Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. Objectives and Hypotheses: Primary Objective: establish validity by comparing the MoCA XpressO vs. the digital MoCA Classic test. Validity Outcome 1: Correlation between the total score of MoCA XpressO and the total score of the digital MoCA Classic test. Hypothesis 1: There will be a significant correlation between the total scores of the MoCA XpressO and MoCA Classic test. Secondary Objective: explore the users' experience of the MoCA XpressO test through subjective feedback from the participant. Outcome 2: subjective feedback about user experience for participant (Likert Scale) Hypothesis 2: user experience will be rated high (>=4) on a Likert scale 1-5. Additional exploratory measures/data: Demographic information (age, level of education etc.); diagnosis; previous MMSE or MoCA score if available; frequency of technological use Study Sample: the target number of participants is 100. Participants will be recruited from the MoCA Memory Clinic and Institute and the Cornwall family practice clinic. Participants in this study will consist of adults age 50 and over, with no restrictions to sex, gender, or ethnicity. There will be an equal number of participants with normal cognition, mild cognitive impairment, and mild AD. They must speak English or French and have at least 6 years of formal schooling. Study locations: 2 clinical sites will recruit potentially eligible participants. (1) MoCA Clinic and Institute, Greenfield Park, Québec, Canada; and (2) Family Medicine Practice, Cornwall, Ontario, Canada Randomization: The order of administration of the MoCA XpressO and the digital MoCA Classic test will be determined randomly so that each test will have similar chances of being first, or second. The same rater will be performing the MoCA Classic test in each clinic participating in the validation study. Blinding: The participants are blinded to the screening test that is being studied. The researcher doing the analysis will be blinded to the order of randomization. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05879562
Study type Interventional
Source MoCA Clinic and Institute
Contact
Status Active, not recruiting
Phase N/A
Start date October 1, 2022
Completion date June 30, 2023

See also
  Status Clinical Trial Phase
Completed NCT02122198 - Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women N/A
Recruiting NCT04356924 - Psychological Treatment to Support the Consequences of Cognitive Impairment N/A
Suspended NCT05542238 - The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury N/A
Terminated NCT04493957 - Evaluation of an Educational Program in the Prevention of the Driving Risks in Patients With Neurocognitive Disorders : ACCOMPAGNE N/A
Recruiting NCT04792983 - Cognition and the Immunology of Postoperative Outcomes
Completed NCT06029920 - Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment N/A
Not yet recruiting NCT05068323 - Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients N/A
Completed NCT04426838 - Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad N/A
Completed NCT04713384 - Remote Bimanual Virtual Rehabilitation Post CVD N/A
Recruiting NCT06284213 - Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
Recruiting NCT06053775 - Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP) N/A
Completed NCT03698695 - A Pharmacodynamics, Safety, and Pharmacokinetics Study of THN201 Versus Donepezil in Healthy Male Volunteers Phase 1
Not yet recruiting NCT05552729 - Effects of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors Phase 1/Phase 2
Recruiting NCT03268109 - COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
Completed NCT03301402 - Air Purifier to Improve Endothelial Function and Carotid Intima Thickness N/A
Completed NCT03187353 - IMProving Executive Function Study Phase 4
Completed NCT05395559 - Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study
Recruiting NCT05030285 - Telehealth Psychotherapy for Anxiety in Persons With Cognitive Impairment N/A
Recruiting NCT04907565 - Impact of Obesity on Post-operative Cognitive Dysfunction: Role of Adipose Tissue
Recruiting NCT04897334 - Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke N/A