Perioperative Cognitive Trajectories in Deferred Surgery (CoTELE-SURGE) (CoTELE-SURGE)

October 28, 2022 updated by: Maura Marcucci, McMaster University

Preoperative and Postoperative Cognitive TrajEctories in oLdEr Patients With Deferred SURGEry Due to the COVID-19 Emergency: a Prospective Cohort Study

Cognition is the way people use their brains to think, understand, remember and make decisions. Cognitive changes are often seen even up to 1 year after surgery. Whether these changes are more than what is expected for someone's age and morbidities is still uncertain. Due to the COVID-19 emergency, many elective surgeries have been delayed, which is stressful for patients, but also represents an opportunity of understanding better how surgery can impact cognitive abilities. The purpose of this study is to explore if and how cognitive performance changes over time for patients aged 65 years or older, whose surgery has been postponed.

due to the COVID-19 emergency, following and assessing the cognitive performance of these patients over time before and after surgery. In particular, in this study, the participant's cognitive performance will be assessed periodically with a computer-based instrument for cognitive testing, self-administered at home, in which tests are based on playing cards.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objectives of the project are to describe perioperative cognitive trajectories of older patients whose elective noncardiac surgery has been deferred because of the COVID-19 emergency, and explore the intra-individual changes in these trajectories from before to after surgery, through periodic remote self-administered cognitive testing. Secondarily, in the same patients, the investigators will also describe the perioperative trajectories in depressive symptoms and pain, and study their correlation with the trajectories in cognitive performance.

The study will be conducted remotely and virtually. The investigators will have an initial videoconference with the participant (and a support person if necessary) to explain the computerized cognitive test battery (i.e. the Cogstate Brief battery, CBB), and train on self-administration through a user-specific link. At each due assessment, the research team will call the participant to remind to complete the CBB; and to assess depressive symptoms, pain, and collect data on intercurrent clinical events (i.e. medication changes, hospitalization, ED or urgent care visits).

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4L8
        • Recruiting
        • McMaster University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Philippe Violette, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients 65 years or older undergoing non-cardiac non-cranial surgery scheduled to happen in 6 weeks or more and expected to stay for at least 1 night in the hospital postoperative.

Description

Inclusion Criteria:

  1. age 65 years or greater;
  2. patient scheduled to perform noncardiac elective surgery expected to require at least an overnight stay in hospital after surgery;
  3. surgery deferred, with a known or probable surgery date in ≥6 weeks;
  4. informed consent provided.

Exclusion Criteria:

  1. patient undergoing cardiac surgery or cranial neurosurgery;
  2. known history of dementia;
  3. unavailability of tablet or computer with an internet connection for remote assessment; 4. patient unable to interact with a tablet or computer due to language, visual, or hearing impairment, or any severely limited mobility of the upper limb joints;

5. patient unable to understand spoken or written English; 6. surgery delayed for an intercurrent clinical event

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study cohort
Patients aged 65 years or greater; scheduled to perform noncardiac elective surgery expected to require at least an overnight stay in hospital after surgery; surgery deferred, with a known or probable surgery date in ≥6 weeks
Procedure: Non-cardiac surgery
Non-cardiac surgery excluding cranial neurosurgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in perioperative cognitive trajectories assessed using the Cogstate Brief Battery (CBB)
Time Frame: After 1-5 days from the initial recruitment, each participant will self-administer the cognitive testing once, and then every month until surgery. Postoperative assessments at 1, 3, 6 and 12 months postoperative
CBB is a computer-based cognitive test extensively validated against standard neuropsychological batteries in cognitively normal older adults, as well as in patients with cognitive impairment, in the community and in different clinical contexts, both in a clinician/researcher-supervised manner, and in an unsupervised fashion. It has been used also in the perioperative setting, showing equivalent or greater reliability, and greater sensitivity than conventional batteries. It consists of four tasks (Detection Task, Identification Task, Learning Task, and One-Back Task) designed to assess psychomotor function, attention, working memory, and visual learning. Each task utilizes stimuli in the form of playing cards. Stimuli characteristics (e.g., color, suit) are manipulated based on the requirements of each task.
After 1-5 days from the initial recruitment, each participant will self-administer the cognitive testing once, and then every month until surgery. Postoperative assessments at 1, 3, 6 and 12 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain trajectories using the Numeric Pain Rating Scale
Time Frame: Baseline assessment after 1-5 days from the initial recruitment and then every month until surgery. Postoperative assessments at 1, 3, 6 and 12 months postoperative
The Numerical Pain Rating Scale (NPRS) is a rapid subjective measure of pain in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). Correlation with other pain-assessment tools and feasibility of its use also in telephone interviews, have been demonstrated. The NPRS will be administered by the research personnel on the phone.
Baseline assessment after 1-5 days from the initial recruitment and then every month until surgery. Postoperative assessments at 1, 3, 6 and 12 months postoperative
Depressive symptoms trajectories using the Geriatric Depression Scale (short form) (GDS)
Time Frame: Baseline assessment after 1-5 days from the initial recruitment and then every month until surgery. Postoperative assessments at 1, 3, 6 and 12 months postoperative
The short form (15-item) version of the GDS is widely used instrument, which has demonstrated good reliability and validity in assessing depressive symptoms in older adults. The GDS Short Form takes an average of 5 to 7 min to complete and will be administered by the research personnel on the phone.
Baseline assessment after 1-5 days from the initial recruitment and then every month until surgery. Postoperative assessments at 1, 3, 6 and 12 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Investigators

  • Principal Investigator: Maura Marcucci, MD, McMaster Univesity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2020

Primary Completion (Anticipated)

January 31, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 5, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

October 31, 2022

Last Update Submitted That Met QC Criteria

October 28, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10829

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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