Before the trial
Click on the link below for information on clinical trial development and processes as a participant.
https://www.recall.org.au/wp-content/uploads/2024/08/toolkit_what-are-clinical-trials-1.mp4
Anyone over the age of 70 without cognitive impairment or dementia, and not taking dementia medications, angiotensin converting enzyme inhibitors, spironolactone, eplerenone, triamterene, aliskiren, amiloride and lithium may be eligible for the study. Once you have consented to take part in the study, we will ask you series of questions to ensure that it is safe for you to take part, for example we will ask you about the medications you are taking.
The RECALL-Pilot study is run by a team at the George Institute for Global Health, an independent research organisation based in Sydney, Australia. The George Institute is affiliated with the University of New South Wales.
To get involved, please complete an Expression of Interest below. A member of our research team will then send you further information and ask you some questions to check your eligibility. Both a doctor from our research team and your nominated GP with check your medical history and medications to determine if you are eligible. If they both approve, you will be contacted with further information about next steps.
Yes, absolutely! We encourage talking to your GP and any family and friends about taking part, to determine if it is right for you. Your GP will also check your information in order to approve your participation in the study.
You will not be paid, nor will you be asked to pay any fees to participate in the RECALL study. However, you will be posted a digital blood pressure monitor that will be yours to keep.
You will need access to the internet, a smartphone or tablet and a computer to take part in the study.
No. We are looking for participants who DO NOT have cognitive impairment or dementia.
Participants of the RECALL-pilot study will need to take a low-dose blood pressure lowering medication. The medication will be taken once daily for 60 days.
During the trial
Please contact the study team on the study Helpline +61 2 8052-4438
Please contact the study team on the study Helpline +61 2 8052-4438
Follow the instruction below to set up your digital blood pressure monitor and watch the following video:
If you miss a dose and it has been less than 6 hours since your usual dose time, take the dose immediately. If it has been more than 6 hours since the usual dose time, take your next dose the following day at the usual time.
Do not take a double dose to make up for the dose you missed.
To keep your medicine safe and effective, it’s important to store it properly. Here are some guidelines to follow:
- Store your medicine in a cool, dry place that’s away from direct sunlight and heat sources. Temperatures under 25°C are best.
- Keep your medicine out of reach of children.
- Avoid storing your medicine in the bathroom, near a sink, on a windowsill, or in a car on a hot day, as these locations can expose the medicine to heat and dampness, which can make it less effective or even render it unusable.
- Don’t store your medicine in the fridge, as the moisture inside the fridge can also reduce its effectiveness.
Do not take potassium supplements while you are taking this medicine unless your doctor instructs you to do so. Avoid eating large quantities of grapefruit or drinking large quantities (over 1.2 litres or about five glasses) of grapefruit juice. Grapefruit juice can increase the risk of side effects of the study medication.
It does not matter what time of the day you take the study medication as long as it is taken at about the same time each day.
The possible side-effects of the low-dose triple blood pressure lowering combination are the same as if you were to take each of the medications separately. However, it is expected that at low doses, such as in this study, any side-effects are unlikely to be severe and to resolve rapidly once the medication is stopped. The known side-effects that may be experienced when a person takes the full dose of the medications being used in the study are listed below:
Common side-effects – occur in 1 to 10 of every 100 patients:
- nausea, diarrhoea, dizziness, muscle pain, low blood pressure.
Uncommon side-effects – occur in 1 to 10 in every 1000 patients:
- sleepiness, pins and needles sensation in the body, insomnia, back pain, blurred vision.
- low appetite, low blood sugar (symptoms of hunger, sweating, shakiness and/or weakness).
- allergies (such as skin rash, itching, hives, swelling and/or shortness of breath).
- swelling in your lower legs or hands, increased uric acid levels.
Rare and very rare side-effects – occur in less than 1 in 1000 patients:
- weight loss, fever, heart irregularities (sensation of fluttering in the chest, racing or slow heart rate, shortness of breath and/or dizziness), weakness, coughing.
All medicines can have side effects. Please contact the study team on the study Helpline +61 2 8052-4438 if you are experiencing any side effects to the antihypertensive medicine. Tell your doctor immediately or go to the hospital if you experience:
- Allergy symptoms including swelling of the lips face, mouth, tongue, or throat.
- Itching skin, spreading rash or blisters.
- Fast or irregular heartbeat, or chest pain.
If you have any questions or concerns about your study medication, please contact the study team on RECALL@georgeinstitute.org.au or call +61 2 8052-4438.
You can download another copy on the Documents page.
You can download another copy on the Documents page.
You can download another copy on the Documents page.
