Peninsula Clinical Trials Unit: Publications

2023

The e-coachER Study – Mental Health and Physical Activity – June 2023
Adding web-based support to exercise referral schemes improves symptoms of depression in people with elevated depressive symptoms: A secondary analysis of the e-coachER randomised controlled trial

The MATE study – Pilot and Feasibility Studies – April 2023
A multicentre, mixed-methodology, pilot, randomised controlled trial in neovascular age-related macular degeneration

The TARS study – Addiction – March 2023
Effectiveness and cost-effectiveness of behavioural support for prolonged abstinence for smokers wishing to reduce but not quit: Randomised controlled trial of physical activity assisted reduction of smoking

The Attachment Study – NIHR Journal – February 2023
Routinely used interventions to improve attachment in infants and young children: a national survey and two systematic reviews

The DIADS Study – International Journal of Environmental Research and Public Health – January 2023
Comparison of Diagnostic Profiles of Deaf and Hearing Children with a Diagnosis of Autism

2022

The PD-Stat Study – Jama Neurology – October 2022
Evaluation of Simvastatin as a Disease-Modifying Treatment for Patients With Parkinson Disease

The e-coachER Study – International Journal of Behavioral Nutrition and Physical Activity – September 2022
A process evaluation, with mediation analysis, of a web-based intervention to augment primary care exercise referral schemes: the e-coachER randomised controlled trial

The BREATHE Study – ERJ Open – August 2022
Mixed-methods feasibility cluster randomised controlled trial of a paramedic-administered breathlessness management intervention for acute-on-chronic breathlessness

The PD Stat Study – Journal of Parkinson's Disease – July 2022
Challenges of Incorporating Digital Health Technology Outcomes in a Clinical Trial: Experiences from PD STAT

The PD Stat Study – Journal of Parkinson's Disease – July 2022
Enhancing Trial Delivery in Parkinson’s Disease: Qualitative Insights from PD STAT

The COVID-19 Study – JMIR Aging – April 2022
Implementing Affordable Socially Assistive Pet Robots in Care Homes Before and During the COVID-19 Pandemic: Stratified Cluster Randomized Controlled Trial and Mixed Methods Study

The SPIRES Study – Pilot and Feasibility Studies – March 2022
Functional standing frame programme early after severe sub-acute stroke (SPIRES): a randomised controlled feasibility trial

2021

The MaKKRO trial – Bone & Joint Open – November 2021
A randomized controlled trial comparing functional outcomes for navigated kinematically aligned total knee arthroplasty versus navigated mechanically aligned total knee arthroplasty

Mental Health Provision in UK Secondary Schools – MDPI – November 2021
Research reports high levels of mental health problems faced by young people in the UK. Schools provide a range of mental health support services, although these are often not robustly evaluated

Health risk behaviours among people with severe mental ill health during the COVID-19 pandemic – PLOS One – October 2021
Analysis of linked cohort data

The ADIR-Deaf Adaptation and the ADOS-2 Deaf Adaptation – Journal of Clinical Medicine – September 2021
Diagnosing Autism Spectrum Disorders in Deaf Children Using Two Standardised Assessment Instruments: The ADIR-Deaf Adaptation and the ADOS-2 Deaf Adaptation

The FLYBITE Study – Wellcome Open Research – June 2021
A clinical study to optimise a sand fly biting protocol for use in a controlled human infection model of cutaneous leishmaniasis

Ferric Derisomaltose (FDI) – BMC Nephrology – March 2021
A multicentre prospective double blinded randomised controlled trial of intravenous iron (ferric Derisomaltose (FDI)) in Iron deficient but not anaemic patients with chronic kidney disease on functional status

The ADOS-2 Study – Journal of Autism and Developmental Disorders – March 2021
Adapting and validating the Autism Diagnostic Observation Schedule Version 2 for use with deaf children and young people

The CANDO Study – Brain, Behaviour, & Immunity - Health – February 2021
Assessment of Cytokines, microRNA and patient related outcome measures in Conversion Disorder/Functional Neurological Disorder (CD/FND): the CANDO clinical feasibility study

The MP Rapid 2019-NCOV Study – Sage Journals – February 2021
Evaluation of the MP Rapid 2019-NCOV IgM/IgG combo POCT test vs. an established platform-based method

The NoPAC Study – Annals of Emergency Medicine – February 2021
The Use of Tranexamic Acid to Reduce the Need for Nasal Packing in Epistaxis (NoPAC): Randomized Controlled Trial

The REACH-HF Study – NIHR Journals – February 2021
A facilitated home-based cardiac rehabilitation intervention for people with heart failure and their caregivers: a research programme including the REACH-HF RCT

The EXPRESS Study – Annals of Clinical Biochemistry – February 2021
Evaluation of the MP Rapid 2019-NCOV IgM/IgG Combo POCT test vs an established platform-based method

The PINS Study – The Bone & Joint Journal – February 2021
A prospective randomised clinical trial comparing a traditional versus an emollient skincare regimen for the care of pin-sites in patients with circular frames

The NAT-C Study – January 2021
A cluster randomised trial of a Needs Assessment Tool for adult Cancer patients and their carers (NAT-C) in primary care: A feasibility study

The SARS-CoV-2 Study – Clinical Medicine Journal – January 2021
Review of hygiene adaptations among UK doctors in controlling the spread of SARS-CoV-2 infection

The BRiMS Study – BMC – January 2021
Balance Right in Multiple Sclerosis (BRiMS): a feasibility randomised controlled trial of a falls prevention programme

2020

The STEPS Study – Clinical Rehabilitation – December 2020
The effectiveness of peroneal nerve functional electrical simulation for the reduction of bradykinesia in Parkinson’s disease: A feasibility study for a randomised control trial

The SAFE Study – BMJ Open – December 2020
SAFE, a new therapeutic intervention for families of children with autism: a randomised controlled feasibility trial

The e-coachER Study – NIHR Journals – November 2020
Adding web-based behavioural support to exercise referral schemes for inactive adults with chronic health conditions: the e-coachER RCT

The e-coachER Study – British Journals of Sports Medicine – November 2020
Randomised controlled trial of an augmented exercise referral scheme using web-based behavioural support for inactive adults with chronic health conditions: the e-coachER trial

The SUMS Study – BMJ Open – October 2020
“I’m in a very good frame of mind”: a qualitative exploration of the experience of standing frame use in people with progressive multiple sclerosis

The LoDED Study – Heart – March 2020
Limit of detection of troponin discharge strategy versus usual care: randomised controlled trial

2010 - 2019

The TACIT Study – Clinical Interventions in Aging – November 2019
Randomised Controlled Trial Of The Effect Of Tai Chi On Postural Balance Of People With Dementia

The SUMS Study – The Lancet Neurology – July 2019
Assessment of a home-based standing frame programme in people with progressive multiple sclerosis (SUMS): a pragmatic, multi-centre, randomised, controlled trial and cost-effectiveness analysis

The BRiMS Study – NIHR Journals Library – June 2019
A self-management programme to reduce falls and improve safe mobility in people with secondary progressive MS: the BRiMS feasibility RCT

The REACH-HF Study – European Journal of Preventive Cardiology – March 2019
The cost effectiveness of REACH-HF and home-based cardiac rehabilitation compared with the usual medical care for heart failure with reduced ejection fraction: A decision model-based analysis

The Heart of Stroke Study – BMJ Open – March 2019
HeART of Stroke: randomised controlled, parallel-arm, feasibility study of a community-based arts and health intervention plus usual care
compared with usual care to increase psychological well-being in people following a stroke

The Sorafenib Study – Journal of Neurology, Neurosurgery & Psychiatry – February 2019
Phase 0 trial investigating the intratumoural concentration and activity of sorafenib in neurofibromatosis type 2

The PASTIES (chronic pain follow-up study) – Anaesthesia – October 2018
The impact of emergency department patient-controlled analgesia (PCA) on the incidence of chronic pain following trauma and non-traumatic abdominal pain

