A Phase 1 interventional study of 3D printed pillbox in Chronic Disease, sponsored by Florida International University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-24.
Sponsored by Florida International University · Phase 1, Interventional, and Treatment
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.
781 studies on the registry are indexed under Chronic Disease; 144 are open to participants now.
This study's enrollment of 14 is below the median of 140 across 582 interventional studies indexed under Chronic Disease.
Browse Chronic Disease studies →Florida International University is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 2-8 Weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2017 to primary completion in May 2017, 4 months.
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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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