Impact of Pillboxes on Medical Adherence
Phase: NA
Conditions: Chronic Disease, Medication Adherence
Sponsor: Florida International University

Protocol:  
Impact of Pillboxes on Medication Adherence 
IRB-18-0451 
NCT03861845  
 
 
 
 
Primary Investigator: 
Jaclyn K. Schwartz, PhD, OTR/L, Assistant Professor 
Occupational Therapy Department 
Florida International University 
Phone: 305-348-3106 
Email: Jaclyn.Schwartz@fiu.edu 
 
 
Version:  
3 
 
 
 
Date: 
February 2019 
 
 
 
 
 

 
2 
SUMMARY OF THE RESEARCH .................................................................................... 3 
BACKGROUND ................................................................................................................ 4 
Scientific Background & Literature Review ................................................................... 4 
RESEARCH OBJECTIVES .............................................................................................. 5 
SUBJECT POPULATION ................................................................................................. 6 
Duration of participation ................................................................................................ 6 
Number of Participants ................................................................................................. 6 
Inclusion & Exclusion Criteria ....................................................................................... 6 
SUBJECT RECRUITMENT .............................................................................................. 7 
Identification of Subjects & Recruitment ....................................................................... 7 
Incentives ..................................................................................................................... 7 
METHODS & ACTIVITIES ............................................................................................... 8 
Instrumentation & Data Collection ................................................................................ 8 
Intervention ................................................................................................................... 9 
Interactions ................................................................................................................. 10 
Data Analysis ................................................................................................................. 11 
BENEFITS & RISKS ....................................................................................................... 12 
Benefits to Subjects .................................................................................................... 12 
Benefits to Society and/or Others ............................................................................... 12 
Reasonably Expected Risks, Harms, and/or Discomforts .......................................... 12 
Minimizing Risks, Harms, and/or Discomforts ............................................................ 12 
INFORMED CONSENT .................................................................................................. 13 
CONFIDENTIALITY & PRIVACY ................................................................................... 14 
Provisions to Protect Privacy ...................................................................................... 14 
Confidentiality of Data ................................................................................................ 14 
Breaking Confidentiality .............................................................................................. 14 
 
 

 
3 
SUMMARY OF THE RESEARCH 
 
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. We 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.  
 
 
 

 
4 
BACKGROUND 
 
Scientific Background & Literature Review  
 
Many individuals do not take medicine as prescribed resulting in declines in health and 
function. Pillboxes are a cost effective and easy to implement intervention that can help 
people better take their medications as prescribed. While some studies find that 
pillboxes can increase medication adherence as much as 5% other studies find that 
pillboxes have no effect. We hypothesize that to be effective pillboxes must be 
customized to the client’s needs and be part of a package of services involving training 
on the device and education. The purpose of this study is to understand the impact of 
customized pillboxes on medication adherence. 
 
1.Vlasnik, J. J., Aliotta, S. L., & DeLor, B. (2005). Medication adherence: factors 
influencing compliance with prescribed medication plans. The Case Manager, 16(2), 47-
51. 
 
2.Bartlett, R. J. (2018, September). Characteristics of Adults Managing 
Vitamins/Supplements and Prescribed Medications- Who Is Using, Not Using, and 
Abandoning Use of Pillboxes?: A Descriptive Study. PubMed, 32(5), 231-239. doi: 
10.1097/NUR.0000000000000395 
 
3.Defanti e Souza, F. and da Silva Santana, C. (2013) A descriptive study about the use 
of pillboxes by older adults. Health, 5, 103-109. doi: 10.4236/health.2013.512A014 
 
4.Bartlett, R. J., Knisely, M. R., Boyer, K., & Pike, C. (2017). Pillbox intervention fidelity 
in medication adherence research: A systematic review. Nursing Outlook, 65(4), 464-
476. doi:10.1016/j.outlook.2016.12.011 
 
5. Schwartz, J.K., Fermin, A., Fine, K., Iglesias, N., Pivarnik, D., Struck, S., Varela, N., & 
Janes, W.E. (2019) Methodology and feasibility of a 3D printed assistive technology 
intervention. Disability and Rehabilitation: Assistive Technology.  
 
 
 

 
5 
RESEARCH OBJECTIVES 
 
The purpose of this study is to: 
 
•Understand the impact of pillbox customization on medication adherence  
•Understand the impact of pillbox customization on device satisfaction  
•Test the feasibility of the research methodology  
 
 
 

 
6 
SUBJECT POPULATION  
 
Duration of participation 
 
Interaction 1: Screening: .5 hrs 
Interaction 2: Informed Consent & Evaluation: 2 hrs  
Interaction 3: Dispersion of pillboxes: 1 hr 
Interaction 4: Follow-up Data Collection: 1.5 hrs  
Total time commitment- approximately 5 hrs  
 
Number of Participants  
We seek to enroll as many as 40 participants in the study. This means we may screen 
as many as 120 individuals to identify the 40 study participants.  
 
Inclusion & Exclusion Criteria  
To be included in this study participants must be 18 years of age or older, speak 
English, and be prescribed to take two or more medications per day, and manage their 
own medications. 
 
Participants will be excluded if they have a significant cognitive impairment, unwilling to 
use a novel pillbox, or are unable to meet with the research team.  
 
 

 
7 
SUBJECT RECRUITMENT  
 
Identification of Subjects & Recruitment 
We will recruit through word of mouth, by sharing study information with local 
organizations that serve adults who take medications, and snowballing (asking 
participants to share the recruitment flyer with other individuals who take medications). 
We will also post electronic flyers on social media. 
 
Incentives  
Participants who complete all study procedures will earn up to $20 in gift cards and a 
pillbox.  On the 1st and 3rd visit, participants will receive a $10 gift card. On the 2nd 
visit, the participant will receive a pillbox worth no more than $15.  
 
 

 
8 
 METHODS & ACTIVITIES  
 
Instrumentation & Data Collection 
Below is a description of each data collection tool.  
 
• Screener Survey - ensures that the individual meets the eligibility criteria for the 
research study. This also allows the individual to describe their preferred contact 
method. 
• Adherence to Refills and Medication Scale - 12 question Likert-like survey 
investigating medication adherence  
• Demographics Questionnaire (Characteristics of Respondents [CORE] Survey) - 
Describes the participants background including race, ethnicity, gender, 
diagnoses, family situation, etc. 
• Performance Assessment of Self Care Skills Medication Subtest - This 
performance-based assessment asks participants to sort a placebo medication. 
Participants are scored on their independence, safety, and adequacy in 
performing the task.  
• Canadian Occupational Performance Measure - Participants discusses their daily 
routine. They score their performance of everyday activities on their importance, 
satisfaction, and performance. 
• Quebec User Evaluation of Satisfaction with Assistive Technology - 12 item 
Likert-scale questionnaire evaluates how satisfied participants are with their 
assistive device and their related services that they experience.  
• Medication Management Instrument For Deficiencies in the Elderly - Examines 
how much the participant knows about their medications, if they know how to 
take their medications, and if they know how to procure their medications. Also 
provides their complete medication list. 
• Exit Interview - Participants will be interviewed regarding their experiences within 
the study. 
• Audio recordings - All interactions will be audio recorded. The PI will assess the 
researcher assistant’s fidelity to the protocol.  
 
 
 

 
9 
Intervention 
Participants in this study will randomized to receive one of the three pillbox 
interventions: 
 
1.Standard Pillbox - Participants will receive a standard seven day a week, one-dose 
per day pillbox. The participant will receive basic training on using the pillbox. 
 
Figure 1. Standard Pillbox 
 
 
2. Off-the-Shelf Pillbox – Participants will receive an off-the-shelf pillbox that was 
purchased specifically for the individual’s needs from a store like CVS, Walgreens, or 
Amazon. The participant will also receive with training and education on using the 
pillbox. 
 
3. Customized 3D printed Pillbox – The participants will receive a customized 3D printed 
pillbox that was designed and manufactured specifically to their individual needs. 
 
 
 
 

 
10 
Interactions 
Research participants will occur in 4 interactions.  
 
1. Screening 
Up to .5 hrs on participant's own time on computer or the participant may be screened 
verbally at a time of their choosing Assessments: screener survey  
 
2. Informed Consent and Evaluation 
Up to 2 hrs 
Lab at FIU or preferred location where both parties (participants and evaluators) agree 
on Assessments: COPM, QUEST, PASS, MedMaIDE, ARMS, and Demographics 
Questionnaire  
 
3. Dispersion of pillboxes 
Up to 1 hr 
Lab at FIU or preferred location where both parties (participants and evaluators) agree 
on  
 
4. Follow-up Data Collection 
Up to 1.5 hrs 
Lab at FIU or preferred location where both parties (participants and evaluators) agree 
on.  
 
