Medication Dispenser to Improve Care at Home for the Elderly

Cognitive Impairment Clinical Trial

Official title:

Next-generation Medication Dispenser to Improve Care at Home for Community-dwelling Elderly

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03511027
• Other study ID #: I2P2: AceAge
• Status: Withdrawn
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: April 2022
• Source: West Park Healthcare Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Medication Adherence

Intervention

Device:
• 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.

Other:
• SME only
At discharge, participants will be provided with self-medication education.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lee Verweel	CapitalCare Group Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Beliefs about medication	The Beliefs About Medication questionnaire, assesses participants cognitive representations of medication.	Baseline (Time 0M)
Secondary	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	Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M)
Secondary	Change in Quality of Life	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)
Secondary	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.	3 months post-baseline (Time 3M), 6 months post-baseline (Time 6M)
Secondary	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.	Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M)
Secondary	Sociodemographic Factors	The investigators will be collecting sociodemographic factors such as: Age, Gender, Education, Income, Postal Code.	Baseline (Time 0M)