School-Based Telemedicine Enhanced Asthma Management

Pediatric Asthma Clinical Trial

— SB-TEAM  

Official title:

School-Based Telemedicine Enhanced Asthma Management: A Randomized Control Trial Using Novel Technology to Improve Preventive Asthma Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650844
• Other study ID #: 42495
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Pediatric Asthma

Intervention

Other:
• School-Based Telemedicine Enhanced Asthma Management

• Enhanced Usual Care

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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) — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Number of Days Without Asthma Symptoms (Symptom Free Days)	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.	Average number of days, over 2 weeks, during peak winter season (November-March), assessed over 4 years.