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

NCT04850833 | Completed

• 1 other identifier: 20-6186
• Study Type: observational
• Target: 390
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Cognitive Impairment (CI)

Outcome Measures

Primary Outcomes (13)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

  Pre-surgery

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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

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

Secondary Outcomes (10)

• The incidence of postoperative delirium post-surgery

  Post-op day 1-3

• Discharge destination of participants from chart review post-surgery

  Post-op day 1-3

• Hospital length of stay (LOS) of participants post-surgery

  Post-op day 1-3

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

  30-days post-surgery

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

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• 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;
• patients scheduled for elective non-cardiac surgery
• able to be contacted by telephone for follow up.

You may not qualify if:

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

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

Related Publications (1)

• 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.

  PMID: 40582463 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Frances Chung, MBBS MD 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: April 7, 2021
• First Posted: April 20, 2021
• Study Start: July 23, 2021
• Primary Completion: April 15, 2023
• Study Completion: May 30, 2023
• Last Updated: August 6, 2024

Record last verified: 2024-07

Locations

CA (2)