Medication Dispenser to Improve Care at Home for the Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

ElastoMeric Infusion Pumps for Hospital AntibioTICs

NCT05150015

Infection, Bacterial

COMPLETED NA

AVERT Plus Post-Market Registry

NCT02436642

Coronary Artery Disease

TERMINATED

Clinical Performance Evaluation of Native Whole Blood Samples of Patients on DOACs With the Perosphere ClotChek™

NCT07012291

Coagulation

RECRUITING

Clinical Trial of New Intermittent Single-use Catheter

NCT05814211

Urinary Incontinence

COMPLETED NA

Evaluation of the Safety and Efficacy of Single-use Precision Filtered Infusion Sets for Intravenous Infusion

NCT04962516

Single-use Precision Filter Infusion Set

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Medication Adherence Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

SME + Karie Device

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

SME only

Intervention Type OTHER

At discharge, participants will be provided with self-medication education.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SME + Karie Device

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 DEVICE

SME only

At discharge, participants will be provided with self-medication education.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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