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临床试验/NCT05253612
NCT05253612已完成不适用

Comparison Between Analog Neurocognitive Tests Conducted by a Trained Test Leader Versus Self-administered Digital Tests: a Protocol for an Equivalence Study

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年2月17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
50
试验地点
1
主要终点
equivalence between the two tests

研究概览

简要总结

The study has a randomized crossover design including qualitative interviews of the participant's test experiences. Healthy participants, ≥60 years are eligible to participate in the study. Cognitive function will be measured by using the International Study Group of Postoperative Cognitive Dysfunction (ISPOCD) test battery and the Mindmore digital test battery. The participants will self-report their likelihood of depression with the geriatric depression scale-15, their user experience of the digital test by a modified version of System Usability scale, and answer questionnaires targeting their experiences of the test sessions. Furthermore, concentration difficulties, according to the Swedish Quality of Recovery-scale will also be measured.

详细描述

Study design: Randomized crossover design including qualitative interviews of the test procedures.

Participants:The participants are planned to be healthy controls (n=50) comprising men and women of >60 years of age. The number of participants is guided by an earlier cross over studies with older adults assessing cognition digitally and analogy The participants will self-report if they meet any of the exclusion criteria: inability to read and speak Swedish, suffering from a nervous system disease, severe psychiatric disorder, alcoholism, drug dependance and severe visual or auditory disorder.

Cognitive tests Verbal episodic memory ISPOCD: The Visual Verbal Learning Test with 15 words that are individually presented over a series of 3 consecutive presentations. Each word is presented visually for 2 seconds. The participant is asked to recall as many words as possible after each trial as well as after 20 min without further presentation of word, i.e. delayed recall.

Mindmore: CERAD is a 10-word verbal learning test with 3 learning trials, a recall trial after ~7 min and a recognition trial. Compared to RAVLT this test is shorter, but also a little less sensitive. Words are read and visually presented in writing to the patient and the patient replies in speech.

Executive, visuospatial (assess processing speed) ISPOCD: The Concept Shifting Test is a trail-making test where the participant is required to alternate between letters and digits. Each part consists of 16 circles on a paper. In part A, the circles are numbered from 1 to 16. The test person is instructed to draw a short over each number in ascending order from 1 to 16, as rapidly as possible. Part B consists of letters from A-P. Part C consists of 8 digits and 8 letters to be paired and the test person is instructed to draw a short over each and letter order (1-A, 2-B, 3-C and so on).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Screening
盲法
None

入排标准

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

入选标准

  • •> 59 years of age
  • •ability to read and speak Swedish,

排除标准

  • •suffering from a nervous system disease,
  • •suffering from a severe psychiatric disorder
  • •alcoholism
  • •drug dependence
  • •severe visual or auditory disorder.

研究组 & 干预措施

ISPOCD test battery

Other

The participants will be randomized to start with ISPOCD test battery followed by Mindmore digitalized cognitive test battery with 2 weeks passing between the cognitive testing for both groups

干预措施: Analog testing conducted by a trained test leader using, ISPOCD test battery (Diagnostic Test)

ISPOCD test battery

Other

The participants will be randomized to start with ISPOCD test battery followed by Mindmore digitalized cognitive test battery with 2 weeks passing between the cognitive testing for both groups

干预措施: self-administered Mindmore digital cognitive screening battery (Diagnostic Test)

Mindmore digitalized cognitive test battery

Other

Strating with Mindmore digitalized cognitive test battery followed by ISPOCD test battery, with 2 weeks passing between the cognitive testing for both groups

干预措施: Analog testing conducted by a trained test leader using, ISPOCD test battery (Diagnostic Test)

Mindmore digitalized cognitive test battery

Other

Strating with Mindmore digitalized cognitive test battery followed by ISPOCD test battery, with 2 weeks passing between the cognitive testing for both groups

干预措施: self-administered Mindmore digital cognitive screening battery (Diagnostic Test)

结局指标

主要结局

equivalence between the two tests

时间窗: through study completion, an average of 6 months

If the data is normal distributed Pearson correlation coefficient will be used to measure the association between ISPOCD and Mindmore four cognitive domains. If the data is non normally distributed Spearman rank correlation will be used. The values for the correlation coefficient irrespectively if using Person or Spearman range between -1.0 and 1.0. A correlation of -1.0 shows a perfect negative correlation, while a correlation of 1.0 shows a perfect positive correlation. However, a correlation equal to 0 does not imply the absence of association

次要结局

  • Concentration difficulties the past 24 hours(through study completion, an average of 6 months)
  • Usability of the digital test version(through study completion, an average of 6 months)
  • Acceptability and Feasibility (I)(through study completion, an average of 6 months)
  • Costs for the different screening tests(through study completion, an average of 6 months)
  • Acceptability and Feasibility (II)(through study completion, an average of 6 months)
  • Depression screening(through study completion, an average of 6 months)

研究者

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

Ulrica Nilsson

Professor

Karolinska Institutet

研究点 (1)

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