A 3D Printed Assistive Technology Intervention

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Disease
• Intervention / Treatment: Device: 3D printed pillbox

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Active Comparator: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Florida International University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 22, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Self-Management; assistive technology; 3 Dimensional Printing
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: IRB-17-0025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No