Chronic Disease, Medication Adherence
Conditions
Keywords
Assistive Technology
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.
Interventions
DEVICEStandard off-the-shelf pillbox
Then the participant will receive a store bought one-dose per day pillbox.
DEVICECustom 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.
DEVICECustom 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.
BEHAVIORALEducation & 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.
BEHAVIORALReflection 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.
Sponsors
Florida International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 6 |
| 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.
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. | 5 |
| 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.
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. | 4 |
| Total | 15 |
Baseline characteristics
| Characteristic | Standard Off-the-shelf Pillbox | Custom Off-the-shelf | Custom Designed and Manufactured | Total |
|---|---|---|---|---|
| Age, Continuous | 38.50 Years STANDARD_DEVIATION 20 | 46.00 Years STANDARD_DEVIATION 20.54 | 35.50 Years STANDARD_DEVIATION 19.05 | 40.20 Years STANDARD_DEVIATION 19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 5 Participants | 4 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Medication Adherence | 11.00 units on a scale STANDARD_DEVIATION 1.9 | 11.20 units on a scale STANDARD_DEVIATION 4.49 | 11.50 units on a scale STANDARD_DEVIATION 1.73 | 11.20 units on a scale STANDARD_DEVIATION 2.78 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 5 Participants | 5 Participants | 4 Participants | 14 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 4 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 0 / 6 | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 | 0 / 4 |
Outcome results
Primary
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.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Off-the-shelf Pillbox | Medication Adherence at 1 Month | 11.83 score on a scale | Standard Deviation 2.71 |
| Custom Off-the-shelf | Medication Adherence at 1 Month | 10.20 score on a scale | Standard Deviation 2.17 |
| Custom Designed and Manufactured | Medication Adherence at 1 Month | 9.33 score on a scale | Standard Deviation 2.08 |
Primary
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.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Off-the-shelf Pillbox | Satisfaction With Pillbox at 1 Month | 4.65 score on a scale | Standard Deviation 0.35 |
| Custom Off-the-shelf | Satisfaction With Pillbox at 1 Month | 4.63 score on a scale | Standard Deviation 0.43 |
| Custom Designed and Manufactured | Satisfaction With Pillbox at 1 Month | 4.72 score on a scale | Standard Deviation 0.28 |
Secondary
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.
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Off-the-shelf Pillbox | Number of Participants Who Completed the Study | 6 Participants |
| Custom Off-the-shelf | Number of Participants Who Completed the Study | 5 Participants |
| Custom Designed and Manufactured | Number of Participants Who Completed the Study | 4 Participants |