Chronic DiseaseNCT03861845
Impact of Pillboxes on Medical Adherence
A study testing Standard off-the-shelf pillbox, Custom off-the-shelf pillbox and Custom designed and manufactured pillbox in people with Chronic Disease and Medication Adherence, run by Florida International University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease, Medication Adherence
- What is being tested?
- Standard off-the-shelf pillbox, Custom off-the-shelf pillbox and Custom designed and manufactured pillbox
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2019to 1 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- speak English
- be prescribed to take two or more medications per day, and manage their own medications.
Who cannot join
- have a significant cognitive impairment
- unwilling to use a novel pillbox
- unable to meet with the research team
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
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.
- Conditions
- Chronic Disease, Medication Adherence
- Being tested
- Standard off-the-shelf pillbox, Custom off-the-shelf pillbox, Custom designed and manufactured pillbox, Education & Training, Reflection on medication routines
- Keywords
- Assistive Technology
- Medical subject headings
- Chronic Disease, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard off-the-shelf pillboxDevice
Then the participant will receive a store bought one-dose per day pillbox.
Custom off-the-shelf pillboxDevice
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.
Custom designed and manufactured pillboxDevice
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 & TrainingBehavioural
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 routinesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard off-the-shelf pillbox | Active comparator | 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. Receives: Device: Standard off-the-shelf pillbox; Behavioral: Education & Training; Behavioral: Reflection on medication routines |
| Custom off-the-shelf | Experimental | 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. Receives: Device: Custom off-the-shelf pillbox; Behavioral: Education & Training; Behavioral: Reflection on medication routines |
| Custom designed and manufactured | Experimental | 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. Receives: Device: Custom designed and manufactured pillbox; Behavioral: Education & Training; Behavioral: Reflection on medication routines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start10 Feb 2019
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaclyn Schwartz, PhD, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861845
- Sponsor's protocol ID
- IRB-18-0451
- Status last verified
- Aug 2020
- First submitted
- 27 Feb 2019
- Last updated
- 26 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Schwartz J, Ballard DH. Feasibility of Customized Pillboxes to Enhance Medication Adherence: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2022 Dec;103(12):2288-2295. doi: 10.1016/j.apmr.2022.03.018. Epub 2022 Apr 14.
PubMed 35430239
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pillboxes on Medical Adherence
- ClinicalTrials.gov ID
- NCT03861845
- Acronym / sponsor ID
- IRB-18-0451
- Conditions
- Chronic Disease, Medication Adherence
- Keywords
- Assistive Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Posted 26 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard off-the-shelf pillbox | Active comparator | Device: Standard off-the-shelf pillbox, Behavioral: Education & Training, Behavioral: Reflection on medication routinesParticipants 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. |
| Custom off-the-shelf | Experimental | Device: Custom off-the-shelf pillbox, Behavioral: Education & Training, Behavioral: Reflection on medication routinesParticipants 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 designed and manufactured | Experimental | Device: Custom designed and manufactured pillbox, Behavioral: Education & Training, Behavioral: Reflection on medication routinesParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- speak English
- be prescribed to take two or more medications per day, and manage their own medications.
Key exclusion criteria (3 listed)
- have a significant cognitive impairment
- unwilling to use a novel pillbox
- unable to meet with the research team
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard off-the-shelf pillboxThen the participant will receive a store bought one-dose per day pillbox. | Device | Standard off-the-shelf pillbox |
| Custom off-the-shelf pillboxThen 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. | Device | Custom off-the-shelf |
| Custom designed and manufactured pillboxThen 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. | Device | Custom designed and manufactured |
| Education & TrainingThe 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. | Behavioural | Custom designed and manufactured, Custom off-the-shelf, Standard off-the-shelf pillbox |
| Reflection on medication routinesThe 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. | Behavioural | Custom designed and manufactured, Custom off-the-shelf, Standard off-the-shelf pillbox |
Primary outcome
Medication Adherence at 1 Month
Time frame: 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
Time frame: 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 secondary outcome
Number of Participants Who Completed the Study
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35430239Schwartz J, Ballard DH. Feasibility of Customized Pillboxes to Enhance Medication Adherence: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2022 Dec;103(12):2288-2295. doi: 10.1016/j.apmr.2022.03.018. Epub 2022 Apr 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaclyn Schwartz, PhD principal investigator
Florida International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard off-the-shelf pillbox, Custom off-the-shelf pillbox and Custom designed and manufactured pillbox in people with Chronic Disease and Medication Adherence, run by Florida International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence at 1 Month (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03861845, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2020.