Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001778178
Ethics application status
Approved
Date submitted
22/10/2019
Date registered
16/12/2019
Date last updated
1/06/2022
Date data sharing statement initially provided
16/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Perioperative Enhancement of Cognitive Trajectory (The PROTECT trial)
Scientific title
Perioperative Enhancement to improve the Cognitive Trajectory of older patients undergoing cardiac and non-cardiac surgery (The PROTECT trial)
Secondary ID [1] 299593 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PROTECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium 314872 0
Postoperative Neurocognitive Disorder 314873 0
Mild Neurocognitive Disorder 314874 0
Major Neurocognitive Disorder 314875 0
Condition category
Condition code
Anaesthesiology 313219 313219 0 0
Anaesthetics
Neurological 313220 313220 0 0
Neurodegenerative diseases
Public Health 313221 313221 0 0
Health promotion/education
Surgery 313222 313222 0 0
Other surgery
Mental Health 313223 313223 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the intervention group will receive postoperative optimisation strategies that closely mirror the validated 'enhanced recovery after surgery - ERAS' principles. This includes effective medical management directed by site anaesthetists and pain specialists (e.g. example reducing the use of benzodiazepines post operatively and facilitating passive emergence from anaesthesia). Nutritional support will be provided by research staff and overseen by site dieticians, ensuring that nutrition and hydration goals are established with the participant throughout the perioperative period. Site physiotherapists will ensure participants in the intervention arm are mobilised as early and frequently as possible postoperatively. Research staff will ensure participants have the required devices for sensory orientation (hearing aids, glasses etc. and liaise with participants’ families to ensure required items are available from home).
In addition, participants randomised to the intervention arm will receive a thorough education session (30 to 60 minutes duration) prior to hospital admission, tailored to their surgery and individual risk factors (e.g. sensory impairments, recent infections). This education will focus on ways to prevent delirium throughout the surgical period and additionally the role of modifiable lifestyle factors for physical and cognitive health (e.g. diet, exercise, stress management, cognitive stimulation, social engagement).
To this end, participants will be supported in a number of ways throughout the perioperative period to make healthy lifestyle changes. These supports include activity tracking devices, which will be worn in the week prior to surgery and 30 days post discharge. In additional participants will receive 1-4 text message prompts up to 6 months post discharge, a monthly phone call up to 12 months post discharge and be provided with the opportunity to attend up to six education sessions of two hours duration. All interventions will be overseen by a case manager. Although the intervention will transpire over 12 months, support will be reduced in a graded fashion over the course of the year.
Intervention code [1] 315846 0
Prevention
Intervention code [2] 315847 0
Lifestyle
Intervention code [3] 316053 0
Treatment: Other
Comparator / control treatment
Participants randomised to the control arm of the study will receive current standard of care from the treating institution. Standard of care is directed by the treating institution without any alterations made by the study team. As care practices may change over the course of the study duration as a function of hospital policy, care provided to participants in both study arms (e.g. medications, mobilisation, education) will be closely monitored.
Control group
Active

Outcomes
Primary outcome [1] 321718 0
Postoperative Neurocognitive Disorder; assessed with a battery of neuropsychological tests that our research team has been using to assess PND for over 15 years.
This battery comprises, the Trail Making Test (TMT), CERAD Word Learning test, Digit Symbol Substitution test, Controlled Oral Word Association test (COWAT), Grooved Pegboard test, Clock Drawing, Wechsler Test of Adult Reading (WTAR) and the Montreal Cognitive Assessment (MoCA),
Timepoint [1] 321718 0
3 months post operatively
Secondary outcome [1] 376004 0
Neurocognitive Disorder; assessed via a battery of neuropsychological tests that our research team has been using for over 15 years.
This battery comprises, the Trail Making Test (TMT), CERAD Word Learning test, Digit Symbol Substitution test, Controlled Oral Word Association test (COWAT), Grooved Pegboard test, Clock Drawing, Wechsler Test of Adult Reading (WTAR) and the Montreal Cognitive Assessment (MoCA),
Timepoint [1] 376004 0
12 Months post operatively
Secondary outcome [2] 376005 0
Postoperative Morbidity Score; derived from the Postoperative Morbidity Survey (Grocott et al., 2007)
Timepoint [2] 376005 0
Discharge from treating institution; 3 months postoperatively; 12 months post operatively
Secondary outcome [3] 376006 0
Clinical Frailty Scale
Timepoint [3] 376006 0
Discharge from treating institution, 3 months postoperatively, 12 months postoperatively
Secondary outcome [4] 376007 0
Functional Disability (Derived from the World Health Organisation Disability Health Schedule 2.0)
Timepoint [4] 376007 0
12 months postoperatively
Secondary outcome [5] 376008 0
Quality of Life (SF-36QoL)
Timepoint [5] 376008 0
12 months postoperatively
Secondary outcome [6] 376009 0
Days Alive and Out of Hospital; defined as the number of days the participant has been alive and not formally admitted to an acute care facility, since the admission that lead to study enrolment.
Timepoint [6] 376009 0
12 months postoperatively

Eligibility
Key inclusion criteria
1. Patients aged 65 years or older, scheduled for cardiac or non-cardiac surgery, requiring at minimum, one night hospital stay
2. Reside within a reasonable proximity to St Vincent's Hospital Melbourne to facilitate neuropsychology follow up and participation with intervention strategies.
3. Capacity to provide written informed consent
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior neurological injury or insult (e.g., major traumatic brain injury)
2. Contraindication to neuropsychological testing such as language, visual or hearing impairment
3. Associated medical problems that may lead to significant complications and subsequent loss to follow or inability to engage with prehabilitation activities.
4. Patients unable to consent independently to their surgery on account of cognitive impairment

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/02/2020
Actual
19/04/2021
Date of last participant enrolment
Anticipated
3/02/2023
Actual
Date of last data collection
Anticipated
2/02/2024
Actual
Sample size
Target
692
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15026 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 28312 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 304073 0
Government body
Name [1] 304073 0
National Health and Medical Research Council
Country [1] 304073 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
University of Melbourne
Parkville
Victoria 3010
Country
Australia
Secondary sponsor category [1] 304290 0
None
Name [1] 304290 0
Address [1] 304290 0
Country [1] 304290 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304565 0
St Vincent's Hospital
Ethics committee address [1] 304565 0
Ethics committee country [1] 304565 0
Australia
Date submitted for ethics approval [1] 304565 0
22/10/2019
Approval date [1] 304565 0
29/01/2020
Ethics approval number [1] 304565 0
SVHM HREC:205/19

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97402 0
A/Prof Lisbeth Evered
Address 97402 0
St Vincent's Hospital
PO Box 2900
Fitzroy VIC
3065
Country 97402 0
Australia
Phone 97402 0
+61 3 92314253
Fax 97402 0
Email 97402 0
lis.EVERED@svha.org.au
Contact person for public queries
Name 97403 0
Kelly Atkins
Address 97403 0
St Vincent's Hospital
PO Box 2900
Fitzroy VIC
3065
Country 97403 0
Australia
Phone 97403 0
+61 3 92314253
Fax 97403 0
Email 97403 0
kelly.ATKINS@svha.org.au
Contact person for scientific queries
Name 97404 0
Kelly Atkins
Address 97404 0
St Vincent's Hospital
PO Box 2900
Fitzroy VIC
3065
Country 97404 0
Australia
Phone 97404 0
+61 3 92314253
Fax 97404 0
Email 97404 0
kelly.ATKINS@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePreventing Delirium and Promoting Long-Term Brain Health: A Clinical Trial Design for the Perioperative Cognitive Enhancement (PROTECT) Trial.2021https://dx.doi.org/10.3233/JAD-210438
N.B. These documents automatically identified may not have been verified by the study sponsor.