 
 

 
11 
Data Analysis 
Researchers will evaluate all variables using descriptive statistics. We will also explore 
the relationship between variables using approaches such as Pearson’s product-
moment correlation. Using this information, we will evaluate the appropriateness of the 
data against the assumptions for commonly used statistical approaches. Data may be 
normalized to increase appropriateness for the test. Then we will engage in means- 
testing using approaches such as t-tests, ANOVAs, Mann-Whitney U, Kruskal-Wallis 
analysis of variance, etc. as determined by looking at the appropriateness of the 
variable for that procedure. Specifically, we aim to compare means within and between 
groups on scores from the COPM & QUEST. 
 
 
For qualitative data, we will use a grounded theory approach, consisting of open, axial, 
and selective coding to generate themes describing the participants answers to open 
ended questions. 
Corbin, J., Strauss, A., & Strauss, A. L. (2014). Basics of qualitative research. sage  
 
 

 
12 
BENEFITS & RISKS  
 
Benefits to Subjects  
There are no direct benefits to participants.  
 
Benefits to Society and/or Others  
Information learned from this study will be used to progress research and improve 
medication adherence for adults.  
 
Reasonably Expected Risks, Harms, and/or Discomforts  
Risk 1) Loss of time, low likelihood, low severity 
Risk 2) Boredom, low likelihood, low severity 
Risk 3) Invasion of privacy, low likelihood, low severity 
Risk 4) Leakage of information, low likelihood, moderate severity Risk 5) Medication 
errors, low likelihood, moderate severity  
 
Minimizing Risks, Harms, and/or Discomforts  
 
Risk 1) Loss of time: Participants can select when and how they participate to limit loss 
of time related to travel. Research team will work with participants in an expedient 
manner. 
 
Risk 2) Boredom: Participants will be informed that they can stop the survey or interview 
at any time. Participants will be informed that they can take breaks as needed during 
the survey or interview.  
 
Risk 3) Invasion of privacy: Participants will be educated that they do not have to talk 
about topics or answer survey items that feel invasive. 
 
Risk 4) Leakage of information: Electronic data will be stored on secure devices and 
servers. Identifying information (e.g., informed consent) will be stored separately from 
survey and interview data.  
 
Risk 5) Medication errors: Participants will be required to verbalize how to use the 
pillboxes. They will also be required to correctly demonstrate how to use the pillboxes 
with placebo medication (i.e. tic-tacs or similar candy). Participants who cannot 
verbalize and demonstrate correctly use of the pillbox will be removed from study 
participation.  
 
 
 
 

 
13 
INFORMED CONSENT  
Informed consent will be provided in a quiet and private environment. Participants will 
be given as much time as they need to consider participation and ask questions of the 
research team. Signed informed consent forms will be stored in the PI's 
office.
 
 

 
14 
CONFIDENTIALITY & PRIVACY  
 
Provisions to Protect Privacy  
• Data will be de-identified 
• Identified information (i.e. informed consents and the master key) will be stored 
separately from the study data.  
• Physical data will be stored securely in a locked filing cabinet in the PIs locked 
office. 
• Electronic data will be stored on the secure FIU OneDrive and backed up on an 
encrypted and password protected external hard drive which is stored in a locked 
filing cabinet in the PIs office. 
• Only members of the research team will have access to the data  
 
Confidentiality of Data  
• Informed consents will be stored in a locked filing cabinet in the PIs locked office. 
• Study data will be collected with the assistance of Qualtrics and will be stored in 
FIU Qualtrics during data collection. After data collection, the data will be 
removed from Qualtrics and stored on FIU One drive. The study data will only be 
associated with the participants ID Code. 
• Audio recordings will be stored on FIU One Drive. 
• The Master Key will be stored on FIU One Drive separate from all study data. 
• The study data and audio/video recordings will be backed up on to an encrypted 
and password protected external hard drive which will be stored in a locked filing 
cabinet in the PIs office. 
• Only members of the research team will have access to the data.  
 
Breaking Confidentiality  
If participant's interview suggests abuse or neglect to themselves or others, it is 
necessary to break confidentiality. In the unlikely event that a participant reports is at 
serious risk to harm themselves or others, the participant will be reported to the 
appropriate authorities.