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

NCT ID: NCT04850833

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 390 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-23
• Study Completion Date: 2023-05-30

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.

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.

Conditions

Cognitive Impairment (CI)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frances Chung, MBBS MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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

Toronto, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 40582463 (View on PubMed)

Other Identifiers

20-6186

Identifier Type: -

Identifier Source: org_study_id