Older People's Unit
Research & Audit
Current OPU Research Studies
The Older People's Unit in Bath Royal United Hospital believes that involvement in high quality research is beneficial for patients, clinicians and the wider population. We aim to increase and promote opportunities for participation for older people who have historically been under-represented in clinical trials.
Parkinson's Disease
CHIEF-PD
This phase III randomised, double-blind placebo controlled trial aims to establish the effect of rivastigmine – a drug normally used to treat people with memory and thinking problems – on the frequency of falls in people with Parkinson's disease.
It is being run from Bath and is funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme.
The study aims to recruit 600 people from 26 sites across the UK. At the RUH we are aiming to recruit 50 patients once the study opens, due end 2019.
Web link: https://chiefpd.blogs.bristol.ac.uk/
PROSPECT-M-UK
This longitudinal study is looking at patients with syndromes known as 'Parkinson's Plus' or Atypical Parkinsonism syndromes; Progressive Supranuclear Palsy, Corticobasal Syndrome and Multisystem Atrophy.
As a centre we shall identify potential patients through clinic appointments and will ask patients who wish to consent to the study, to donate blood for DNA purposes. Patients will also be given copies of questionnaires to complete and return to study centre. This will give valuable information in these rarer conditions.
Vision in Parkinson's Disease (VIPD)
This cross-sectional, longitudinal study, run by University College London is looking at visual processing in Parkinson's disease (PD), how and why this can become impaired in people with the condition and how this is linked to other areas of cognition.
Participants are asked to perform computer-based visual tasks once yearly over a three year period and to provide a one-off blood sample for genetic analysis. The RUH is currently recruiting to this study
Web link: https://www.ucl.ac.uk/ion/research/centres/movement-disorders-centre/research/clinical-studies#VIP
PD Med
A large multi-centre randomised assessment of the relative clinical and cost effectiveness of classes of drugs used to treat people with Parkinson's disease.
This study has been running at the RUH for 12 years. It is in follow up only.
Web link: http://www.birmingham.ac.uk/research/activity/mds/trials/bctu/trials/pd/pdmed/index.aspx
PRoBaND ('Tracking Parkinson's')
PRoBaND is a prospective, observational, multi-centre study run from Glasgow involving Parkinson's disease (PD) gene testing in patients with recent onset PD and first degree relatives of patients with recent onset or young (under 50 years) onset PD, comparing relatives of gene test positive patients, with relatives of gene test negative patients.
PRoBaND is the largest and most detailed prospective study of PD in the UK.The RUH recruited 57 patients to this study.
Since its inception in 2012 several study extensions have been granted and patients continue to be followed up here at the RUH where study visits involve the completion of questionnaires, a motor function assessment and a cognitive assessment.Web link: http://www.trackingparkinsons.org.uk/
BIAL PD Chart Review
This commercial study is a multi-centre, non-interventional pilot study using retrospective data to obtain information about the use of healthcare resources by patients with Parkinson's disease who have been treated with entacapone and opicapone, two medications which are used in the management of Parkinson's symptoms.
The study is currently in set-up.
BIAL EON
This is a commercial study looking at the safety and effectiveness of two different types of treatment for Parkinson's disease for people. It will compare data from those who are prescribed levodopa and opicapone with those who are prescribed solely levodopa .
Patients will be followed up for 12 months following their recruitment to the study. BIAL EON is a multinational, multicentre, prospective non-interventional study to which we aim to recruit 5 patients once the study opens.
Web link: https://clinicaltrials.gov/ct2/show/NCT03959540
Nose2Diagnose
This study seeks to detect and identify compounds on the skin of people with Parkinson's disease (PD) in order to find out more about how skin chemicals differ between people with Parkinson's and those without. It was inspired by a woman called Joy Milne who is able to detect a unique body odour on people with PD. Results from the study may lead to the development of a diagnostic test for the condition, something that doesn't currently exist.
Initially only people with Parkinson's disease who had not been started on medication for the condition were eligible to take part, however the more recent phase of recruitment was open to anyone with the diagnosis as well as controls (people without Parkinson's disease) who were between the ages of 18-90.
Recruitment has just closed. The RUH recruited 41 people to this study
Web link: https://www.youtube.com/watch?v=XB0QgwVffvk
SUCCESS
This is an observational, prospective, multinational, multi-centre study comparing the effectiveness of 2 types of Parkinson's medication - safinamide and rasagiline – and comparing them with other drugs used to treat the condition.
