Information for participants
CREDO Research Project
The CREDO Research Project (CREDO) is for participants in the 45 and Up Study.
Mood symptoms and cardiovascular disease are common in our community and often present together. The object of this research project is to investigate the effectiveness of an evidence-based internet program for depressive symptoms in patients being treated for, or at risk of developing, cardiovascular disease.
Management
CREDO is being conducted by a team at the University of Sydney and the Australian National University. It is led by Professor Ian Hickie and Associate Professor Nick Glozier of the Brain & Mind Research Institute at the University of Sydney.
To ensure participant confidentiality, the 45 and Up Study Coordinating Centre at the Sax Institute is inviting 45 and Up Study participants to take part in CREDO.
CREDO has been funded by the Heart Foundation and beyondblue: the national depression initiative.
What the CREDO Research Project will involve
Invited participants who consent to join this research project will be asked to do up to six things:
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Initial contact: Visit the CREDO website and log on using a unique ID number which will be provided by the 45 and Up Study when inviting participation. Participants will be asked to complete a brief set of questions on the website about their current mood to establish whether they are eligible to participate.
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Survey: If a participant is eligible to participate, they will be asked to complete a short survey on the website (which will take approximately 10 minutes) including questions about their medical history, current medications and some lifestyle habits such as exercise.
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Memory and thinking skills (“cognitive”) tests: Participants will then be asked to undertake some tests of memory and thinking skills. There are three different skills tests which will take around 10 minutes. The results will be reported back to participants later in the study.
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Intervention: Consenting participants will then be emailed to confirm that they still wish to take part. If they do, they will be allocated to one of two internet programs. Both of these have lots of health information and participants will need to visit them once a week for twelve weeks. Participants will be asked if they are willing to be contacted by phone during this time to see if they need any help with the sites.
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Survey and cognitive tests: At the end of the twelve week program participants will be asked to take the survey and cognitive tests again.
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Six months after completion of the intervention, and again at twelve months, participants will be contacted via e-mail and/or phone and again asked to complete the survey about mood, their medical history and medications as well as the cognitive tests. If unable to complete the survey online, participants will be asked to do so over the telephone. Results from the cognitive tests, including any changes from the first time they were completed will be provided to participants that request them.
Please note that invitations to participate in CREDO have only been sent to a random sample of 45 and Up Study participants and unfortunately we cannot take volunteers at this time.
How much time is involved?
We anticipate that participants will need around half an hour to an hour every week for twelve weeks to complete the tasks that will be asked in the respective internet programs. Also, over the course of the project participants will be asked to complete four online surveys and complete cognitive tests – once before starting the program, once at the end of the program and another six months and then again twelve months later. We anticipate each survey and set of cognitive tests will take about 20 minutes to complete on each occasion.
How the researchers will use the information
We believe this project will help us to understand more about the methods and resources that may be helpful for promoting improved wellbeing in patients being treated for, or at risk of developing, cardiovascular disease.
All information collected will be treated completely confidentially and used for health research only. Participant information may be used within health research for approved 45 and Up Study research projects to investigate factors affecting the health of Australians in mid to later life. All 45 and Up Study research projects must demonstrate that they are in the public interest and have the potential to provide important information to improve health.
Once this research project is complete, the information participants have provided will be included in the 45 and Up Study data.
Our commitment to security and confidentiality
The 45 and Up Study is bound by Commonwealth and State privacy legislation and guidelines, including the Health Records and Information Privacy Act and the NSW Health Privacy Manual. The 45 and Up Study has strict procedures and systems to safeguard confidentiality.
The information provided will be identified by an ID number and identifying details (such as name and address) will be removed from the information given to the CREDO Research Project as soon as possible and stored separately.
Hard copy and online survey answers, website data, and all information collected over the phone will be recorded and stored in a password protected computer at the Brain & Mind Research Institute and will only be accessible to authorised research staff. We are committed to maintaining the security of all the information that will be collected throughout this project. No information will be released in a way that would allow an individual to be identified, except as is required by law.
All information gathered online will be stored on the University of Sydney Faculty of Medicine server and is subject to all reasonable security measures. However, any user of the Internet and the World Wide Web should be aware that it is an insecure public network that gives rise to a potential risk that a user’s transactions are being viewed, intercepted or modified by another party or that data which the user downloads may contain computer viruses or other defects.
The conduct of the 45 and Up Study is overseen by the University of NSW Human Research Ethics Committee and the conduct of the CREDO Research Project is overseen by the University of Sydney Human Research Ethics Committee.
By agreeing to be part of the CREDO Research Project, you agree to the 45 and Up Coordinating Centre providing your completed 45 and Up Study questionnaire to the CREDO Researchers.
How the information will help you, and others
We believe that participants will find participation in this trial interesting and valuable. We anticipate that many will benefit personally from the study and participation in the research project will help us to understand more about the methods and resources that may be helpful for promoting improved wellbeing in patients being treated for, or at risk of developing, cardiovascular disease.
Are there any risks/discomforts or side effects associated with this project?
Taking part in the project is considered to be of very low risk. Sometimes, the cognitive tests may cause mild anxiety (i.e. feeling nervous). However, this gets better after a little practice. Each participant has the opportunity to practice each of the tests before undertaking the real test.
Will CREDO participants be told of the findings of the project?
CREDO participants will receive a summary of the sub-study’s findings via email once the project is completed. They will also be provided with their individual test scores if they choose to receive them.
Will anyone else know the results?
All aspects of the research project, including results, will be strictly confidential and only researchers directly associated with the project will have access to information on participants, except as required by law. A report of the project may be submitted for publication or presented at scientific meetings, but individual participants will not be identifiable in such a report or presentation. We will also include a summary of the results here on the 45 and Up Study website (www.45andUp.org.au). The results will also be included in the 45 and Up Study’s participant newsletter.
The information you give will be held in a secure location for 15 years after publications, after which time any identifying information will be destroyed.
Can I tell other people about the 45 and Up Study and the CREDO Research Project?
Yes. Please note, however, that the 45 and Up Study is no longer accepting new participants and that invitations to participate in CREDO have only been sent to a random sample of 45 and Up Study participants.
What if I don’t want to take part?
Participation in this project is entirely voluntary. If you do not wish to participate, you need take no further action.
Can I withdraw from the CREDO Research Project?
Participation in CREDO is completely voluntary. You are not obliged to take part and, if you do take part, you can withdraw at any time by calling the 45 and Up Study Infoline on 1300 45 11 45. You can withdraw from CREDO and still remain in the 45 and Up Study.
More information
You can call the 45 and Up Study Infoline on 1300 45 11 45 to find out more about this research project. Participants in this sub-study will also receive a summary report of the findings at the end of the project.
Participants in this project may also contact the researchers directly:
Trial Manager, The CREDO Research Project
Brain & Mind Research Institute
100 Mallet Street
Camperdown NSW 2050
Telephone: 02 9351 0830
Email: credo@med.usyd.edu.au
Further assistance
Sometimes people who are very distressed have thoughts of harming themselves. If at any time you feel this way we suggest that you contact one of the following numbers or seek help from your doctor:
Lifeline – 13 11 14
beyondblue info line – 1300 22 46 36
Salvo Care Line NSW – 1300 36 36 22
Complaints or reservations about the ethical conduct of this research
Any person with concerns or complaints about the conduct of the CREDO Research Project can contact the Manager, Ethics Administration, University of Sydney on 02 8627 8175 (telephone); 02 8627 8180 (fax) or human.ethics@usyd.edu.au (email). Any issues raised will be treated in confidence and investigated fully and you will be informed of the outcome.