跳至主要内容
临床试验/NCT03877744
NCT03877744已完成不适用

Using Interactive Virtual Presence to Remotely Assist Parents With Child Restraint Installations

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 1,498 人开始时间: 2020年1月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,498
试验地点
2
主要终点
Percentage of Inspection Points Correctly Installed From Pre Installation to Post Installation

研究概览

简要总结

Motor vehicle crashes cause the death of an American child every 3 hours, more than any other cause. When installed correctly, car seats reduce risk of serious injury and death to infants and young children. Unfortunately, a large portion of child restraints is installed incorrectly. A network of trained technicians work across the country to assist parents in achieving correct use of child restraints through scheduled "car seat checks," where technicians work with parents to install restraints in their vehicles. Car seat checks are effective in reducing errors in child restraint installations. However, the services are highly underutilized.

The present study evaluates use of interactive virtual presence technology (also called interactive merged reality) to remotely assist parents to install child restraints correctly into their vehicles. Building from small pilot studies on the topic, the investigators will conduct a randomized non-inferiority trial to evaluate whether parents who install child restraints while communicating with a remote expert technician via interactive virtual presence achieve installations and learning that are not inferior in their safety to parents who install restraints live with a remote technician onsite.

The investigators will recruit 1476 parents at 7 locations nationwide and randomly assign consenting parents to install their child restraint either via interactive virtual presence or with a live technician. The correctness of installation safety will be assessed using objective checklists, both following installation and again four months later. The investigators aim to demonstrate that child restraint installation is accurate (>90% correct) when conducted remotely via interactive virtual presence, that such installations are not inferior to the accuracy of installation with a live on-site expert, and that parents learn and retain information about correct child restraint installation.

详细描述

Motor vehicle crashes cause the death of an American child every 3 hours, more than any other cause. When installed correctly, car seats (also called "child restraints") reduce risk of serious injury and death to infants and young children roughly threefold. Unfortunately, a large portion of child restraints is installed incorrectly. A network of trained technicians, many affiliated with Safe Kids Worldwide, work across the country to assist parents in achieving correct use of child restraints through scheduled "car seat checks," where technicians work with parents to install restraints in their vehicles. Car seat checks are effective in reducing errors in child restraint installations. However, the services are highly underutilized due to barriers in access, scheduling complications, and resources to staff the car seat checks sufficiently to meet demand.

The present study evaluates use of interactive virtual presence technology (also called interactive merged reality) - joint and simultaneous remote verbal and visual interaction and exposure to the same 3D stimuli - to remotely assist parents to install child restraints correctly into their vehicles. If effective, this technology could supplement or replace car seat checks, significantly reduce the number of errors made in car seat installations nationwide, and revolutionize how government, industry, and non-profit agencies help parents install restraints.

Building from small pilot studies on the topic, the investigators propose a large randomized non-inferiority trial to evaluate whether parents, including especially underserved parents in rural areas and/or of underrepresented racial or ethnic minority background, who install child restraints while communicating with a remote expert technician via interactive virtual presence achieve installations and learning that are not inferior in their safety to parents who install restraints live with a remote technician onsite. Non-inferiority trials are a type of randomized trial whereby a novel treatment (in this case, interactive virtual presence to install child restraints) is compared to an existing treatment known to be effective (in this case, live one-on-one installation of restraints) to demonstrate the novel treatment does not perform inferiorly to the existing treatment known to be effective.

To accomplish the study goals, the investigators will recruit 1476 parents at 7 Safe Kids locations nationwide and randomly assign consenting parents to install their child restraint either via interactive virtual presence or with a live technician. The correctness of installation safety will be assessed using objective checklists, both following installation and again four months later. The investigators aim to demonstrate that child restraint installation is accurate (>90% correct) when conducted remotely via interactive virtual presence, that such installations are not inferior to the accuracy of installation with a live on-site expert, and that parents learn and retain information about correct child restraint installation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • own a vehicle and have a child who rides in that vehicle using a child restraint fastened with a harness.

排除标准

  • not physically capable of installing a child restraint into a vehicle, which may exclude individuals with various disabilities.
  • not able to communicate orally in English or Spanish, although significant demand for training in other languages may alter this exclusion criteria in the future

结局指标

主要结局

Percentage of Inspection Points Correctly Installed From Pre Installation to Post Installation

时间窗: baseline to post intervention about an hour later

Percentage of inspection points in car seat installation that are correctly installed, as assessed using objective scoring scheme

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

David Schwebel

University Professor & Associate Dean

University of Alabama at Birmingham

研究点 (2)

Loading locations...

相似试验

Using Interactive Virtual Presence to Remotely... | 临床试验