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临床试验/NCT04190329
NCT04190329已完成不适用

Feasibility of an Extended Test Battery and Influencing Factors for Detecting Frailty

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年12月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Duration to run the test battery

研究概览

简要总结

The aim of the prospective study is to assess the feasibility of a screening and baseline measurement protocol that is planned for a main study (PRÄP-GO) in a collective of 30 patients ageing 70+ scheduled for elective surgery. Comprehensive geriatric assessment scores and modified Fried frailty phenotype component evaluation are performed in all patients at baseline before elective surgery. The assessment of cognitive tests is conducted with a battery of neuropsychological tests, computer-based tests from the Cambridge Neuropsychological Test Automated Battery [CANTAB®] and non-computer based tests. Frailty scores from 0 to 5 (i.e., 1 point for each component; 0 = best to 5 = worst) represent robust (0), pre-frail (1-2), and frail (3-5) health status. 10 patients without Frailty, 10 patients with Pre-Frailty and 10 patients with Frailty should be analyzed in this study and receive further comprehensive geriatric assessment testing up to seven days after surgery/discharge (before 7 postoperative days).

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
70 Years 至 —(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

Duration to run the test battery

时间窗: 1 day (Once only at screening)

The duration of the screening test battery is measured with a stopwatch.

次要结局

  • Problems to conduct the test battery(1 day (Once only at screening))
  • Acceptance of test battery(1 day (Once only at screening))
  • Intelligibility of the patient Diary 2(Up to day 7 after surgery)
  • Implementation rate of the patient Diary 3(Up to day 7 after surgery)
  • Change in pain(Baseline, day 3 after surgery and discharge or day 7 after surgery)
  • Intelligibility of the patient Diary 1(Up to day 7 after surgery)
  • Nutritional status 1(Baseline and discharge or day 7 after surgery)
  • Nutritional status 4(Baseline and discharge or day 7 after surgery)
  • Length of intensive care unit stay(Participants will be followed for the duration of hospital stay, an expected average of 1 day.)
  • Nutritional status 2(Baseline and discharge or day 7 after surgery)
  • Intelligibility of the patient Diary 3(Up to day 7 after surgery)
  • Handgrip strength(Baseline, day 3 after surgery and discharge or day 7 after surgery)
  • Nutritional status 3(Baseline and discharge or day 7 after surgery)
  • Intra- and postoperative organ complications(Up to 7 days after surgery)
  • Length of stay(Participants will be followed for the duration of hospital stay, an expected average of 7 days.)
  • Mobility(Baseline, day 3 after the operation and discharge or day 7 after surgery)

研究者

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

Claudia Spies

Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin

Charite University, Berlin, Germany

研究点 (1)

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