Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04787536
Status:
UNKNOWN
Last Update Posted:
2022-10-31
First Post:
2021-03-03
Brief Title:
Perioperative Cognitive Trajectories in Deferred Surgery CoTELE-SURGE
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Preoperative and Postoperative Cognitive TrajEctories in oLdEr Patients With Deferred SURGEry Due to the COVID-19 Emergency a Prospective Cohort Study
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
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:
CoTELE-SURGE
Brief Summary:
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 someones 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 participants 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
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 participants 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
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 ie 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 ie medication changes hospitalization ED or urgent care visits
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 ie 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 ie medication changes hospitalization ED or urgent care visits
Study Oversight
Has Oversight DMC:
None
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?:
None