The RUH aims to recruit 10 patients to this study which is currently in set-up.
Web link: https://clinicaltrials.gov/ct2/show/NCT03994328
PRIME-PD
PRIME-PD is a trial which will evaluate a new model of care that aims to improve the quality of life for people living with Parkinson's disease across 2 health hubs, one in Bath, UK and one in Nijmegen in the Netherlands. In the UK, the trial will be run by the University of Bristol and carried out via the Royal United Hospitals Bath NHS Foundation Trust.
The UK aims to recruit approximately 500 people to the trial which aims to reduce fragmented care delivery in order to tackle what can be very troublesome and debilitating symptoms for people with Parkinson's disease. The study team will be developing and evaluating a new model of proactive and integrated care that addresses patients' needs promptly and provides patients with care from professionals with specialised skills and expertise in the management of Parkinson's symptoms.
The project is funded by The Gatsby Foundation and is due to open to recruitment in Spring 2020
Web link: https://www.bristol.ac.uk/news/2018/september/parkinsons-study.html
PD-Stat
This study is looking at Simvastatin as a neuroprotective treatment for Parkinson's disease (PD). It is a double-blind, randomised, placebo controlled study in patients with moderately severe Parkinson's disease.
It is run from Plymouth and currently in follow-up here at the RUH where we recruited 7 patients. It is one of a number of studies backed by the Cure Parkinson's Trust, aimed at exploring whether any drugs used for other purposes may also reduce the progression of PD.
Web link: https://penctu.psmd.plymouth.ac.uk/pdstat/
Synapses
This is a study of a new monoamine oxidase inhibitor called safinimide, used in Parkinson's disease (PD). It is a phase IV non-randomised, commercial, European, multi-centre, retrospective-prospective cohort study to observe safinamide's safety profile and pattern of use in clinical practice during the first post-commercialisation phase.
The RUH was the first UK site to recruit a patient to this study with a total of 7 patients recruited overall.
The study is closed to both recruitment and follow-up with the central study team now involved in close-out activities.
Muscular Frailty (Sarcopenia)
LACE
This study, run from Dundee, is looking at whether a combination of an amino-acid dietary supplement and a commonly used drug Perindopril (an 'ACE inhibitor') could improve muscle strength in those who have become physically frail.
The RUH recruited 9 patients to this national, non-commercial study which is currently in follow-up
Web link: http://www.lacetrial.org.uk/home
Audit
RCP Falls and Fragility Fracture Audit Programme (FFFAP)
The Royal United Hospital makes monthly submissions to the RCP Falls and fragility fracture audit programme (FFFAP) which includes the National Hip Fracture Database (NHFD).
(http://www.nhfd.co.uk/20/hipfractureR.nsf/).
Within the FFFAP the RUH has recently contributed to the National Inpatient Audit of Falls and we have submitted facilities audit data and patient level date to the Fracture Liaison Service Database(FLS-DB)
(https://www.rcplondon.ac.uk/projects/fracture-liaison-service-database-fls-db)
Data from the NFHD and FLS-DB contribute to annual reports commissioned by Healthcare Quality Improvement Partnership (HQIP). These data are also available and are used by research groups around the country to answer specific falls and fractures related research questions aimed at improving the quality of care.
Locally the NHFD make available dynamic charts for key performance indicators which allow us to monitor our performance.
https://www.rcplondon.ac.uk/projects/falls-and-fragility-fracture-audit-programme-fffap
UK Parkinson's Audit
The UK Parkinson's Audit is a biannual audit looking at the state of Parkinson's services across the UK. It covers all areas of service provision, including medical (covering both elderly care and neurology services, and nurse specialist services), physiotherapy, occupational therapy and speech and language therapy. It is run with the support of Parkinson's UK.
The 2015 UK Parkinson's Audit gave the biggest ever picture of the state of Parkinson's services, showcasing good practice but highlighting many areas for improvement. It was the first to include a Patient Reported Experience Measure (PREM), giving people with Parkinson's a stronger voice in rating the services they receive.
OPU runs two local Parkinson's services covering Bath and North-east Somerset and Wiltshire. We see patients of all ages, not just older patients. Both services participated fully in the 2015 audit, and the summary report can be found here:
https://www.parkinsons.org.uk/sites/default/files/audit2015_summaryreport.pdf
Two of our consultants, Dr Sara Evans and Dr Veronica Lyell, sit on the national Clinical Steering group for the audit, and produced the latest report.