Next-generation Medication Dispenser to Improve Care at Home for Community-dwelling Elderly
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Change in Medication Adherence
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: SME + Karie Device (Device)
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.
Intervention: SME only (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in Quality of Life(Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M))
- 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))
- 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))
- Sociodemographic Factors(Baseline (Time 0M))
Investigators
Lee Verweel
Manager, West Park Healthcare Centre
West Park Healthcare Centre