Project title: Healthy Brain Initiative – Brain Health Registry
Application number: 2018-12H
(Name of) Principal investigator: Professor Cassandra Szoeke
You are invited to participate in the Healthy Brain Initiative - Brain Health Registry (HBI-BHR) project.
The overall goal of this project is to improve our understanding of health across the lifespan in order to promote healthy brains and prevent disease in all Australians.
The questions you answer will give us valuable insight into the interactions of clinical, lifestyle and socioeconomic factors that may affect brain health. This information could assist in developing guidelines for modifying lifestyle factors that promote brain health.
Who is undertaking the project?
This research is being conducted by Professor Cassandra Szoeke, Professor Michael Weiner and Professor John Hopper.
Professor Cassandra Szoeke, PhD: Professor Cassandra Szoeke brings together high level management and communication skills with scientific expertise. She led the research program in neurodegenerative diseases, mental disorders and brain health at the Australian Commonwealth Science and Industry Organisation and then became a Clinical Consultant to CSIRO. She is a practicing physician in internal medicine with subspecialisation in neurology. In addition to her medical qualifications she has an honours degree in genetics and pharmacology, and completed her PhD thesis in epidemiology examining women’s healthy ageing. Her postdoctoral studies were conducted between Stanford University and Duke University and focussed on public health and policy. She has been in clinical research for over a decade with more than 100 publications in peer-reviewed journals and is a reviewer for national and international journals and funding bodies. She has been the recipient of numerous national and international awards for her research work, is regularly invited to chair and speak at international and national conferences, and has been the invited expert to international roundtables. She has held roles on scientific, management and business development committees of several major population-based Australian studies (budgets over $5 million). She is currently the Director of Healthy Ageing Programs at the University of Melbourne (Women’s Healthy Ageing Project; WHAP) and the Australian Healthy Ageing Organisation.
Professor Michael Weiner, MD: Professor Michael Weiner has been undertaking research for almost 50 years, and is the Principal Investigator of the Alzheimer's Disease Neuroimaging Initiative, a 10-year national longitudinal study of over 1,500 subjects which is aimed at validating biomarkers for Alzheimer’s disease. He also launched the BrainHealthRegistry.org, a registry with the overall goal of accelerating development of effective treatments for brain diseases. This registry recruits, screens, and longitudinally monitors brain function on thousands of participants all over the USA. His overall research goals are to participate in the development of effective treatments and methods for early detection of Alzheimer's disease and other brain disorders. In 1980, Prof Weiner was one of the first investigators to use nuclear magnetic resonance to investigate the metabolism of organs inside a living animal. This technique subsequently became magnetic resonance spectroscopy (MRS). In 1988, his group used MRS to show that the amino acid N acetyl aspartate (NAA), a marker of healthy nerve cells, is reduced in the epileptic focus in the brain. This marker is now used to help identify the epileptic focus prior to surgery in epilepsy patients. In 2004, Prof Weiner's group reported that reduced NAA predicts development of Alzheimer's disease in mildly impaired elderly subjects. They have also demonstrated that brain blood flow is reduced in Alzheimer's disease and in patients with mild impairment. Prof Weiner has over 800 published articles. In 2006, he received the William S. Middleton Award, the highest scientific honour bestowed by the Department of Veterans Affairs. In 2010 he was named one of the ‘Rock Stars of Science’. He also received the Gold Medal of Paul Sabatier University and the City of Toulouse, France. In 2011 he received the Ronald and Nancy Reagan Research Award from the Alzheimer’s Association. In 2012 he received the Potamkin Award from the American Academy of Neurology and the American Brain Foundation.
Professor John Hopper, AM: Professor John Hopper, AM, was one of the nine inaugural Australia Fellows awarded by NHMRC in 2007 and is currently a NHMRC Senior Principal Research Fellow. He is a Professorial Fellow with a PhD in Mathematical Statistics, and is currently Director (Research) of the Centre for Epidemiology and Biostatistics in the School of Population Global Health at the University of Melbourne. He has published more than 900 papers, specialising in the statistical methodology and its application for analysing twin and family data, and addressing the genetic and environmental aetiology of diseases and health. He is principal or co-investigator on multiple case-control-family studies across a range of diseases and conditions, particularly breast cancer and colorectal cancer (both funded by the National Institutes of Health (USA)), prostate cancer, melanoma, childhood cancer and asthma. He is a co-investigator on several cohort studies, including Health 2020 and long term follow-up of the 1968 Tasmanian Asthma Study. Prof Hopper has been Director of the Australian Twin Registry (now Twins Research Australia) since 1990 and has been awarded a NHMRC CRE grant in Twin Research in 2014.
What will I be asked to do?
- You will be sent a link for the HBI-BHR online questionnaire.
- You will be asked to complete online questionnaires and computerised tests about your memory, attention and thinking.
- At the end of the questionnaire you will be asked whether you would like to invite a study partner to participate (NOTE this is optional)
This study involves completing an online questionnaire designed to gather general health information about you. It will include topics such as demographics, general health history, family health history, mood, quality of life, physical activity, sleep, diet and alcohol intake, smoking, physical function, social relationships and negative life events.
Each task will have an approximated time to complete shown in the online portal, and the entire questionnaire will take approximately 30-45 minutes to complete. In addition to the questionnaire, there will be three cognitive tasks that will take approximately 35 minutes to complete. These tasks are engaging and a bit like a “brain game” however will provide us with valuable information about your memory, attention and thinking. At this stage some of the cognitive tasks can only be completed using a desktop computer; even if you can’t complete these, we still highly value your contribution to the other tasks and questions that can be completed using another device (e.g., a mobile phone or tablet).
The online tool (questionnaire and cognitive tasks) are designed in the way that you can stop at any time once you've completed a particular section. You will get a reminder to complete unfinished section/s in your own time within the two-week timeframe.
Study partners are often used in clinical research to provide more detailed and accurate information about a participant’s health status. At the end of the questionnaire, you will be asked whether you want to invite a study partner to take part in the program. This is voluntary and if you choose not to do this, it will not affect your participation in the rest of the study. If you nominate a study partner, they will also be able to voluntarily decline this invitation. If you do choose to nominate a study partner and they accept this invitation, they will be sent an email to answer questions about you, and participate in the main questionnaire. Neither yourself or your study partner will be able to see each other’s responses, and all information will be kept confidential.
How much time will the project take?
The entire online experience will take approximately 1 to 1.5 hours to complete. If you don't have this amount of time, you don't need to complete all of the tasks in one sitting. We will send you weekly reminders (no more than three) to come back and complete any unfinished tasks.
If there are any tasks that make you uncomfortable and you do not wish to complete, you can skip that task and move on to the next. While we encourage you to complete as many of the tasks as possible, any amount of information you are able to provide to us is still of great value.
We will also invite you to return to complete the survey every 12 months for as many years as you wish. If you no longer want to be contacted, you can withdraw your consent at any time.
Are there any risks associated with participating in this project?
As with the collection of any personal (private) information, there is a very slight risk of accidental disclosure of information or breach of computer security. Extensive safeguards are in place to minimise this potential risk, with hard copies of your information stored in locked cabinets within the principal investigator’s office and electronic copies stored on file with password restricted access. Data sharing between the Healthy Brain Initiative and Brain Health Registry will also occur via safe data transfer procedures.
The questionnaires may be upsetting or distressing to you and may make you feel uncomfortable. However, you are free to decline to answer any questions. Below are some Australian helplines and support services that you can contact in case of distress; and these resources are also provided in the online questionnaire.
You are also welcome to contact the study staff atwho may provide you with the relevant information.
Phone: 13 11 14
Lifeline is a national charity providing all Australians with access to 24 hours a day, 7 days a week crisis support and suicide prevention services.
Phone: 1300 224 636
Beyondblue are available 24 hours a day, 7 days a week to discuss any negative thoughts and feelings, stress or other mental health concerns. They are able to point you in the right direction for further support.
National Dementia Helpline
Phone: 1800 100 500
The National Dementia Helpline can provide information on reducing your risk of dementia, support to help manage the impact of dementia and suggest services in your area. The helpline operates nationally from 9am to 5pm Monday to Friday (excluding public holidays).
What are the benefits of the research project?
There are no direct personal benefits from participating in this project. However, there are a lot of benefits to the wider community. By participating in this project you are making a direct contribution to valuable research that has the potential to improve brain function for all Australians.
The data you provide will assist us in understanding social and behavioural determinants of brain health, and influence policies and practice towards better prevention and early detection of brain health issues that may have a long-term impact on wellbeing.
Can I withdraw from the study?
