Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000147987
Ethics application status
Approved
Date submitted
16/12/2019
Date registered
12/02/2020
Date last updated
12/02/2020
Date data sharing statement initially provided
12/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Neurocognitive Outcomes of Cardiac Arrest: Effects of Online Cognitive Training.
Scientific title
Neurocognitive Outcomes of Cardiac Arrest: A Randomised Controlled Trial of Online Neurorehabilitation
Secondary ID [1] 300102 0
Nil known
Universal Trial Number (UTN)
U1111-1245-4625
Trial acronym
NOCA: Phase 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurocognitive Impairment 315626 0
Cardiac Arrest 315627 0
Depression
315628 0
Anxiety 315629 0
Condition category
Condition code
Neurological 313922 313922 0 0
Other neurological disorders
Mental Health 313923 313923 0 0
Anxiety
Cardiovascular 313924 313924 0 0
Other cardiovascular diseases
Mental Health 314347 314347 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention will begin 45-90 days post cardiac event. Consenting participants will be randomly assigned to one of two groups: (1) eight weeks of online neurocognitive training (30 minutes three times per week) or (2) normal clinical management. Participants in the intervention group will receive eight weeks of computerised neurocognitive training applied via the internet platform Happyneuron (Scientific Brain Training, Villeurbanne Cedex, Frankreich). This platform has been chosen after extensive evaluation of the likely training and transfer effects of similar interventions. Twenty-­four training (3 per week over an 8 week period) sessions of 30 minutes each will be performed. In each training session the participants will perform tasks that target functioning across the neuropsychological domains of memory, attention, language, executive functions, and visuo­spatial ability. Participants will attend an individual coaching session before beginning the programme, with training sessions completed at home online. Participant progress will be monitored remotely with 15 minutes of telephone contact on a weekly basis.
Intervention code [1] 316379 0
Treatment: Other
Intervention code [2] 316380 0
Rehabilitation
Intervention code [3] 316381 0
Behaviour
Comparator / control treatment
The control group will receive standard care (that is, normal clinical management from their cardiac team).
Control group
Active

Outcomes
Primary outcome [1] 322312 0
Cognitive impairment as reflected by NIH Toolbox Cognition global outcome score and domain scores on tests of:

1. Memory
2. Attention / Executive Function
3. Processing Speed
Timepoint [1] 322312 0
Primary intervention outcome timepoint at completion (8 weeks).
Primary outcome [2] 322316 0
Mental health - PROMIS anxiety test scores
Timepoint [2] 322316 0
8 week follow-up
Primary outcome [3] 322317 0
Mental Health - PROMIS depression test scores
Timepoint [3] 322317 0
8 week follow-up
Secondary outcome [1] 378067 0
Long-term cognitive functioning as reflected by NIH Toolbox Cognition global outcome score and domain scores on tests of:

1. Memory
2. Attention / Executive Function
3. Processing Speed
Timepoint [1] 378067 0
3 months post-completion (6 months after cardiac arrest)
9 months post completion (12 months after cardiac arrest)
Secondary outcome [2] 378069 0
Long term mental health - PROMIS anxiety test scores
Timepoint [2] 378069 0
3 months post-completion (6 months after cardiac arrest)
9 months post completion (12 months after cardiac arrest)
Secondary outcome [3] 378070 0
Long term mental health - PROMIS depression test scores
Timepoint [3] 378070 0
3 months after completion (6 months after cardiac arrest)
6 months after completion (12 months after cardiac arrest)
Secondary outcome [4] 379403 0
Quality of life - PROMIS QoL domains
Timepoint [4] 379403 0
3 months post-intervention (6 months post arrest)
6 months post-intervention (12 months post arrest)

Eligibility
Key inclusion criteria
Participants identified in the earlier observational phase of the NOCA project as demonstrating cognitive deficits 30-45 days post arrest will be invited to participate in the randomised controlled trial of online neurocognitive training. Cognitive deficits will be defined as scores <1.5 standard deviations (SD) below the normative mean of the NIH Toolbox cognitive assessment score. Inclusion criteria for the observational phase are:

The inclusion criteria for those participants recruited from the NOCA observational study are:
1. Have experienced out-of-hospital cardiac arrest and received ambulance assistance and transport to hospital.
2. Aged 50 years and over
3. Presence of return of spontaneous circulation following cardiac arrest;
4. Discharged to home by 30 days
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non English-speaking
Discharged to a rehabilitation centre
Remains hospitalised at 30 days post-arrest

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed by a centralised, computer-generated randomisation process
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation via computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on clinical registry data, it is estimated that 72 participants will be eligible for inclusion in the trial.
Primary outcomes will be analysed using repeated measure one-way repeated measures multivariate analysis of variance to assess for time and intervention effects.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/02/2020
Actual
Date of last participant enrolment
Anticipated
17/12/2021
Actual
Date of last data collection
Anticipated
16/12/2022
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 28878 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 304545 0
Charities/Societies/Foundations
Name [1] 304545 0
National Heart Foundation of Australia - Vanguard Grant
Country [1] 304545 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Road
Melbourne
VIC 3004
Country
Australia
Secondary sponsor category [1] 304822 0
None
Name [1] 304822 0
Address [1] 304822 0
Country [1] 304822 0
Other collaborator category [1] 281117 0
Charities/Societies/Foundations
Name [1] 281117 0
Florey Institute of Neuroscience and Mental Health
Address [1] 281117 0
245 Burgundy Street
Heidelberg
VIC 3084
Country [1] 281117 0
Australia
Other collaborator category [2] 281118 0
Government body
Name [2] 281118 0
Ambulance Victoria
Address [2] 281118 0
31 Joseph Street
Blackburn North
VIC 3130
Country [2] 281118 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304972 0
Human Research Ethics Committee - Austin Health
Ethics committee address [1] 304972 0
Ethics committee country [1] 304972 0
Australia
Date submitted for ethics approval [1] 304972 0
22/11/2017
Approval date [1] 304972 0
25/05/2018
Ethics approval number [1] 304972 0
25/05/2018

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

Contacts
Principal investigator
Name 98818 0
Dr Rosalind Case
Address 98818 0
Dept of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Rd
Melbourne
VIC 3000
Country 98818 0
Australia
Phone 98818 0
+61 449002658
Fax 98818 0
Email 98818 0
[email protected]
Contact person for public queries
Name 98819 0
Rosalind Case
Address 98819 0
Dept of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Rd
Melbourne
VIC 3000
Country 98819 0
Australia
Phone 98819 0
+61 449002658
Fax 98819 0
Email 98819 0
[email protected]
Contact person for scientific queries
Name 98820 0
Rosalind Case
Address 98820 0
Dept of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Rd
Melbourne
VIC 3000
Country 98820 0
Australia
Phone 98820 0
+61 449002658
Fax 98820 0
Email 98820 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial pertaining to the primary and secondary outcome measures, after de-identification;
When will data be available (start and end dates)?
Immediately following publication, no end date determined.
Available to whom?
Researchers who provide provide a methodologically sound proposal as assessed on a case-by-case basis at the discretion of the Primary Sponsor.
Available for what types of analyses?
To achieve the aims in the approved proposal
IPD meta-analyses
How or where can data be obtained?
Access subject to approval by Principal Investigator - Dr Rosalind Case, [email protected]


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
No additional documents have been identified.