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Trial registered on ANZCTR


Registration number
ACTRN12617000513314
Ethics application status
Approved
Date submitted
3/02/2017
Date registered
7/04/2017
Date last updated
19/11/2019
Date data sharing statement initially provided
19/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive and Lifestyle interventions to Understand the impact on the Elderly of anaesthesia and Surgery (The CLUES trial)
Scientific title
Cognitive and Lifestyle interventions to Understand the impact on the Elderly of anaesthesia and Surgery: A pilot study for an international multi-centre cluster randomized controlled trial. The effect of cognitive and lifestyle interventions on disability free survival at 12 months post surgery.
Secondary ID [1] 291055 0
NIL
Universal Trial Number (UTN)
Trial acronym
CLUES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium 301850 0
Dementia 301851 0
Postoperative Cognitive Dysfunction 301921 0
Surgery 301922 0
Anaesthesia 301923 0
Condition category
Condition code
Anaesthesiology 301529 301529 0 0
Anaesthetics
Surgery 301530 301530 0 0
Other surgery
Neurological 301531 301531 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive a preoperative education package about cognitive and lifestyle intervention strategies to reduce the risk of cognitive decline.
Participants in this arm of the study will be educated in five components of risk prevention strategies prior to their surgery – exercise, cognitive interventions, nutrition, and modification of health risk factors and stimulation of social engagement.
Participants in the intervention group will complete approx. 60 minutes of education at enrolment to the study. In this session they will be encouraged to complete 20-30 mins of physical exercise each day, along with spending at least 10 minutes completing some cognitive training each day. This means approx. 30-40 min of activity each day, which may include activities already completed by participant. There is no specific exercise program unless the participant requests, the exercise could involve a 20-30 walk. Nutrition and health risk factors will also be discussed, and possible modification strategies suggested. Current social engagement will also be discussed, with participants encouraged to be engaging in regular social activities each week. This education session will occur at least one month prior to surgery, to allow uptake of strategies.
Research Assistants will educate and inform the patient and family at enrolment during a detailed face-to-face interview, and monitor compliance with each component of the intervention by regular phone calls and support for the duration of the trial.
Follow up phone calls will be completed following surgery, and 30 days following surgery. These phone calls will take approx. 5 minutes.
Participants will also complete neuropsychological testing at enrolment to the study, 3 and 12 months following surgery, each of these follow ups will take approx. 60 mins to complete. Weekly motivational phone calls will be offered to participants during the intervention period - which will vary dependent on participants time on waiting list for their surgery. The intervention period will last from enrolment date until surgery.

Participants will complete a questionnaire during the intervention period to determine their degree of uptake for each aspect of the intervention.

Education given to participants will be based on the guidelines outlined on the Cognitive Care website
http://cognitivecare.gov.au/

Trained research assistants will deliver education sessions at recruitments, and complete neuropsychological testing. This will occur in the participants home, or at the hospital where participant is recruited, depending on participants preference.
Intervention code [1] 297050 0
Behaviour
Intervention code [2] 297051 0
Lifestyle
Intervention code [3] 297093 0
Prevention
Comparator / control treatment
Standard care - no change in cognitive or lifestyle activities prior to surgery.
Participants randomised to the standard care arm of the study, will also complete neuropsychological testing at enrolment to the study, complete phone follow up at time of surgery, 30 days following surgery and complete neuropsychological testing again 3 and 12 months following surgery.
Control group
Active

Outcomes
Primary outcome [1] 300940 0
Disability free survival at 12 months as assessed by the WHODAS
Timepoint [1] 300940 0
12 months following surgery
Primary outcome [2] 301487 0
Feasibility will be measured by uptake of the education program by research participants. This will be assessed by telephone interview.
Timepoint [2] 301487 0
30 days post surgery
Secondary outcome [1] 331342 0
level of depression
Timepoint [1] 331342 0
assessed by GDS at 3 and 12 month post surgery follow up

Eligibility
Key inclusion criteria
1. 65yrs and older
2. Sufficient English to complete consent and neuropsychological testing
3. Current referral to a surgeon for further treatment including any elective surgical procedure or diagnostic procedure requiring sedation.
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior neurological deficit (eg Stroke)
2. Contraindication to neuropsychological testing such as language, visual or hearing impairment
3. Patients requiring 3rd party consent for their procedure
4. Patients who will undergo surgery within 1 month of their initial visit (to allow sufficient time for uptake of intervention)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The current pilot study will include 2 sites with individual randomization.
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 15238 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 295494 0
Other Collaborative groups
Name [1] 295494 0
Australian and New Zealand College of Anaesthetists
Address [1] 295494 0
630 St Kilda Road
Melbourne
3004
VICTORIA
Country [1] 295494 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
PO Box 2900
Fitzroy
VIC 3065
Country
Australia
Secondary sponsor category [1] 294314 0
None
Name [1] 294314 0
Address [1] 294314 0
Country [1] 294314 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296824 0
St Vincent's Hospital HREC
Ethics committee address [1] 296824 0
PO Box 2900
Fitzroy
VIC 3065
Ethics committee country [1] 296824 0
Australia
Date submitted for ethics approval [1] 296824 0
19/11/2016
Approval date [1] 296824 0
28/11/2016
Ethics approval number [1] 296824 0
HREC-A 185/16

Summary
Brief summary
The present study will utilise the new diagnostic criteria for perioperative cognitive disorders. Together with current best practice guidelines of multidomain interventions to test whether, when offered as a packaged intervention, these interventions reduce the incidence of disability occurring as a result of perioperative cognitive decline in older adults undergoing anaesthesia and surgery.
This has the capacity to reduce healthcare costs, delay decline, improve outcomes and reduce the loss of quality-adjusted life years as a result of disability from cognitive impairment.
Seven key modifiable risk-factors have been identified (diabetes, hypertension, obesity, smoking, depression, cognitive inactivity and physical inactivity) which account for approximately 50% of all Alzheimer's Disease (AD) and a 10-25% reduction in these could prevent 1.3 million cases of AD worldwide. Several proof-of-concept randomised controlled studies have been undertaken to develop population-level interventions with positive results. Five intervention components have been identified (nutrition, physical exercise, cognitive training, management of vascular and metabolic risk factors and stimulation of social engagement) demonstrating a significant effect on overall cognition.
The preoperative education package will include these five intervention components:
1. Physical exercise
2. Cognitive training
3. Nutrition
4. Management of Risk Factors
5. Stimulation of Social Engagement

Hypothesis: Preoperative implementation of proven risk reduction interventions for cognitive impairment will reduce the incidence of disability as a result of perioperative cognitive disorders and reduce associated social, healthcare and community costs.

The current pilot study will assess feasibility of study design and intervention components prior to undertaking the complete study.
Trial website
http://www.cognition.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72138 0
A/Prof Lisbeth Evered
Address 72138 0
St Vincent's Hospital
PO Box 2900
Fitzroy VIC
3065
Country 72138 0
Australia
Phone 72138 0
+61 3 9231 2251
Fax 72138 0
Email 72138 0
Lis.EVERED@svha.org.au
Contact person for public queries
Name 72139 0
Ms Sarah Maher
Address 72139 0
St Vincent's Hospital
PO Box 2900
Fitzroy VIC
3065
Country 72139 0
Australia
Phone 72139 0
+61 3 9231 2072
Fax 72139 0
Email 72139 0
Sarah.MAHER@svha.org.au
Contact person for scientific queries
Name 72140 0
A/Prof Lisbeth Evered
Address 72140 0
St Vincent's Hospital
PO Box 2900
Fitzroy VIC
3065
Country 72140 0
Australia
Phone 72140 0
+61 3 9231 2251
Fax 72140 0
Email 72140 0
Lis.EVERED@svha.org.ua

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is intended that the IPD will be made available for this trial but specific details have not yet been ascertained.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Clinical study report
Ethical approval
Analytic code
How or where can supporting documents be obtained?
Type [1] 5758 0
Study protocol
Citation [1] 5758 0
Link [1] 5758 0
Email [1] 5758 0
lis.evered@svha.org.au
Other [1] 5758 0
Attachment [1] 5758 0
Type [2] 5759 0
Statistical analysis plan
Citation [2] 5759 0
Link [2] 5759 0
Email [2] 5759 0
lis.evered@svha.org.au
Other [2] 5759 0
Attachment [2] 5759 0
Type [3] 5760 0
Informed consent form
Citation [3] 5760 0
Link [3] 5760 0
Email [3] 5760 0
lis.evered@svha.org.au
Other [3] 5760 0
Attachment [3] 5760 0
Type [4] 5761 0
Clinical study report
Citation [4] 5761 0
Link [4] 5761 0
Email [4] 5761 0
lis.evered@svha.org.au
Other [4] 5761 0
Attachment [4] 5761 0
Type [5] 5762 0
Ethical approval
Citation [5] 5762 0
Link [5] 5762 0
Email [5] 5762 0
lis.evered@svha.org.au
Other [5] 5762 0
Attachment [5] 5762 0
Type [6] 5763 0
Analytic code
Citation [6] 5763 0
Link [6] 5763 0
Email [6] 5763 0
lis.evered@svha.org.au
Other [6] 5763 0
Attachment [6] 5763 0
Summary results
No Results