跳至主要内容
临床试验/NCT05879562
NCT05879562进行中(未招募)不适用

Montreal Cognitive Assessment (MoCA) XpressO: Validation of a Digital Self-administered Cognitive Pre-screening Tool for the General Adult Population

MoCA Clinic and Institute2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年10月1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
100
试验地点
2
主要终点
Correlation between the MoCA XpressO and the Digital MoCA

研究概览

简要总结

The investigators conducted a validation study for the Montreal Cognitive Assessment (MoCA)-XpressO compared to the digital-MoCA test (version 8.1) as the gold standard. Participants were recruited from the MoCA clinic and a family practice. Ethics approval was received, and all participants provided informed consent. A crossover study design was applied to the MoCA-XpressO and the digital-MoCA test; participants were randomized for the order of administration. The investigators only recruited participants who did not complete a MoCA test during the 3 months prior to the study. A logistic regression model was built, and the accuracy of the model was evaluated by the sensitivity, specificity, and area under the Receiver Operating Characteristic (ROC) curve.

详细描述

Introduction:

The MoCA XpressO is a self-administered medical digital cognitive screening test. This test can help individuals assess whether they should have concerns regarding their cognition and should bring these concerns up to their physician. The test can be administered in an empty office in the clinic, or in the comfort of the patient's home.

The MoCA Classic test was first published in 2005 by Nasreddine et al. (The Montreal Cognitive Assessment, MoCA: A Brief Screening Tool for Mild Cognitive Impairment. J Am Geriatr Soc, 2005, 53:695-9.) The MoCA Classic test (version 8.2) is a one-page 30-point test administered in 10 minutes. The test and administration instructions are freely accessible at www.mocatest.org. The test is available in over 55 languages and dialects. The MoCA Classic assesses several cognitive domains. The short-term memory recall task (5 points) involves two learning trials of five nouns and delayed recall after approximately 5 minutes. Visuospatial abilities are assessed using a clock-drawing task (3 points) and a three-dimensional cube copy (1 point). Multiple aspects of executive functions are assessed using an alternation task adapted from the trail-making B task (1 point), a phonemic fluency task (1 point), and a two-item verbal abstraction task (2 points). Attention, concentration and working memory are evaluated using a target detection task (1 point), a serial subtraction task (3 points), and a forward and backward digit sequence task (1 point each). Language is assessed using a three-item confrontation naming task with low- familiarity animals (3 points), a two-item syntactically complex sentence repetition task (2 points), and the aforementioned fluency task. Finally, orientation to time and place is evaluated (6 points).

Study objectives/purpose:

This study seeks to validate the MoCA XpressO self-administered digital test compared to the MoCA Classic test for adults aged 50+. The study's goal is to confirm its performance as a viable screening tool to flag concerns regarding cognition in this population.

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
Single (Participant)

盲法说明

Participants are blinded to which test is the one being validated.

入排标准

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

入选标准

  • Age 50 years and over
  • All gender inclusive
  • All sex inclusive
  • Fluent in English or in French
  • Minimum 6 years of formal education
  • Minimum total score of 11/30 on MoCA test

排除标准

  • Age younger than 50 years
  • Less than 6 years of formal schooling
  • Total score on MoCA test less than 11/30

结局指标

主要结局

Correlation between the MoCA XpressO and the Digital MoCA

时间窗: up to 30 minutes (for completion of all intervention included in the study)

Correlation between the total score of MoCA XpressO and the total score of the Digital MoCA Classic

次要结局

  • Correlation between scores of sub-tests on MoCA-XpressO and the Digital MoCA(up to 30 minutes (for completion of all interventions in the study))

研究者

发起方
MoCA Clinic and Institute
申办方类型
Other
责任方
Sponsor

研究点 (2)

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