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

Sponsor
Dr. Frances Chung (Other)
Overall Status
Recruiting
CT.gov ID
NCT04850833
Collaborator
(none)
390
3
32.7
130
4

Study Details

Study Description

Brief Summary

This is a prospective multicenter cohort study, which will determine the prevalence of unrecognized 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 determine the correlation between CI and measures of postoperative delirium (POD), sleep disturbances, functional ability, and instrumental activities of daily living (IADL) in geriatric surgical patients. This study will target geriatric patients from the pre-operative clinics at Toronto Western Hospital, Toronto General 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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The primary aim of this study is to determine the prevalence of unrecognized cognitive impairment (CI) pre-operatively in older surgical adults using virtual or telephone cognitive instruments and its correlation to measures of POD, sleep disturbances, functional ability, and IADL.

    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, a single cognitive question, World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), Instrumental Activity of Daily Living (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. 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), visual analog sleep quality scale (VAS sleep quality), 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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    390 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Post-operative Functional Disability in Unrecognized Cognitive Impairment (POF) Study: an Observational Cohort Study in Patients Undergoing Non-cardiac Surgery
    Actual Study Start Date :
    Jul 25, 2021
    Anticipated Primary Completion Date :
    Apr 15, 2023
    Anticipated Study Completion Date :
    Apr 15, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Cognitive Impairment via virtual assessment [30- days post-surgery]

      Administration of cognitive status questionnaire

    2. Cognitive Impairment via virtual assessment [90-days post-surgery]

      Administration of cognitive status questionnaire

    3. Cognitive Impairment via virtual assessment [180-days post-surgery]

      Administration of cognitive status questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Major Inclusion Criteria:
    • patients ≥ 65 years old;

    • patients scheduled for elective non-cardiac surgery

    • and who are able to be contacted by telephone for follow up.

    Major Exclusion Criteria:
    • patients with previous dementia diagnosis,

    • patients scheduled for outpatient surgery,

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Toronto General Hospital Toronto Ontario Canada M5G 2C4
    2 399 Bathurst St., Toronto Western Hospital, Dept. of Anesthesia Toronto Ontario Canada M5T2S8
    3 Mount Sinai Hospital Toronto Ontario Canada

    Sponsors and Collaborators

    • Dr. Frances Chung

    Investigators

    • Principal Investigator: Frances Chung, MBBS MD FRCPC, University Health Network, Toronto

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Frances Chung, Anesthesiologist, University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT04850833
    Other Study ID Numbers:
    • 20-6186
    First Posted:
    Apr 20, 2021
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 24, 2022