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OpenTrials
Completed

NCT Number: NCT03861845

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.

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Key information

Conditions

Chronic Disease Behavior Disease Attributes Health Behavior Medication Adherence Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida International University

Miami, Florida, 33199, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard off-the-shelf pillbox

Device

Then the participant will receive a store bought one-dose per day pillbox.

Custom off-the-shelf pillbox

Device

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

Device

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

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Medication Adherence at 1 Month

    Time frame: 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.

  2. Satisfaction With Pillbox at 1 Month

    Time frame: 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 outcomes

  1. Number of Participants Who Completed the Study

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 4, 2019
Registry last updated
Aug 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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