Cognitive Trajectories After Surgery, a Clinical, Observational Feasibility Study

NCT05564195 | Completed

• 1 other identifier: 2022-03593-01
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Research problem and specific questions: Approximately 2.8 million surgeries are conducted yearly in Sweden and of these almost 50% are persons ≥ 60 years. Postoperative cognitive recovery is a concern for older persons. To date, there is no evidence for treating postoperative neurocognitive decline (POCD) and no assessment of cognitive function is routinely performed. The purpose is to is to test digital monitoring in clinical practice: I) test recruitment process and measure attrition rate; II) estimate the difference in main clinical outcomes (POCD) that will inform sample size calculations for the longitudinal observational mixed methods study, III) determine the usability and feasibility of digital monitoring. Participants: 50 patients ≥60 years undergoing inpatient surgery. Outcomes: depression, frailty, cognitive function, postoperative recovery and functional status .

Conditions

Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (5)

• Recruitment process and attrition rate

  Number of possible participants vs. number of participants who accept to participate and number of participants who complete the study

  Through study completion, an average of 8 months

• Changes in postoperative cognitive function, part 1

  Consortium to Establish a Registry for Alzheimer´s Disease (CERAD) A 10-word verbal learning test with 3 learning trials, a recall trial after \~7 min.

  Before surgery and day 1 or 2, and 3 weeks after surgery

• Changes in postoperative cognitive function, part 2

  Trail Making Test (TMT- A \& B), consisting of of 25 circles with letters or numbers on the screen. 4\. Symbol Digits Processing Test (SDPT).The test consist of nine symbol-digit pairings at the top of the screen, one symbol in the middle of the screen, and a number grid at the bottom of the screen.

  Before surgery and day 1 or 2, and 3 weeks after surgery

• Changes in postoperative cognitive function, part 3

  Stroop Colour-Word Test (SCW). 24 words spelling out a the name of a colour which is printed in contrasting ink colours (e.g., the word "green" printed with red ink), and the participant is asked to tell the printed colour of the word rather than the word rather than the actual meaning of the word.

  Before surgery and day 1 or 2, and 3 weeks after surgery

• Changes in postoperative cognitive function, part 4

  Symbol Digits Processing Test (SDPT).The test consist of nine symbol-digit pairings at the top of the screen, one symbol in the middle of the screen, and a number grid at the bottom of the screen.

  Before surgery and day 1 or 2, and 3 weeks after surgery

Secondary Outcomes (7)

• Frailty

  Before surgery

• Signs of and changes in depression

  Before surgery and 3 weeks after surgery

• Changes in functional capacity

  Before surgery and 3 weeks after surgery

• Changes in postoperative recovery

  Before surgery and day 1 or 2, and 3 weeks after surgery

• Usability of Mindmore-P

  3 weeks after surgery

Study Arms (1)

Patients undergoing elective surgery with a duration of > 60 minutes

Participants included will be patients undergoing planned non-cardiac surgery with general anesthesia that are \>60 years of age, have a Mini-mental state examination score of \>24, are able to speak Swedish and does not suffer from uncorrected severe visual or auditory disorder, disease of the central nervous system, psychiatric diseases including alcoholism or drug dependence, current motor impairment in dominant hand, or colour-blindness.

Diagnostic Test: Postoperative cognitive function

Interventions

Postoperative cognitive function DIAGNOSTIC_TEST

Digital cognitive tests - Mindmore-P, will be used to assess neurocognitive capacity and includes tests of verbal episodic memory, executive functions, visuospatial function and attention. The cognitive tests are self-administered on a touch screen tablet (10.1" 20-30 min Windows). The Mindmore-P is a web-application running on a full-screen Chrome browser. The test is administered by using a capacitive touchscreen with features that record detailed information such as timing, pauses, and lifting of finger from the touchscreen. Speech recognition is used in the screening of verbal memory and language.

Patients undergoing elective surgery with a duration of > 60 minutes

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants included will be patients undergoing planned non-cardiac surgery with general anesthesia (n=50) at a hospital in Stockholm, Sweden.

You may qualify if:

• \>60 years of age undergoing elective non-cardiac surgery with general anesthesia.
• Duration of surgery \>60 minutes
• Mini-mental state examination score \>24.

You may not qualify if:

• Mini-mental state examination, cut-off score of \<23 indicating cognitive impairment
• Unable to read and speak Swedish
• Uncorrected severe visual or auditory disorder,
• Disease of the central nervous system
• Psychiatric diseases
• Alcoholism or drug dependence
• Current motor impairment in dominant hand
• Colour-blindness.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Ersta Hospital, Sweden: collaborator

Study Sites (1)

Ulrica Nilsson

Stockholm, 141 83, Sweden

Location

Related Publications (1)

• Amirpour A, Eckerblad J, Thorell A, Bergman L, Nilsson U. Usability and feasibility of a digital cognitive screening tool measuring older adults' early postoperative neurocognitive recovery: a protocol for a pilot study. BMJ Open. 2023 Jul 21;13(7):e070404. doi: 10.1136/bmjopen-2022-070404.

  PMID: 37479514 DERIVED

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ulrica Nilsson, Professor

  Karolinska Insitutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: October 3, 2022
• Study Start: January 10, 2023
• Primary Completion: October 4, 2024
• Study Completion: October 4, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

SE (1)