Case study: Study delivered in Dorset is looking at preventing falls in those with Parkinson’s Disease
The CHIEF PD study is running at 33 sites in the UK
Over 60% of people living with Parkinson’s Disease report experiencing a fall each year according to Parkinson’s UK.
Having a fall can result in broken bones, injuries and hospital admission. In addition, people report losing their confidence in walking and can become more isolated and anxious.
Whilst research into prevention and slowing of the disease continues, an NIHR-funded study being delivered at University Hospitals Dorset and 32 other centres across the UK is trialling how one drug can improve the risk of falls in patients living with Parkinson’s.
The drug called rivastigmine is currently approved in the UK to improve the brain function of patients with dementia. Looking at the use of an already approved drug is a benefit, say researchers, as the safety and tolerability is already known.
The CHIEF-PD study, which is sponsored by the University of Bristol and funded by the NIHR Evaluation, Trials and Studies Coordinating Centre, has been running at sites UK wide including across the Wessex region.
Almost 20 participants have been recruited to the study in Dorset, contributing to the total current recruitment figure of just over 250 participants.
As part of the study, participants are asked to wear a patch daily for one year which either contains a drug called rivastigmine, or placebo (a ‘dummy’ patch). Each day they are asked to record their dose and whether they have experienced a fall in a simple diary.
For World Parkinson’s Day, we spoke to Dr Emily Henderson, an Academic Consultant Geriatrician and Chief Investigator of the CHIEF-PD study about the trial and its aims.
Emily said, “Falls are a really common problem that people living with Parkinson's tend to experience, particularly as the condition progresses. The vast majority of patients will experience at least one fall and it can have a really devastating impact on people's quality of life and their confidence in going about their day-to-day activities.
“This drug could potentially help to address balance issues. There's historically always been a focus on the loss of dopamine in Parkinson's disease that leads to the slowness of movement, muscle rigidity and shaking. However, we also know that another chemical in the brain called acetylcholine diminishes as the disease progresses. Rivastigmine, the drug we are trialling with the CHIEF-PD study, acts to compensate for that loss of acetylcholine which is particularly important in memory, thinking, and walking.”
Emily explained that there is typically a lack of awareness of the broad range of symptoms that affect those living with the condition, some of which cause the biggest impact on people’s quality of life.
Emily said, “It’s really important to raise awareness of the fact that you’re at a higher risk of experiencing falls if you’re living with Parkinson’s. If someone living with Parkinson’s has fallen or had a near miss, it's really important that they highlight that to their treating specialist.
“People should also have their bone health assessed, and then staying physically active is really important. Taking part in research such as the CHIEF-PD study also has the potential to help you now or help our treatment of people with a condition in future. Therefore if you are a person with Parkinson’s who has experienced a fall it is worthwhile considering whether you could help us answer this important question in Parkinson’s care by taking part in this trial.”
“I'm always astounded by the willingness of people who are living with a very complex condition, to go above and beyond and take part in research. It is humbling that they are willing to undertake something that may benefit people who develop the condition in future. ”
The study team have taken innovative approaches to recruitment as a result of the pandemic, to make it as easy as possible for people to take part.
Emily said, “The COVID-19 pandemic has afforded us the opportunity to do hybrid visits, remote consent, and explore new ways to bring research to people that doesn't necessarily involve them travelling miles. We are exploring cutting edge ways to enrol people to clinical trials, for example drugs being delivered to participants rather than them having to necessarily go to hospital sites and pharmacies to collect medication.
The total recruitment target of 600 participants is hoped to be achieved by July 2022.
Emily explained, “Recruitment remains our biggest challenge, it's not insurmountable but it is something we need to persevere with. We are working with staff shortages where people have been affected by COVID-19 and there's been a lot of resource diversion to COVID-19 studies. People have worked very hard for a very sustained period through the pandemic.
Emily’s highlights of the study so far have been the enthusiasm of participants and the support of all the healthcare and academic professionals who have played a part in making the study happen.
“I remain very inspired and thankful to have wonderful people supporting us at recruiting sites as well as at the University, NIHR and the whole Parkinson’s community that makes this ambitious and important trial successful”
Emily said, “If we achieve our recruitment goal and deliver a study of this magnitude, that's a massive strategic win for Parkinson's care. In terms of the difference it will make, if we were able to reproduce the success of the phase two study, and show that this drug is helpful, it would be a step change in the care that we can offer patients.”
The CHIEF-PD study is running at 33 sites across the UK. To find out more about the study, visit www.chiefpd.blogs.bristol.ac.uk/about-the-trial.
To sign up to hear about research opportunities in your area, visit bepartofresearch.nihr.ac.uk.