Clinical trial NCT03511027: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Medication Adherence
Cognitive Impairment
Keywords: Medication Adherence
Medication Dispensing
Homecare
Elderly
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
Collaborators: name: CapitalCare Group Inc.
First posted: 2018-04-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Change in Medication Adherence
timeFrame: Baseline (Time 0 Months), 3-months post-baseline(Time 3 Months), 6 months post-baseline (Time 6 Months)
Secondary outcomes:
measure: Beliefs about medication
timeFrame: Baseline (Time 0M)
measure: Change in Self-Medication Behaviours
timeFrame: Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M)
measure: Change in Quality of Life
timeFrame: Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M)
measure: Economic Analysis
timeFrame: 3 months post-baseline (Time 3M), 6 months post-baseline (Time 6M)
measure: Change in Healthcare Consumption
timeFrame: Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M)
measure: Sociodemographic Factors
timeFrame: Baseline (Time 0M)
Other outcomes:
Locations:
Study officials:
affiliation: West Park Healthcare Centre
name: Tim Pauley, MSc
role: PRINCIPAL_INVESTIGATOR
References: