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Trial Portfolio


COVID studies

 

TrialDescriptionChief Investigator(s)

BRACE

BCG Vaccination to Reduce the Impact of COVID-19 in Healthcare Workers (BRACE Trial) http://medicine.exeter.ac.uk/research/healthresearch/primarycare/brace

This exciting Clinical Drug Trial aims to assess the effectiveness of a BCG vaccination vs. Placebo in participants working in healthcare settings. Up to 1000 participants will be recruited into GP surgeries in the Exeter area and randomised to either the intervention or control group. The trial involves blood samples taken at baseline, 3, 6, 9 and 12 months, with a symptom diary to fill in to track symptoms which may be related to SARS-CoV-2 (COVID-19) infection. The BCG vaccination is a licensed Medicinal Product with a proven safety profile, with non-specific effects that may protect against, or reduce severity / duration of COVID-19.

Professor John Campbell

COVID-Nurse

This interventional trials aims to assess a COVID-Specific nursing care protocol addressing fundamental care requirements of patients hospitalised with SARS-CoV-2 Infection, who have not been ventilated. Treatment outcomes will include patient experience, care quality and functional ability.

Professor David Richards

COVID-eWHELD

 

eWHELD aims to provide support to care homes during the COVID-19 outbreak by supporting the workforce, independence of residents, local authorities and providers of care, during a time of facing significant pressures due to COVID-19. eWHELD will provide evidence based, supported, digital training with coaching to enable care staff to meet this challenge. The research element of the study will invite eWHELD coaches, care home managers and dementia champions to opt in to an evaluation of the programme to enable optimisation for a separate clinical trial of the optimised intervention and roll out of the programme nationally

Professor Clive Ballard


Ongoing studies

TrialDescriptionChief Investigator(s)
 BASH  Paul Stallard is leading a new trial that investigates incorporating a self-harm prevention phone app called Blueice into the treatment of young people currently recieving care from Child and Adolescent Mental Health Services (CAMHS).  Paul Stallard
 CASPER CF  The purpose of this research led by Adilia Warris is to clinically validate the defined posaconazole regimen, to assess its tolerability and safety, and the clinical efficacy in children and young people with Cystic Fibrosis and Aspergillus infection aged 8 to 18. The study will be performed in 35 sites across 12 European countries. At the moment the study is in the set-up phase with the aim to include the first patient in April 2020.  Adilia Warris (A.Warris@exeter.ac.uk)
 DECODE   Study of dementia identification system (DECODE), and its use in primary care and as a memory clinic triage tool.  Dr David Llewellyn
 ECOWEB  This exciting project aims to increase insight into how emotions work and the skills of spotting, understanding, and managing emotions in young people. The trial will take place over one year to find out what influences mood, how emotions change over time, and which emotional skills best increase well-being using a phone app. This study is currently in set-up.  Ed Watkins (E.R.Watkins@exeter.ac.uk)

ERICA

ERICA brings technology into the mix to aid GP’s to detect early symptomatic cancer, facilitating earlier referral and subsequently, swifter treatment and increased survival rates. 710 GP practices will take part, leading to an estimated 12,780 pariticipants recruited. This trial will investigate the clinical and cost effectiveness of detecting cancer at an earlier stage than what is the current standard within the UK.

