Preoperative Cognitive Training for Postoperative Cognitive Dysfunction

NCT03353987 | Terminated

• 1 other identifier: 2017312-5034
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative Cognitive Dysfunction (POCD) is a state of decline in cognitive ability after surgery and is frequently seen among our elderly population. Many studies have looked into predictive risk factors for POCD while research is underway to search for pre-emptive measures to avoid this unfavourable outcome. Most will be looking at utilizing mobile software applications of cognitive training but in many poorer countries, owning electronic devices may not be an option or may be culturally less acceptable among the older patients. Hence, the investigators intend to investigate if a home-based logbook for cognitive training will reduce the incidence of POCD in a single centre study.

Conditions

Cognitive Decline; Cognitive Impairment; Cognitive Deterioration

Keywords

Post-op cognitive dysfunction; Cognitive training; Logbook; Elderly

Outcome Measures

Primary Outcomes (2)

• Postoperative cognitive dysfunction

  Any patient having deficit in 2 or more neuropsychological tests will be deemed to have POCD. A deficit in any test will be defined as a negative difference in scores and if the absolute value of each of these change scores is larger than one standard deviation (SD) of the baseline in the same cognitive test from all subjects. Any patient having deficit in 2 or more neuropsychological tests.

  One week after surgery

• Postoperative cognitive dysfunction

  Any patient having deficit in 2 or more neuropsychological tests will be deemed to have POCD. A deficit in any test will be defined as a negative difference in scores and if the absolute value of each of these change scores is larger than one standard deviation (SD) of the baseline in the same cognitive test from all subjects. Any patient having deficit in 2 or more neuropsychological tests.

  One year after surgery

Secondary Outcomes (5)

• Identify age as a risk factor for developing POCD

  One week and 1 year after surgery

• Identify the association between types of surgery performed with developing POCD

  One week and 1 year after surgery

• Identify the association between duration of anaesthesia with developing POCD

  One week and 1 year after surgery

• Duration of home based cognitive training to prevent POCD

  One week and 1 year after surgery

• Correlation between delirium and POCD

  Post-op Day 1 to 3

Study Arms (2)

Control

NO INTERVENTION

Preoperative counselling will be given upon recruitment Patients will be given instructions to continue their normal routine.

Cognitive Training

EXPERIMENTAL

Preoperative counselling will be given upon recruitment Patients are taught cognitive training and are asked to perform a prescribed set of one-hour cognitive training daily for a minimum of 10 days and up to 1 month prior to surgery.

Behavioral: Cognitive training

Interventions

Cognitive training BEHAVIORAL

Procedure 1. A therapist will go through the daily routine of the participants at home before starting the intervention 2. Selections of exercise items based on familiar items/ activities at home 3. Given a memory logbook with list of household items, names and numbers and newspaper cuttings from the previous week 4. Taught on how to perform the exercises 5. Perform at least one hour per day 6. Both spatial and visual memory strategies will be used for memory training: simple mnemonics, associations, visualisations, rhymes 7. Advised to follow-up with the therapist to review on the progress and compliance of exercises weekly 8. The difficulty of the exercise will be adjusted weekly List of exercises: 1. Memorizing a set of lists, household items, names and numbers 2. Summarising the contents of newspaper cuttings within a set of time 3. Searching and listing sets of words from newspaper cuttings

Also known as: Home based Cognive Training

Cognitive Training

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged 65 years of age or older, ASA I-III
• Elective surgery (excluding neuro and cardiac surgery)
• Date of surgery at least 10 days and up to one month from date of recruitment
• Duration from induction of anaesthesia to end of anaesthesia minimum 2 hours
• Expected post-operative hospital stay at least 48 hours
• Able and willing to give informed consent
• Literate
• Willing to undergo cognitive and delirium assessments, perform daily cognitive training and able to return for follow-up assessments at 1 week, 3 months (phone call) and 1 year.

You may not qualify if:

• Glasgow coma scale \< 15
• Geriatric depression score (GDS-5) ≥ 2
• Pre-existing psychiatric disorder or delirium
• Severe visual, hearing or speech impairment
• General anaesthetic within the last 6 months

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

Related Publications (1)

• 1. Caza N. Progress in brain research 2008; 169: 409-22. 2. Deiner S. British journal of anaesthesia 2009; 103(suppl_1): i41-i6. 3. Wang W. Medical science monitor: international medical journal of experimental and clinical research 2014; 20: 1908. 4. Saniova B. Medical Science Monitor 2009; 15(5): CS81-CS7. 5. Cann C. Anaesthesia 2010; 65(12): 1166-9. 6. Monk TG. Anesthesiology: The Journal of the American Society of Anesthesiologists 2008; 108(1): 18-30. 7. Johnson T. The Journal of the American Society of Anesthesiologists 2002; 96(6): 1351-7. 8. Saleh AJ. Medical science monitor: international medical journal of experimental and clinical research 2015; 21: 798. 9. Bitsch M. Acta Orthopaedica Scandinavica 2004; 75(4): 378-89. 10. Newman MF. New England Journal of Medicine 2001; 344(6): 395-402. 11. Steinmetz J. Anaesthesia 2016; 71(S1): 58-63. 12. Hertzog C. Psychological science in the public interest 2008; 9(1): 1-65. 13. O'doherty A. British journal of anaesthesia 2013; 110(5): 679-89. 14. Kawano T. Anesthesiology: The Journal of the American Society of Anesthesiologists 2015; 123(1): 160-70. 15. Humeidan ML. . Clinical therapeutics 2015; 37(12): 2641-50.

  BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Pui San Loh

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The attending anaesthetist and assessors will be blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer

Model Details: Home based cognitive training (CogniTrain) Intervention: Using memory logbook and newspaper cuttings for cognitive improvement

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 27, 2017
• Study Start: January 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: August 5, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 6 months after publication
• Access Criteria: Written requests with supporting reasons to primary investigator for review among all investigators

Locations

MY (1)