Detect CI (Cognitive Impairment) Study

Cognitive Impairment (CI) Clinical Trial

— CI  

Official title:

Evaluation of Rapid Cognitive Screening Tools for Detection of Cognitive Impairment in Older Surgical Patients: A Prospective Cohort Study - Detect CI Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06030765
• Other study ID #: 22-5810
• Status: Recruiting
• Start date: September 15, 2023
• Est. completion date: August 30, 2025

Study information

• Verified date: July 2023
• Source: University Health Network, Toronto
• Contact: Sazzadul Islam
• Phone: 4166622686
• Email: sazzadul.islam[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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, or MoCA and the prevalence of elevated levels of plasma biomarker of phosphorylated tau 181 (pTau181) and neurofilament-light chain (NfL) in the patients meeting the CI criteria. 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.

Description:

The primary aims of the study is to (1) determine the diagnostic accuracy (sensitivity, specificity, and the AUC) of two rapid cognitive screening tools (AD8 and Mini-Cog) against the MoCA in the older surgical population and (2) determine the prevalence of CI as detected by the cognitive screening tests (AD8, Mini-Cog, or MoCA) and to determine the prevalence of elevated plasma biomarkers associated with neurodegenerative and/or vascular diseases using plasma (pTau181 or NfL) biomarkers in those with CI as detected by the screening tools. The secondary aims are to (1) describe the distribution of plasma pTau181 or NfL biomarkers in patients meeting the CI criteria by the AD8, Mini-Cog, or MoCA, (2) compare the trajectory of patient-reported outcomes at baseline, 30-, and 90-day post-surgery in patients with or without CI as detected by the cognitive screening tests, and (3) compare clinical outcomes in patients with or without CI as detected by the cognitive screening tests.

The study consists of four consecutive time points, including one preoperative assessment and three postoperative assessments occurring during participants' hospital stay and at 30- and 90-day post-surgery. In the preoperative assessment 1-30 days before their scheduled surgery, patients will be asked to complete the AD8, Mini-Cog, MoCA and the STOP-Bang Questionnaire in-person. If a patient screens positive on one or more of the three cognitive screening tools, they will have blood drawn for pTau181 and NfL bioassay analysis. Additionally, patients will be asked to complete the following assessments via an online survey or over the telephone prior to their scheduled surgery: WHODAS-2.0 (World Health Organization Disability Assessment Schedule 2.0), 5-item FRAIL Questionnaire, PHQ-4 (4-Item Patient Health Questionnaire for Anxiety and depression), VAS (visual analog scale) pain, SQS (Single Item Sleep Quality Scale), and a single question on QoL (quality of life).

The first postoperative time point will occur during participants' stay at the hospital in which postoperative delirium (POD), postoperative complications, length of stay (LOS), and discharge destination will be assessed. At 30- and 90-day postoperatively, chart review will be performed to assess clinical outcomes, such as postoperative complications, all-cause mortality, and hospital readmission. Patient-reported outcomes, including WHODAS 2.0, 5-item FRAIL Questionnaire, PHQ-4, VAS pain, and QoL, will also be assessed through an online survey or over the telephone.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 213
• Est. completion date: August 30, 2025
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment (CI)

Locations

Country	Name	City	State
Canada	399 Bathurst St., Toronto Western Hospital, Dept. of Anesthesia	Toronto	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnostic accuracy (sensitivity, specificity, and AUC)	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
Primary	The diagnostic accuracy (sensitivity, specificity, and 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
Primary	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
Primary	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
Primary	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
Primary	Prevalence of elevated plasma biomarkers	The prevalence of elevated plasma biomarkers associated with neurogenerative and/or vascular diseases using plasma pTau181 biomarkers in those with CI as detected by the screening tools.	Pre-surgery
Primary	Prevalence of elevated plasma biomarkers	The prevalence of elevated plasma biomarkers associated with neurogenerative and/or vascular diseases using plasma NfL biomarkers in those with CI as detected by the screening tools.	Pre-surgery
Secondary	Distribution of plasma biomarkers	The distribution of plasma pTau181 biomarkers in patients meeting the CI criteria by the cognitive screening tools.	Pre-surgery
Secondary	Distribution of plasma biomarkers	The distribution of plasma NfL biomarkers in patients meeting the CI criteria by the cognitive screening tools.	Pre-surgery
Secondary	Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery	The trajectory and prevalence or incidence of functional disability as measured through the WHODAS 2.0 (World Health Organization Disability Assessment Schedule 2.0) in participants with CI vs those without. A five-point rating scale is used for each question (none = 0, mild = 1, moderate = 2, severe = 3, extreme/cannot do = 4), and a higher WHODAS score indicates greater disability.	Pre-surgery, 30- and 90-days post-surgery
Secondary	Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery	The trajectory and prevalence or incidence of frailty as measured through the 5-item FRAIL questionnaire in participants with CI vs those without. It is scored from 0-5 where higher scores indicate frailty.	Pre-surgery, 30- and 90-days post-surgery
Secondary	Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery	The trajectory and prevalence or incidence of pain as measured through the VAS Pain (Visual Analog Scale for Pain) in participants with CI vs those without. It is scored from 0-10 where a lower score indicates worse pain.	Pre-surgery, 30- and 90-days post-surgery
Secondary	Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery	The trajectory and prevalence or incidence of depression and anxiety as measured through the PHQ-4 (4-Item Patient Health Questionnaire) in participants with CI vs those without. It is scored from 0-12 where a higher score indicates depression and anxiety.	Pre-surgery, 30- and 90-days post-surgery
Secondary	Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery	The trajectory and prevalence or incidence of obstructive sleep apnea (OSA) as measured through the STOP-Bang Questionnaire in participants with CI vs those without. It is scored from 0-8 where a higher score indicates higher risk for OSA.	Pre-surgery
Secondary	Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery	The trajectory and prevalence or incidence of sleep disturbances as measured through the SQS (Single Item Sleep Quality Scale) in participants with CI vs those without. It is scored from 0-10 where a lower score indicates sleep disturbances.	Pre-surgery
Secondary	Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery	The trajectory and prevalence or incidence of quality of life as measured through the single question on Quality of Life (QoL) in participants with CI vs those without. It is scored from 0-100 where a lower score indicates worse quality of life.	Pre-surgery, 30- and 90-days post-surgery
Secondary	Clinical outcomes post-surgery	The incidence of postoperative delirium as assessed by the Confusion Assessment Method (CAM) conducted by the nursing team and through medical chart review.	1-3 days post-surgery
Secondary	Clinical outcomes post-surgery	Postoperative complications	1-3 days post-surgery
Secondary	Clinical outcomes post-surgery	Hospital length of stay (LOS)	1-3 days post-surgery
Secondary	Clinical outcomes post-surgery	Discharge destination (assess where the participant will be discharged to once out of hospital up to 30-days post-op)	1-3 days post-surgery
Secondary	Clinical outcomes post-surgery	Mortality	30- and 90-days post-surgery
Secondary	Clinical outcomes post-surgery	Readmission	30- and 90-days post-surgery
Secondary	Clinical outcomes post-surgery	Postoperative complications	30- and 90-days post-surgery