If you’re affected by dementia, there are good reasons to take part in research studies. But you don’t have to: it’s always your choice.
You might join a research study to feel you‘re:
contributing to the search for the cause, treatment and cure for dementia
learning more about your own situation
potentially finding a drug that might prove to be of some help, even if it isn’t a cure.
getting something from participating in research, even if it’s just a placebo, or the feeling that you’re drawing attention to your condition.
You might not join a research study because:
many studies require you to be available for several visits, which may not be convenient
some studies exclude people who have another illness or are taking other medication, and it can be disappointing to be turned down for a research project
taking part in a medication study involves the risks of side effects
not knowing if you’re taking the real drug or a placebo can be frustrating.
Questions to ask the researchers
Before you participate, ask the researchers:
what is the main purpose of the research or clinical trial?
where will the study happen? Will it take place in your home or at a hospital?
how long will the study last? Several months or even years?
how often and at what time will the appointments be, and how much time is required for each one?
can appointments be changed at short notice?
will you be separated from your carer during the appointments?
how do you get to the research centre? At what cost?
what happens if you can’t finish the study?
who will have access to the information from the study?
is your information confidential?
can you continue to see your GP while you’re participating in the study?
can you keep taking medications prescribed by doctor during the study?
how will your safety be monitored?
has the study received approval from the appropriate Ethics Committee?
If you’re participating in a drug trial, ask:
is it important to take drugs at a set time? Does the researcher need to be told if this does not happen?
how will the drugs be administered?
will drugs be difficult to swallow?
is there a possibility that your cognitive ability will get worse as a result of the trial?
what are the potential risks, benefits and side effects of the drug? (Remember to ask about side effects, like incontinence, sleep disturbances and irritability).
what other tests or assessment will be undertaken prior to or during the trials?
who should family members call if you have side effects?
what are the alternative treatments besides the one being tested in the trial?
Your rights as a participant
That the research project will be carried out in a manner conforming to the The Australian clinical trial handbook and the appropriate Ethics Committee guidelines.
To be fully informed about all the procedures involved in the research and the possible associated risks, discomforts, side effects and inconveniences.
To have all identifying information about you kept confidential, unless they have agreed otherwise.
That consent is voluntary and you may withdraw at any time, without having to give an explanation, or refuse to take part in a particular aspect of the research.
Not to have future treatment by that doctor or hospital jeopardised by such withdrawal.
In the video below, Annette Moxey, Manager of the Dementia Australia Research Foundation, guides you through:
the benefits of participating in research
the different types of study
how to find and volunteer for studies
what to consider before you sign up.
Dementia expert webinar: clinical trials and research opportunities, with Dr Annette Moxey
Transcript
[Beginning of recorded material]
[Title card: Dementia Australia]
[Title card: Participating in dementia research – Dr Annette Moxey, Manager, Dementia Australia Research Foundation]
Dr Moxey: Hello, my name is Annette Moxey, and my current role is manager of the research arm of Dementia Australia, the Dementia Australia Research Foundation. It is an absolute pleasure to be able to talk to you today about participating in dementia research. I'd like to begin by acknowledging the traditional owners of the land on which we meet today. I'd also like to pay my respects to elders past and present, and to our shared futures.
Today, I'd like to talk a little bit about why people might like to participate in research and what the benefits might be. The different types of research studies that are being conducted by researchers, and what you should consider before participating in research, including your rights and the potential risks and benefits of the research itself. And then finally, how to find out about studies, how to volunteer in them, that are being conducted in your area.
So, participation is essentially being a subject of a research study. Most of us, in some way, have benefitted from research without necessarily realising it. For example, when we take a medication, receive a diagnostic test, or even experience a particular type of model of care, we are doing so because numerous studies evaluated the effectiveness, safety, and appropriateness of the intervention, and concluded that it will improve our quality of life.
There are many different reasons for wanting to be involved in dementia research, which may include being able to make a positive contribution towards finding a cause, a treatment, or a cure for dementia, or even preventing the development of dementia in the first instance. You may wish to participate in a trial to access treatments that are not yet widely available free of cost.
Research participation can lead to the improvement of care of people living with dementia. It can help those with dementia, as well as those who may develop the disease in the future, this may provide hope for people who are living with dementia, their families, and future generations. And participating in research is also a way to play an active role in your own healthcare, but importantly, every study contributes to valuable knowledge regardless of whether or not the outcomes or what the research team had actually hoped for.
