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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01650844
Other study ID # 42495
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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