Cognitive Impairment, Medication Adherence
Conditions
Keywords
Medication Adherence, Medication Dispensing, Homecare, Elderly
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).
Interventions
DEVICESME + 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.
OTHERSME only
At discharge, participants will be provided with self-medication education.
Sponsors
CapitalCare Group Inc.
Lee Verweel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Medication Adherence | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Medication Behaviours | Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M) | The investigators will use the Self-Efficacy for Appropriate Medication Scale (SEAMS) to determine participants behaviours and attitudes about self-medication |
| Change in Quality of Life | Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M) | The investigators will use the EQ-5D to measure changes in quality of life throughout the study. |
| Beliefs about medication | Baseline (Time 0M) | The Beliefs About Medication questionnaire, assesses participants cognitive representations of medication. |
| Change in Healthcare Consumption | Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M) | 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. |
| Sociodemographic Factors | Baseline (Time 0M) | The investigators will be collecting sociodemographic factors such as: Age, Gender, Education, Income, Postal Code. |
| Economic Analysis | 3 months post-baseline (Time 3M), 6 months post-baseline (Time 6M) | 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. |
Outcome results
None listed