Medication AdherenceNCT03511027
Medication Dispenser to Improve Care at Home for the Elderly
A study testing SME + Karie Device and SME only in people with Medication Adherence and Cognitive Impairment, run by Lee Verweel.
Trial summary
The purpose of this study is to investigate the efficacy of the Karie Automated Medication delivery device in enhancing medication adherence among a group of elderly patients with mild to moderate cognitive decline. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Cognitive Impairment
- What is being tested?
- SME + Karie Device and SME only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2018to 1 Oct 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Need to manage medications independently at home
- Stabilized on medication, as per pharmacist/physician discretion; and
- Mild-moderate cognitive/physical impairments, as per OT assessment
- Montreal Cognitive Assessment (MoCA) score not less than 16
- English speaking
Who cannot join
- Absent from community for more than one month during study
- Inability to access study site pharmacy following discharge
About this study
Official title: Next-generation Medication Dispenser to Improve Care at Home for Community-dwelling Elderly
The purpose of this study is to investigate the efficacy of the Karie Automated Medication delivery device in enhancing medication adherence among a group of elderly patients with mild to moderate cognitive decline.
Read the detailed description
Given the risks associated with poor adherence and the apparent contribution of good adherence to reducing hospitalizations and emergency department (ED) visits, interventions for promoting good adherence should be pursued. To this end, a number of devices have been developed to promote medication adherence, though with limited success due to reliability, cost, etc. The purpose of this study is to investigate the efficacy of the Karie Automated Medication Delivery Device in enhancing medication adherence among a group of community-dwelling patients immediately following discharge from inpatient rehabilitation.
This study will utilize a multi-site randomized controlled trial design. One week prior to discharge from inpatient rehab, consenting patients will be randomly assigned to receive medication self-management education only (SME) or medication self-management education + Karie (SME+K). Both sites (West Park Healthcare Centre, and CapitalCare) will recruit 150 participants for the study. At each site, 75 patients will be in the intervention group (SME + Karie) and 75 will be in the control group (SME only).
- Conditions
- Medication Adherence, Cognitive Impairment
- Being tested
- SME + Karie Device, SME only
- Keywords
- Medication Adherence, Medication Dispensing, Homecare, Elderly
- Medical subject headings
- Medication Adherence, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SME + Karie DeviceDevice
For the duration of the study, participants will use the Karie device to promote medication adherence. The Karie device prompts users to take their medication in the right amount at the right time.
SME onlyOther
At discharge, participants will be provided with self-medication education.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (SME + Karie Device) | Experimental | Patients randomly assigned to receive SME+Karie will 1) undergo Screening for Self Medication Readiness to determine self-management capacity, 2) will receive self-medication education (SME) by a study Occupational Therapist, and 3) receive a 5-day self-medication performance assessment by an Registered Nurse prior to discharge. In addition, this group will receive orientation to the Karie Automated Medication Delivery by the study Occupational Therapist. The participants in the intervention arm will use the Karie device for all applicable medications for the study duration. Receives: Device: SME + Karie Device |
| Control (SME only) | Active comparator | West Park has a "Self-Medication Education Program" policy in place which seeks to establish independent medication self-medication capacity during the inpatient stay. Eligibility criteria for SME include a need to manage medications independently at home; stabilized on medication (as per pharmacist/physician discretion); and mild-moderate cognitive/physical impairments (as per an OT assessment). During SME participants receive training by an Occupational Therapist, followed by a 5-day self-medication performance assessment by an Registered Nurse prior to discharge. Participants in the SME group will fill prescriptions as usual for the duration of study. Receives: Other: SME only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Medication Adherence
The Medication Adherence Questionnaire (MAQ) and medication 7 day recall will measure participants adherence to their medications over time.Both of these measures will be taken at the same time-points throughout the study.
Measured: Baseline (Time 0 Months), 3-months post-baseline(Time 3 Months), 6 months post-baseline (Time 6 Months)
Secondary outcomes (6)
Beliefs about medication
The Beliefs About Medication questionnaire, assesses participants cognitive representations of medication.
Measured: Baseline (Time 0M)
Change in Self-Medication Behaviours
The investigators will use the Self-Efficacy for Appropriate Medication Scale (SEAMS) to determine participants behaviours and attitudes about self-medication
Measured: Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M)
Change in Quality of Life
The investigators will use the EQ-5D to measure changes in quality of life throughout the study.
Measured: Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M)
Economic Analysis
To determine the affect that the Karie device has on economic indicators, the investigators will be observing staffing hours (OT, Pharmacist), medication costs, and medication wastage. This will be documented by staff and will be self-reported.
Measured: 3 months post-baseline (Time 3M), 6 months post-baseline (Time 6M)
Change in Healthcare Consumption
To determine any changes in healthcare consumption, the investigators will be observing the number of hospitalizations, visits to the GP, and visits to ER for all causes in all of the participants.
Measured: Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M)
Sociodemographic Factors
The investigators will be collecting sociodemographic factors such as: Age, Gender, Education, Income, Postal Code.
Measured: Baseline (Time 0M)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start1 Aug 2018
- Primary completion1 Sep 2019
- Study completion1 Oct 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will utilize a multi-site randomized controlled trial design. One week prior to discharge from inpatient rehab, consenting patients will be randomly assigned to receive medication self-management education only (SME) or medication self-management education + Karie (SME+K).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee Verweel
- Sponsor type
- University, hospital or other
- Collaborators
- CapitalCare Group Inc.
