Cognitive ChangeCOMPASSNCT05563597
Cognitive Monitoring in Planned Arthroplasty Surgery
An observational study of Cognitive Change, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- How many people
- 117 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Aug 2018to 31 Mar 2020
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients over the age of 60 undergoing elective hip or knee joint replacement surgery plus volunteer controls from primary care.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Feasibility study testing a prospective observational methodology to assess the feasibility of serial remote monitoring of cognition with CogTrack™, an online cognitive assessment tool.
Read the detailed 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.
- Conditions
- Cognitive Change
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients approached
Number of patients approached
Measured: 18 months
Number of patients recruited
Number of patients recruited
Measured: 18 months
Number of patients declining
Number of patients declining
Measured: 18 months
Number of withdrawals plus reason if given
Number of withdrawals plus reason if given
Measured: 18 months
Completion rate of remote cognitive assessment
Completion rate of remote cognitive assessment
Measured: 18 months
Completion rate of secondary assessment
Completion rate of secondary assessments
Measured: 18 months
IT accessibility
IT accessibility
Measured: 18 months
Acceptability questionnaire
Acceptability questionnaire
Measured: 18 months
Secondary outcomes (8)
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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 18 months
Single question of subjective memory deterioration:
- Assess how patients subjectively perceive any cognitive changes when compared to objective measures.
Measured: 18 months
Clock drawing test (semi quantitative, score out of 3):
- 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start6 Aug 2018
- Primary completion15 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Torbay and South Devon NHS Foundation 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, Wesnes Cognition Ltd
- Responsible party
- Sponsor
- Investigators
- Gary Minto, Study chair, University Hospital Plymouth NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563597
- Sponsor's protocol ID
- 17/P/166
- Acronym
- COMPASS
- Status last verified
- Jul 2019
- First submitted
- 9 Jul 2019
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Monitoring in Planned Arthroplasty Surgery
- ClinicalTrials.gov ID
- NCT05563597
- Acronym / sponsor ID
- COMPASS / 17/P/166
- Conditions
- Cognitive Change
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Collaborators
- Torbay and South Devon NHS Foundation 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, Wesnes Cognition Ltd
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 3 Oct 2022 (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.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 60 undergoing elective hip or knee joint replacement surgery plus volunteer controls from primary care.
Key inclusion criteria (6 listed)
- Secondary Care (cases)
- Age over 60 years
- Listed for elective hip replacement
- Listed for elective knee replacement
- Able to consent for surgery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients approached
Time frame: 18 months
Number of patients approached
Number of patients recruited
Time frame: 18 months
Number of patients recruited
Number of patients declining
Time frame: 18 months
Number of patients declining
Number of withdrawals plus reason if given
Time frame: 18 months
Number of withdrawals plus reason if given
Completion rate of remote cognitive assessment
Time frame: 18 months
Completion rate of remote cognitive assessment
Completion rate of secondary assessment
Time frame: 18 months
Completion rate of secondary assessments
IT accessibility
Time frame: 18 months
IT accessibility
Acceptability questionnaire
Time frame: 18 months
Acceptability questionnaire
8 secondary outcomes
Cognitive assessment
Time frame: 18 months
3D-CAM scores:
Time frame: 18 months
Short form of the Informant Questionnaire on Cognitive Decline in the Elderly (Short IQCODE)2:
Time frame: 18 months
Pain score:
Time frame: 18 months
Opioid and sedative consumption in previous 6 hours:
Time frame: 18 months
Mood:
Time frame: 18 months
Single question of subjective memory deterioration:
Time frame: 18 months
Clock drawing test (semi quantitative, score out of 3):
Time frame: 18 months
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 3 Oct 2022.
- Individual participant dataSharing planned: No. No plan to share data with other researchers
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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.
Gary Minto study chair
University Hospital Plymouth NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Change, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
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 6 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: finished, as of the sponsor's last update on 3 Oct 2022. 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 United Kingdom. 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 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?
Number of patients approached (time frame: 18 months). The study lists 8 primary outcomes in all. 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 3 Oct 2022.