Impact of Pillboxes on Medical Adherence

Not Applicable

Completed

• Conditions: Medication Adherence; Chronic Disease

• Registration Number: NCT03861845
• Lead Sponsor: Florida International University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-10
• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-04
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Status Verified: 2020-08
• Results First Submitted: 2020-08-03
• Results First Submitted QC: 2020-08-12
• Last Update Submitted: 2020-08-12
• Results First Posted: 2020-08-26
• Last Update Posted: 2020-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Medication Adherence at 1 Month	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.
Satisfaction With Pillbox at 1 Month	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Completed the Study	1 month	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.

Trial Locations

Locations (1)

Florida International University; 🇺🇸 Miami, Florida, United States