Study Start Date: August 2012
• Actual Primary Completion Date: July 2017
• Actual Study Completion Date: July 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: School-based Telemedicine Enhanced Asthma Mangement Group; We will use a web-based system to assess asthma severity or control and will send a symptom report to the child's primary care physician (PCP). Children randomized to the SB-TEAM group, will receive a telemedicine visit in the school health office at the start of the school year to provide an initial asthma assessment. The telemedicine provider will deliver brief asthma education and referrals to community resources, and will send a guideline-based preventive medication prescription electronically to a local pharmacy. The pharmacy will deliver the medications to home and school, and the school nurse will administer the medication as directly observed therapy throughout the school year. Follow-up telemedicine assessments will occur twice during the study period. These follow-up visits will focus on assessment of control, assessment of ongoing triggers or co-morbid conditions, and brief asthma education.	Other: School-Based Telemedicine Enhanced Asthma Management
Active Comparator: Enhanced Usual Care Group; Children randomized to the enhanced usual care group will receive a symptom assessment using national care guidelines, a recommendation for appropriate preventive medications, and asthma education materials. We will use the web-based system to send a symptom report to the child's PCP with guideline-based recommendations for preventive care. We will provide systematic feedback to the family and providers at the same intervals as in the SB-TEAM group's telemedicine visits, by prompting providers to use care guidelines, and caregivers to schedule recommended follow-up visits with the PCP.	Other: Enhanced Usual Care

Outcome Measures

Primary Outcome Measures :

1. Average Number of Days Without Asthma Symptoms (Symptom Free Days) [ Time Frame: Average number of days, over 2 weeks, during peak winter season (November-March), assessed over 4 years. ]
   The primary outcome measure is asthma morbidity between groups. We will measure asthma morbidity by looking at the average number of days without asthma symptoms (symptom free days) over 2 weeks, during each follow-up assessment during the peak winter season (November-March). Symptom free days are defined as 24 hour periods of no asthma symptoms including, coughing, wheezing, tightness in the chest or shortness of breath. The number of symptom free days will be reported by the child's caregiver.

Eligibility Criteria

• Ages Eligible for Study: 3 Years to 10 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Physician-diagnosed asthma (based on parent report)

2. Persistent asthma or poor asthma control (based on NHLBI guidelines). Any 1 of the following:

   • In past month, >2 days per week with asthma symptoms
   • >2 days per week with rescue medication use
   • >2 days per month with nighttime symptoms
   • >=2 asthma episodes during the past year that required systemic corticosteroids.
3. Age >=3 and =<10 years
4. Attending school in Rochester City School District preschools or elementary schools

Exclusion Criteria:

1. Inability to speak and understand English or Spanish
2. No access to a phone for follow-up surveys
3. Family planning to leave the district within fewer than 6 months.
4. The child 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.
5. Children in foster care or other situations in which consent cannot be obtained from a guardian.

Contacts and Locations

Locations

United States, New York

University of Rochester

Rochester, New York, United States, 14642

Sponsors and Collaborators

University of Rochester

National Heart, Lung, and Blood Institute (NHLBI)

  Study Documents (Full-Text)

Documents provided by Jill Halterman, University of Rochester:

Study Protocol and Statistical Analysis Plan  [PDF] July 11, 2017

More Information

Publications of Results:

Halterman JS, Fagnano M, Tajon RS, Tremblay P, Wang H, Butz A, Perry TT, McConnochie KM. Effect of the School-Based Telemedicine Enhanced Asthma Management (SB-TEAM) Program on Asthma Morbidity: A Randomized Clinical Trial. JAMA Pediatr. 2018 Mar 5;172(3):e174938. doi: 10.1001/jamapediatrics.2017.4938. Epub 2018 Mar 5.

Other Publications:

Halterman JS, Tajon R, Tremblay P, Fagnano M, Butz A, Perry TT, McConnochie KM. Development of School-Based Asthma Management Programs in Rochester, New York: Presented in Honor of Dr Robert Haggerty. Acad Pediatr. 2017 Aug;17(6):595-599. doi: 10.1016/j.acap.2017.04.008. Epub 2017 Apr 18. Review.

Holderness H, Chin N, Ossip DJ, Fagnano M, Reznik M, Halterman JS. Physical activity, restrictions in activity, and body mass index among urban children with persistent asthma. Ann Allergy Asthma Immunol. 2017 Apr;118(4):433-438. doi: 10.1016/j.anai.2017.01.014. Epub 2017 Mar 6.

• Responsible Party: Jill Halterman, Associate Professor of Pediatrics, University of Rochester
• ClinicalTrials.gov Identifier: NCT01650844
• Other Study ID Numbers: 42495
• First Posted: July 26, 2012
• Results First Posted: April 17, 2018
• Last Update Posted: September 28, 2018
• Last Verified: August 2018

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases