Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT04850833
Status:
COMPLETED
Last Update Posted:
2024-08-06
First Post:
2021-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-operative Functional Disability in Unrecognized Cognitive Impairment (POF) Study
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
Post-operative Functional Disability in Unrecognized Cognitive Impairment (POF) Study: an Observational Cohort Study in Patients Undergoing Non-cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: