A 3D Printed Assistive Technology Intervention: A Phase I Trial
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic Disease
- Sponsor
- Florida International University
- Enrollment
- 14
- Primary Endpoint
- Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST2.0)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •English-speaking
- •Adults (ages 18+ years)
- •Use a pillbox at least weekly
- •Prescribed 2+ medications
- •Willing to try a new 3D printed pillbox
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST2.0)
Time Frame: 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)
Time Frame: 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
Time Frame: 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.