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临床试验/NCT03162081
NCT03162081进行中(未招募)不适用

Medication Misuse and Dependence in Elderly Patients

University Hospital, Akershus0 个研究点目标入组 500 人开始时间: 2017年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
500
主要终点
Dependence y/n

研究概览

简要总结

The project focuses on investigating problematic medication use, especially overuse of potentially addictive drugs among the elderly.

The investigators aim firstly to develop and validate instruments for detecting and describing behavioral aspects and consequences of dependence on, and misuse of, prescription medication among elderly.

In addition to evaluating diagnostic utility of screening instruments, the investigators aim to identify and report characteristics, risk factors and consequences of medication misuse and dependence among the elderly.

详细描述

Elderly represent a particularly vulnerable group with many contributing factors including age-related multifactorial morbidity, cognitive function, polypharmacy, dependence and multiple prescribers with suboptimal communication. Centrally active pain killers and sedative/hypnotic medications give increased risk of addiction, adverse drug events, reduced physical and/or cognitive function.

The project comprises diagnostic accuracy, descriptive screening, cross-sectional and case-control studies, with aims to: i) assess diagnostic utility of instruments for elderly patients; ii) describe risk factors for medication misuse and dependence; iii) describe consequences of the use of centrally active medications among elderly compared to a control population.

Moreover, the investigators aim to examine the association between medication misuse and changes in cognitive function, focusing on deficits in specific domains of cognition. An additional aim is to explore the possibility of dissociating such cognitive changes from other causes of mild cognitive impairment (MCI) associated with development of dementia.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted to geriatric or Neurology dept of hospital during inclusion time

排除标准

  • MMSE < 21,
  • diagnosis of pre-existing severe depression or psychotic disease,
  • pre-existing dementia diagnosis,
  • new pain requiring start-up of central pain killers not previously used,
  • Palliative treatment.
  • Insufficient Norwegian language
  • Serious visual disturbance and hearing impairment
  • Strongly reduced general health precluding partcipation in interview and questionnaires

结局指标

主要结局

Dependence y/n

时间窗: Within 2 weeks of admission

DSM-IV defined substance dependence assessed by MINI interview

Medication misuse y/n

时间窗: Past year prior to in-hospital stay (data collected within 2 weeks of admission)

Use of any of: opiates/benzodiazepine/Z-hypnotics \>5 days per week for \>3 months

次要结局

  • TUG(Within 2 weeks of admission)
  • COGNISTAT(Within 2 weeks of admission)
  • No of days of use of defined addictive medications/month(Within 2 weeks of admission)
  • No.of inappropriate medications for elderly at discharge(Within 2 weeks (index stay may in some cases be somewhat longer))
  • MCI - Mild cognitive impairment(Within 2 weeks of admission)
  • BIS-11(Within 2 weeks of admission)
  • BIS/BAS score(Within 2 weeks of admission)
  • MMSE(Within 2 weeks of admission)
  • EQ-5D(Within 2 weeks of admission)
  • SLB(Within 2 weeks of admission)
  • Neuropsychological profiles(Within 2 weeks of admission)
  • No.of inappropriate medications for elderly at admission(Within 2 weeks of admission)
  • Substance use disorder(Within 2 weeks)
  • Use of addictive medication y/n(Within 2 weeks of admission)
  • No. of possible side effects(Within 2 weeks of admission)
  • No. of possible serious interactions(Within 2 weeks of admission)
  • No.of inappropriate medications for elderly during in-hospital stay(Within 2 weeks of admission)

研究者

发起方
University Hospital, Akershus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christofer Lundqvist

Principal investigator

University Hospital, Akershus

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