Prof. Willie Hamilton 

HEMISPAIRE A trial lead by John Charity comparing 2 ways of performing partial hip replacement to see which most improves patient function and recovery after surgery. Ethics approval has been obtained and recruitment has commenced. John Chairty (J.Charity@exeter.ac.uk)
HPC Recruiting 72 participants from 6 sites, this trial will assess the feasibility of a Randomised Controlled Trial involving a group programme to improve health and well-being of parent carers of children with disabilities vs. waiting list control groups. Dr. Chris Morris
IDEAL 2 This 5 year longitudinal trial characterise the social and psychological factors that support or constrain the ability of Person With Dementia and Primary Carer to live well with any type of dementia. This will aid in future policy-making initiatives to preserve independence and reduce disability in people with dementia. Linda Clare l.Clare@exeter.ac.uk
IMPULSE-PLESSEY Sensitivity and Specificity of a mobile lead-one ECG like device for the detection of
Atrial Fibrillation (AF)
Phil Keeling/Dr Chris Clark
INTERPRESS IPD  The association between inter-arm blood pressure difference, cardiovascular disease, and mortality: an Individual Patient Data meta-analysis (INTERPRESS-IPD Dr Chris Clark 
MICROBIO Andrew Jones will be investigating the effects of Nitric Oxide (NO) supplementation (through consumption of leafy greens) on cardiovascular health in both younger an older adults Andrew Jones
MIKROBE Recruiting from sites in Exeter and Oxford, this trial will recruit 40 participants to investigate the effectiveness of either 1 stage or 2 stage revision surgery for prosthetic knee infection. This is a feasibility stud y to assess how to best deliver the study on a larger scale. MIKROBE has recently received ethical approval. Andrew Toms (A.Tomes@exeter.ac.uk)
MODULATE LBP (HELP-NOW) Multicentre, Double Blind, Randomised Controlled Trial of 10kHz High- Frequency Spinal Cord Stimulation for Chronic Neuropathic Low Back Pain Dr Adnan Al-Kaisy
NIGHTCAP A 12 month factorial trial will assess 1) personalised night-time care planning, 2) structured sleep hygiene, 3) hypnotic drug review and 4) control group in 4 different treatment arms. The purpose of this multi-factor trial is to provide overview of night-time care for individuals living with dementia, and assess the use of hypnotic drugs within each treatment arm at 4 months. Sleep disturbance and quality of life will be measured as secondary outcomes. Dr. Anne Corbett (A.M.J.Corbett@exeter.ac.uk)
PHENSERINE An exciting new trial in development is Clive Ballard's new phase 2 ACE inhibitor trial for Phenserine Fausidil. The protocol is in development and ethics will be sought early this year.     Clive Ballard (C.Ballard@exeter.ac.uk)
SHAPE Ingelin Testad's trial combines 3 current interventions for early stage dementia including self management, health promotion and e-learning. This aims to improve self-efficacy of patients compared to treatment as usual. Ingelin Testad
THRIVE This novel study will incorporate the use of a pre-existing intervention (Dialectical Behaviour Therapy) for personality disorder and apply it to patients who are experiencing Bi-polar Disorder. More specifically, this intervention will help with the mood swings that can be experienced, which patients report to be difficult to cope with. Kim Wright (K.A.Wright@exeter.ac.uk)
TRIAL-STIM Does a screening trial for spinal cord stimulation in patients with chronic pain of neuropathic origin have clinical utility and cost-effectiveness? Sam Eldabe
TRIMASTER This trial compares patient response to 3 different third line glucose lowering treatments. O bjectives are to: 1) test specific drug response categories 2) assess use and design of current studies as a future methodology 3) develop resource s for assessing biomarkers and drug response mechanisms in relation to drug response. Andrew Hattersley (A.T.Hattersley@exeter.ac.uk)
UDIRECT This exciting study aims to improve care for patients with distal radial fractures. It will compare Point of Care Ultrasound (POCUS) to that of the Usual Care Control which is multiple X-ray imaging, involving transport burden for the service user, and financial burden for the health service. POCUS is easily administered by all emergency department staff and reduces ionizing radiation exposure to all parties, and would reduce the need for surgery due to increased success of manipulation pre-casting. Andrew Appleboam
VIT D This novel study will utilise vitamin D supplements and investigate the protective effects they may have in early onset dement ia in adults with age associated cognitive decline Dr. Anne Corbett (A.M.J.Corbett@exeter.ac.uk)

VOLITION

A feasibility trial involved in developing an intervention aimed at supporting older patients with multimorbidity in shared decision making when visiting a GP. Recruitment for this study commences in January 2020.

Joanne Butterworth (J.E.Butterworth@exeter.ac.uk)


Completed studies

TrialDescriptionChief investigator(s)
Esteem Study of the effectiveness and cost effectiveness of telephone triage of patients requesting same day consultations in general practice: a cluster randomised controlled trial comparing nurse-led and GP-led management systems with usual care. Prof. John Campbell
COBRA Cost and Outcome of BehaviouRal Activation Prof. Dave Richards
CADENCE 
CAre in carDiac rEhabilitatioN serviCEs for patients with new onset depression  Prof. John Campbell
BAcPAc Integrating Behavioural Activation and Physical Activity promotion  Prof Paul Farrand
PREVENT Effectiveness and cost-effectiveness of mindfulness-based cognitive therapy compared with maintenance antidepressant treatment in the prevention of depressive
relapse or recurrence
Prof William Kuyken (formerly Department of Psychology, Exeter)

SPA

Singing groups to help improve wellbeing for those with post-stroke aphasia Dr Mark Tarrant
REACH-HF Rehabilitation Enablement in Chronic Heart Failure Prof. Rod Taylor and  Dr Hayes Dalal 
HeLP The Healthy Lifestyles Programme Trial
ISRCTN description
Assoc. Prof Katrina Wyatt
STARS Supporting Teachers and Children in Schools
ISRCTN description
Prof. Tamsin Ford
PANTS Personalising Anti-TNF therapy in Crohn disease Dr Tariq Ahmad
ExTraMATCH II Exercise training for chronic heart failure Prof Rod Taylor
IMPROVE-2 Implementing multifactorial psychotherapy research in online virtual environments
ISRCTN description
Prof. Ed Watkins