Medication AdherenceNCT03513224
The eDosette Pilot Study
A study testing eDosette in people with Medication Adherence, run by McMaster University.
Trial summary
Medication non-adherence can lead to serious health issues for older adults. This study is a four week study in older adults using a new device, the eDosette, which dispenses and records how one takes their medications, and subsequently makes this information available to the primary care team by the internet. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence
- What is being tested?
- eDosette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age 65 and over
- taking five or more medications (including supplements)
- using or willing to use a blister pack or dosette
- currently managing their medications independently
- living independently
- English speaking
Who cannot join
- a documented diagnosis of mild cognitive impairment or dementia
- living in any form of assisted living facility
- currently palliative
- currently deemed medically unstable by their primary care team
About this study
Official title: The Use of an Electronic Medication Administration-monitoring Device to Improve Medication Adherence and Reduce Medication Regimen Complexity in Community Dwelling Seniors: A Prospective Pilot Study
Medication non-adherence can lead to serious health issues for older adults. This study is a four week study in older adults using a new device, the eDosette, which dispenses and records how one takes their medications, and subsequently makes this information available to the primary care team by the internet. This study aims to show that the eDosette can report how well a group of older adults living independently in the community are taking their medications (e.g. "medication adherence"). This study hopes to show that the eDosette intervention could play a role in medication adherence by improving conversations between older adults and primary care.
- Conditions
- Medication Adherence
- Being tested
- eDosette
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eDosetteOther
The eDosette is an internet-enabled, medication administration monitoring unit that has been previously tested for feasibility in older adults. The eDosette was designed to be compatible with different types of weekly medication blister packs and dosettes, and monitors medication-taking behaviour in a patient's home. The eDosette securely transmits this information to a secure server where the information is converted to individual medication administration records. Patients can also use the eDosette to notify their primary care team of potential medication side effects.
| Study group | Role | What they receive |
|---|---|---|
| eDosette | Experimental | Not described Receives: Other: eDosette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Four-week medication adherence rate
Each participant's observed medication adherence for the entire study was calculated by dividing the total medication doses taken correctly by the total doses in the study. The numerator, total medication doses taken correctly is calculated by subtracting from the total doses any missed or late doses as determined by the eDosette. Missed doses is defined as any dose still present on image data after the next daily scheduled dose time); late doses is defined as any dose taken outside the two-hour time window of the average time of dose administration - e.g. 08h00-10h00 for a 09h00 average dose time. The denominator, total doses, was defined as the total number of pills prescribed for a patient to take during the study.
Measured: 4 weeks
Secondary outcomes (4)
Thematic content of pharmacist-participant discussion during the study
Retrospective chart reviews were performed to extract content on these discussions.
Measured: 4 weeks
Frequency of medication changes noted
Retrospective chart reviews were performed to extract content on these changes.
Measured: 4 weeks
Change in MRCI score
Medication Regimen Complexity Index (MRCI) were calculated at baseline and 4 weeks by the pharmacist based on medication listed obtained from dispensing pharmacies.
Measured: 4 weeks
Participant feedback
An exit-feedback survey was administered asking participants to rank their experience with the eDosette. The survey also asked participants to identify the three best and worst aspects of the eDosette.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start1 Sep 2016
- Primary completion31 Aug 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henry Siu, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513224
- Sponsor's protocol ID
- CAT2015-25
- Status last verified
- Apr 2018
- First submitted
- 19 Apr 2018
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siu HY, Mangin D, Howard M, Price D, Chan D. Developing and testing an electronic medication administration monitoring device for community dwelling seniors: a feasibility study. Pilot Feasibility Stud. 2017 Feb 1;3:5. doi: 10.1186/s40814-016-0118-3. eCollection 2017.
PubMed 28168041
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of an Electronic Medication Administration-monitoring Device to Improve Medication Adherence and Reduce Medication Regimen Complexity in Community Dwelling Seniors: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT03513224
- Acronym / sponsor ID
- CAT2015-25
- Conditions
- Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Medication non-adherence can lead to serious health issues for older adults. This study is a four week study in older adults using a new device, the eDosette, which dispenses and records how one takes their medications, and subsequently makes this information available to the primary care team by the internet. This study aims to show that the eDosette can report how well a group of older adults living independently in the community are taking their medications (e.g. "medication adherence"). This study hopes to show that the eDosette intervention could play a role in medication adherence by improving conversations between older adults and primary care.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eDosette | Experimental | Other: eDosette |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- age 65 and over
- taking five or more medications (including supplements)
- using or willing to use a blister pack or dosette
- currently managing their medications independently
- living independently
Key exclusion criteria (4 listed)
- a documented diagnosis of mild cognitive impairment or dementia
- living in any form of assisted living facility
- currently palliative
- currently deemed medically unstable by their primary care 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 |
|---|---|---|
| eDosetteThe eDosette is an internet-enabled, medication administration monitoring unit that has been previously tested for feasibility in older adults. The eDosette was designed to be compatible with different types of weekly medication blister packs and dosettes, and monitors medication-taking behaviour in a patient's home. The eDosette securely transmits this information to a secure server where the information is converted to individual medication administration records. Patients can also use the eDosette to notify their primary care team of potential medication side effects. | Other | eDosette |
Primary outcome
Four-week medication adherence rate
Time frame: 4 weeks
Each participant's observed medication adherence for the entire study was calculated by dividing the total medication doses taken correctly by the total doses in the study. The numerator, total medication doses taken correctly is calculated by subtracting from the total doses any missed or late doses as determined by the eDosette. Missed doses is defined as any dose still present on image data after the next daily scheduled dose time); late doses is defined as any dose taken outside the two-hour time window of the average time of dose administration - e.g. 08h00-10h00 for a 09h00 average dose time. The denominator, total doses, was defined as the total number of pills prescribed for a patient to take during the study.
4 secondary outcomes
Thematic content of pharmacist-participant discussion during the study
Time frame: 4 weeks
Frequency of medication changes noted
Time frame: 4 weeks
Change in MRCI score
Time frame: 4 weeks
Participant feedback
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Background: PubMed 28168041Siu HY, Mangin D, Howard M, Price D, Chan D. Developing and testing an electronic medication administration monitoring device for community dwelling seniors: a feasibility study. Pilot Feasibility Stud. 2017 Feb 1;3:5. doi: 10.1186/s40814-016-0118-3. eCollection 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing eDosette in people with Medication Adherence, run by McMaster University.
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 6 inclusion and 4 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 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Four-week medication adherence rate (time frame: 4 weeks). 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 NCT03513224, 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 1 May 2018.