Feasibility of an Extended Test Battery and Influencing Factors for Detecting Frailty
2020年10月7日 更新者：Claudia Spies、Charite University, Berlin, Germany
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).
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
30
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Berlin、德国、13353
- Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
70年 及以上 (年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients undergoing elective surgery aged ≥70 years, including 10 patients without Frailty, 10 patients with Pre-Frailty and 10 patients with Frailty.
描述
Inclusion criteria:
- Age ≥ 70 years
- Male and female patients
- Patient eligible for inclusion: by the patient, preoperatively
- elective surgery
- Expected anesthesia duration> 60min
Exclusion criteria:
- Severe cardiological or pulmonary disease (NYHA IV, Gold IV)
- Intracranial interventions
- Moribund patients (palliative situation)
- Not enough language skills
- Non-consenting patients
- Participation in another prospective intervention study for study inclusion or throughout the study period.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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10 non-frail (robust) study patients
Patients fulfill 0 criteria according to modified Fried frailty score.
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10 pre-frail study patients
Patients fulfill 1-2 criteria criteria according to modified Fried frailty score.
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10 frail study patients
Patients fulfill 3, 4 or 5 criteria according to modified Fried frailty score.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Duration to run the test battery
大体时间：1 day (Once only at screening)
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The duration of the screening test battery is measured with a stopwatch.
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1 day (Once only at screening)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Acceptance of test battery
大体时间：1 day (Once only at screening)
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The study patient´s acceptance of the screening test battery is measured with a questionnaire.
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1 day (Once only at screening)
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Problems to conduct the test battery
大体时间：1 day (Once only at screening)
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Problems while performing the test battery are categorized according to a standardized protocol.
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1 day (Once only at screening)
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Change in pain
大体时间：Baseline, day 3 after surgery and discharge or day 7 after surgery
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Pain is measured with a pain score, a higher score indicates more pain.
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Baseline, day 3 after surgery and discharge or day 7 after surgery
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Intelligibility of the patient Diary 1
大体时间：Up to day 7 after surgery
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Number of completed items
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Up to day 7 after surgery
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Intelligibility of the patient Diary 2
大体时间：Up to day 7 after surgery
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Number of completed days
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Up to day 7 after surgery
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Intelligibility of the patient Diary 3
大体时间：Up to day 7 after surgery
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Coherence of the diary with clinical patient record
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Up to day 7 after surgery
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Implementation rate of the patient Diary 3
大体时间：Up to day 7 after surgery
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Up to day 7 after surgery
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Handgrip strength
大体时间：Baseline, day 3 after surgery and discharge or day 7 after surgery
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Handgrip strength measured using a Dynamometer.
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Baseline, day 3 after surgery and discharge or day 7 after surgery
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Mobility
大体时间：Baseline, day 3 after the operation and discharge or day 7 after surgery
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Mobility is measured using the Charité Mobilitäts-Index (CHARMI®).
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Baseline, day 3 after the operation and discharge or day 7 after surgery
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Nutritional status 1
大体时间：Baseline and discharge or day 7 after surgery
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Nutritional status 1 is measured using serum albumin.
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Baseline and discharge or day 7 after surgery
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Nutritional status 2
大体时间：Baseline and discharge or day 7 after surgery
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Nutritional status 2 is measured using arm circumference.
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Baseline and discharge or day 7 after surgery
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Nutritional status 3
大体时间：Baseline and discharge or day 7 after surgery
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Nutritional status 3 is measured using calf circumference.
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Baseline and discharge or day 7 after surgery
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Nutritional status 4
大体时间：Baseline and discharge or day 7 after surgery
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Nutritional status 4 is measured using the Mini Nutritional Assessment - Short Form (MNA®-SF).
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Baseline and discharge or day 7 after surgery
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Intra- and postoperative organ complications
大体时间：Up to 7 days after surgery
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Up to 7 days after surgery
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Length of intensive care unit stay
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 1 day.
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Participants will be followed for the duration of hospital stay, an expected average of 1 day.
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Length of stay
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 7 days.
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Participants will be followed for the duration of hospital stay, an expected average of 7 days.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Cognitive Status
大体时间：1 day (Once only at screening)
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Neuropsychological testing
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1 day (Once only at screening)
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Depression
大体时间：1 day (Once only at screening)
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The assessment of Depression is measured with the - Patient Health Questionnaire (PHQ-8)
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1 day (Once only at screening)
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Frailty
大体时间：1 day (Once only at screening)
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Frailty is operationalized using modified Fried frailty criteria.
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.
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1 day (Once only at screening)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Claudia Spies, MD Prof.、Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité Univerisitätsmedizin Berlin
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年12月18日
初级完成 (实际的)
2020年7月16日
研究完成 (实际的)
2020年7月20日
研究注册日期
首次提交
2019年11月28日
首先提交符合 QC 标准的
2019年12月4日
首次发布 (实际的)
2019年12月9日
研究记录更新
最后更新发布 (实际的)
2020年10月8日
上次提交的符合 QC 标准的更新
2020年10月7日
最后验证
2020年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.