NCT03861845

Impact of Pillboxes on Medical Adherence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Florida International University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study uses an experimental design to test the impact of different types of pillboxes on medication adherence. Participants in this study will randomized to receive one of the three pillbox interventions: 1) A standard seven day a week, one-dose per day pillbox with training 2) an off-the-shelf pillbox that was purchased specifically for the individual's needs with training and education, or 3) a customized 3D printed pillbox that was designed and manufactured specifically to the individual's needs with training and education. Participants will have three visits with the research team to collect baseline data, receive the pillbox, and collect follow up data. 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.

Conditions

• Chronic Disease
• Medication Adherence

Interventions

Type	Name	Description
DEVICE	Standard off-the-shelf pillbox	Then the participant will receive a store bought one-dose per day pillbox.
DEVICE	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.
DEVICE	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.
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2019-02-10
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2019-03-04
• Last updated: 2020-08-26
• Results posted: 2020-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study