Telehealth Enhanced Asthma Management (TEAM)
2020年10月6日 更新者：Arkansas Children's Hospital Research Institute
This study will conduct a 12-month randomized trial with 48 pediatric patients (aged 6-18 years) with persistent asthma to compare outcomes among patients with follow-up visits managed via telemedicine (TM) vs. in-person (IP) visits.
研究概览
详细说明
The overarching hypothesis is that utilization of TM for asthma follow-up will result in improved clinical outcomes such as Asthma Control Test (ACT) scores, lung function and medication adherence compared to participants receiving IP follow-up care.
The Investigator also hypothesize that TM follow-up will result in higher caregiver satisfaction because families will be able to receive quality subspecialty care in their community (TM) compared to those who travel a distance to receive care (IP).
研究类型
介入性
注册 (实际的)
15
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Arkansas
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Little Rock、Arkansas、美国、72202
- Arkansas Children's Hospital Research Institute
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
6年 至 18年 (孩子、成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- age ≥6- and ≤18 years
- persistent asthma as defined by national guidelines standards
- receives care at an ACH asthma subspecialty clinic
- reside ≤1.5 hour drive from Jonesboro, Springdale, Texarkana, or Fort Smith, AR
Exclusion Criteria:
- Significant underlying respiratory disease other than asthma, such as cystic fibrosis
- significant co-morbid conditions, such as individuals with developmental or physical impairments that could interfere with the ability to communicate via interactive video
- current smoker
- severe asthma exacerbation requiring intubation in the past 12 months
- no access to a smartphone or internet
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Telemedicine Group
Telemedicine participants will have asthma subspecialty follow-up visits conducted via real-time audio and video conferencing in conjunction with electronic examination peripherals and remote pulmonary function testing (PFT).
Participants will receive a survey link to complete an electronic survey to assess Asthma Control Test (ACT) score, healthcare utilization, and satisfaction.
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Pediatric patients with persistent asthma will be recruited to compare outcomes among patients with follow-up visits managed via telemedicine vs. in-person visits.
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有源比较器：In-Person Group
In-Person participants will have asthma subspecialty follow-up visits at a subspecialty clinic.
They will receive pulmonary function testing (PFT).
Participants will receive a survey link to complete an electronic survey to assess Asthma Control Test (ACT) score, healthcare utilization, and satisfaction.
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Pediatric patients with persistent asthma will be recruited to compare outcomes among patients with follow-up visits managed via telemedicine vs. in-person visits.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean difference in ACT score at the final assessment (12 months) after adjusting for baseline
大体时间：At baseline and 12 months
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ACT is used for symptoms monitoring as per guidelines and has been identified as an appropriate asthma control composite score in clinical research.
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At baseline and 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Routine Follow up Asthma Visit
大体时间：At baseline, 4 months, 8 months, 12 months
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Physical examination to assess current asthma problems, symptoms, medication and the child's overall health.
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At baseline, 4 months, 8 months, 12 months
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Lung Function via Spirometry
大体时间：Baseline and 12 months
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Spirometry
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Baseline and 12 months
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Airway Inflammation via Spirometry
大体时间：Baseline and 12 months
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Spirometry
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Baseline and 12 months
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Healthcare Utilization
大体时间：At baseline, 4 months, 8 months, 12 months
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Patient report of the number of acute exacerbation in the past 12 months resulting in hospitalizations, emergency room or sick visits or steroid use.
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At baseline, 4 months, 8 months, 12 months
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Medication Adherence
大体时间：At baseline, 4 months, 8 months, 12 months
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Adherence will be defined as receiving ≥3 controller medication refills/6 months or achieving an Asthma Medication Ratio (AMR) of ≥0.5 based on national asthma guidelines.
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At baseline, 4 months, 8 months, 12 months
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Rescue Medication Use
大体时间：At baseline, 4 months, 8 months, 12 months
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Assessment of rescue medication use by caregiver report.
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At baseline, 4 months, 8 months, 12 months
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Clinic Visit Attendance Rate
大体时间：At baseline, 4 months, 8 months, 12 months
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Participant clinic attendance / Completion rate for Telemedicine and In-Person group.
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At baseline, 4 months, 8 months, 12 months
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Visit Satisfaction
大体时间：At baseline, 4 months, 8 months, 12 months
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Participant report of satisfaction with asthma follow up visit
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At baseline, 4 months, 8 months, 12 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Tamara T. Perry, MD、Arkansas Children's Research Institute
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年3月6日
初级完成 (实际的)
2019年8月8日
研究完成 (实际的)
2019年10月1日
研究注册日期
首次提交
2018年1月9日
首先提交符合 QC 标准的
2018年1月22日
首次发布 (实际的)
2018年1月29日
研究记录更新
最后更新发布 (实际的)
2020年10月8日
上次提交的符合 QC 标准的更新
2020年10月6日
最后验证
2020年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.