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Trial registered on ANZCTR


Registration number
ACTRN12618001874202
Ethics application status
Approved
Date submitted
14/11/2018
Date registered
16/11/2018
Date last updated
16/11/2018
Date data sharing statement initially provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
CogNet: Developing and evaluating an online Healthy Brain Ageing psychoeducation and cognitive training intervention for older adults
Scientific title
CogNet: Developing and evaluating an online Healthy Brain Ageing psychoeducation and cognitive training intervention for older adults with Mild Cognitive Impairment
Secondary ID [1] 296600 0
CogNet
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Older adults 310409 0
Cognitive Impairment 310410 0
Psychological Wellbeing 310411 0
Condition category
Condition code
Neurological 309124 309124 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CogNet is a six-week online psychoeducation and cognitive training program targeting common cognitive concerns experienced by many older adults, as well as modifiable risk factors for dementia.

The program has been adapted to an online format, with topics arranged into five core ‘cognitive’ modules and seven health/psychosocial/lifestyle modules addressing risk factors for dementia. Each module will provide participants with education and practical instruction on a variety of strategies targeting cognition, mood disturbance, and medical or lifestyle factors known to affect cognition and psychosocial wellbeing.

Participants who are allocated to the intervention arm will complete a total 12 modules over the course of the six-week program (i.e. two modules per week). The modules include:
1. Introduction to the Brain and Cognitive Changes in Ageing
2. Introduction to Learning and Memory
3. External Memory Strategies
4. Internal Memory Strategies
5. Executive Functions
6. Vascular Risk Factors
7. Diet
8. Exercise
9. Sleep Habits and Sleep Quality
10. Depression and Anxiety
11. Behavioural Strategies for Wellbeing
12. Psychological Strategies for Wellbeing

Intervention condition:
Participants allocated to the intervention group will log into the CogNet platform and complete two 60-90 minute modules per week for six-weeks, to complete 12 modules in total. Two new modules will become available to access each week throughout the intervention period. Participants will be encouraged to progress through the modules in order; however, the modules will become available weekly regardless of whether or not the individual has completed each of the previous modules. Each module will provide participants with current, evidence-based psychoeducation as well as examples and practical instruction on a variety of strategies targeting cognition (e.g. chunking, PQRST technique, strategic diary use, structured problem solving etc.), as well as recommendations for management of mood disturbance or lifestyle factors known to affect cognition and psychosocial wellbeing.
Participants will receive two reminders via email to complete modules each week, to maximise adherence.

Intervention code [1] 312908 0
Treatment: Other
Comparator / control treatment
Participants allocated to the waitlist control condition will undergo a six-week period of treatment as usual, with weekly (on day 2 and 5 of the week based on when the participant enrolled in the study) standardized emails from the research team containing simple tips for healthy brain ageing. All participants in the control condition will receive the same emails in the same order. This is intended to provide the equivalent degree of research contact during the intervention period. After completing the follow-up assessments, the control participants will be offered the opportunity to complete the online CogNet program if they would like to do so.
Control group
Active

