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A 3D Printed Assistive Technology Intervention

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03353038
Enrollment
14
Registered
2017-11-24
Start date
2017-01-31
Completion date
2017-05-31
Last updated
2017-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease

Keywords

assistive technology, 3 Dimensional Printing, Self-Management

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.

Interventions

DEVICE3D 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.

Sponsors

Florida International University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Treatment-Emergent Adverse Events1 week and again at 2-8 WeeksThe 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.
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST2.0)2-8 WeeksThe 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 WeeksMedication 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026