Clinical trial NCT05563597: Cognitive Monitoring in Planned Arthroplasty Surgery
Official title: Cognitive Monitoring in Planned Arthroplasty Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Change
Lead sponsor: University Hospital Plymouth NHS Trust
Sponsor class: OTHER
Collaborators: name: Torbay and South Devon NHS Foundation Trust
name: Claremont Medical Practice, Exmouth
name: Peninsula Collaboration for Leadership in Applied Research and Care (PenCLAHRC)
name: Peninsula Public Involvement Group (PenPIG), a division of PenCLAHRC
name: South West Anaesthesia Research Matrix (SWARM)
name: The Rame Group Practice, Torpoint
name: Wesnes Cognition Ltd
First posted: 2022-10-03
Enrollment: 117
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over the age of 60 undergoing elective hip or knee joint replacement surgery plus volunteer controls from primary care.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients approached
timeFrame: 18 months
measure: Number of patients recruited
timeFrame: 18 months
measure: Number of patients declining
timeFrame: 18 months
measure: Number of withdrawals plus reason if given
timeFrame: 18 months
measure: Completion rate of remote cognitive assessment
timeFrame: 18 months
measure: Completion rate of secondary assessment
timeFrame: 18 months
measure: IT accessibility
timeFrame: 18 months
measure: Acceptability questionnaire
timeFrame: 18 months
Secondary outcomes:
measure: Cognitive assessment
timeFrame: 18 months
measure: 3D-CAM scores:
timeFrame: 18 months
measure: Short form of the Informant Questionnaire on Cognitive Decline in the Elderly (Short IQCODE)2:
timeFrame: 18 months
measure: Pain score:
timeFrame: 18 months
measure: Opioid and sedative consumption in previous 6 hours:
timeFrame: 18 months
measure: Mood:
timeFrame: 18 months
measure: Single question of subjective memory deterioration:
timeFrame: 18 months
measure: Clock drawing test (semi quantitative, score out of 3):
timeFrame: 18 months
Other outcomes:
Locations:
city: Torquay
country: United Kingdom
facility: Torbay and South Devon NHS Trust
state: Devon
Study officials:
affiliation: University Hospital Plymouth NHS Trust
name: Gary Minto
role: STUDY_CHAIR
References: