A 3D Printed Assistive Technology Intervention: A Phase I Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 主要终点
- Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST2.0)
研究概览
简要总结
The purpose of this study is to understand the feasibility of using a 3D printer to create tailored assistive technology rehabilitation devices. Specifically, we are investigating if a tailored 3D printed pillbox is safe, acceptable, and effective compared to an off-the-shelf generic pillbox. In this study, approximately 20 people with chronic health conditions who use pillboxes will describe their satisfaction and medication adherence with their current pillbox using a series of surveys and interviews. Then they will partake in an interview about their pillbox, medications, and routines. Based on the interview, the research team will 3D print a new pillbox tailored to the participant's preferences, abilities, and medication regimen. Then the participant will use the pillbox for 2-8 weeks. At the end, the participant will answer the same questions describing their satisfaction and medication adherence with the new pillbox using a series of surveys and interviews. This research will reveal important knowledge about the potential of 3D printing in the clinic and effectiveness of customized assistive technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking
- •Adults (ages 18+ years)
- •Use a pillbox at least weekly
- •Prescribed 2+ medications
- •Willing to try a new 3D printed pillbox
排除标准
- •Have significant cognitive impairment evidenced by a score of 10+ on the short blessed test
- •Unable to meet with the research team in person and by phone
研究组 & 干预措施
Off-The-Shelf Pillbox vs 3D Printed Pillbox
Participants in the study were pillbox users at baseline. Participants described their experiences and preferences with their own pillbox. Then participants will be given a 3D printed pillbox. Researchers will compare participants' experiences and preferences between their off-the-shelf pillbox used at baseline and the customized 3D printed pillbox delivered to participants as part of the study.
干预措施: 3D printed pillbox (Device)
结局指标
主要结局
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST2.0)
时间窗: 2-8 Weeks
The participant will complete the QUEST 2.0 to describe their satisfaction with the 3D printed pillbox as compared to their satisfaction with the off the shelf pillbox. This will demonstrate the acceptability of the device.
Adherence to Refills and Medications Scale (ARMS)
时间窗: 2-8 Weeks
Medication adherence as measured by the ARMS will demonstrate the preliminary efficacy of the of the 3D printed assistive technology. Specifically, it will help determine if the pillbox helped participants better take their medications as prescribed.
Incidence of Treatment-Emergent Adverse Events
时间窗: 1 week and again at 2-8 Weeks
The participant will be asked if they experienced any changes in their health or major issues using their pillbox at 1 week and at the end of the study. Also, all participants were educated to contact to the study team should they experience an adverse event.
次要结局
未报告次要终点