Cognitive Impairment Clinical Trial
— CogniTrainOfficial title:
Cognitive Training to Prevent Postoperative Cognitive Dysfunction in Older Patients - A Randomised Controlled Trial
Verified date | August 2019 |
Source | University of Malaya |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 17 |
Est. completion date | May 31, 2019 |
Est. primary completion date | May 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: 1. Aged 65 years of age or older, ASA I-III 2. Elective surgery (excluding neuro and cardiac surgery) 3. Date of surgery at least 10 days and up to one month from date of recruitment 4. Duration from induction of anaesthesia to end of anaesthesia minimum 2 hours 5. Expected post-operative hospital stay at least 48 hours 6. Able and willing to give informed consent 7. Literate 8. 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. Exclusion Criteria: 1. Glasgow coma scale < 15 2. Geriatric depression score (GDS-5) = 2 3. Pre-existing psychiatric disorder or delirium 4. Severe visual, hearing or speech impairment 5. General anaesthetic within the last 6 months |
Country | Name | City | State |
---|---|---|---|
Malaysia | University Malaya | Kuala Lumpur | Wilayah Persekutuan Kuala Lumpur |
Lead Sponsor | Collaborator |
---|---|
University of Malaya |
Malaysia,
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Identify age as a risk factor for developing POCD | Correlation between patient age (in years) to POCD (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 and 1 year after surgery | |
Secondary | Identify the association between types of surgery performed with developing POCD | Correlation between surgical procedures (orthopaedic/ general surgery/ ENT/ gynaecology) to POCD (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 and 1 year after surgery | |
Secondary | Identify the association between duration of anaesthesia with developing POCD | Correlation between duration of anaesthesia (hours) to POCD (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 and 1 year after surgery | |
Secondary | Duration of home based cognitive training to prevent POCD | Analysis of correlation between the total duration of cognitive training (hours) and incidence of POCD (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 and 1 year after surgery | |
Secondary | Correlation between delirium and POCD | Analysis of correlation between positive CAM tests and incidence of POCD (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.) |
Post-op Day 1 to 3 |
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