Information for participants
What is the goal of the STAREE study?
As people age, their health and quality of life may be affected by frailty, memory decline and chronic diseases such as heart disease and stroke. Unfortunately, some older people will eventually develop some level of disability that results in a loss of independence and the need for residential care. STAREE is a clinical research study investigating whether a cholesterol lowering medication known as a statin can prolong good health and maintain independence amongst older people.
What will happen if you join the study?
If you would like to participate in this study, you will be invited to attend a visit with STAREE staff at either your General Practice clinic, local study centre, linked community venue or over the phone.
At this first visit, you will have an opportunity to:
- Ask STAREE staff any questions you have about the study,
- Provide your informed consent if you decide to take part,
- Discuss your medical history and current medication use with STAREE staff,
- Fill in some questionnaires, and
- Take some basic measurements (height, blood pressure etc.)
Once you have consented to participate in the study, you will be asked to:
- Take a daily tablet for 4 weeks,
- Complete some pathology tests (blood and urine samples), and
- Attend an appointment with your GP to ensure they are happy for you to participate
After 4 weeks you will attend a second visit with STAREE staff where we will:
- Check that you were able to take the 4 weeks of medication,
- Complete some further questionnaires and activities, and
- Check your pathology results
You will then be required to attend annual study visits, for a period of approximately 5 years, where you will undergo memory and physical ability tests and physical measurements
Who is eligible to take part in STAREE?
You may be eligible to take part in the STAREE study if you are:
- Over 70 years of age,
- Live independently in the community,
- Are not currently taking any cholesterol lowering medication, and
- Do not have a history of cardiovascular disease, stroke or diabetes
How can I become involved?
If you are interested in becoming a please call us on 1800 770 664. One of ourSTAREE staff members who will ask you a number of questions to determine if you are eligible to participate.
Alternatively please email firstname.lastname@example.org with your contact number and a STAREE staff member will call you back as soon as possible.
Which statin is being used?
The statin selected for this trial is Atorvastatin (known under the trade name Lipitor or Atorva). Atorvastatin was selected as it is the most commonly prescribed statin in Australia and tends to result in a lower number of side effects relative to other statins.
What dosage will I be given?
The dosage of statin used in the STAREE trial is 40mg daily and is considered a moderate dose. As statins can cause side effects, your dosage of study medication will commence at 20mg and for most participants will increase to 40mg over the first month. If you suffer from side effects, please contact your GP who can adjust the dosage for you while on the trial.
Will I know if I am in the statin or placebo group?
The STAREE study is a randomised double-blind study which ensures that for the duration of the study, no one knows which group (placebo or statin) a participant belongs to. This includes STAREE staff, participants, and participant’s GPs. This is done to ensure that the study results are a true representation of the effects of statins and that there is no bias in the results. Once the study has concluded, participants, and their GPs, will be notified of which medication they were taking.
Where do I have to travel to if I agree to be part of the study?
Participants in this study will need to travel to their local GP clinic or community centre to attend the study visits. There is also an opportunity for participants to visit our clinical trial centre in Commercial Road near the Alfred Hospital.
Please note: Due to the current COVID-19 situation, participants in some states will be asked to complete appointments over the phone instead of face-to-face.
Who is funding the STAREE study?
100% of STAREE’s funding comes from the government via the National Health and Medical Research Council.
If you have any further questions about the STAREE study, please contact our trial team on 1800 770 664.