Medication Dispenser to Improve Care at Home for the Elderly

April 26, 2022 updated by: Lee Verweel

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.

Study Overview

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention (SME + Karie Device)
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.
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.
Active Comparator: Control (SME only)
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.
At discharge, participants will be provided with self-medication education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Time 0 Months), 3-months post-baseline(Time 3 Months), 6 months post-baseline (Time 6 Months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beliefs about medication
Time Frame: Baseline (Time 0M)
The Beliefs About Medication questionnaire, assesses participants cognitive representations of medication.
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)
The investigators will use the Self-Efficacy for Appropriate Medication Scale (SEAMS) to determine participants behaviours and attitudes about self-medication
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)
The investigators will use the EQ-5D to measure changes in quality of life throughout the study.
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)
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.
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)
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.
Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M)
Sociodemographic Factors
Time Frame: Baseline (Time 0M)
The investigators will be collecting sociodemographic factors such as: Age, Gender, Education, Income, Postal Code.
Baseline (Time 0M)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Tim Pauley, MSc, West Park Healthcare Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

March 23, 2018

First Submitted That Met QC Criteria

April 17, 2018

First Posted (Actual)

April 27, 2018

Study Record Updates

Last Update Posted (Actual)

May 3, 2022

Last Update Submitted That Met QC Criteria

April 26, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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