Trial Outcomes & Findings for Impact of Pillboxes on Medical Adherence (NCT NCT03861845)
NCT ID: NCT03861845
Last Updated: 2020-08-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
1 month
Results posted on
2020-08-26
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
4
|
|
Overall Study
COMPLETED
|
6
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
All participants enrolled in the study were analyzed. All participants completed the study.
Baseline characteristics by cohort
| Measure |
Standard Off-the-shelf Pillbox
n=6 Participants
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.
|
Custom Off-the-shelf
n=5 Participants
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.
|
Custom Designed and Manufactured
n=4 Participants
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
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.50 Years
STANDARD_DEVIATION 20.00 • n=99 Participants • All participants enrolled in the study were analyzed. All participants completed the study.
|
46.00 Years
STANDARD_DEVIATION 20.54 • n=107 Participants • All participants enrolled in the study were analyzed. All participants completed the study.
|
35.50 Years
STANDARD_DEVIATION 19.05 • n=206 Participants • All participants enrolled in the study were analyzed. All participants completed the study.
|
40.20 Years
STANDARD_DEVIATION 19.00 • n=157 Participants • All participants enrolled in the study were analyzed. All participants completed the study.
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
12 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
15 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
14 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
Medication Adherence
|
11.00 units on a scale
STANDARD_DEVIATION 1.90 • n=99 Participants
|
11.20 units on a scale
STANDARD_DEVIATION 4.49 • n=107 Participants
|
11.50 units on a scale
STANDARD_DEVIATION 1.73 • n=206 Participants
|
11.20 units on a scale
STANDARD_DEVIATION 2.78 • n=157 Participants
|
PRIMARY outcome
Timeframe: 1 monthMedication 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.
Outcome measures
| Measure |
Standard Off-the-shelf Pillbox
n=6 Participants
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.
|
Custom Off-the-shelf
n=5 Participants
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.
|
Custom Designed and Manufactured
n=4 Participants
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.
|
|---|---|---|---|
|
Medication Adherence at 1 Month
|
11.83 score on a scale
Standard Deviation 2.71
|
10.20 score on a scale
Standard Deviation 2.17
|
9.33 score on a scale
Standard Deviation 2.08
|
PRIMARY outcome
Timeframe: 1 monthThe 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.
Outcome measures
| Measure |
Standard Off-the-shelf Pillbox
n=6 Participants
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.
|
Custom Off-the-shelf
n=5 Participants
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.
|
Custom Designed and Manufactured
n=4 Participants
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.
|
|---|---|---|---|
|
Satisfaction With Pillbox at 1 Month
|
4.65 score on a scale
Standard Deviation 0.35
|
4.63 score on a scale
Standard Deviation 0.43
|
4.72 score on a scale
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: 1 monthThis 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.
Outcome measures
| Measure |
Standard Off-the-shelf Pillbox
n=6 Participants
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.
|
Custom Off-the-shelf
n=5 Participants
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.
|
Custom Designed and Manufactured
n=4 Participants
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.
|
|---|---|---|---|
|
Number of Participants Who Completed the Study
|
6 Participants
|
5 Participants
|
4 Participants
|
Adverse Events
Standard Off-the-shelf Pillbox
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Custom Off-the-shelf
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Custom Designed and Manufactured
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place