Outcomes
Primary outcome [1] 308100 0
The primary outcome of this study is visual learning as assessed by the Paired Associated Learning Subtest of the Cambridge Neuropsychological Test Automated Battery (CANTAB) Connect web-based testing.
Timepoint [1] 308100 0
Timepoint: baseline (before randomisation), post-intervention follow-up (within two-weeks of completing the intervention).
Secondary outcome [1] 353959 0
Objective change in sustained attention, as measured by the Rapid Visual Information Processing test (CANTAB).
Timepoint [1] 353959 0
Timepoint: baseline (before randomisation), post-intervention follow-up (within two-weeks of completing the intervention).
Secondary outcome [2] 353960 0
Objective change in executive function, as measured by the One Touch Stockings of Cambridge test (CANTAB).
Timepoint [2] 353960 0
Timepoint: baseline (before randomisation), post-intervention follow-up (within two-weeks of completing the intervention).
Secondary outcome [3] 353961 0
Objective change in working memory, as measured by the Spatial Working Memory test (CANTAB).
Timepoint [3] 353961 0
Timepoint: baseline (before randomisation), post-intervention follow-up (within two-weeks of completing the intervention).
Secondary outcome [4] 353962 0
Change in participant subjective reports of memory functioning, using the Multifactorial Memory Questionnaire.
Timepoint [4] 353962 0
Timepoint: baseline (before randomisation), post-intervention follow-up (within two-weeks of completing the intervention).
Secondary outcome [5] 353963 0
Change in participant subjective reports of cognitive complaints, using the Healthy Brain Ageing Questionnaire.
Timepoint [5] 353963 0
Timepoint: baseline (before randomisation), post-intervention follow-up (within two-weeks of completing the intervention).
Secondary outcome [6] 353964 0
Change in participant subjective report of affective symptoms, using the Geriatric Depression Scale and the Geriatric Anxiety Scale.
Timepoint [6] 353964 0
Timepoint: baseline (before randomisation), post-intervention follow-up (within two-weeks of completing the intervention).
Secondary outcome [7] 353965 0
Change in participant subjective reports of daily functioning, using the Healthy Brain Ageing Functional Assessment Tool.
Timepoint [7] 353965 0
Timepoint: baseline (before randomisation), post-intervention follow-up (within two-weeks of completing the intervention).
Secondary outcome [8] 353966 0
Change in participant subjective reports of quality of life, using the WHO Quality of Life BREF.
Timepoint [8] 353966 0
Timepoint: baseline (before randomisation), post-intervention follow-up (within two-weeks of completing the intervention).
Secondary outcome [9] 353967 0
Change in participant subjective reports of drug and alcohol use, using the Alcohol Use Disorders Identification Test, and the Alcohol, Smoking and Substance Use Involvement Screening Test.
Timepoint [9] 353967 0
Timepoint: baseline (before randomisation), post-intervention follow-up (within two-weeks of completing the intervention).
Secondary outcome [10] 353968 0
Change in participant subjective reports of physical health, using the Healthy Brain Ageing Nutrition Questionnaire and the Active Australia Survey.
Timepoint [10] 353968 0
Timepoint: baseline (before randomisation), post-intervention follow-up (within two-weeks of completing the intervention).
Secondary outcome [11] 353969 0
Change in participant subjective reports of sleep quality, using the Pittsburgh Sleep Quality Index.
Timepoint [11] 353969 0
Timepoint: baseline (before randomisation), post-intervention follow-up (within two-weeks of completing the intervention).
Secondary outcome [12] 353970 0
Participant satisfaction/evaluation of the program system, using the System Usability Scale.
Timepoint [12] 353970 0
Timepoint: post-intervention follow-up (within two-weeks of completing the intervention).
Secondary outcome [13] 353971 0
Participant satisfaction/evaluation of the program content, using the structured Healthy Brain Ageing Satisfaction questionnaire.
Timepoint [13] 353971 0
Timepoint: post-intervention follow-up (within two-weeks of completing the intervention).

Eligibility
Key inclusion criteria
• Have subjective concerns about their cognition
• Screen positive for Mild Cognitive Impairment based on telephone screening, including the Memory and Ageing Telephone Screen and additional gold-standard neuropsychological tests assessing basic auditory attention and working memory (WAIS-III Digit Span subtest), processing speed (Oral Trail Making Test Part A), mental flexibility (Oral Trail Making Test Part B), and verbal fluency (Controlled Oral Word Association Test).
• Be 50 years at the time of baseline assessment
• Be willing to complete a 6-week psychoeducation and cognitive training program online, comprising two sessions per week
• Be willing to complete an online follow-up assessment within two weeks of completing the intervention or control period
• Have sufficient hearing ability to communicate via telephone
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Have a formal or suspected diagnosis of neurodegenerative disorder, including Alzheimer’s disease, Vascular dementia, Frontotemporal Dementia, or Lewy-Body Dementia
• Have a history of stroke
• Have other major neurological or medical problems known to affect cognition (e.g. epilepsy, cancer, ADHD)
• Have a history of head injury with loss of consciousness >30-minutes
• Have an intellectual disability
• Have insufficient English language skills for neuropsychological assessment which is conducted in English
• Have a history of non-affective psychiatric illness (e.g. schizophrenia, psychosis)
• Current/past alcohol or substance dependence (other than nicotine)
• Current use of other psychological or computerised CT therapy (internet or clinician-delivered).

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 involves contacting the holder of the allocation schedule who is "off-site" or at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table create by computer software (i.e. 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
Baseline group differences will be analysed using independent samples t-tests or Chi Square tests, as appropriate. A repeated measures analysis of variance (ANOVA) will then be used to examine group differences following the intervention/control period. Analyses will be two-tailed with alpha = 0.05. Based on our prior work (Diamond et al., 2015; Norrie et al., 2011), we expect a medium effect size (f ~ 0.23) improvement. We estimate a sample size of N = 64 will enable us to detect this effect with 95% power; therefore, we are recruiting a sample of 80 participants to allow for 20% attrition.

