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临床试验/NCT01650844
NCT01650844已完成不适用

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

University of Rochester2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2012年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
2
主要终点
Average Number of Days Without Asthma Symptoms (Symptom Free Days)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
3 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Physician-diagnosed asthma (based on parent report)
  • 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.
  • Age >=3 and =<10 years
  • Attending school in Rochester City School District preschools or elementary schools

排除标准

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

研究组 & 干预措施

School-based Telemedicine Enhanced Asthma Mangement Group

Experimental

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.

干预措施: School-Based Telemedicine Enhanced Asthma Management (Other)

Enhanced Usual Care Group

Active Comparator

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.

干预措施: Enhanced Usual Care (Other)

结局指标

主要结局

Average Number of Days Without Asthma Symptoms (Symptom Free Days)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jill Halterman

Associate Professor of Pediatrics

University of Rochester

研究点 (2)

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