Study Results
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View full resultsBasic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2019-02-10
2019-05-01
Brief Summary
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Risks to the study include loss of time, boredom, invasion of privacy, and medication errors. The investigators have taken precautions to mitigate these risks. This study will improve understanding of medication adherence and potentially help us better address poor medication adherence which needlessly causes morbidity, mortality, and costs over $300 million in unnecessary healthcare costs each year.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Standard off-the-shelf pillbox
Participants will engage in reflection on medication routines. Then they will receive a standard off-the-shelf pillbox. Finally, the participants will receive education \& training on how to use the pillbox.
Standard off-the-shelf pillbox
Then the participant will receive a store bought one-dose per day pillbox.
Education & Training
The participant will receive education and training on how to use the pillbox and how to incorporate the pillbox and taking medications into their daily routine.
Reflection on medication routines
The participant will reflect on his or her daily routine, medication regimen, and use of existing pillboxes. The participant will also engage in a hands-on standardized pillbox task.
Custom off-the-shelf
Participants will engage in reflection on medication routines. Then they will receive a custom off-the-shelf pillbox. Finally, the participants will receive education \& training on how to use the pillbox.
Custom off-the-shelf pillbox
Then the participant will be administered an off-the-shelf pillbox that was purchased specifically for the participant's preferences, routine, medication regimen, and skills/abilities.
Education & Training
The participant will receive education and training on how to use the pillbox and how to incorporate the pillbox and taking medications into their daily routine.
Reflection on medication routines
The participant will reflect on his or her daily routine, medication regimen, and use of existing pillboxes. The participant will also engage in a hands-on standardized pillbox task.
Custom designed and manufactured
Participants will engage in reflection on medication routines. Then they will receive a custom designed and manufactured pillbox. Finally, the participants will receive education \& training on how to use the pillbox.
Custom designed and manufactured pillbox
Then the participant will describe any design preferences for the pillbox. The researcher will design and manufacture the pillbox using a 3D printer, publically available 3D printing object repository, and computer aided design software.
Education & Training
The participant will receive education and training on how to use the pillbox and how to incorporate the pillbox and taking medications into their daily routine.
Reflection on medication routines
The participant will reflect on his or her daily routine, medication regimen, and use of existing pillboxes. The participant will also engage in a hands-on standardized pillbox task.
Interventions
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Standard off-the-shelf pillbox
Then the participant will receive a store bought one-dose per day pillbox.
Custom off-the-shelf pillbox
Then the participant will be administered an off-the-shelf pillbox that was purchased specifically for the participant's preferences, routine, medication regimen, and skills/abilities.
Custom designed and manufactured pillbox
Then the participant will describe any design preferences for the pillbox. The researcher will design and manufacture the pillbox using a 3D printer, publically available 3D printing object repository, and computer aided design software.
Education & Training
The participant will receive education and training on how to use the pillbox and how to incorporate the pillbox and taking medications into their daily routine.
Reflection on medication routines
The participant will reflect on his or her daily routine, medication regimen, and use of existing pillboxes. The participant will also engage in a hands-on standardized pillbox task.
Eligibility Criteria
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Inclusion Criteria
* speak English
* be prescribed to take two or more medications per day, and manage their own medications.
Exclusion Criteria
* unwilling to use a novel pillbox
* unable to meet with the research team
18 Years
ALL
No
Sponsors
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Florida International University
OTHER
Responsible Party
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Principal Investigators
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Jaclyn Schwartz, PhD
Role: PRINCIPAL_INVESTIGATOR
Florida International University
Locations
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Florida International University
Miami, Florida, United States
Countries
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References
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Schwartz J, Ballard DH. Feasibility of Customized Pillboxes to Enhance Medication Adherence: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2022 Dec;103(12):2288-2295. doi: 10.1016/j.apmr.2022.03.018. Epub 2022 Apr 14.
Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB-18-0451
Identifier Type: -
Identifier Source: org_study_id
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