Postoperative Cognitive DysfunctionCognigramNCT02964221
Cognitive Changes After Major Joint Replacement
An observational study of Postoperative Cognitive Dysfunction and Mild Cognitive Impairment, run by Dr. Stephen Choi.
Trial summary
Patients assume that cognitive performance rapidly returns to baseline after anesthesia and surgery. Several studies have shown that one week after major non-cardiac surgery about 27% of patients have postoperative cognitive dysfunction (POCD) and 10% of patients at 3 months. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Mild Cognitive Impairment, Delirium
- What is being tested?
- Cognitive Testing
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2016to 1 May 2017
- Phase
- Observational
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing total hip arthroplasty (THA) or total knee arthroplasty (TKA) at the Holland Orthopedic and Arthritic Centre (HOAC) at Sunnybrook Health Sciences Centre (SHSC).
Who may be able to join
- All patients ≥ 50 years of age undergoing elective total hip or knee arthroplasty at Sunnybrook Health Sciences Centre
Who cannot join
- Lack of informed consent
- Inability to comply with study procedures or follow-up visits
- Patients with diagnosed dementia or those being treated with donepezil (Aricept®)
- Patients with severe cognitive impairment defined as baseline with a CBB score of equal to or less than 80 in at least one of the 4 CBB domains
- Patients with psychiatric diagnoses including schizophrenia, bipolar disorder, major depressive mood disorder
- Patients undergoing a second joint replacement \& previously enrolled in this study within the past 6 months
About this study
Official title: Assessing Postoperative Cognitive Changes After Major Joint Arthroplasty: A Feasibility Study Using the CogState Brief Battery
Patients assume that cognitive performance rapidly returns to baseline after anesthesia and surgery. Several studies have shown that one week after major non-cardiac surgery about 27% of patients have postoperative cognitive dysfunction (POCD) and 10% of patients at 3 months. Very few studies have assessed the incidence of POCD beyond 3 months. POCD significantly reduces quality of life. Identifying risk factors for POCD is important because it is associated with prolonged hospital stay, loss of independence, and premature retirement. There is an urgent need to measure and document the level of cognitive change associated with surgery with an easy to use tool, both prior to admission and after discharge. This information can be used to plan appropriate care paths and to identify or test the efficacy of potential new treatments to alter the negative trajectory.
Read the detailed description
Postoperative cognitive dysfunction (POCD) is thought to affect a significant proportion of patients after major surgery (up to 10% at 3 months). This is potentially a major public health issue because patients with POCD have prolonged hospital admission, loss of independence and mortality. Undoubtedly, if POCD is as prevalent and devastating as has been previously reported, the decision to undergo elective surgery should be influenced by the risk of developing POCD. Given the scope of the issue, the deficiencies in the literature surrounding POCD are concerning. There are many methodological issues with previous studies and the diagnosis of POCD in the perioperative period.
It is imperative that the true natures of postoperative cognitive changes are elucidated so that preoperative risk stratification can be appropriately determined. This will lead to care pathways and interventions that can modify any possible downward changes thereby reducing the negative impact on patients and the health care system.
Study Hypothesis: The incidence of postoperative cognitive changes in the joint arthroplasty population is influenced by postoperative complications, pre-existing mild cognitive impairment, and pre-existing comorbid conditions.
Study Objectives:
- To conduct a pilot study for six to 12 months to assess both the rate of recruitment (goal of 15 participants/month) and postoperative in-person follow-up (at 6 weeks and 4.5 months), and determine if a large-scale study of 600 participants is feasible
- To determine the sensitivity and accuracy of Cognigram (CogState Brief Battery - CBB) for detecting changes in cognitive function during the perioperative period
- To determine whether pre-existing mild cognitive impairment (MCI), preoperative chronic inflammatory states, and acute postoperative complications affect changes in postoperative cognitive function
- Conditions
- Postoperative Cognitive Dysfunction, Mild Cognitive Impairment, Delirium, Cognitive Deficit, Cognitive Change, Working Memory
- Being tested
- Cognitive Testing
- Medical subject headings
- Postoperative Cognitive Complications, Cognitive Dysfunction, Delirium, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TestingOther
Computerized CogState Brief Battery (CBB), Cognigram, assesses changes in four cognitive domains including psychomotor function, attention, learning and memory, and working memory. The CBB is a computerized test based on card games that can be administered online. .
