Impact of Pillboxes on Medical Adherence

Chronic Disease Clinical Trial

Official title:

Impact of Pillboxes on Medical Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03861845
• Other study ID #: IRB-18-0451
• Status: Completed
• Phase: N/A
• Start date: February 10, 2019
• Est. completion date: May 1, 2019

Study information

• Verified date: August 2020
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Medication Adherence

Intervention

Device:
• 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.

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.
• 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.

Locations

Country	Name	City	State
United States	Florida International University	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida International University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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