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A 3D Printed Assistive Technology Intervention

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03353038
First Posted: November 24, 2017
Last Update Posted: November 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Florida International University
  Purpose
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.

Condition Intervention Phase
Chronic Disease Device: 3D printed pillbox Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 3D Printed Assistive Technology Intervention: A Phase I Trial

Resource links provided by NLM:


Further study details as provided by Florida International University:

Primary Outcome Measures:
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: 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.

  • Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST2.0) [ Time Frame: 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) [ Time Frame: 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.


Enrollment: 14
Actual Study Start Date: January 2017
Study Completion Date: May 2017
Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Florida International University
ClinicalTrials.gov Identifier: NCT03353038     History of Changes
Other Study ID Numbers: IRB-17-0025
First Submitted: November 6, 2017
First Posted: November 24, 2017
Last Update Posted: November 24, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Florida International University:
assistive technology
3 Dimensional Printing
Self-Management

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes