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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United Kingdom1 site
  • Torbay and South Devon NHS Trust

    Torquay, Devon

Other trials in United Kingdom

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients approached

    Number of patients approached

    Measured: 18 months

  2. Number of patients recruited

    Number of patients recruited

    Measured: 18 months

  3. Number of patients declining

    Number of patients declining

    Measured: 18 months

  4. Number of withdrawals plus reason if given

    Number of withdrawals plus reason if given

    Measured: 18 months

  5. Completion rate of remote cognitive assessment

    Completion rate of remote cognitive assessment

    Measured: 18 months

  6. Completion rate of secondary assessment

    Completion rate of secondary assessments

    Measured: 18 months

  7. IT accessibility

    IT accessibility

    Measured: 18 months

  8. Acceptability questionnaire

    Acceptability questionnaire

    Measured: 18 months

Secondary outcomes (8)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Single question of subjective memory deterioration:

    • Assess how patients subjectively perceive any cognitive changes when compared to objective measures.

    Measured: 18 months

  8. 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.

  1. First posted3 Oct 2022
  2. Study start6 Aug 2018
  3. Primary completion15 Mar 2020
  4. Study completion31 Mar 2020

Resources

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)
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

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.

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