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Trial registered on ANZCTR


Registration number
ACTRN12616001320448
Ethics application status
Approved
Date submitted
19/09/2016
Date registered
21/09/2016
Date last updated
26/02/2020
Date data sharing statement initially provided
26/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Healthy Brain Ageing E-Health Platform: Validating Online Strategies to Recruit and Assess Older Adults at Risk of Cognitive Decline
Scientific title
The Healthy Brain Ageing E-health Platform: Validating Recruitment Strategies and Online Assessment Tools for Older Adults at Risk of Cognitive Decline
Secondary ID [1] 290182 0
Nil known
Universal Trial Number (UTN)
U1111-1187-0626
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 300116 0
Dementia 300117 0
Depression 300118 0
Anxiety 300119 0
Cardiovascular risk 300120 0
Sleep disturbance 300121 0
Condition category
Condition code
Neurological 299998 299998 0 0
Dementias
Mental Health 300190 300190 0 0
Depression
Mental Health 300191 300191 0 0
Anxiety

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
31
Target follow-up type
Days
Description of intervention(s) / exposure
Online screening for ‘at risk’ profiles: Cognitive and modifiable risk data:

Modifiable risk factors: All participants (n=1500) will be asked to complete the HBA E-health Questionnaire (duration: up to 1 hour) to provide details about their demographics, medical history, mental health history (e.g., Generalized Anxiety Disorder Assessment (GAD-7), Kessler Psychological Distress Scale (K-10), cognition and functional status (e.g., HBA Functional Assessment Tool, WHO Disability Assessment Schedule 2.0), sleep (e.g., Pittsburgh Sleep Quality Index (PSQI), physical activity (e.g., Active Australia Survey), nutrition and dietary habits (e.g., HBA Food Frequency Screening Questionnaire), alcohol and substance use history (e.g., Alcohol Use Disorders Identification Test (AUDIT-C), Alcohol, Smoking and Substance Involvement Screening Tests (ASSIST)), medications, and quality of life (e.g., WHO Quality of Life Scale). All data necessary for enabling comparisons with Australian-based dementia prediction algorithms for older individuals and the European-based personalised lifestyle for brain health (LIBRA) global score for middle-aged individuals will be collected. Modifiable risk factors for cognitive decline include the following: depressive symptoms (K-10>20); hypertension; hypercholesterolaemia; heart disease; high risk of Type 2 diabetes (AUSDRISK score=12) or diagnosed Type 1 or Type 2 diabetes; smoker, low education (less than year 9); low exercise (Active Australia guidelines for sufficient physical activity); obesity (BMI>30). Although not formally identified in the recent reviews of established risks, we will also define as risk a person with poor sleep quality (PSQI>5), or excess alcohol consumption (AUDIT-C>4).

Cognitive decline: All participants will also complete an online cognitive assessment using CogState (duration: 15 minutes). Age-related cognitive decline will be defined as at least 1SD decline on CogState relative to age and education matched normative data.

Face-to face clinical assessments:
A subsample (n=180) participants will be drawn from the broader group and invited to attend their nearest study site (i) The Healthy Brain Ageing Clinic, Brain and Mind Centre, Camperdown; ii) Alzheimer’s Australia NSW Community Centre, Newcastle; iii) Alzheimer’s Australia NSW Community Centre, Port Macquarie) for detailed (face-to-face) neuropsychological, medical and psychological assessment (described in more detail below) within one month of when they completed the online assessments..
i) Medical assessment (duration: up to 1 hour): A medical professional will review the patient’s medical history with an emphasis on vascular risk factors and diabetes as well as details regarding family medical history. Biomedical measurements include height, weight, waist circumference, and blood pressure. Finally, in order to obtain objective markers of key health outcomes, a nurse or staff member trained in blood collection procedures will take a blood sample that will be tested for cardiovascular markers (e.g., HDL/LDL cholesterol).

ii) Neuropsychological assessment (duration: 1 hour): The clinical neuropsychologist will conduct a brief clinical interview to collect details about the participant’s background, education and occupation, cognition and functional status. Participants will also complete approximately one hour of neuropsychological tests including Digit Span from the Wechsler Adult Intelligence Scale, Third Edition (WAIS-III), Logical Memory subtests from the Wechsler Memory Scale, Third Edition (WMS-III), Rey Auditory Verbal Learning Test (RAVLT), Rey-Osterrieth Complex Figure Test, Controlled Oral Word Association Test, Semantic Fluency, Trail Making Test A and B, Boston Naming Test, Clock Drawing Test, and the Delis-Kaplan Executive Functioning System (D-KEFS) Color-Word Interference subtest (D-KEFS).

iii) Mood assessment (duration: up to 1 hour): To assess each participant’s mood and psychiatric history, the clinical neuropsychologist will ask semi-structured interview questions including the Structured Clinical Interview for the Hamilton Depression Scale and modules A (Major Depressive Episode), N (Generalized Anxiety Disorders), and O (Rule-Out Medical, Organic or Drug Causes for All Disorders) of the Mini International Neuropsychiatric Interview, Version 6.0.

Both the online assessments and the face-to-face assessments will only occur one time.
Intervention code [1] 295786 0
Early Detection / Screening
Comparator / control treatment
Validation will comprise of assessment of the capability of two components of Cogstate (the overall CBB and memory sub-test, conducted on the e-health platform) against the ability to detect memory impairment on gold-standard neuropsychological tests (i.e., Rey Auditory Verbal Learning Test and Logical Memory) collected in clinic. In addition, we will determine the validity of other risk factors assessed via the platform to detect cases of interest. In particular, participants who attend the HBA clinic for face-to-face assessment will undergo the following assessments:
i) Medical assessment: Review of the patient’s medical history with an emphasis on vascular risk factors and diabetes as well as details regarding family medical history. Biomedical measurements include height, weight, waist circumference, and blood pressure. Finally, in order to obtain objective markers of key health outcomes, a nurse or staff member trained in blood collection procedures will take a blood sample that will be tested for cardiovascular markers.

ii) Neuropsychological assessment: The clinical neuropsychologist will conduct a brief clinical interview to collect details about the participant’s background, education and occupation, cognition and functional status. Participants will also complete approximately one hour of neuropsychological tests including Digit Span from the Wechsler Adult Intelligence Scale, Third Edition (WAIS-III), Logical Memory subtests from the Wechsler Memory Scale, Third Edition (WMS-III), Rey Auditory Verbal Learning Test (RAVLT), Rey-Osterrieth Complex Figure Test, Controlled Oral Word Association Test, Semantic Fluency, Trail Making Test A and B, Boston Naming Test, Clock Drawing Test, and the Delis-Kaplan Executive Functioning System (D-KEFS) Color-Word Interference subtest (D-KEFS).

iii) Mood assessment: To assess each participant’s mood and psychiatric history, semi-structured interview questions will be used including the Structured Clinical Interview for the Hamilton Depression Scale and modules A (Major Depressive Episode), N (Generalized Anxiety Disorders), and O (Rule-Out Medical, Organic or Drug Causes for All Disorders) of the Mini International Neuropsychiatric Interview, Version 6.0.
Control group
Active

Outcomes
Primary outcome [1] 299489 0
Feasibility of recruitment will primarily be assessed based on our ability to meet recruitment targets in specified project timelines.
Timepoint [1] 299489 0
1 year post commencement of recruitment
Primary outcome [2] 299490 0
We will assess the capacity of the overall Cognitive Brief Battery conducted on the e-health platform against the ability to detect memory impairment on gold-standard neuropsychological tests (RAVLT and Logical Memory), collected in face-to-face clinic settings.
Timepoint [2] 299490 0
Cogstate completed at baseline and face-to-face clinic assessment conducted within 1 month of completion of the online screening measures.
Primary outcome [3] 299674 0
We will assess the capacity of the memory sub-test from Cogstate Brief Battery conducted on the e-health platform against the ability to detect memory impairment on gold-standard neuropsychological tests (RAVLT and Logical Memory), collected in face-to-face clinic settings.
Timepoint [3] 299674 0
Cogstate completed at baseline and face-to-face clinic assessment conducted within 1 month of completion of the online screening measures.
Secondary outcome [1] 327316 0
We will assess and compare response rates across the various methods of recruitment and advertising (i.e., physician referral, print advertising, social media, etc.).
Timepoint [1] 327316 0
2 years post commencement of recruitment
Secondary outcome [2] 327317 0
Qualitative and quantitative techniques will be used to evaluate the online assessment measures offered through the HBA e-health platform with the aim of further refining the system for future users.

Evaluation survey questions will include:
1. How long did it take you to complete the HBA E-health questionnaire?
2, How many sessions did it take you to complete the survey?
3. How easy was the survey to use? (5 point Likert scale)
4. How easy were the questions to understand? (5 point Likert scale)
5. If you did not complete the survey, why did you discontinue?
*The questions did not apply to me.
*I did not have enough time to finish the survey.
*The survey was too long.
*I had computer and/or internet problems when trying to complete the survey.
*The survey was boring.
*The survey was hard to read and understand (e.g., words too small, too many words, scrolling through the pages was problematic).
*I did not feel comfortable answering all of the mandatory questions.
*Other
6. How worried about your privacy were you when responding to the survey? (5 point Likert scale)
7. How long did it take you to complete the thinking and memory tests?
8. What changes to the online assessments would you recommend? (text box)
Timepoint [2] 327317 0
2 years post commencement of recruitment

