Medication Dispenser to Improve Care at Home for the Elderly

NCT03511027 | Withdrawn

• 1 other identifier: I2P2: AceAge
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Medication Adherence; Cognitive Impairment

Keywords

Medication Adherence; Medication Dispensing; Homecare; Elderly

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Time 0 Months), 3-months post-baseline(Time 3 Months), 6 months post-baseline (Time 6 Months)

Secondary Outcomes (6)

• Beliefs about medication

  Baseline (Time 0M)

• Change in Self-Medication Behaviours

  Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M)

• Change in Quality of Life

  Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M)

• Economic Analysis

  3 months post-baseline (Time 3M), 6 months post-baseline (Time 6M)

• Change in Healthcare Consumption

  Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M)

Study Arms (2)

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.

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.

Other: SME only

Interventions

SME + Karie Device 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 (SME + Karie Device)

SME only OTHER

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

Control (SME only)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lee Verweel: lead
• CapitalCare Group Inc.: collaborator

MeSH Terms

Conditions

Medication Adherence; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Tim Pauley, MSc

  West Park Healthcare Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Manager, West Park Healthcare Centre

Model Details: 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).

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 27, 2018
• Study Start: August 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: October 1, 2020
• Last Updated: May 3, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share