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临床试验/NCT03024541
NCT03024541已完成不适用

Longitudinal Analysis of Cumulative Exposure to Anticholinergic and Sedative Drugs Measured With the Drug Burden Index

University of Groningen0 个研究点目标入组 9,985 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9,985
主要终点
LASA study: Alphabet Coding Task

研究概览

简要总结

Anticholinergic and sedative drugs are frequently prescribed to older people, despite their negative impact on older people's physical and cognitive function. To estimate the cumulative exposure to anticholinergic and sedative drugs, Hilmer et al. published the Drug Burden Index (DBI) in 2007. The present study aims to complement previous study findings showing higher DBI values to be associated with physical and cognitive impairment. Most previously conducted studies of the DBI were either cross-sectional or were longitudinal but with short follow-ups. Furthermore, it remains unknown whether higher DBI values carry extra risks for patients with dementia. Finally, relatively little is known about the stability of DBI values over time. The current project therefore aims to examine (1) longitudinal relationships between long-term cumulative exposure to anticholinergic and sedative drugs as measured with the DBI and cognitive and physical function, (2) to examine interaction effects between DBI exposure and dementia, and (3) to examine trajectories of DBI exposure, i.e. DBI exposure remaining stable, declining, increasing or fluctuating over time. These project aims will be studied with longitudinal data from eligible participants > 60 years from the LASA study with participants being followed-up during two decades, and the longitudinal data from the InterRAI consortium. Various clinical outcomes regarding cognitive and physical function will be studied. Data will be analysed with generalised linear mixed models and Latent Class Growth Analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

LASA study: Alphabet Coding Task

时间窗: 21 years: 7 waves separated by 3 year intervals

次要结局

  • LASA study: Mini Mental Status Examination(21 years: 7 waves separated by 3 year intervals)
  • LASA study: Verbal Fluency Test: Phonemic fluency(collected at 7th wave after 21 years (cross-sectional))
  • LASA study: 15-Words Test: Word Learning(21 years: 7 waves separated by 3 year intervals)
  • LASA study: 15-Words Test: Delayed Recall(21 years: 7 waves separated by 3 year intervals)
  • LASA study: Digit Span Forward from Wechsler Adult Intelligence Scale(collected at 7th wave after 21 years (cross-sectional))
  • LASA study: Chair Stands Test(21 years: 7 waves separated by 3 year intervals)
  • LASA study: Walking Test(21 years: 7 waves separated by 3 year intervals)
  • LASA study: Balance Test(21 years: 7 waves separated by 3 year intervals)
  • LASA study: Verbal Fluency Test: Semantic fluency(collected at 7th wave after 21 years (cross-sectional))
  • LASA study: Digit Span Backward from Wechsler Adult Intelligence Scale(collected at 7th wave after 21 years (cross-sectional))
  • LASA study: Functional Independence Scale(18 years: 6 waves with 3 year intervals)
  • LASA study: Cardigan Test(21 years: 7 waves separated by 3 year intervals)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katja Taxis

Professor

University of Groningen

相似试验

Longitudinal Analysis of Drug Burden Index | 临床试验