Cognitive DeclineCogniTrainNCT03353987
Preoperative Cognitive Training for Postoperative Cognitive Dysfunction
A study testing Cognitive training in people with Cognitive Decline and Cognitive Impairment, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Decline, Cognitive Impairment, Cognitive Deterioration
- What is being tested?
- Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2018to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Training to Prevent Postoperative Cognitive Dysfunction in Older Patients - A Randomised Controlled Trial
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.
Read the detailed description
Background:
Postoperative Cognitive Dysfunction (POCD) is a state in which a decline in cognitive ability after surgery persist from early postoperative period to a much longer term. It is said to be a subtle disorder of thought processes that influences domains of cognition such as memory especially short-term memory, inattention and inability to focus with the presence of generalized slowness. In fact, a lot of older patients and their loved ones claim they are 'never the same' after the surgery. It is to be distinguished from postoperative delirium, a diagnosis portrayed through several symptoms that occurs acutely after surgery, fluctuates with time and has a tendency to be transient. POCD, on the other hand, is difficult to diagnose and only detected by comparing postoperative results of neuropsychological battery tests to those done as baseline preoperatively.
Advanced age is a major risk for developing POCD.6 Studies done by the International Study of Postoperative Cognitive Dysfunction (ISPOCD) group had found an incidence of POCD at 19.2% within 1 week and 6.2% in 3 months. Similar studies have reported a higher figure of 36.1% at 1 week after surgery for this phenomenon. In certain high-risk groups, the range ascends to 16 - 62% with an average of 35% in hip fracture patients9 and up to 60% for those who underwent cardiac surgery that persist in 10-30% after 6 months.
Hypothesis:
As far as research is concerned, tremendous efforts are now underway to look for causes of POCD and its risk factors but most importantly, find ways to avoid this disability over time. Clinicians instinctively prescribe prehabilitation in preparation for surgery through various physical conditioning to improve patients' physiological cardio-respiratory reserve in the hope for better recovery. The investigators hypothesize that the same holds true with cognitive function and by optimizing mental 'fitness', the pre-conditioning can attribute to a decrease in POCD.
Currently, there are a few ongoing trials such as NeuroBics in US15 for non-cardiac surgery and Cog-train in UK for cardiac patients investigating the role of using electronic-based 'brain' intervention before surgery. The investigators aim to test the feasibility of using a home based logbook with easy applicability as the cognitive training to produce equally favourable results in reducing POCD since the socio-economic pattern of our older population is different from the west. Senior citizens may not be familiar with or have difficulty to afford electronic devices and are less engaged with web-based Internet as reflected by data from a local service provider that found only 3.9% of their user base in the country is over the age of 60.
Sample size:
Based on 36% POCD at one week from a previous study8 and our proposed 50% reduction to 18% incidence with intervention, a total of 232 participants (including 10% drop-out rate) are required at a 1:1 ratio between groups to achieve an 80% powered study and Type 1 error of 5%.
A preliminary analysis will be done at 50 recruited patients to look for feasibility of continuing this study.
- Being tested
- Cognitive training
- Keywords
- Post-op cognitive dysfunction, Cognitive training, Logbook, Elderly
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
Also called Home based Cognive Training
Procedure
- A therapist will go through the daily routine of the participants at home before starting the intervention
- Selections of exercise items based on familiar items/ activities at home
- Given a memory logbook with list of household items, names and numbers and newspaper cuttings from the previous week
- Taught on how to perform the exercises
- Perform at least one hour per day
- Both spatial and visual memory strategies will be used for memory training: simple mnemonics, associations, visualisations, rhymes
- Advised to follow-up with the therapist to review on the progress and compliance of exercises weekly
- The difficulty of the exercise will be adjusted weekly
List of exercises:
- Memorizing a set of lists, household items, names and numbers
- Summarising the contents of newspaper cuttings within a set of time
- Searching and listing sets of words from newspaper cuttings
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One year after surgery
Secondary outcomes (5)
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.)
Measured: One week and 1 year after surgery
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.)
Measured: One week and 1 year after surgery
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.)
Measured: One week and 1 year after surgery
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.
Measured: One week and 1 year after surgery
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.)
Measured: Post-op Day 1 to 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start1 Jan 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Why it stopped: Patients are not compliant to the daily logbook exercises before surgery. Most will only perform once during training or maximum twice.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Home based cognitive training (CogniTrain) Intervention: Using memory logbook and newspaper cuttings for cognitive improvement
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Loh Pui San, University of Malaya
- Investigators
- Pui San Loh, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353987
- Sponsor's protocol ID
- 2017312-5034
- Acronym
- CogniTrain
- Status last verified
- Aug 2019
- First submitted
- 21 Nov 2017
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD that underlie results in a publication
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training to Prevent Postoperative Cognitive Dysfunction in Older Patients - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03353987
- Acronym / sponsor ID
- CogniTrain / 2017312-5034
- Keywords
- Post-op cognitive dysfunction, Cognitive training, Logbook, Elderly
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patients are not compliant to the daily logbook exercises before surgery. Most will only perform once during training or maximum twice.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Postoperative Cognitive Dysfunction (POCD) is a state in which a decline in cognitive ability after surgery persist from early postoperative period to a much longer term. It is said to be a subtle disorder of thought processes that influences domains of cognition such as memory especially short-term memory, inattention and inability to focus with the presence of generalized slowness. In fact, a lot of older patients and their loved ones claim they are 'never the same' after the surgery. It is to be distinguished from postoperative delirium, a diagnosis portrayed through several symptoms that occurs acutely after surgery, fluctuates with time and has a tendency to be transient. POCD, on the other hand, is difficult to diagnose and only detected by comparing postoperative results of neuropsychological battery tests to those done as baseline preoperatively.
Advanced age is a major risk for developing POCD.6 Studies done by the International Study of Postoperative Cognitive Dysfunction (ISPOCD) group had found an incidence of POCD at 19.2% within 1 week and 6.2% in 3 months. Similar studies have reported a higher figure of 36.1% at 1 week after surgery for this phenomenon. In certain high-risk groups, the range ascends to 16 - 62% with an average of 35% in hip fracture patients9 and up to 60% for those who underwent cardiac surgery that persist in 10-30% after 6 months.
Hypothesis:
As far as research is concerned, tremendous efforts are now underway to look for causes of POCD and its risk factors but most importantly, find ways to avoid this disability over time. Clinicians instinctively prescribe prehabilitation in preparation for surgery through various physical conditioning to improve patients' physiological cardio-respiratory reserve in the hope for better recovery. The investigators hypothesize that the same holds true with cognitive function and by optimizing mental 'fitness', the pre-conditioning can attribute to a decrease in POCD.
Currently, there are a few ongoing trials such as NeuroBics in US15 for non-cardiac surgery and Cog-train in UK for cardiac patients investigating the role of using electronic-based 'brain' intervention before surgery. The investigators aim to test the feasibility of using a home based logbook with easy applicability as the cognitive training to produce equally favourable results in reducing POCD since the socio-economic pattern of our older population is different from the west. Senior citizens may not be familiar with or have difficulty to afford electronic devices and are less engaged with web-based Internet as reflected by data from a local service provider that found only 3.9% of their user base in the country is over the age of 60.
Sample size:
Based on 36% POCD at one week from a previous study8 and our proposed 50% reduction to 18% incidence with intervention, a total of 232 participants (including 10% drop-out rate) are required at a 1:1 ratio between groups to achieve an 80% powered study and Type 1 error of 5%.
A preliminary analysis will be done at 50 recruited patients to look for feasibility of continuing this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Home based cognitive training (CogniTrain) Intervention: Using memory logbook and newspaper cuttings for cognitive improvement
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Preoperative counselling will be given upon recruitment Patients will be given instructions to continue their normal routine. |
| Cognitive Training | Experimental | Behavioral: Cognitive trainingPreoperative 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive trainingAlso: Home based Cognive TrainingProcedure 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 | Behavioural | Cognitive Training |
Primary outcome
Postoperative cognitive dysfunction
Time frame: One week after surgery
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.
Postoperative cognitive dysfunction
Time frame: One year after surgery
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.
5 secondary outcomes
Identify age as a risk factor for developing POCD
Time frame: One week and 1 year after surgery
Identify the association between types of surgery performed with developing POCD
Time frame: One week and 1 year after surgery
Identify the association between duration of anaesthesia with developing POCD
Time frame: One week and 1 year after surgery
Duration of home based cognitive training to prevent POCD
Time frame: One week and 1 year after surgery
Correlation between delirium and POCD
Time frame: Post-op Day 1 to 3
Results and safety
The study was stopped early (reason given: Patients are not compliant to the daily logbook exercises before surgery. Most will only perform once during training or maximum twice.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Background1. 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.
- Individual participant dataSharing planned: Yes. Only IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pui San Loh principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training in people with Cognitive Decline and Cognitive Impairment, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Patients are not compliant to the daily logbook exercises before surgery. Most will only perform once during training or maximum twice.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative cognitive dysfunction (time frame: One week after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03353987, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.