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Cognitive Impairment (CI)NCT04850833

Post-operative Functional Disability in Unrecognized Cognitive Impairment (POF) Study

An observational study of Cognitive Impairment (CI), run by University Health Network, Toronto at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective multicenter cohort study, which will determine the prevalence of preoperative cognitive impairment (CI) using the Modified Telephone Interview for Cognitive Status (TICS-M), Eight-items interview to Differentiate Aging and Dementia (AD8), Telephone Montreal Cognitive Assessment (T-MoCA), and a… 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
390 participants
Where
2 sitesCanada
Study dates
23 Jul 2021to 30 May 2023
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
  • Older adult

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

Major Inclusion Criteria:

  • patients ≥ 65 years old;
  • patients scheduled for elective non-cardiac surgery
  • able to be contacted by telephone for follow up.

Major Exclusion Criteria:

  • patients with previous dementia diagnosis,
  • patients scheduled for outpatient surgery,

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

Other trials in Canada

About this study

Official title: Post-operative Functional Disability in Unrecognized Cognitive Impairment (POF) Study: an Observational Cohort Study in Patients Undergoing Non-cardiac Surgery

This is a prospective multicenter cohort study, which will determine the prevalence of preoperative cognitive impairment (CI) using the Modified Telephone Interview for Cognitive Status (TICS-M), Eight-items interview to Differentiate Aging and Dementia (AD8), Telephone Montreal Cognitive Assessment (T-MoCA), and a single cognitive question from the Centers for Disease Control and Prevention (CDC). We would also determine the (1) the degree of agreement in screening results between each cognitive screening tool, (2) risk factors associated with screening positive for CI on each tool, and (3) the prevalence and/or trajectory of postoperative delirium, sleep disturbances, functional disability, instrumental activities of daily living (IADL), depression, quality of health, frailty, and pain in older surgical patients and its association with CI. This study will target older patients from the pre-operative clinics at Toronto Western Hospital and Mount Sinai Hospital (MSH), Toronto. Research staff will identify eligible patients who are scheduled for elective non-cardiac surgery. Written informed consent to participate in the study will be obtained from all patients.

Read the detailed description

The primary aim of this study is to (1) determine the prevalence of CI preoperatively in older surgical adults using virtual or telephone cognitive instruments, (2) determine the degree of agreement in screening results between each cognitive screening tool, and (3) explore the prevalence and trajectory of preoperative and postoperative outcomes and its association with CI. The outcomes include functional disability, IADL, sleep disturbances, quality of health, frailty, pain and depression.

In a preoperative assessment 1-30 days prior to their scheduled surgery, patients will be asked via telephone to complete TICS-M and T-MoCA and an online questionnaire, including the AD8, CDC single cognitive question, World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), IADL, EuroQol 5 Dimension (EQ-5D-5L), Geriatric Depression Scale (GDS), 5-item FRAIL questionnaire, (FRAIL), visual analog pain scale (VAS pain), Single-item Sleep Quality Scale (SQS), Pittsburgh Sleep Quality Index (PSQI), and STOP questionnaire. These questionnaires will be repeated at follow-up visits at 30-, 90-, and 180-days post-surgery. At the hospital on post-operatively days 1-3, the Confusion Assessment Method (CAM), SQS, and VAS pain will be administered during the in-person visit. Chart review of delirium will also be conducted during patients' stay at the hospital.

Medical subject headings
Cognitive Dysfunction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of cognitive impairment via remote (virtual/telephone) assessment

    Prevalence of cognitive impairment via remote (virtual/telephone) assessment as detected by the TICS-m (modified telephone interview for cognitive status). The TICS-m is scored from 0-50 with a score of 31 or below indicating cognitive impairment.

    Measured: Pre-surgery, 30-, 90- and 180-days post-surgery

  2. Prevalence of cognitive impairment via remote (virtual/telephone) assessment

    Prevalence of cognitive impairment via remote (virtual/telephone) assessment as detected by the T-MoCA (telephone Montreal cognitive assessment). The T-MoCA is scored from 0-22 with a score of 18 or below indicating cognitive impairment.

    Measured: Pre-surgery, 30-, 90- and 180-days post-surgery

  3. Prevalence of cognitive impairment via remote (virtual/telephone) assessment

    Prevalence of cognitive impairment via remote (virtual/telephone) assessment 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, 30-, 90- and 180-days post-surgery

  4. Prevalence of cognitive impairment via remote (virtual/telephone) assessment

    Prevalence of cognitive impairment via remote (virtual/telephone) assessment as detected by the CDC Single Cognitive Question. The CDC Single Cognitive Question is a yes/no question where answers of yes indicate cognitive impairment.

    Measured: Pre-surgery, 30-, 90- and 180-days post-surgery

  5. Degree of agreement in screening results (Cohen's Kappa (κ) coefficients)

    The degree of agreement in screening results among the screening tools by calculating Cohen's Kappa (κ) coefficients.

    Measured: Pre-surgery

  6. The trajectories and prevalence or incidence of patient-reported outcomes

    The trajectories 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 vs without preoperative functional disability and in participants with vs without CI. 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-, 90- and 180-days post-surgery

  7. The trajectories and prevalence or incidence of patient-reported outcomes

    The trajectories and prevalence or incidence of instrumental activities of daily living (IADL) as measured through the IADL in participants with CI vs those without. It is scored from 0-8 where a higher score indicates high function and independence.