There are many different types of research studies out there. Some are conducted in a laboratory whilst others are in hospitals or even conducted online. There are three main study designs that I'd just like to mention, and they're ones that you may come across when you're looking for research to participate in.
Observational studies are ones where researchers observe the effect of a risk factor, or a diagnostic test, or a treatment, or any type of intervention or factor, and without trying to actually change who is or isn't exposed to it – so they'll collect information from people and compare that data over time. For example, researchers may look at a potential risk factor for dementia, let's just say smoking for an example, and observe a group of people over many years to see if those who are non-smokers were more likely to, or less likely to, develop dementia than non-smokers. Observational studies can find associations between things, but may not necessarily prove that one thing will cause another.
In contrast, experimental studies involve an intervention such as a clinical trial to test a particular drug. Experimental studies are usually randomised, meaning that the participants may be allocated to the intervention group, or a control group, that does not actually receive the intervention at all. They may do this, say, by flipping a coin or pulling a random number out of a hat. The researchers then study what happens to the people in each group. Any difference in the outcomes can then be linked to the intervention that's under investigation. The trials may also be double-blind which is another term that you might hear of, meaning that neither the participant or the researcher actually knows which group the participant has been assigned to. This can be achieved by using a placebo as a control group, which looks identical to the intervention in every way, but actually has no active properties. So, these are all techniques that researchers use to make sure that they're not consciously or unconsciously manipulating the results of their study to obtain the outcomes that they may wish to see.
As I mentioned, clinical trials are a type of experimental study. A well-designed clinical trial is actually the gold standard for proving that a treatment or a medical approach actually works. However, before conducting clinical trials in people, researchers first test the intervention for safety, effectiveness, and potential problems in laboratories. This may include experiments using animal models or cell cultures. If the intervention is approved for testing in people, the trials move through various phases starting with a small group of volunteers, then gradually increasing in size. For example, the purpose of a phase one trial is to work out whether a medical approach such as a drug is safe, to identify any potential side effects, and to figure out what the actual appropriate dose would be.
In contrast, a phase four trial is done after an intervention has actually been marketed. These studies are designed to monitor the effectiveness of the approved intervention in the general population, and to collect information about any adverse effects associated with that widespread use over a longer period of time.
However, sometimes though, researchers would like to gather people's insights into a problem or obtain feedback as to why an intervention work, or perhaps didn't work. In this instance, they may conduct what is known as a qualitative study, and actually talk to participants either individually or in a group situation, and record their views. These types of studies do not involve analysing numbers or medical test results as a clinical trial would, but rather, they look for themes and patterns that emerge out of what people say. The findings of qualitative studies may inform the development of an intervention such as an educational program. The feedback may also be used to increase the likelihood that an intervention is actually used in the real world.
Regardless of the type of study, participating in research should be a positive experience, and researchers are keen to ensure that participants are treated well, and their safety and wellbeing is respected. There are, of course, pros and cons to participating in research, which people should consider before they agree to take part in a study. For example, you may wish to check that the research has been approved by a Human Research Ethics Committee. The researcher should provide you with an information statement about the project, and a consent form for you to review and sign if you are happy to proceed. This information statement will include the name of the ethics committee that approved the research, and also contact details should you wish to ring them with any concerns about the research that you participated in. The ethics committee is usually attached to the researchers' university or hospital.
You should also be fully informed about the procedures involved in the research and the possible associated risks, discomforts, side effects, inconveniences, as well as all the benefits. You can take as long as you need to make a decision about whether or not to participate in the study. Researchers should also ensure that all identifying information about you is kept confidential, unless you have agreed otherwise. Your name, for example, should never appear next to your results in a publication or presentation about that particular research study. You should also be aware that consent is voluntary, and you may withdraw at any time without giving an explanation, or you could refuse to take part in a certain aspect of the research study. And also, too, your future treatment by a doctor or hospital who might be conducting the research should not be jeopardised by the fact that you've withdrawn from the study. In addition, the researchers can also provide you with a summary of the research findings, and you should be encouraged to ask for those findings if you're got an interest in the outcomes of the study.
One thing I'd like to just make a comment on is about consent because informed consent is an important part of all research projects. People in the early stages of dementia may make a decision on their own, but as the dementia progresses, such decisions may need to be made by their substitute decision maker. The rules about who needs to give consent for a person with dementia to be involved in a research project vary somewhat amongst the different states and territories. For example, in some places the guardianship authority or board may need to approve participation in a clinical trial for people who do not have that capacity to consent for themselves. Often, consent may be given by the person's substitute decision maker, such as a guardian, partner, or a family member. But the main thing to remember is that participation in any research project is entirely voluntary, you may withdraw from the study at any time without giving a reason.
So, you've decided to participate, so what sorts of things might you expect? Well, depending on the type of study you may receive an actual intervention such as a drug, or maybe an exercise program, or an education program, a model of care, and so on. The intervention could be anything depending on what the researcher is actually looking at. You might be asked to complete a questionnaire or an interview, so that the researchers can collect some data. You may be asked to undergo a series of tests or assessments. You might only need to do this once, or the researchers are looking to see if there's any changes over time, they may repeat the tests at regular intervals over a number of months, or weeks, or years. This could include things like blood tests, brain scans, cognitive testing, and other sorts of measures.
You may also receive reimbursement for your time. Researchers may look at recovering any of your travel expenses, if you have to travel to a hospital or stay overnight in a hospital for particular treatments. Though, you should ask if those expenses are covered by the research project. However, the most important factor in many research studies is the number of participants that have been recruited, as this will ensure that the findings of the study are reliable, and also, scientifically robust. For researchers, recruiting participants for dementia related studies can actually be quite difficult, as it often takes longer than expected to find the right people who are eligible for the study. This can result in studies taking longer to deliver, insufficient study samples also limit the effectiveness and scope of the research, and impacts the data analysis, and therefore, how useful or generalisable the findings might be. Therefore, there is a need for a systematic and inclusive approach for people with dementia and carers to express their interest in participating in research.
Fortunately, there are many ways to find out about research that is being conducted in your area and participate in a clinical trial. The Dementia Australia Research Foundation has, for a number of years, provided a free online service for Australian researchers who are looking to recruit for their studies. Potential participants can search for studies in their area through our website listing and contact the research team directly if they want to participate or would like to learn more about the study. Depending on schedules, we’ll sometimes also promote the studies in newsletters and social media posts. Researchers who would like to list their study on our website can actually just click on that link there and fill in their details.
So, here is a snapshot of our listing on the Dementia Australia website. The portal includes a range of studies, and people can search the listing to find those in their state and territory. All studies on our website must have ethics approval from a recognised Human Research Ethics Committee, so we don't post anything that hasn't gone through that review.
Fortunately, though, there are sophisticated registries as well that can help you identify a study to participate in that use algorithms to link participants to research studies, and they're now gaining a lot of popularity. One of these such registries is what's known as StepUp for Dementia Research. For example, people over the age of 18 can register with StepUp. This database matches volunteers, which can be people with dementia, carers, and members of the general public that don't have dementia at all to studies where they meet the eligibility criteria.
The database has been developed by a team from the University of Sydney and is sometimes referred to as an online dating for research. In 2021, the database currently has around 1,100 volunteers registered. So, here's a snapshot of the StepUp for Dementia Research website. If you're interested in registering for this on this platform, there's a sign-up button on the home page, and it'll also have the contact details of the StepUp team, so you may wish to get in touch to find out more, and register if you're interested.
Another example of a recruitment registry is the Australian Dementia Network or ADNeT Research Volunteer Portal. One of ADNeT's initiatives is to develop a large, highly characterised cohort of people with dementia, or who are at increased risk of dementia, for participation in clinical trials and observational studies looking at the progression of the disease over time. Those who have registered with ADNeT will be referred to their local trial delivery site, like at a hospital or a memory clinic for enrollment in clinical trials, where again, they meet the eligibility criteria for the trial.
This initiative seeks to give Australians access to the latest potential therapies through the participation in trials. It will also help Australian researchers find participants to trial new therapies and advance observational research so that we can learn more about the development and the progression of dementia. So again, here is a snapshot of the ADNeT Research Volunteer Portal where you can obtain further information and register your interest on the website if you like.
In summary, participating in dementia research can be a very rewarding experience. Depending on the topic, there are many different types of studies that you can volunteer for. But before participating in a study, make sure that you're informed of all the potential risks and benefits, and remember that participation is voluntary, you can withdraw from the study at any time without giving a reason.
Finally, researchers are always looking for participants and online databases are available to match you with the right study. Thank you for your time today, and I hope you've learnt a little bit more about how to participate in dementia research. And if you have any queries, please do not hesitate to get in touch with the research team. Our email address is listed there, which is foundation@dementia.org.au.
[Title card: Together we can reshape the impact of dementia]
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