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临床试验/NCT05552027
NCT05552027已完成2 期

Sensor Network With Active Instructional Content to Prevent Child Safety Seat Misuse

Minnesota HealthSolutions1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2022年6月15日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
92
试验地点
1
主要终点
Number of Participants With Installation Errors

研究概览

简要总结

The objective of the study is to evaluate an innovative child safety seat user engagement system (CCS system) designed to actively educate, instruct, and alarm caregivers with information associated with automatically-sensed safety seat misuses/errors via a smartphone application.

详细描述

The primary objective of the study is to evaluate whether child safety seat users correct more critical misuse errors in child safety seat usage with the seat with the CCS system than the same seat with no sensor system. The CCS system will provide ongoing, tailored support to users at the time of an error. Videos will be available to users via a smartphone and provide short "how to" instructions that demonstrate how to correctly perform each safety seat behavior (e.g., tighten harness straps) and how to avoid common mistakes. The overall goal of the CCS system is to prevent child safety seat critical misuses and reduce deaths and injuries in children riding in motor vehicles. In the proposed study, adult participants will be asked to attend one in-person study visit and complete three (3) scenarios in which they will be asked to identify and correct errors in child safety seat use. Participants will be randomized to either the intervention group which will use the CCS system during each scenario or the control group which will not use the CCS system during each scenario.

研究设计

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

盲法说明

Participants will be randomly assigned to the intervention group or control group upon arrival at the study visit. Assignment status will not be concealed from the research assistants enrolling the participant, the participants themselves, or the rest of the study team.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Males or Females ages 18-75 years
  • •Has harnessed/fastened a child into a car seat in the last five (5) years
  • •Has a valid driver's license

排除标准

  • •Non-fluency in written and/or spoken English
  • •Participant cannot install a safety seat due to a physical or health limitation

研究组 & 干预措施

Intervention

Experimental

Participants will harness the car seat in 3 separate scenarios with the sensor system enabled to provide feedback.

干预措施: CCS System- Prototype (Device)

Control

Other

Participants will harness the car seat in 3 separate scenarios with the sensor system disabled in order to not provide feedback.

干预措施: CCS System- Control (Device)

结局指标

主要结局

Number of Participants With Installation Errors

时间窗: Once during the only study visit: up to 30 mins

For each misuse scenario participants will be asked to correct the error in the seat installation or the harness tension. Convertible seats will be used for this phase. For each scenario, we will use a huggable images test doll (age and weight of the doll will be indicated to participants). Study team will record seat direction (forward vs rear facing), harness tension (newtons), insecure attachment of the seat to the vehicle (yes/no).

次要结局

未报告次要终点

研究者

发起方
Minnesota HealthSolutions
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Sara Seifert

MPH

Minnesota HealthSolutions

研究点 (1)

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