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
About this trial
This is an interventional treatment trial for Chronic Disease focused on measuring assistive technology, 3 Dimensional Printing, Self-Management
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
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
NCT ID
NCT03353038
First Posted
November 6, 2017
Last Updated
November 22, 2017
Sponsor
Florida International University
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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