Clinical trial NCT04787536: Perioperative Cognitive Trajectories in Deferred Surgery (CoTELE-SURGE)
Official title: Preoperative and Postoperative Cognitive TrajEctories in oLdEr Patients With Deferred SURGEry Due to the COVID-19 Emergency: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Cognitive Dysfunction
Depressive Symptoms
Postoperative Pain
Keywords: Older patients
Non-cardiac surgery
Cognitive trajectories
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in perioperative cognitive trajectories assessed using the Cogstate Brief Battery (CBB)
timeFrame: 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 outcomes:
measure: Pain trajectories using the Numeric Pain Rating Scale
timeFrame: 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
measure: Depressive symptoms trajectories using the Geriatric Depression Scale (short form) (GDS)
timeFrame: 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
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster Univesity
name: Maura Marcucci, MD
role: PRINCIPAL_INVESTIGATOR
References: