Validation of a Digital Self-Administered Cognitive Screening Tool: MoCA-XpressO

NCT05879562 | Unknown

• 1 other identifier: MoCA Xpresso 01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Impairment; Cognitive Change; Cognitive Deficit; Assessment, Self

Keywords

Cognitive screening; Cognition; Cognitive impairment; Cognitive decline; Self-assessment

Outcome Measures

Primary Outcomes (1)

• Correlation between the MoCA XpressO and the Digital MoCA

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

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

Secondary Outcomes (1)

• 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)

Study Arms (2)

MoCA-Xpresso first

EXPERIMENTAL

Participants in the study will complete the MoCA-Xpresso test before the digital-MoCA classic test.

Diagnostic Test: MoCA-Xpresso

MoCA-Xpresso second

EXPERIMENTAL

Participants in the study will complete the digital-MoCA classic test before the MoCA-Xpresso test.

Diagnostic Test: MoCA-Xpresso

Interventions

MoCA-Xpresso DIAGNOSTIC_TEST

MoCA-Xpresso is a home-based, self-administered digital cognitive screening tool, based on a tablet device.

MoCA-Xpresso first; MoCA-Xpresso second

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• MoCA Clinic and Institute: lead

Study Sites (1)

MoCA Clinic and Institute

Greenfield Park, Quebec, J4V 2J2, Canada

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Cognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Study Officials

• Ziad Nasreddine, MD

  MoCA Clinic and Institute, 4896 Taschereau Blvd bureau 230, Greenfield Park, Quebec J4V 2J2

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to which test is the one being validated.
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 30, 2023
• Study Start: October 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-05

Locations

CA (1)