Clinical trial NCT01650844: School-Based Telemedicine Enhanced Asthma Management
Official title: School-Based Telemedicine Enhanced Asthma Management: A Randomized Control Trial Using Novel Technology to Improve Preventive Asthma Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Asthma
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-07-26
Enrollment: 400
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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.

Primary outcomes:
measure: Average Number of Days Without Asthma Symptoms (Symptom Free Days)
timeFrame: Average number of days, over 2 weeks, during peak winter season (November-March), assessed over 4 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.