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A 3D Printed Assistive Technology Intervention

Primary Purpose

Chronic Disease

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
3D printed pillbox
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Disease focused on measuring assistive technology, 3 Dimensional Printing, Self-Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Active Comparator

    Arm Label

    Off-The-Shelf Pillbox vs 3D Printed Pillbox

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 6, 2017
    Last Updated
    November 22, 2017
    Sponsor
    Florida International University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03353038
    Brief Title
    A 3D Printed Assistive Technology Intervention
    Official Title
    A 3D Printed Assistive Technology Intervention: A Phase I Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    May 2017 (Actual)
    Study Completion Date
    May 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Florida International University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Disease
    Keywords
    assistive technology, 3 Dimensional Printing, Self-Management

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Off-The-Shelf Pillbox vs 3D Printed Pillbox
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    3D printed pillbox
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Incidence of Treatment-Emergent Adverse Events
    Description
    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
    Title
    Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST2.0)
    Description
    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
    Title
    Adherence to Refills and Medications Scale (ARMS)
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A 3D Printed Assistive Technology Intervention

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