A 3D Printed Assistive Technology Intervention

Phase 1

Completed

• Conditions: Chronic Disease
• Interventions: Device: 3D printed pillbox

• Registration Number: NCT03353038
• Lead Sponsor: Florida International University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2017-11
• Study First Submitted: 2017-11-06
• Study First Submitted QC: 2017-11-22
• Last Update Submitted: 2017-11-22
• Study First Posted: 2017-11-24
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Off-The-Shelf Pillbox vs 3D Printed Pillbox	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.

Primary Outcome Measures

Name	Time	Method
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST2.0)	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)	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	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.