search
Back to results

Medication Dispenser to Improve Care at Home for the Elderly

Primary Purpose

Medication Adherence, Cognitive Impairment

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SME + Karie Device
SME only
Sponsored by
Lee Verweel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Medication Adherence focused on measuring Medication Adherence, Medication Dispensing, Homecare, Elderly

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Absent from community for more than one month during study
  • Inability to access study site pharmacy following discharge

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention (SME + Karie Device)

    Control (SME only)

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Beliefs about medication
    The Beliefs About Medication questionnaire, assesses participants cognitive representations of medication.
    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
    Change in Quality of Life
    The investigators will use the EQ-5D to measure changes in quality of life throughout the study.
    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.
    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.
    Sociodemographic Factors
    The investigators will be collecting sociodemographic factors such as: Age, Gender, Education, Income, Postal Code.

    Full Information

    First Posted
    March 23, 2018
    Last Updated
    April 26, 2022
    Sponsor
    Lee Verweel
    Collaborators
    CapitalCare Group Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03511027
    Brief Title
    Medication Dispenser to Improve Care at Home for the Elderly
    Official Title
    Next-generation Medication Dispenser to Improve Care at Home for Community-dwelling Elderly
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    COVID-19
    Study Start Date
    August 1, 2018 (Actual)
    Primary Completion Date
    September 1, 2019 (Actual)
    Study Completion Date
    October 1, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Lee Verweel
    Collaborators
    CapitalCare Group Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Medication Adherence, Cognitive Impairment
    Keywords
    Medication Adherence, Medication Dispensing, Homecare, Elderly

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention (SME + Karie Device)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control (SME only)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    SME + Karie Device
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    SME only
    Intervention Description
    At discharge, participants will be provided with self-medication education.
    Primary Outcome Measure Information:
    Title
    Change in Medication Adherence
    Description
    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.
    Time Frame
    Baseline (Time 0 Months), 3-months post-baseline(Time 3 Months), 6 months post-baseline (Time 6 Months)
    Secondary Outcome Measure Information:
    Title
    Beliefs about medication
    Description
    The Beliefs About Medication questionnaire, assesses participants cognitive representations of medication.
    Time Frame
    Baseline (Time 0M)
    Title
    Change in Self-Medication Behaviours
    Description
    The investigators will use the Self-Efficacy for Appropriate Medication Scale (SEAMS) to determine participants behaviours and attitudes about self-medication
    Time Frame
    Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M)
    Title
    Change in Quality of Life
    Description
    The investigators will use the EQ-5D to measure changes in quality of life throughout the study.
    Time Frame
    Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M)
    Title
    Economic Analysis
    Description
    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.
    Time Frame
    3 months post-baseline (Time 3M), 6 months post-baseline (Time 6M)
    Title
    Change in Healthcare Consumption
    Description
    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.
    Time Frame
    Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M)
    Title
    Sociodemographic Factors
    Description
    The investigators will be collecting sociodemographic factors such as: Age, Gender, Education, Income, Postal Code.
    Time Frame
    Baseline (Time 0M)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: Absent from community for more than one month during study Inability to access study site pharmacy following discharge
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tim Pauley, MSc
    Organizational Affiliation
    West Park Healthcare Centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No, individual patient data will only be available to the study investigators identified on the Research Ethics Board applications at each study site.

    Learn more about this trial

    Medication Dispenser to Improve Care at Home for the Elderly

    We'll reach out to this number within 24 hrs