Cognitive Monitoring in Planned Arthroplasty Surgery

Cognitive Change Clinical Trial

— COMPASS  

Official title:

Cognitive Monitoring in Planned Arthroplasty Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05563597
• Other study ID #: 17/P/166
• Status: Completed
• Start date: August 6, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: July 2019
• Source: University Hospital Plymouth NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: March 31, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Change

Locations

Country	Name	City	State
United Kingdom	Torbay and South Devon NHS Trust	Torquay	Devon

Sponsors (8)

Lead Sponsor	Collaborator
University Hospital Plymouth NHS Trust	Claremont Medical Practice, Exmouth, Peninsula Collaboration for Leadership in Applied Research and Care (PenCLAHRC), Peninsula Public Involvement Group (PenPIG), a division of PenCLAHRC, South West Anaesthesia Research Matrix (SWARM), The Rame Group Practice, Torpoint, Torbay and South Devon NHS Foundation Trust, Wesnes Cognition Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients approached	Number of patients approached	18 months
Primary	Number of patients recruited	Number of patients recruited	18 months
Primary	Number of patients declining	Number of patients declining	18 months
Primary	Number of withdrawals plus reason if given	Number of withdrawals plus reason if given	18 months
Primary	Completion rate of remote cognitive assessment	Completion rate of remote cognitive assessment	18 months
Primary	Completion rate of secondary assessment	Completion rate of secondary assessments	18 months
Primary	IT accessibility	IT accessibility	18 months
Primary	Acceptability questionnaire	Acceptability questionnaire	18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Single question of subjective memory deterioration:	o Assess how patients subjectively perceive any cognitive changes when compared to objective measures.	18 months
Secondary	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