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Impact of Pillboxes on Medical Adherence

Primary Purpose

Chronic Disease, Medication Adherence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard off-the-shelf pillbox
Custom off-the-shelf pillbox
Custom designed and manufactured pillbox
Education & Training
Reflection on medication routines
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Disease focused on measuring Assistive Technology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Florida International University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard off-the-shelf pillbox

Custom off-the-shelf

Custom designed and manufactured

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 27, 2019
Last Updated
August 12, 2020
Sponsor
Florida International University
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1. Study Identification

Unique Protocol Identification Number
NCT03861845
Brief Title
Impact of Pillboxes on Medical Adherence
Official Title
Impact of Pillboxes on Medical Adherence
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 10, 2019 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida International University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Medication Adherence
Keywords
Assistive Technology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard off-the-shelf pillbox
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Custom off-the-shelf
Arm Type
Experimental
Arm Description
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.
Arm Title
Custom designed and manufactured
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Standard off-the-shelf pillbox
Intervention Description
Then the participant will receive a store bought one-dose per day pillbox.
Intervention Type
Device
Intervention Name(s)
Custom off-the-shelf pillbox
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Custom designed and manufactured pillbox
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education & Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reflection on medication routines
Intervention Description
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 Outcome Measure Information:
Title
Medication Adherence at 1 Month
Description
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.
Time Frame
1 month
Title
Satisfaction With Pillbox at 1 Month
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Number of Participants Who Completed the Study
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaclyn Schwartz, PhD
Organizational Affiliation
Florida International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida International University
City
Miami
State/Province
Florida
ZIP/Postal Code
33199
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Pillboxes on Medical Adherence

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