Impact of Pillboxes on Medical Adherence

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.

Study Overview

• Status: Completed
• Conditions: Chronic Disease; Medication Adherence
• Intervention / Treatment: Device: Standard off-the-shelf pillbox; Behavioral: Education & Training; Behavioral: Reflection on medication routines; Device: Custom off-the-shelf pillbox; Device: Custom designed and manufactured pillbox

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33199
      • Florida International University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age or older
• speak English
• be prescribed to take two or more medications per day, and manage their own medications.

Exclusion Criteria:

• have a significant cognitive impairment
• unwilling to use a novel pillbox
• unable to meet with the research team

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Standard off-the-shelf pillbox; Then the participant will receive a store bought one-dose per day pillbox.; 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.
Experimental: 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.	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.; 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.
Experimental: 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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence at 1 Month	Medication adherence will be measured by the Adherence to Refills and Medications Scale (ARMS). The ARMS is a 7-item assessment. Participants indicate the extent of their adherence on a 4-point Likert-like scale. Scores range from 7 - 28, with higher scores indicating worse medication adherence.	1 month
Satisfaction With Pillbox at 1 Month	The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) quantifies a participant's satisfaction with their pillbox on a five-point Likert-like scale across 8 features (dimensions, weight, ease in opening/closing the device, safety and security, durability, ease of use, comfort, and effectiveness). A score of 1 indicates not satisfied at all and a score of 5 indicates being very satisfied. Scores indicate the average score on the Likert-like scale.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Completed the Study	This metric serves to describe the feasibility of the study and indicates the number of individuals that completed all study interactions. All individuals who enrolled into the study and signed an informed consent document are included in this calculation.	1 month

Collaborators and Investigators

• Sponsor: Florida International University
• Investigators: Principal Investigator: Jaclyn Schwartz, PhD, Florida International University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2019
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: February 27, 2019
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (Actual): March 4, 2019

Study Record Updates

• Last Update Posted (Actual): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 12, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Assistive Technology
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: IRB-18-0451

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No