Impact of Pillboxes on Medical Adherence

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Pillboxes on Medical Adherence

Conditions
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Chronic Disease, Medication Adherence

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard off-the-shelf pillbox<br>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<br>* Then the participant will receive a store bought one-dose per day pillbox.<br>Behavioral: Education & Training<br>* 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.<br>Behavioral: Reflection on medication routines<br>* 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.<br>|
| Experimental: Custom off-the-shelf<br>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<br>* 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.<br>Behavioral: Education & Training<br>* 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.<br>Behavioral: Reflection on medication routines<br>* 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.<br>|
| Experimental: Custom designed and manufactured<br>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<br>* 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.<br>Behavioral: Education & Training<br>* 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.<br>Behavioral: Reflection on medication routines<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Assistive Technology