Impact of Pillboxes on Medical Adherence

• Sponsor: Florida International University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03861845
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 3
• Actual Duration (Months): 2.6
• Patients Per Site Per Month: 5.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Disease; Medication Adherence	Device: Standard off-the-shelf pillbox; Device: Custom off-the-shelf pillbox; Device: Custom designed and manufactured pillbox; Behavioral: Education & Training; Behavioral: Reflection on medication routines	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Impact of Pillboxes on Medical Adherence
• Actual Study Start Date: Feb 10, 2019
• Actual Primary Completion Date: May 1, 2019
• Actual Study Completion Date: May 1, 2019

Arms and Interventions

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.	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.; 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 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.	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.; 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Florida International University	Miami	Florida	United States	33199

Sponsors and Collaborators

• Florida International University

Investigators

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

Study Documents (Full-Text)

• Informed Consent Form - Dec 12, 2018
• Study Protocol and Statistical Analysis Plan - Feb 1, 2019

More Information

Publications

None provided.

• Responsible Party: Florida International University
• ClinicalTrials.gov Identifier: NCT03861845
• Other Study ID Numbers: IRB-18-0451
• First Posted: Mar 4, 2019
• Last Update Posted: Aug 26, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Florida International University: Assistive Technology
• Additional relevant MeSH terms: Chronic Disease

Study Results

Participant Flow

Arm/Group Title	Standard Off-the-shelf Pillbox	Custom Off-the-shelf	Custom Designed and Manufactured
Arm/Group 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. Standard off-the-shelf pillbox: Then the participant will receive a store bought one-dose per day pillbox. 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.	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. 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. 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.	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. 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. 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.
Period Title: Overall Study
STARTED	6	5	4
COMPLETED	6	5	4
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Standard Off-the-shelf Pillbox	Custom Off-the-shelf	Custom Designed and Manufactured	Total
Arm/Group 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. Standard off-the-shelf pillbox: Then the participant will receive a store bought one-dose per day pillbox. 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.	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. 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. 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.	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. 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. 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.	Total of all reporting groups
Overall Participants	6	5	4	15
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	38.50 (20.00)	46.00 (20.54)	35.50 (19.05)	40.20 (19.00)
Sex: Female, Male (Count of Participants)
Female	2 33.3%	1 20%	0 0%	3 20%
Male	4 66.7%	4 80%	4 100%	12 80%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 100%	5 100%	4 100%	15 100%
Not Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	5 83.3%	5 100%	4 100%	14 93.3%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	1 16.7%	0 0%	0 0%	1 6.7%
Medication Adherence (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	11.00 (1.90)	11.20 (4.49)	11.50 (1.73)	11.20 (2.78)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Off-the-shelf Pillbox	Custom Off-the-shelf	Custom Designed and Manufactured
Arm/Group 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. Standard off-the-shelf pillbox: Then the participant will receive a store bought one-dose per day pillbox. 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.	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. 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. 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.	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. 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. 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.
Measure Participants	6	5	4
Mean (Standard Deviation) [score on a scale]	11.83 (2.71)	10.20 (2.17)	9.33 (2.08)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Off-the-shelf Pillbox	Custom Off-the-shelf	Custom Designed and Manufactured
Arm/Group 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. Standard off-the-shelf pillbox: Then the participant will receive a store bought one-dose per day pillbox. 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.	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. 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. 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.	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. 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. 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.
Measure Participants	6	5	4
Mean (Standard Deviation) [score on a scale]	4.65 (0.35)	4.63 (0.43)	4.72 (0.28)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Off-the-shelf Pillbox	Custom Off-the-shelf	Custom Designed and Manufactured
Arm/Group 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. Standard off-the-shelf pillbox: Then the participant will receive a store bought one-dose per day pillbox. 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.	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. 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. 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.	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. 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. 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.
Measure Participants	6	5	4
Count of Participants [Participants]	6 100%	5 100%	4 100%

Adverse Events

Time Frame	1 month
Arm/Group Title	Standard Off-the-shelf Pillbox		Custom Off-the-shelf		Custom Designed and Manufactured
Arm/Group 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. Standard off-the-shelf pillbox: Then the participant will receive a store bought one-dose per day pillbox. 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.		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. 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. 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.		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. 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. 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.
All Cause Mortality
	Standard Off-the-shelf Pillbox		Custom Off-the-shelf		Custom Designed and Manufactured
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/5 (0%)		0/4 (0%)
Serious Adverse Events
	Standard Off-the-shelf Pillbox		Custom Off-the-shelf		Custom Designed and Manufactured
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/5 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Standard Off-the-shelf Pillbox		Custom Off-the-shelf		Custom Designed and Manufactured
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/5 (0%)		0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.