Cognitive Impairment (CI)CINCT06030765
Detect CI (Cognitive Impairment) Study
An observational study of Cognitive Impairment (CI), run by University Health Network, Toronto at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Impairment (CI)
- How many people
- 383 participants
- Where
- 2 sitesCanada
- Study dates
- 15 Sep 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients scheduled to undergo elective inpatient non-cardiac surgery under general and/ or regional anesthesia
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
399 Bathurst St., Toronto Western Hospital, Dept. of Anesthesia
Toronto, Ontario, M5T2S8
Mount Sinai Hospital
Toronto, Ontario
About this study
Official title: Evaluation of Rapid Cognitive Screening Tools for Detection of Cognitive Impairment in Older Surgical Patients: A Prospective Cohort Study - Detect CI Study
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.
Read the detailed 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, MoCA, or CDC cognitive question). The secondary aims are to (1) 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 (2) 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, CDC cognitive question, and the STOP-Bang Questionnaire in-person.
Additionally, patients will be asked to complete the following assessments via an online survey, over the telephone, or in-person 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.
- Conditions
- Cognitive Impairment (CI)
- Medical subject headings
- Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-surgery
Secondary outcomes (16)
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.
Measured: Pre-surgery, 30- and 90-days post-surgery
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.
Measured: Pre-surgery, 30- and 90-days post-surgery
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.
Measured: Pre-surgery, 30- and 90-days post-surgery
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.
Measured: Pre-surgery, 30- and 90-days post-surgery
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.
Measured: Pre-surgery
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.
Measured: Pre-surgery
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.
Measured: Pre-surgery, 30- and 90-days post-surgery
Incidence of clinical outcomes post-surgery
Incidence of postoperative delirium as assessed by the Confusion Assessment Method (CAM) conducted by the nursing team and through medical chart review.
Measured: 1-3 days post-surgery
Incidence of adverse clinical outcomes post-surgery
Incidence of postoperative complications
Measured: 1-3 days post-surgery
Clinical outcomes post-surgery
Hospital length of stay (LOS)
Measured: 1-3 days post-surgery
Clinical outcomes post-surgery
Discharge destination (assess where the participant will be discharged to once out of hospital up to 30-days post-op)
Measured: 1-3 days post-surgery
Incidence of adverse clinical outcomes post-surgery
Incidence of mortality
Measured: 30- and 90-days post-surgery
Incidence of adverse clinical outcomes post-surgery
Incidence of readmission
Measured: 30- and 90-days post-surgery
Incidence of adverse clinical outcomes post-surgery
Incidence of postoperative complications
Measured: 30- and 90-days post-surgery
Incidence of adverse clinical outcomes post-surgery
Incidence of emergency department visit
Measured: 30- and 90-days post-surgery
Incidence of adverse clinical outcomes post-surgery
Incidence of re-operation or revision surgery
Measured: 30- and 90-days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start15 Sep 2023
- Primary completion20 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Impairment (CI)Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frances Chung, MBBS FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030765
- Sponsor's protocol ID
- 22-5810
- Acronym
- CI
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2023
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Rapid Cognitive Screening Tools for Detection of Cognitive Impairment in Older Surgical Patients: A Prospective Cohort Study - Detect CI Study
- ClinicalTrials.gov ID
- NCT06030765
- Acronym / sponsor ID
- CI / 22-5810
- Conditions
- Cognitive Impairment (CI)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 383 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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, MoCA, or CDC cognitive question). The secondary aims are to (1) 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 (2) 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, CDC cognitive question, and the STOP-Bang Questionnaire in-person.
Additionally, patients will be asked to complete the following assessments via an online survey, over the telephone, or in-person 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients scheduled to undergo elective inpatient non-cardiac surgery under general and/ or regional anesthesia
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- previous neurocognitive disorder (e.g., dementia) diagnosis;
- uncontrolled psychiatric disorders;
- hearing and/or vision impairment;
- unable to write or hold pen;
- undergoing neurosurgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The diagnostic accuracy (sensitivity, specificity
Time frame: Pre-surgery
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).
The diagnostic accuracy (AUC)
Time frame: Pre-surgery
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).
Prevalence of cognitive impairment (CI) via cognitive screening tools
Time frame: Pre-surgery
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.
Prevalence of cognitive impairment (CI) via cognitive screening tools
Time frame: Pre-surgery
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.
Prevalence of cognitive impairment (CI) via cognitive screening tools
Time frame: Pre-surgery
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.
Prevalence of cognitive impairment (CI) via cognitive screening tools
Time frame: Pre-surgery
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.
16 secondary outcomes
Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
Time frame: Pre-surgery, 30- and 90-days post-surgery
Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
Time frame: Pre-surgery, 30- and 90-days post-surgery
Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
Time frame: Pre-surgery, 30- and 90-days post-surgery
Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
Time frame: Pre-surgery, 30- and 90-days post-surgery
Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
Time frame: Pre-surgery
Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
Time frame: Pre-surgery
Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
Time frame: Pre-surgery, 30- and 90-days post-surgery
Incidence of clinical outcomes post-surgery
Time frame: 1-3 days post-surgery
Incidence of adverse clinical outcomes post-surgery
Time frame: 1-3 days post-surgery
Clinical outcomes post-surgery
Time frame: 1-3 days post-surgery
Clinical outcomes post-surgery
Time frame: 1-3 days post-surgery
Incidence of adverse clinical outcomes post-surgery
Time frame: 30- and 90-days post-surgery
Incidence of adverse clinical outcomes post-surgery
Time frame: 30- and 90-days post-surgery
Incidence of adverse clinical outcomes post-surgery
Time frame: 30- and 90-days post-surgery
Incidence of adverse clinical outcomes post-surgery
Time frame: 30- and 90-days post-surgery
Incidence of adverse clinical outcomes post-surgery
Time frame: 30- and 90-days post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frances Chung, MBBS FRCPC principal investigator
University Health Network, Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment (CI), run by University Health Network, Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic accuracy (sensitivity, specificity (time frame: Pre-surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.