Phase II - Modular Convertible Child Safety Seat to Improve Usage
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Correct use of top tether, prototype seat
研究概览
简要总结
Child car safety seats (or "car seats") are an important tool to keep children safe in motor vehicle crashes, but are often misused by parents and caregivers. The installation of car seats can be time consuming and confusing. A new type of swivel car seat is being developed to potentially alleviate some of the typical frustrations that might lead to car seat misuse, specifically the visibility and usage of the top tether feature. This study aims to evaluate the new car seat product and determine whether the new design results in fewer installation errors compared to a traditional car seat.
Primary objective: To compare the number of top tether installation errors produced with a production-ready prototype swivel child safety seat vs. a traditional (control) seat.
Secondary objective: To assess self-reported preference and opinions on the swivel child safety seat design.
详细描述
Background: A preliminary Phase I study has already been conducted, in which volunteer focus groups provided qualitative feedback on a new prototype design. For this Phase II study, the revised prototype will be quantitatively and qualitatively evaluated by a larger sample of volunteers. Volunteer adult participants will be asked to complete two car seat installations: one with the new swivel prototype, and one with a traditional control car seat. Basic instruction manuals will be provided. The types and frequency of installation errors for each car seat will be quantified, and qualitative feedback on the product designs will be collected via survey.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 18 and 65
- •Care provider to a child who is up to 4 years of age
- •Have installed a child safety seat in the last 2 years
- •Able to lift and install a child safety seat into a vehicle
- •English speaking.
排除标准
- •Not meeting any of the above
结局指标
主要结局
Correct use of top tether, prototype seat
时间窗: 1 study visit, an average of 30 minutes
Number of participants who correctly install the top tether in the prototype swivel seat
Correct use of top tether, traditional seat
时间窗: 1 study visit, an average of 30 minutes
Number of participants who correctly install the top tether in the traditional seat
次要结局
- Correct overall installation, prototype seat(1 study visit, an average of 30 minutes)
- Correct overall installation, traditional seat(1 study visit, an average of 30 minutes)
- Opinion on modular child seat design and instructions(1 study visit, an average of 30 minutes)
研究者
Julie Mansfield
Research Associate Professor
Minnesota HealthSolutions