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Brief Battery (CBB) score from baseline to 4.5 months after surgery
Change in Cognitive Brief Battery (CBB) score from baseline to 4.5 months after surgery
Measured: 4.5 months after surgery
Secondary outcomes (3)
Proportion of patients developing severe cognitive dysfunction at 4.5 months after surgery (defined as CBB score less than 80)
Proportion of patients developing severe cognitive dysfunction at 4.5 months after surgery (defined as CBB score less than 80)
Measured: 4.5 months after surgery
Proportion of patients developing mild cognitive impairment at 4.5 months after surgery defined as CBB score between 81 and 90
Proportion of patients developing mild cognitive impairment at 4.5 months after surgery defined as CBB score between 81 and 90
Measured: 4.5 months after surgery
The effect of pre-operative mild cognitive impairment, pre-operative chronic inflammatory states, postoperative delirium, and postoperative complications on the incidence of mild cognitive impairment and severe cognitive dysfunction at 4.5 months
The effect of pre-operative mild cognitive impairment, pre-operative chronic inflammatory states, postoperative delirium, and postoperative complications on the incidence of mild cognitive impairment and severe cognitive dysfunction at 4.5 months
Measured: 4.5 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study start15 Jun 2016
- Primary completion1 May 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Stephen Choi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Stephen Choi, Sunnybrook Health Sciences Centre
- Investigators
- Stephen Choi, MD,FRCPC,MSc, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964221
- Sponsor's protocol ID
- 045-2015
- Acronym
- Cognigram
- Status last verified
- May 2017
- First submitted
- 1 Nov 2016
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Postoperative Cognitive Changes After Major Joint Arthroplasty: A Feasibility Study Using the CogState Brief Battery
- ClinicalTrials.gov ID
- NCT02964221
- Acronym / sponsor ID
- Cognigram / 045-2015
- Conditions
- Postoperative Cognitive Dysfunction, Mild Cognitive Impairment, Delirium, Cognitive Deficit, Cognitive Change, Working Memory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dr. Stephen ChoiUniversity, hospital or other
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 16 Nov 2016 (estimated)
- 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.
Patients assume that cognitive performance rapidly returns to baseline after anesthesia and surgery. Several studies have shown that one week after major non-cardiac surgery about 27% of patients have postoperative cognitive dysfunction (POCD) and 10% of patients at 3 months. Very few studies have assessed the incidence of POCD beyond 3 months. POCD significantly reduces quality of life. Identifying risk factors for POCD is important because it is associated with prolonged hospital stay, loss of independence, and premature retirement. There is an urgent need to measure and document the level of cognitive change associated with surgery with an easy to use tool, both prior to admission and after discharge. This information can be used to plan appropriate care paths and to identify or test the efficacy of potential new treatments to alter the negative trajectory.
Detailed description
Postoperative cognitive dysfunction (POCD) is thought to affect a significant proportion of patients after major surgery (up to 10% at 3 months). This is potentially a major public health issue because patients with POCD have prolonged hospital admission, loss of independence and mortality. Undoubtedly, if POCD is as prevalent and devastating as has been previously reported, the decision to undergo elective surgery should be influenced by the risk of developing POCD. Given the scope of the issue, the deficiencies in the literature surrounding POCD are concerning. There are many methodological issues with previous studies and the diagnosis of POCD in the perioperative period.
It is imperative that the true natures of postoperative cognitive changes are elucidated so that preoperative risk stratification can be appropriately determined. This will lead to care pathways and interventions that can modify any possible downward changes thereby reducing the negative impact on patients and the health care system.
Study Hypothesis: The incidence of postoperative cognitive changes in the joint arthroplasty population is influenced by postoperative complications, pre-existing mild cognitive impairment, and pre-existing comorbid conditions.
Study Objectives:
- To conduct a pilot study for six to 12 months to assess both the rate of recruitment (goal of 15 participants/month) and postoperative in-person follow-up (at 6 weeks and 4.5 months), and determine if a large-scale study of 600 participants is feasible
- To determine the sensitivity and accuracy of Cognigram (CogState Brief Battery - CBB) for detecting changes in cognitive function during the perioperative period
- To determine whether pre-existing mild cognitive impairment (MCI), preoperative chronic inflammatory states, and acute postoperative complications affect changes in postoperative cognitive function
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing total hip arthroplasty (THA) or total knee arthroplasty (TKA) at the Holland Orthopedic and Arthritic Centre (HOAC) at Sunnybrook Health Sciences Centre (SHSC).
Key inclusion criteria (1 listed)
- All patients ≥ 50 years of age undergoing elective total hip or knee arthroplasty at Sunnybrook Health Sciences Centre
Key exclusion criteria (6 listed)
- Lack of informed consent
- Inability to comply with study procedures or follow-up visits
- Patients with diagnosed dementia or those being treated with donepezil (Aricept®)
- Patients with severe cognitive impairment defined as baseline with a CBB score of equal to or less than 80 in at least one of the 4 CBB domains
- Patients with psychiatric diagnoses including schizophrenia, bipolar disorder, major depressive mood disorder
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 TestingComputerized CogState Brief Battery (CBB), Cognigram, assesses changes in four cognitive domains including psychomotor function, attention, learning and memory, and working memory. The CBB is a computerized test based on card games that can be administered online. . | Other | – |
Primary outcome
Change in Cognitive Brief Battery (CBB) score from baseline to 4.5 months after surgery
Time frame: 4.5 months after surgery
Change in Cognitive Brief Battery (CBB) score from baseline to 4.5 months after surgery
3 secondary outcomes
Proportion of patients developing severe cognitive dysfunction at 4.5 months after surgery (defined as CBB score less than 80)
Time frame: 4.5 months after surgery
Proportion of patients developing mild cognitive impairment at 4.5 months after surgery defined as CBB score between 81 and 90
Time frame: 4.5 months after surgery
The effect of pre-operative mild cognitive impairment, pre-operative chronic inflammatory states, postoperative delirium, and postoperative complications on the incidence of mild cognitive impairment and severe cognitive dysfunction at 4.5 months
Time frame: 4.5 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Stephen Choi, MD,FRCPC,MSc principal investigator
Sunnybrook Health Sciences Centre
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction and Mild Cognitive Impairment, run by Dr. Stephen Choi.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Cognitive Brief Battery (CBB) score from baseline to 4.5 months after surgery (time frame: 4.5 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2017.