Cognitive Trajectories After Surgery, a Clinical, Observational Feasibility Study

Postoperative Cognitive Dysfunction Clinical Trial

— POCOR  

Official title:

Cognitive Trajectories After Surgery, a Clinical, Observational Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05564195
• Other study ID #: 2022-03593-01
• Status: Recruiting
• Start date: January 10, 2023
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: Karolinska Institutet
• Contact: Ulrica Nilsson, Professor
• Phone: 0046 8 524 838 22
• Email: ulrica.nilsson[@]ki.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Description:

The aim is to evaluate the digital cognitive monitoring (Mindmore-P) in clinical practice by:

I) Test recruitment process and measure attrition rate. II) To establish whether it is possible to detect early signs of neurocognitive decline, using a digital postoperative cognitive screening tool i.e. Mindmore-P.

III) To investigate if there are any associations between choice of anesthetic drugs, delirium, duration of anesthesia, preoperative frailty, depression symptoms, postoperative delirium, physical function, and early postoperative recovery.

IV) Determine the usability and feasibility of Mindmore-P. V) Determine patients' experiences of early cognitive recovery in relation to signs of cognitive decline or no signs measured bythe four tests included in Mindmore-P

METHODS AND ANALYSIS Study design This is an observational feasibility study.

Participants included will be patients undergoing planned non-cardiac surgery with general anesthesia (n=50) at a hospital in Stockholm, Sweden. The sample size is based on the incidence of early cognitive decline at 1-2 weeks postoperatively of approximately 13-25%.

Inclusion criteria:

1. >60 years of age undergoing elective non-cardiac surgery with general anesthesia.

2. Duration of surgery >60 minutes

3. Mini-mental state examination (MMSE) score >24.

Exclusion criteria:

1. Unable to read and speak Swedish

2. 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.

Recruitment At the patient's preoperative anaesthesia consultation, a research nurse will provide oral and written information about the study. The details of the study and its potential benefits as well as risks will be explained carefully to the patient. If the patient agrees to participate in the study, they will undergo a MMSE screening to examine if they are eligible for the study.

Outcomes, look below.

Analysis Descriptive statistics of demographic data will be presented with number, percentage, and mean (sd) or min-max, as appropriate. As recommended by Borchers et al review from 2021, mild POCD (1-2 standard deviation [sd]) and major POCD (>2 sd) will be specified for each test result and POCD is present if at least two tests indicates decline.

Usability and attrition rates will be presented with descriptive statistics. Preoperative depression (GDS), frailty (CFS), postoperative recovery (SwQoR), functional status (WHODAS) will be compared between the groups, using Kruskal Wallis ANOVA followed by Mann-Whitney U-test and a Bonferroni correction. To analyse intraindividual differences over time in cognitive performance, the same statistical tests will be used as well as multivariate logistic regression analysis. A p-value of <0.05 will be statistically significant in all analyses, Qualitative data will be analysed with thematic analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• >60 years of age undergoing elective non-cardiac surgery with general anesthesia.

• Duration of surgery >60 minutes

• Mini-mental state examination score >24.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction

Intervention

Diagnostic Test:
• Postoperative cognitive function
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.

Locations

Country	Name	City	State
Sweden	Ulrica Nilsson	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Ersta Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Frailty	Clinical Frailty Scale, including 9-item ranging from 1 - very vital to 9 - terminally ill.	Before surgery
Secondary	Signs of and changes in depression	Geriatric Depression Scale (GDS), consisting of 15 items to be answered with Yes or No. A score of 5 to 10 indicates probable depression and a score of more than 10 indicates definite depression.	Before surgery and 3 weeks after surgery
Secondary	Changes in functional capacity	World Health Organization Disability Assessment Schedule 2.0 (WHODAS), thats consists of 12-item. Sum score ranges from 0-48, with increasing scores reflecting increasing disability	Before surgery and 3 weeks after surgery
Secondary	Changes in postoperative recovery	Swedish version of Quality of Recovery, SwQoR, including 24 different postoperative symptoms to be rated on 11-point numerical scales from 0, "none of the time", to 10, "all of the time" Global score ranging from 0, "excellent quality of postoperative recovery," to 240, "extremely poor quality of recovery," with cutoff values of less than 31 at day 7 and less than 21 at day 14 indicating good recovery	Before surgery and day 1 or 2, and 3 weeks after surgery
Secondary	Usability of Mindmore-P	System Usability Scale (SUS), consisting of 10 items to be answered on a 5-point scale from "strongly agree" to "strongly disagree".	3 weeks after surgery
Secondary	Feasibility and patients' experiences of early postoperative cognitive recovery	Semi-structured, one-on-one interviews exploring patients' experiences of being assessed for cognitive performance and using Mindmore-P including assessment of facilitators and barriers, will be conducted. The participants will be asked to communicate freely on their experiences of their postoperative recovery.	One month after surgery
Secondary	Signs of and changes in postoperative delirium	Nursing Delirium Screening Scale NU-DESC, an observational five-item scale where symptoms delirium are rated from 0 to 2. A score of 2 or more indicates delirium	After surgery twice a day on postoperative day 1-2