Cognitive Monitoring in Planned Arthroplasty Surgery

Study Overview
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Brief Summary
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Feasibility study testing a prospective observational methodology to assess the feasibility of serial remote monitoring of cognition with CogTrack™, an online cognitive assessment tool.

Detailed Description
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A feasibility study testing a prospective observational methodology at two secondary care sites (Derriford Hospital, University Hospitals Plymouth NHS Trust and Torbay Hospital, Torbay and South Devon NHS Foundation Trust) and open to interested primary care practices (who refer patients to secondary care). Serial cognitive testing will be performed using CogTrack™, a validated online cognitive assessment tool, over approximately an 11-week period. CogTrack™ requires two practice sessions to familiarise participants13, so the baseline CogTrack™ score will be that which is performed on the third occasion. Surgical patients will be tested both pre- and post-operatively. Non-surgical patients will have the assessments done at times to mirror those in the surgical group. Target is to recruit 150 participants in the surgery group and 50 control patients from primary care. The demographics and other data will be directly entered onto a secure electronic eCRF by a member of the research team. Only networked trust computers will be used and data entered onto a password protected database held on a shared network drive.

Official Title
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Cognitive Monitoring in Planned Arthroplasty Surgery

Conditions
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Cognitive Change

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Secondary Care (cases) Age over 60 years Listed for elective hip replacement Listed for elective knee replacement Able to consent for surgery Primary Care (controls) matched population by age Exclusion Criteria: Patient refusal Operation in the previous 12 months Patients lacking capacity to sign their own consent form for surgery Patients already with a diagnosis of dementia or deemed to lack capacity Operation date within 3 weeks

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients approached | Number of patients approached | 18 months | 
| Number of patients recruited | Number of patients recruited | 18 months | 
| Number of patients declining | Number of patients declining | 18 months | 
| Number of withdrawals plus reason if given | Number of withdrawals plus reason if given | 18 months | 
| Completion rate of remote cognitive assessment | Completion rate of remote cognitive assessment | 18 months | 
| Completion rate of secondary assessment | Completion rate of secondary assessments | 18 months | 
| IT accessibility | IT accessibility | 18 months | 
| Acceptability questionnaire | Acceptability questionnaire | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive assessment | CogTrack™ : This is an online validated tool to assess cognition that takes approximately 20 minutes to deliver and can be done remotely by the patient provided they have a computer with keyboard that can connect to the internet. The first two assessments done will be training for the patient to gain familiarity and will not count as study data. Scores are returned in 9 relevant domains Attention Intensity Index, a composite score of reaction times from 3 different tasks will be the primary quantitative endpoint Scores are not released to the patient or the assessor: results are uploaded to a secure database under a unique study code. Therefore, data will remain anonymous to the researchers of Wesnes Cognition Ltd. However, the clinical research team will be able to link the data to demographic and other data collected. Password protection on all databases maintains confidentiality at all times. | 18 months | 
| 3D-CAM scores: | To detect patients with delirium The confusion assessment method (CAM)1 is widely adopted as a validated way to diagnose delirium, including in the post-operative period. However, in the clinical setting it can be challenging to deliver due to requirement of interviewer training and variation in application. A new 3-minute diagnostic assessment, the 3D-CAM, has been developed and validated as a diagnostic assessment with high sensitivity and specificity for delirium. It is important to identify those patients with delirium as this is often short-lived but may have longer term consequences. Tools scale consists of delirium being present or absent | 18 months | 
| Short form of the Informant Questionnaire on Cognitive Decline in the Elderly (Short IQCODE)2: | To detect patients with possible dementia This is a widely used tool for the initial assessment of possible dementia. Each question on the IQCODE is scored from 1 to 5. A score of 3 means that the subject is rated on average as 'no change'. A score of 4 means an average of 'a bit worse'. A score of 5 an average of 'much worse'. The IQCODE result is achieved by adding the score for each question and dividing by the number of questions. For the short IQCODE, divide by 16. A cutting point of 3.31/3.38 for dementia achieves a balance of sensitivity and specificity. | 18 months | 
| Pain score: | To categorise patients as potentially being distracted, or not, by pain from performing the CogTrack™ test Pain may affect cognitive processes and motivation. Therefore, it is important to ascertain levels of pain that patients experienced during the study and how this has affected their activity. VAS score: 0 (no pain)- 10 (worst pain) | 18 months | 
| Opioid and sedative consumption in previous 6 hours: | Opioids and sedatives may affect cognition and hence we will be collecting this information alongside the cognitive testing. Opioid consumption will be converted to oral morphine equivalent doses (Appendix 7). Analgesics tend to have their highest pharmacological activity for the first few hours after a dose, hence the 6 hour window This information will be gathered as part of the online CogTrack™ assessment using a free text box for participants to enter the drugs and doses they have taken in the preceding 6 hours It is important this information is collected at each CogTrack™ assessment | 18 months | 
| Mood: | Mood may affect someone's motivation and ability to do some of the assessments We will therefore include a simple validated scale of mood, which will form part of the CogTrack™ cognitive assessment. This is quick to complete and by having it as part of the online package it reduces burden on patients as well as researchers. | 18 months | 
| Single question of subjective memory deterioration: | o Assess how patients subjectively perceive any cognitive changes when compared to objective measures. | 18 months | 
| Clock drawing test (semi quantitative, score out of 3): | o Clock drawing has been used extensively in the study of cognitive changes. It assesses a range of cognitive functions, is relatively quick to administer (approximately 5 minutes) and acceptable to patients. A score of 0-3 is given depending of the presence of certain features of the performed task. Scale of marking 0-3 | 18 months |