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Information for participants

FAQs

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.

It is thought that statins may reduce decline in physical and mental function as well as reducing the incidence of heart disease, stroke and dementia. Therefore, statin treatment may help to preserve healthy, independent living for longer.

All drugs, including statins, have side-effects. Most side-effects of statins are mild and temporary. However, it is not known if the benefits from taking statins outweigh the risk of adverse events in older people. STAREE will be the first clinical trial to investigate this.

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 your General Practice clinic, local study centre or linked community venue.

STAREE staff will explain what participation in the study involves

  • You will be able to ask STAREE staff any questions you have about the study
  • If you decide to participate you will be asked to give your informed consent
  • STAREE staff will ask you about your medical history and current medication use
  • You will be asked to fill in some questionnaires
  • You will have some basic measurements taken (height, blood pressure etc.)
  • You will be given a pathology request form for blood and urine samples

Once you have consented to participate in the study, you will be asked to:

  • Take a tablet for 4 weeks
  • Attend a visit with your GP to ensure they are happy for you to participate

After 4 weeks you will be asked to:

  • Check that you were able to take the 4 weeks of medication
  • Complete some further questionnaires
  • Check your pathology results
  • Check your GP has approved your participation in the study

If you agree to continue in the study:

  • You will be required to take statin or placebo/dummy tablets every day for five years
  • You and the study staff will not know which of these you may be taking
    STAREE staff will regularly phone you during the study to discuss medical conditions that may arise and medication use
  • You will be required to attend annual study visits where you will undergo memory and physical ability tests and physical measurements
  • By participating in this study, you will help us learn more about the benefits and risks of statins in people aged 70 years and over. This knowledge will guide the use of statins by millions of people around the world. Participation of individuals such as yourself is vital for a successful study.

How to get involved

Are you interested in becoming a participant and located in Victoria, Western Australia, South Australia, Tasmania, Queensland or New South Wales?

Then please call us on 1800 770 664 to speak to a STAREE staff member who will ask you a number of questions to determine if you are eligible to participate.

Alternatively please email staree@monash.edu with a contact number and a STAREE staff member will call you back.

Ethics approval

This project is being carried out in accordance with the National Statement on Ethical Conduct in Human Research (2007) produced by the National Health and Medical Research Council of Australia. This statement was developed to protect the interests of trial participants who agree to human research studies.

The ethical aspects of this research project have been approved by the following human research ethics committees:

FAQs for participants

What dosage will I be given if I am part of the trial?

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.

Which statin is being used?

The statin selected for this trial is Atorvastatin (40mg). It has been known under the trade name Lipitor or Atorva. Like all statins, it works by blocking the action of a protein in the liver that is needed to make cholesterol. This action lowers cholesterol and lipid levels in the blood.

Am I able to find out 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.

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.

Misinformation about STAREE

In August 2017, incorrect claims were made via national radio and social media that STAREE is funded by pharmaceutical companies – ‘big pharma.’ The same source also warned that elderly people should not be taking statins, that STAREE is taking advantage of vulnerable elderly Australians and that participating in STAREE is a health risk.

These claims are false.

STAREE does not accept funding from the pharmaceutical industry. 100% of STAREE’s funding is from the government via the National Health and Medical Research Council.

The risks and benefits of statins in the healthy elderly are unknown. The aim of STAREE is to identify and measure these, and all prospective participants undergo a physical health check. Anyone with health issues that may be exacerbated by statins cannot join the trial. Participant well-being and informed consent are our greatest concerns.

For in-depth accurate information on this matter, read here. If you have heard these claims and would like to discuss them, please contact our trial team on 1800 770 664.

How to become involved

Contact the STAREE centre Come to two visits at the start of trial See your GP Take study medication every day