- Responsible party
- Sponsor-investigator, Lee Verweel, West Park Healthcare Centre
- Investigators
- Tim Pauley, MSc, Principal investigator, West Park Healthcare Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511027
- Sponsor's protocol ID
- I2P2: AceAge
- Status last verified
- Apr 2022
- First submitted
- 23 Mar 2018
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, individual patient data will only be available to the study investigators identified on the Research Ethics Board applications at each study site.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next-generation Medication Dispenser to Improve Care at Home for Community-dwelling Elderly
- ClinicalTrials.gov ID
- NCT03511027
- Acronym / sponsor ID
- I2P2: AceAge
- Conditions
- Medication Adherence, Cognitive Impairment
- Keywords
- Medication Adherence, Medication Dispensing, Homecare, Elderly
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lee VerweelUniversity, hospital or other
- Collaborators
- CapitalCare Group Inc.
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 27 Apr 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.
The purpose of this study is to investigate the efficacy of the Karie Automated Medication delivery device in enhancing medication adherence among a group of elderly patients with mild to moderate cognitive decline.
Detailed description
Given the risks associated with poor adherence and the apparent contribution of good adherence to reducing hospitalizations and emergency department (ED) visits, interventions for promoting good adherence should be pursued. To this end, a number of devices have been developed to promote medication adherence, though with limited success due to reliability, cost, etc. The purpose of this study is to investigate the efficacy of the Karie Automated Medication Delivery Device in enhancing medication adherence among a group of community-dwelling patients immediately following discharge from inpatient rehabilitation.
This study will utilize a multi-site randomized controlled trial design. One week prior to discharge from inpatient rehab, consenting patients will be randomly assigned to receive medication self-management education only (SME) or medication self-management education + Karie (SME+K). Both sites (West Park Healthcare Centre, and CapitalCare) will recruit 150 participants for the study. At each site, 75 patients will be in the intervention group (SME + Karie) and 75 will be in the control group (SME only).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will utilize a multi-site randomized controlled trial design. One week prior to discharge from inpatient rehab, consenting patients will be randomly assigned to receive medication self-management education only (SME) or medication self-management education + Karie (SME+K).
| Arm | Type | Receives |
|---|---|---|
| Intervention (SME + Karie Device) | Experimental | Device: SME + Karie DevicePatients randomly assigned to receive SME+Karie will 1) undergo Screening for Self Medication Readiness to determine self-management capacity, 2) will receive self-medication education (SME) by a study Occupational Therapist, and 3) receive a 5-day self-medication performance assessment by an Registered Nurse prior to discharge. In addition, this group will receive orientation to the Karie Automated Medication Delivery by the study Occupational Therapist. The participants in the intervention arm will use the Karie device for all applicable medications for the study duration. |
| Control (SME only) | Active comparator | Other: SME onlyWest Park has a "Self-Medication Education Program" policy in place which seeks to establish independent medication self-medication capacity during the inpatient stay. Eligibility criteria for SME include a need to manage medications independently at home; stabilized on medication (as per pharmacist/physician discretion); and mild-moderate cognitive/physical impairments (as per an OT assessment). During SME participants receive training by an Occupational Therapist, followed by a 5-day self-medication performance assessment by an Registered Nurse prior to discharge. Participants in the SME group will fill prescriptions as usual for the duration of study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Need to manage medications independently at home
- Stabilized on medication, as per pharmacist/physician discretion; and
- Mild-moderate cognitive/physical impairments, as per OT assessment
- Montreal Cognitive Assessment (MoCA) score not less than 16
- English speaking
Key exclusion criteria (2 listed)
- Absent from community for more than one month during study
- Inability to access study site pharmacy following discharge
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 |
|---|---|---|
| SME + Karie DeviceFor the duration of the study, participants will use the Karie device to promote medication adherence. The Karie device prompts users to take their medication in the right amount at the right time. | Device | Intervention (SME + Karie Device) |
| SME onlyAt discharge, participants will be provided with self-medication education. | Other | Control (SME only) |
Primary outcome
Change in Medication Adherence
Time frame: Baseline (Time 0 Months), 3-months post-baseline(Time 3 Months), 6 months post-baseline (Time 6 Months)
The Medication Adherence Questionnaire (MAQ) and medication 7 day recall will measure participants adherence to their medications over time.Both of these measures will be taken at the same time-points throughout the study.
6 secondary outcomes
Beliefs about medication
Time frame: Baseline (Time 0M)
Change in Self-Medication Behaviours
Time frame: Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M)
Change in Quality of Life
Time frame: Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M)
Economic Analysis
Time frame: 3 months post-baseline (Time 3M), 6 months post-baseline (Time 6M)
Change in Healthcare Consumption
Time frame: Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M)
Sociodemographic Factors
Time frame: Baseline (Time 0M)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Individual participant dataSharing planned: No. No, individual patient data will only be available to the study investigators identified on the Research Ethics Board applications at each study site.
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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.
Tim Pauley, MSc principal investigator
West Park Healthcare Centre
Questions about this trial
What is this clinical trial studying?
A study testing SME + Karie Device and SME only in people with Medication Adherence and Cognitive Impairment, run by Lee Verweel.
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 5 inclusion and 2 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: withdrawn, as of the sponsor's last update on 3 May 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Medication Adherence (time frame: Baseline (Time 0 Months), 3-months post-baseline(Time 3 Months), 6 months post-baseline (Time 6 Months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2022.