ANZCTR - Registration

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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

3/06/2021

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]

NIL

Universal Trial Number (UTN)

Trial acronym

CLUES

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Delirium

Dementia

Postoperative Cognitive Dysfunction

Surgery

Anaesthesia

Condition category

Condition code

Anaesthesiology

Anaesthetics

Surgery

Other surgery

Neurological

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]

Behaviour

Intervention code [2]

Lifestyle

Intervention code [3]

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]

Disability free survival at 12 months as assessed by the WHODAS

Timepoint [1]

12 months following surgery

Primary outcome [2]

Feasibility will be measured by uptake of the education program by research participants. This will be assessed by telephone interview.

Timepoint [2]

30 days post surgery

Secondary outcome [1]

level of depression

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Withdrawn

Reason for early stopping/withdrawal

Lack of funding/staff/facilities

Date of first participant enrolment

Anticipated

1/01/2020

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]

3065 - Fitzroy

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Australian and New Zealand College of Anaesthetists

Address [1]

630 St Kilda Road
Melbourne
3004
VICTORIA

Country [1]

Australia

Primary sponsor type

Hospital

Name

St Vincent's Hospital

Address

PO Box 2900
Fitzroy
VIC 3065

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital HREC

Ethics committee address [1]

PO Box 2900
Fitzroy
VIC 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/11/2016

Approval date [1]

28/11/2016

Ethics approval number [1]

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

A/Prof Lisbeth Evered

Address

St Vincent's Hospital
PO Box 2900
Fitzroy VIC
3065

Country

Australia

Phone

+61 3 9231 2251

Fax

Lis.EVERED@svha.org.au

Contact person for public queries

Name

Sarah Maher

Address

St Vincent's Hospital
PO Box 2900
Fitzroy VIC
3065

Country

Australia

Phone

+61 3 9231 2072

Fax

Sarah.MAHER@svha.org.au

Contact person for scientific queries

Name

Lisbeth Evered

Address

St Vincent's Hospital
PO Box 2900
Fitzroy VIC
3065

Country

Australia

Phone

+61 3 9231 2251

Fax

Lis.EVERED@svha.org.ua

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Email
5758	Study protocol	lis.evered@svha.org.au
5759	Statistical analysis plan	lis.evered@svha.org.au
5760	Informed consent form	lis.evered@svha.org.au
5761	Clinical study report	lis.evered@svha.org.au
5762	Ethical approval	lis.evered@svha.org.au
5763	Analytic code	lis.evered@svha.org.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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