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临床试验/NCT03511027
NCT03511027撤回不适用

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

Lee Verweel0 个研究点开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
Change in Medication Adherence

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Change in Medication Adherence

时间窗: 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.

次要结局

  • 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))
  • 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 Healthcare Consumption(Baseline (Time 0M), 3-months post-baseline(Time 3M), 6 months post-baseline (Time 6M))
  • Sociodemographic Factors(Baseline (Time 0M))

研究者

发起方
Lee Verweel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lee Verweel

Manager, West Park Healthcare Centre

West Park Healthcare Centre

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