    Measured: Pre-surgery, 30-, 90- and 180-days post-surgery

  8. The trajectories and prevalence or incidence of patient-reported outcomes

    The trajectories and prevalence or incidence of sleep disturbances as measured through the PSQI (Pittsburgh Sleep Quality Index) in participants with CI vs those without. It is scored from 0-21 where a higher score indicates worse sleep quality.

    Measured: Pre-surgery, 30-, 90- and 180-days post-surgery

  9. The trajectories and prevalence or incidence of patient-reported outcomes

    The trajectories and prevalence or incidence of sleep quality 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 higher score indicates better sleep quality.

    Measured: Pre-surgery, 30-, 90- and 180-days post-surgery

  10. The trajectories and prevalence or incidence of patient-reported outcomes

    The trajectories and prevalence or incidence of depression as measured through the GDS (Geriatric Depression Scale) in participants with vs without preoperative depression and in participants with vs without CI. It is scored from 0-15 where a higher score indicates depression.

    Measured: Pre-surgery, 30-, 90- and 180-days post-surgery

  11. The trajectories and prevalence or incidence of patient-reported outcomes

    The trajectories 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-, 90- and 180-days post-surgery

  12. The trajectories and prevalence or incidence of patient-reported outcomes

    The trajectories and prevalence or incidence of frailty as measured through the 5-item FRAIL questionnaire (Fatigue, resistance, ambulation, illnesses, and loss of weight) in participants with vs without preoperative frailty and in participants with vs without CI. It is scored from 0-5 where higher scores indicate frailty.

    Measured: Pre-surgery, 30-, 90- and 180-days post-surgery

  13. The trajectories and prevalence or incidence of patient-reported outcomes

    The trajectories and prevalence or incidence of quality of health as measured through the EQ5D5L (EuroQol 5 Dimension) in participants with CI vs those without. Each dimension on the tool has five response levels and one level from each dimension is combined to give a health state ranging from 11111 (full health) to 55555 (worst health). The health states are converted into a single index utility where lower values indicate worse quality of health

    Measured: Pre-surgery, 30-, 90- and 180-days post-surgery

Secondary outcomes (10)

  1. The incidence of postoperative delirium post-surgery

    The incidence of postoperative delirium as measured by the Confusion Assessment Method (CAM) conducted by the research and nursing team and medical chart review.

    Measured: Post-op day 1-3

  2. Discharge destination of participants from chart review post-surgery

    Discharge destination (assess where the participant will be discharged to once out of hospital up to 30-days post-op)

    Measured: Post-op day 1-3

  3. Hospital length of stay (LOS) of participants post-surgery

    Hospital length of stay

    Measured: Post-op day 1-3

  4. Days spent at home (DAH30) of participants post-surgery

    DAH30 (days spent at home) at 30 days post-surgery

    Measured: 30-days post-surgery

  5. Mortality (number of participants who have died) post-surgery

    Mortality

    Measured: 30-, 90- and 180-days post-surgery

  6. Number of participants who have been re-admitted to the hospital post-surgery

    Hospital re-admission

    Measured: 30-, 90- and 180-days post-surgery

  7. Number of participants who have visited the emergency department post-surgery

    Emergency department visit

    Measured: 30-, 90- and 180-days post-surgery

  8. Incidence of postoperative complications of participants post-surgery

    All-cause postoperative complications

    Measured: 30-, 90- and 180-days post-surgery

  9. Incidence of re-operation or revision surgery post-surgery

    Re-operation or revision surgery

    Measured: 30-, 90- and 180-days post-surgery

  10. Risk factors for screening positive on each cognitive screening tool

    Preoperative risk factors associated with screening positive on each cognitive screening tool

    Measured: Pre-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2021
  2. Study start23 Jul 2021
  3. Primary completion15 Apr 2023
  4. Study completion30 May 2023

Resources

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
390 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04850833
Sponsor's protocol ID
20-6186
Status last verified
Jul 2024
First submitted
7 Apr 2021
Last updated
6 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Park S, Yan E, Saripella A, Wong J, Tang-Wai DF, Chung F. Clinical Diagnoses After Positive Cognitive Screening: A Case Series of Older Surgical Patients. A A Pract. 2026 Jun 8;20(6):e02174. doi: 10.1213/XAA.0000000000002174. eCollection 2026 Jun 1.

    PubMed 42257605

  • Lu YT, Yan E, Alhamdah Y, Kapoor P, Lovblom LE, Saripella A, Wong J, Chung F. The prevalence and trajectory of frailty in older surgical patients: A longitudinal multicentre cohort study. Anaesth Crit Care Pain Med. 2025 Sep;44(5):101582. doi: 10.1016/j.accpm.2025.101582. Epub 2025 Jun 27.

    PubMed 40582463

  • Yan E, Butris N, Alhamdah Y, Kapoor P, Lovblom LE, Islam S, Saripella A, Wong J, Tang-Wai DF, Mah L, Alibhai SMH, Tartaglia MC, He D, Chung F. The utility of remote cognitive screening tools in identifying cognitive impairment in older surgical patients: An observational cohort study. J Clin Anesth. 2024 Oct;97:111557. doi: 10.1016/j.jclinane.2024.111557. Epub 2024 Jul 23.

    PubMed 39047531

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?

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: finished, as of the sponsor's last update on 6 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Prevalence of cognitive impairment via remote (virtual/telephone) assessment (time frame: Pre-surgery, 30-, 90- and 180-days post-surgery). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04850833, which also lists 3 linked publications.

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 6 Aug 2024.

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