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临床试验/NCT04896502
NCT04896502已完成不适用

Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers

University of Arkansas1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2019年9月26日最近更新:
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
27
试验地点
1
主要终点
Number of Subjects With a Significant Change in D. Pteronyssinus Levels at End of Study Evaluation

研究概览

简要总结

The study is about comparing asthma home assessments/interventions by telemedicine compared to providing education alone. Interactive Video (IAV) defines telemedicine. It allows two-way communication in real-time with both audio and visual communication between the subject and someone from the study team. It is similar to using Face Time on a mobile device. Asthma home assessments/interventions are used to identify things in a home that can make asthma symptoms worse, called triggers. Reducing these triggers in the home can improve asthma.

详细描述

In this study, supplies will be given to some participants to help reduce or remove triggers from the home. One example is dust mites. These are microscopic bugs that are found in every home, cannot be seen by the naked eye, and make asthma symptoms worse. Part of the study includes collecting two dust samples from home to check dust mite levels at the beginning of the study and at the end. This study may help elucidate whether telemedicine home assessments work better than education alone at lowering dust mite levels and improving a child's asthma symptoms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age ≥ 5 years and ≤ 18 years
  • •Have a diagnosis of persistent asthma as defined by national guidelines criteria1
  • •Patient receives care in Arkansas Children's Hospital (ACH) primary care, in patient and/or specialty clinics
  • •Patient has had at least one or more acute exacerbations of asthma within the 12 months prior to enrollment that led to an emergency department visit, hospital admission, or prescription for systemic steroids
  • •English speaking participants/parents
  • •Access to WIFI, smartphone or mobile device (tablet)

排除标准

  • •Age <5 or >18 years
  • •Non-English speaking participants/parents
  • •Patients not receiving primary and/or asthma specialty care or inpatient services at ACH
  • •Inability of patient or family to participate in TM evaluation due to lack of access to WIFI or smartphone or mobile device

研究组 & 干预措施

Telemedicine Arm

Experimental

For the proposed study, participants will randomized to receive TM home assessments/interventions performed by a trained home visitor (HV) or standard of care asthma trigger education by the HV. Those who are randomized to TM home assessments/interventions will complete a baseline home assessment and two follow-up visits, 2 months apart. Visits will assess the presence of potential asthma triggers in the home and frequency of asthma symptoms/exacerbations. TM participants will be provided education and materials necessary to reduce asthma triggers in the home. Follow-up visits will assess the interval change in presence of asthma triggers, change in daily asthma symptoms/exacerbations, and participant/family retention of education.

干预措施: Interactive Video (IAV) Telemedicine (Other)

Standard of Care Education

Active Comparator

For subjects randomized to receive standard of care asthma education, written and verbal information will be provided regarding identification and removal of potential asthma triggers in the home but no formal assessment of the home will be performed, nor will participants in this arm receive trigger reduction materials.

干预措施: Standard of Care Education (Behavioral)

结局指标

主要结局

Number of Subjects With a Significant Change in D. Pteronyssinus Levels at End of Study Evaluation

时间窗: 4 months

Comparison of D. pteronyssinus levels collected in participant homes at baseline and at end of study with measure of number of subjects with a significant change

次要结局

  • Patient Satisfaction(6 months)
  • Differences in ACT Score Between Telemedicine and Standard of Care Groups(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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