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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 301178 0
Charities/Societies/Foundations
Name [1] 301178 0
Dementia Australia Research Foundation
Address [1] 301178 0
Level 1, AMA House
42 Macquarie Street
Barton ACT 2600
Country [1] 301178 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Clinical Trials Support
Level 3, F23 Administration Building
Corner of Eastern Avenue and City Road
The University of Sydney
NSW 2008
Country
Australia
Secondary sponsor category [1] 300799 0
None
Name [1] 300799 0
Address [1] 300799 0
Country [1] 300799 0
Other collaborator category [1] 280423 0
Individual
Name [1] 280423 0
Prof Sharon Naismith
Address [1] 280423 0
Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050
Country [1] 280423 0
Australia
Other collaborator category [2] 280424 0
Individual
Name [2] 280424 0
Dr Loren Mowszowski
Address [2] 280424 0
Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050
Country [2] 280424 0
Australia
Other collaborator category [3] 280425 0
Individual
Name [3] 280425 0
Alena Rahmanovic
Address [3] 280425 0
Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050
Country [3] 280425 0
Australia
Other collaborator category [4] 280426 0
Individual
Name [4] 280426 0
Stacey West
Address [4] 280426 0
Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050
Country [4] 280426 0
Australia
Other collaborator category [5] 280427 0
Individual
Name [5] 280427 0
Ashlee Turner
Address [5] 280427 0
Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050
Country [5] 280427 0
Australia
Other collaborator category [6] 280428 0
Individual
Name [6] 280428 0
Bradley Skinner
Address [6] 280428 0
Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050
Country [6] 280428 0
Australia
Other collaborator category [7] 280429 0
Individual
Name [7] 280429 0
Jake Palmer
Address [7] 280429 0
Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050
Country [7] 280429 0
Australia
Other collaborator category [8] 280430 0
Individual
Name [8] 280430 0
Dr Andrew McKinnon
Address [8] 280430 0
Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050
Country [8] 280430 0
Australia
Other collaborator category [9] 280431 0
Individual
Name [9] 280431 0
Adam Vujic
Address [9] 280431 0
Level 2, Building M02G,
Brain and Mind Centre,
100 Mallett Street,
Camperdown NSW 2050
Country [9] 280431 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301920 0
University of Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 301920 0
Human Ethics Office
Level 2, Margaret Telfer Building (K07)
The University of Sydney
NSW 2006
Ethics committee country [1] 301920 0
Australia
Date submitted for ethics approval [1] 301920 0
04/09/2018
Approval date [1] 301920 0
07/09/2018
Ethics approval number [1] 301920 0
2018/635

Summary
Brief summary

This feasibility pilot study will evaluate whether a structured Healthy Brain Ageing (HBA) cognitive training (CT) and psychoeducation program delivered as an online intervention (i.e. CogNet) is efficacious for cognitive performance. The program is designed to improve cognitive and psychosocial functioning in older adults with Mild Cognitive Impairment (MCI). While the program has been shown to be successful in over 400 participant’s to-date, thus far we have only been able to offer our HBA intervention to those participants who were both able to physically access our specialised facility and staff, and were agreeable to participate in a group-based intervention. By translating this program to an online platform, we are able to make it more accessible for older adults ‘at risk’ for dementia and we now seek to evaluate the efficacy, feasibility and acceptability of the CogNet intervention in a group of older adults with MCI.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88562 0
Dr Haley LaMonica
Address 88562 0
Level 2, Building M02G,
Brain and Mind Centre
Campderdown NSW 2050

Country 88562 0
Australia
Phone 88562 0
+61 2 9351 0785
Fax 88562 0
Email 88562 0
haley.lamonica@sydney.edu.au
Contact person for public queries
Name 88563 0
Dr Haley LaMonica
Address 88563 0
Level 2, Building M02G,
Brain and Mind Centre
Campderdown NSW 2050

Country 88563 0
Australia
Phone 88563 0
+61 2 9351 0785
Fax 88563 0
Email 88563 0
haley.lamonica@sydney.edu.au
Contact person for scientific queries
Name 88564 0
Dr Haley LaMonica
Address 88564 0
Level 2, Building M02G,
Brain and Mind Centre
Campderdown NSW 2050

Country 88564 0
Australia
Phone 88564 0
+61 2 9351 0785
Fax 88564 0
Email 88564 0
haley.lamonica@sydney.edu.au

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 individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication of the main results (no end date determined).
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Only those appropriate for achieving the aims of the approved proposal.
How or where can data be obtained?
Access will be subject to approvals by the Principal Investigator.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
Summary results
No Results