跳至主要内容
临床试验/NCT01602731
NCT01602731已完成不适用

Targeted Intervention to Improve Medication Adherence in Cognitively Impaired Patients With Heart Failure

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2012年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Feasibility of AMDD to Improve Medication Adherence Via Completion Rate

研究概览

简要总结

Trialing an automated medication dispensing device (AMDD) to improve medication adherence in patients with heart failure.

详细描述

Background:

Medication adherence [MA] is a complex issue depending on both patient and healthcare factors. Non-adherence due to patient-dependent factors is common; analyses of large broad-based clinical trials in the general population demonstrate that 20-30% of study medication doses may be missed. In community-dwelling HF patients with polypharmacy this percentage is likely even higher. One of the factors in poor adherence in elderly non-HF patients has been shown to be cognitive impairment [CI]. Non-adherence to medical regimen is one factor that is associated with worse outcomes in patients with HF, including readmissions. Measures that improve MA are also likely to improve outcomes.

Objectives:

We evaluated a novel intervention incorporating new technology with the goal of improving adherence in patients with HF and CI. Specific objectives of the study were (1) to assess the feasibility of using the Automated Medication Dispensing Device (AMDD) in veterans with HF and CI by measuring patient qualifying rate, consent rate, user rate, patient-level response rate, medication-level response rate, and success rate, (2) to calculate the improvement of MA based on pill counts before and after the introduction of the AMDD, and (3) qualitatively describe patient satisfaction with the AMDD and the reasons for not using the AMDD.

Methods:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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
否

入选标准

  • •Patients with established diagnosis of clinical heart failure
  • •English-speaking
  • •Able to provide informed consent
  • •Able to participate in cognitive function testing
  • •Age over 18

排除标准

  • •Life expectancy < 6 months
  • •Documented dementia requiring a caregiver
  • •inability to set up the AMDD at the patient's home due to technical limitations

研究组 & 干预措施

Automated Medication Dispensing Device

Experimental

Subjects with <88% medication adherence, determined by 30-day pillcount, and with cognitive impairment (determined by Saint Louis University Mental Status score) proceeded to AMDD portion of study.

干预措施: Automated Medication Dispensing Device (Device)

结局指标

主要结局

Feasibility of AMDD to Improve Medication Adherence Via Completion Rate

时间窗: 4 months

Rate that patient population completed set-up of AMDD was evaluated quantitatively.

次要结局

  • Efficacy of AMDD to Improve Medication Adherence(30-day pill count before the use of AMDD and with AMDD)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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