Torbay and South Devon NHS Trust
Torquay, Devon, United Kingdom
NCT Number: NCT05563597
Feasibility study testing a prospective observational methodology to assess the feasibility of serial remote monitoring of cognition with CogTrack™, an online cognitive assessment tool.
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Notify Me60 year and older
All sexes
Observational
Torquay, Devon, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 18 months
Number of patients approached
Time frame: 18 months
Number of patients recruited
Time frame: 18 months
Number of patients declining
Time frame: 18 months
Number of withdrawals plus reason if given
Time frame: 18 months
Completion rate of remote cognitive assessment
Time frame: 18 months
Completion rate of secondary assessments
Time frame: 18 months
IT accessibility
Time frame: 18 months
Acceptability questionnaire
Time frame: 18 months
CogTrack™ :
Time frame: 18 months
Tools scale consists of delirium being present or absent
Time frame: 18 months
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.
Time frame: 18 months
VAS score: 0 (no pain)- 10 (worst pain)
Time frame: 18 months
Time frame: 18 months
Time frame: 18 months
o Assess how patients subjectively perceive any cognitive changes when compared to objective measures.
Time frame: 18 months
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
University Hospital Plymouth NHS Trust
Other
Acronym: COMPASS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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