A 3D Printed Assistive Technology Intervention

Chronic Disease Clinical Trial

Official title:

A 3D Printed Assistive Technology Intervention: A Phase I Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03353038
• Other study ID #: IRB-17-0025
• Status: Completed
• Phase: Phase 1
• First received: November 6, 2017
• Last updated: November 22, 2017
• Start date: January 2017
• Est. completion date: May 2017

Study information

• Verified date: November 2017
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Device:
• 3D printed pillbox
The research team interviewed the participant about their habits, routines, preferences, medications, and skills and abilities. Based on the interview, the research team designed and printed a customized 3D printed pillbox.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Florida International University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	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.	1 week and again at 2-8 Weeks
Primary	Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST2.0)	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.	2-8 Weeks
Primary	Adherence to Refills and Medications Scale (ARMS)	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.	2-8 Weeks