Peninsula Clinical Trials Unit: Non-CTIMPs

The following trials are fully managed

ART*

Title: Does early mobilisation after Ankle fracture surgery enhance Recovery? A pragmatic multi-centre randomised controlled Trial with qualitative component and health economic analysis comparing the use of plaster versus support boot.

Chief investigator: Mr Anuraag Sangar, Poole Hospital NHS Foundation Trust

Engager II*

Title: Developing and evaluating a collaborative care intervention for prisoners, with common mental health problems, near to and after release.

Chief investigator: Dr Richard Byng, PUPSMD, Plymouth University

e-coachER

Title: A multi-centred RCT of an augmented exercise referral scheme using web-based behavioural support in individuals with metabolic, musculo-skeletal and mental health conditions.

Chief investigator: Professor Adrian Taylor, PUPSMD, Plymouth University

MCL Biobank

Title: Establishing a biobank and database as a national resource for characterising indolent and aggressive forms of mantle cell lymphoma.

Chief investigator: Professor Simon Rule, Plymouth Hospitals NHS Trust

CRUK

Reach-HF

Title: Rehabilitation enablement in chronic heart failure – A programme of research to develop and evaluate a home-based intervention for patients with heart failure.

Chief investigator: Dr Hasnain Dalal, Royal Cornwall Hospitals NHS Trust

ISRCTN78539530       Protocol paper

SAFE

Title: A study to establish the feasibility of a definitive randomised controlled trial evaluating SAFE, an intervention for families of children with autism.

Chief investigator: Dr Rebecca McKenzie, Faculty of Arts and Humanities, Plymouth University


SWIMS

Title: The South West impact of multiple sclerosis project – a patient-orientated  longitudinal study of the impact of multiple sclerosis in South West England.

Chief investigator: Professor John Zajicek, University of St Andrews

TACIT

Title: Developing a sustainable research programme to prevent falls and promote physical activity among older people with dementia.

Chief investigator: Dr Samuel Nyman, Bournemouth University

TOPS-UK

Title: A study to test the methods and costs of an online programme for adolescents who have survived a brain injury: Teen online problem solving (TOPS-UK).

Chief Investigator: Dr Anna Adlam, University of Exeter

ISRCTN10906069

The following trials are supported through the provision of randomisation and/or data services

ADepT

Title: Improving depression treatment outcomes by better repairing positivity deficits: Development and pilot randomised controlled trial evaluation of a novel psychosocial therapy.

Chief investigator: Dr Barnaby Dunn, University of Exeter

Study website

Cadence

Title: A feasibility study and pilot study to establish methods for assessing the acceptability, and clinical and cost-effectiveness of enhanced psychological care in cardiac rehabilitation services for patients with new onset depression compared with usual care.

Chief investigator: Professor John Campbell, University of Exeter

Compod

Title: Community-based Prevention of Diabetes (ComPoD): A randomised trial with a waiting list control group to evaluate the effectiveness and cost-effectiveness of a third sector led, community-based diabetes prevention programme.

Chief investigators: Dr Colin Greaves and Dr Jane Smith, University of Exeter

HeART of Stroke

Title: A feasibility study of a randomised controlled trial of an Arts for Health group intervention to support self-confidence and psychological wellbeing following a stroke.

Chief investigator: Dr Caroline Ellis-Hill, Bournemouth University

Improve II

Title: Integrating multifactorial psychotherapy research in an NHS Setting: A fractional factorial randomised trial delivering internet psychotherapy for depression.

Chief investigator: Professor Edward Watkins, University of Exeter

MYRIAD

Title: Promoting mental health and building resilience in adolescence: Investigating mindfulness and attentional control.

Chief investigator: Professor Mark Williams,  University of Oxford

Study Website    ISRCTN86619085

REACT

Title: A randomised controlled trial and economic evaluation of a community-based physical activity intervention to prevent mobility-related disability for retired older people. The REACT (REtirement in ACTion) study.

Chief investigator: Dr Afroditi Stathi, University of Bath

Study website    ISRCTN45627165

STARS

Title: The effectiveness and cost effectiveness of the incredible years teacher classroom management programme in primary school children: a cluster RCT with parallel economic and process evaluations.

Chief Investigator: Professor Tamsin Ford, University of Exeter

Study website    ISRCTN84130388

STEPS

Title: The effectiveness of peroneal nerve functional electrical stimulation (FES) for improving mobility in Parkinson’s disease: A pragmatic two site feasibility study for an assessor blinded randomised control trial (STEPS).

Chief investigator: Dr Paul Taylor, Salisbury NHS Foundation Trust

SUMS

Title: A multi-centre randomised controlled trial to assess the effectiveness and cost effectiveness of a home-based self-management standing frame programme in people with progressive MS.

Chief investigator: Dr Jenny Freeman, Plymouth University

Study website       ISRCTN69614598


* PenCTU provides senior trial management oversight in these projects in addition to full data management services