Yes, participants can withdraw from the study. Participation in this study is completely voluntary and you are not under any obligation to participate.
You may withdraw from the study at any time by logging into the study's website and clicking 'Withdraw consent' on the home page. Choosing not to participate will in no way affect your current or future medical care.
The information you have provided prior to withdrawing will not be removed from the Healthy Brain Initiative: Brain Health Registry, and we will continue to use the information you provided prior to withdrawal for data linkage and research purposes.
Will anyone else know the results of the project?
This project is a collaborative partnership between the Healthy Brain Initiative at ACU and Brain Health Registry at University of California San Francisco. All online questionnaire data will be securely store on encrypted portal belonging to University of California San Francisco. A secure data sharing protocol between Brain Health Registry and Healthy Brain Initiative has been established and the data will be transferred using a secure data sharing cloud platform (BOX). Only the Principal Investigators and approved research personnel will have access to your personal information (e.g. email, name) and this information will be password protected. All other researchers will have no access to your personal information and will have to obtain special permission to obtain access to the non-identifiable data.
Research findings will be disseminated via publications, reports, media and conferences. All data used will be de-identified and reported in aggregated format. No individual or identifiable information will be used in a publication.
What is data linkage and what information will be used?
Data linkage is a valuable tool for creating a bigger picture of the health and wellbeing of the Australian population. We are also requesting to link your information provided to us in the questionnaires with information about your medical history from a variety of healthcare providers, such as doctors and hospitals. Your privacy and confidentiality will be strictly protected during the data linkage process.
Specifically, some of the information you provide us with will be sent to the Australian Institute of Health and Welfare for linkage to the Pharmaceutical Benefits Scheme, Medicare Benefits Schedule, Australian Cancer Registry, National Aged Care Database and other national registries. It will also be sent to state or Australian Department of Health, for linkage to hospital administrative data. All this will be done using established secure data exchange processes and the creation of a Linkage ID. Once this ID is established and connected to your study ID, all personal information is removed from the database and stored separately from your responses. We also request your permission to allow us to share your data with other researchers who are currently, or in the future, conducting research studies similar to this one.
The data requested to be linked from the external data sources may comprise of information related to your admission to public or private hospitals, including surgeries and use of anaesthetics, presentation to emergency departments and the reason for it, what medications you were/are prescribed and by whom and how often you use them, all information relating to your visits to GPs and other health professionals; as well as with data from other similar studies that you advise us you are participating or have participated in. Access to similar data collected from other studies you have taken part in (e.g., past health, lifestyle or cognitive data) helps us to look at patterns and predictors of brain health over time.
If you have been referred to this project through another research study, updated contact information (e.g. your name, DOB, postal address, phone number, and email address) and study data (e.g., collected questionnaire, cognitive, health or medical data) may also be shared between the HBI-BHR and the referring study. This will be subject to specific confidentiality and data sharing arrangements negotiated between the relevant study investigators and institutions. The purpose of this is to improve the research activities and outcomes of both the HBI-BHR and referring studies.
By signing the attached Consent Form, you authorise release of, or access to, your medical history (both past and into the future). Any information obtained through this process will be de-identified by our research team and kept confidential, as per all other information about you collected in the study. Access to these original records will be restricted to the study coordinator and Principal investigator. A de-identified database of all relevant information will be used to communicate relevant information. Your original records will not be shared.
Will I be able to find out the results of the project?
We will keep you informed about the progress of the Healthy Brain Initiative by sending you an electronic newsletter that will outline project progress, important findings, publications and presentations, and policy changes based on the project recommendations.
What if I have a complaint or concerns?
The study has been reviewed by the Human Research Ethics Committee at Australian Catholic University (ACU) (review number 2018-12H).
If you have any complaints or concerns about the conduct of the project, you may write to the manager of the Human Research Ethics Committee, care of the Office of the Deputy Vice-Chancellor (Research).
c/o Office of the Deputy Vice-Chancellor (Research)
Australian Catholic University
North Sydney Campus, PO Box 968
North Sydney, NSW 2059
Phone: (02) 9739 2519
Fax: (02) 9739 2870
Any complaint or concern will be treated in confidence and fully investigated. You will be informed of the outcome.
Professor Cassandra SzoekeDirector of the Healthy Brain Program
Principal Investigator of the Healthy Brain Initiative
Australian Catholic University
215 Spring Street, Melbourne 3000.