Adaptations to the RVA Breathes clinical trial due to the COVID-19 pandemic.

Adaptations to the RVA Breathes clinical trial due to the COVID-19 pandemic.
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DOI:
10.1016/j.conctc.2021.100871
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发表时间:
2021-12
影响因子:
1.5
通讯作者:
Schechter MS
Schechter MS
中科院分区:
其他
文献类型:
--
作者:
Everhart RS;Dempster KW;Withers D;Mazzeo SE;Corona R;Thacker LR 2nd;Schechter MS

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RVA呼吸是一个社区项目,旨在改善生活在低收入城市地区儿童的哮喘管理和护理协调,目前正在一项随机临床试验中进行评估。2020年3月,由于COVID-19大流行,RVA呼吸被转换为远程计划;本报告提供了对RVA呼吸试验所做修改的最新情况。此外,鉴于参与项目的家庭在地方和国家层面受到COVID-19和重大社会动荡的不成比例的影响,本文概述了招募和吸引在此期间承受不成比例沉重负担的家庭参与试验的策略。2020年4月开始为在2019冠状病毒病发病前参加该计划的家庭提供远程会议(电话或视频);2020年7月,新家庭开始使用经调整的同意程序远程登记。基线、干预和随访会议根据家庭偏好通过电话或视频进行。实施了一些策略,以吸引照顾者和儿童通过电话或视频而不是亲自完成措施。使用非接触式程序将有形的干预材料和参与者的付款送到家庭家中。尽管大流行带来的健康风险和社会隔离任务增加,但我们的团队能够通过过渡到远程模式,适应并安全地继续进行一项大型社区临床试验。在确定RVA呼吸作为一个远程项目是否对儿童哮喘产生与面对面干预相同的影响方面仍然存在挑战。
RVA Breathes, a community program to improve asthma management and care coordination among children living in a low-income, urban area, is being evaluated in a randomized clinical trial. In March 2020, RVA Breathes was converted to a remote program due to the COVID-19 pandemic; this report provides an update on the modifications made to the RVA Breathes trial. Additionally, given that families in the program have been disproportionally impacted by both COVID-19 and significant social unrest at both the local and national level, strategies used to enroll and engage families in the trial who bore disproportionately high burdens during this time period are outlined. Remote sessions (telephone or video) for families enrolled in the program prior to the onset of COVID-19 began in April 2020; enrollment of new families began remotely in July 2020 using adapted consent procedures. Baseline, intervention, and follow-up sessions were delivered either via the telephone or video depending upon family preference. Strategies were implemented to engage caregivers and children in completing measures over the telephone or video versus in person. Tangible intervention materials and participant payments were dropped off at family homes using contactless procedures. Our team was able to adapt and safely continue a large, community-based clinical trial, despite the increased health risks and social isolation mandates from the pandemic, by transitioning to a remote format. Challenges remain in determining whether RVA Breathes as a remote program has had the same impact on child asthma as the face-to-face interventions that comprised its original format.
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发表时间: 2020-07
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