Eligibility
Key inclusion criteria
Adults between the ages of 50 and 70 who speak fluent English and who have concerns about their cognition (but not a formal diagnosis of dementia) or mood are eligible to participate in this study.
Minimum age
50 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals will be excluded from the study if they are aged <50 years or >70 years, do not speak fluent English, have been diagnosed with dementia, or do not have concerns about their cognition or mood.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We aim to recruit 1500 participants to complete the HBA E-health Questionnaire and CogState. A subsample of 180 participants will be drawn from this broader group and invited to attend their nearest study site (i) The Healthy Brain Ageing Clinic, Brain and Mind Centre, Camperdown; ii) Alzheimer’s Australia NSW Community Centre, Newcastle; iii) Alzheimer’s Australia NSW Community Centre, Port Macquarie) for detailed (face-to-face) neuropsychological, medical and psychological assessment (this component is optional).

Through a newly developed partnership with Alzheimer’s Australia, we have the opportunity to recruit large numbers of participants from across NSW, ensuring that we are recruiting a representative sample of the total population. Alzheimer's Australia is extremely supportive of this project and plan to active promote the study. The sample size of 1500 participants was determined in collaboration with Alzheimer's Australia based on the response rates they have had to other online surveys.

Once we have successfully reached our target sample size in each site (total n =180), an additional 1320 participants will still be able to complete the online assessment so as to allow for engagement of those interested as well as to provide relevant data as per study aims regarding feasibility of recruitment.

Feasibility of recruitment will primarily be assessed based on our ability to meet recruitment targets in specified project timelines. Additionally, we will assess and compare response rates across the various methods of recruitment and advertising (i.e., physician referral, print advertising, social media, etc.).

In terms of validity, we will assess the capacity of two components of Cogstate (the overall CBB and memory sub-test, conducted on the e-health platform) against the ability to detect memory impairment on gold-standard neuropsychological tests (RAVLT and Logical Memory), collected in clinic. We will fit receiver operating characteristic (ROC) curves to verify (or modify) the validity of the Cogstate cut-scores for future selected prevention trials. We note that while Cogstate has been validated in prior community samples, establishing the validity of screening tools for the e-health population of interest is a fundamental requirement for new populations. In addition, we will determine the validity of other risk factors assessed via the platform to detect cases of interest. This component of the validation is required for indicated and selective trials, which we also plan to do using the e-health platform (e.g. use a depression intervention to target depressive symptoms coupled with cognitive decline), as well as comparison with other validated dementia risk algorithms (e.g. CAIDE, LIBRA).

At the conclusion of their involvement in the study, qualitative and quantitative techniques will be used to evaluate the online assessment measures offered through the HBA e-health platform with the aim of further refining the system for future users.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/10/2016
Actual
9/10/2016
Date of last participant enrolment
Anticipated
28/09/2018
Actual
17/12/2018
Date of last data collection
Anticipated
31/10/2018
Actual
17/12/2018
Sample size
Target
300
Accrual to date
Final
134
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294437 0
University
Name [1] 294437 0
The University of Sydney
Country [1] 294437 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Brain and Mind Centre, Healthy Brain Ageing Program, 94 Mallet Street, Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 293290 0
None
Name [1] 293290 0
Address [1] 293290 0
Country [1] 293290 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295867 0
Human Research Ethics Committee, University of Sydney
Ethics committee address [1] 295867 0
Ethics committee country [1] 295867 0
Australia
Date submitted for ethics approval [1] 295867 0
11/04/2016
Approval date [1] 295867 0
24/05/2016
Ethics approval number [1] 295867 0
2016/389

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

Contacts
Principal investigator
Name 68718 0
Prof Sharon Naismith
Address 68718 0
Brain and Mind Centre, 94 Mallet Street, Camperdown, NSW 2050
Country 68718 0
Australia
Phone 68718 0
+61 02 9351 0781
Fax 68718 0
+61 02 9351 0551
Email 68718 0
sharon.naismith@sydney.edu.au
Contact person for public queries
Name 68719 0
Haley LaMonica
Address 68719 0
Brain and Mind Centre, 94 Mallet Street, Camperdown, NSW 2050
Country 68719 0
Australia
Phone 68719 0
+61 02 9351 0785
Fax 68719 0
+61 02 9351 0551
Email 68719 0
haley.lamonica@sydney.edu.au
Contact person for scientific queries
Name 68720 0
Haley LaMonica
Address 68720 0
Brain and Mind Centre, 94 Mallet Street, Camperdown, NSW 2050
Country 68720 0
Australia
Phone 68720 0
+61 02 9351 0785
Fax 68720 0
+61 02 9351 0551
Email 68720 0
haley.lamonica@sydney.edu.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
No additional documents have been identified.