Detect CI (Cognitive Impairment) Study

NCT06030765 | Active Not Recruiting

• 1 other identifier: 22-5810
• Study Type: observational
• Target: 383
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective multicenter cohort study which will evaluate rapid (administration time ≤ 5 minutes) cognitive screening tools that can be administered preoperatively in older patients undergoing noncardiac surgery. Namely, our study will determine the diagnostic accuracy (sensitivity, specificity, and area under the curves \[AUC\]) of two rapid, easily administered cognitive screening tools: the Mini-Cog and the Ascertain Dementia 8-item Questionnaire (AD8) against the Montreal Cognitive Assessment (MoCA). Additionally, we will examine the prevalence of cognitive impairment (CI) in patients meeting the CI criteria by either the AD8, Mini-Cog, MoCA, or a single cognitive question from the Centers for Disease Control and Prevention \[CDC\]. This study will target older patients from surgical offices and/or pre-admission clinics at Toronto General (TGH), Toronto Western (TWH), and Mount Sinai Hospital (MSH), Toronto, Ontario. The identification and recruitment of eligible patients will be a collaborative effort between the nurses, surgeons, anesthesiologists, and the research team. Written informed consent to participate in the study will be obtained from all patients.

Conditions

Cognitive Impairment (CI)

Outcome Measures

Primary Outcomes (6)

• The diagnostic accuracy (sensitivity, specificity

  The diagnostic accuracy (sensitivity and specificity) of the AD8 (Eight-item Interview to Differentiate Aging and Dementia) and Mini-Cog against the MoCA (Montreal Cognitive Assessment).

  Pre-surgery

• The diagnostic accuracy (AUC)

  The AUC (Area under the Receiver Operating Characteristic Curve (ROC)) of the AD8 (Eight-item Interview to Differentiate Aging and Dementia) and Mini-Cog against the MoCA (Montreal Cognitive Assessment).

  Pre-surgery

• Prevalence of cognitive impairment (CI) via cognitive screening tools

  The prevalence of CI as detected by the AD8 (Eight-item Interview to Differentiate Aging and Dementia). The AD8 is scored from 0-8 with a score of two or more indicating cognitive impairment.

  Pre-surgery

• Prevalence of cognitive impairment (CI) via cognitive screening tools

  The prevalence of CI as detected by the Mini-Cog. The Mini-Cog is scored from 0-5 with a score of two or less indicating cognitive impairment.

  Pre-surgery

• Prevalence of cognitive impairment (CI) via cognitive screening tools

  The prevalence of CI as detected by the MoCA (Montreal Cognitive Assessment). The MoCA is scored from 0-30 with a score of 25 or less indicating cognitive impairment.

  Pre-surgery

• Prevalence of cognitive impairment (CI) via cognitive screening tools

  The prevalence of CI as detected by the CDC (Centers of Disease Control and Prevention) cognitive question. The CDC cognitive question is a simple yes or no question, with a response of yes indicating cognitive impairment.

  Pre-surgery

Secondary Outcomes (16)

• Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery

  Pre-surgery, 30- and 90-days post-surgery

• Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery

  Pre-surgery, 30- and 90-days post-surgery

• Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery

  Pre-surgery, 30- and 90-days post-surgery

• Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery

  Pre-surgery, 30- and 90-days post-surgery

• Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery

  Pre-surgery

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo elective inpatient non-cardiac surgery under general and/ or regional anesthesia

You may qualify if:

• patients ≥ 65 years old;
• competent to provide informed consent in English;
• undergoing elective non-cardiac surgery;
• education ≥ 8 years;
• able to be contacted by telephone.

You may not qualify if:

• previous neurocognitive disorder (e.g., dementia) diagnosis;
• uncontrolled psychiatric disorders;
• hearing and/or vision impairment;
• unable to write or hold pen;
• undergoing neurosurgery;
• unable to provide informed consent.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

399 Bathurst St., Toronto Western Hospital, Dept. of Anesthesia

Toronto, Ontario, M5T2S8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Frances Chung, MBBS FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: September 11, 2023
• Study Start: September 15, 2023
• Primary Completion: December 20, 2024
• Study Completion: December 31, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

CA (2)