The REACH-HF Study – European Journal of Preventive Cardiology – October 2018
The effects and costs of home-based rehabilitation for heart failure with reduced ejection fraction: The REACH-HF multicentre randomized controlled trial

The REACH-HFpEF Pilot Study – BMJ Open – March 2018
A randomised controlled trial of a facilitated home-based rehabilitation intervention in patients with heart failure with preserved ejection fraction and their caregivers

The HeLP Trial – Paediatric Exercise Science – March 2018
Children's compliance with wrist worn accelerometry within a cluster randomised controlled trial: Findings from The Healthy Lifestyles Programme (HeLP)

The HeLP Trial – NIHR Journals Library – January 2018
Cluster randomised controlled trial and economic and process evaluation to determine the effectiveness and cost effectiveness of a novel intervention [Healthy Lifestyles Programme (HeLP)] to prevent obesity in school children

The HeLP Trial – The Lancet Child & Adolescent Health – November 2017
Effectiveness of the Healthy Lifestyles Programme (HeLP) to prevent obesity in UK primary-school children: a cluster randomised controlled trial

The HeLP Trial – International Journal of Behavioral Nutrition and Physical Activity – November 2017
Intervention fidelity in the definitive cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP) trial: findings from the process evaluation

The STOPCUTS Trial – Pilot and Feasibility Studies – October 2017
Pilot parallel randomised controlled trial of protective socks against usual care to reduce skin tears in high risk people

Cost-effectiveness of screening for permanent hearing loss in children at school entry – BMJ Open – July 2017
A directly comparative two-gate case–control diagnostic accuracy study of the pure tone screen and HearCheck screener tests for identifying hearing impairment in school children

The DeCoDer Trial – NIHR Journals Library – June 2017
The data Debt Counselling for Depression in Primary Care: An Adaptive Randomised Controlled Pilot Trial

The PASTIES Trial – Association of Anaesthetists – May 2017
The cost‐effectiveness of patient‐controlled analgesia vs. standard care in patients presenting to the Emergency Department in pain, who are subsequently admitted to hospital

The HeLP Trial – BMC Public Health – April 2017
Trial baseline characteristics of a cluster randomised controlled trial of a school-located obesity prevention programme; the Healthy Lifestyles Programme (HeLP) trial

The DIAT Trial – BMJ Open – March 2017
A pre-consultation web-based tool to generate an agenda for discussion in diabetes outpatient clinics to improve patient outcomes (DIAT): a feasibility study

The HeLP Trial – BMC Public Health – December 2016
Detailed statistical analysis plan for a cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP), a novel school-based intervention to prevent obesity in school children

The SES Trial – NIHR Journals Library – May 2016
A programme of studies including assessment of diagnostic accuracy of school hearing screening tests and a cost-effectiveness model of school entry hearing screening programmes

The TWIST Trial – Clinical Rehabilitation – February 2016
Does the use of Nintendo Wii Sports TM improve arm function? Trial of Wii TM in Stroke: A randomised controlled trial and economics analysis

The Scrutiknee Trial – Pilot and Feasibility Studies – February 2016
Western medical acupuncture in a group setting for knee osteoarthritis: results of a pilot randomised controlled trial

The REACH-HF Trial – Chronic Illness – December 2015
Needs of caregivers in heart failure management: A qualitative study

The REVERT Trial – The Lancet – August 2015
Postural modification to the standard Valsalva manoeuvre for emergency treatment of supraventricular tachycardias (REVERT): a randomised controlled trial

The PASTIES Trial – British Medical Journal – May 2015
PAin SoluTions In the Emergency Setting (PASTIES) - patient controlled analgesia versus routine care in emergency department patients with pain from traumatic injuries: randomised trial

The PASTIES Trial – British Medical Journal – April 2015
PAin SoluTions In the Emergency Setting (PASTIES) - patient controlled analgesia versus routine care in emergency department patients with non-traumatic abdominal pain: randomised trial

The TWIST Trial – Clinical Rehabilitation – March 2015
Participant and caregiver experience of the Nintendo Wii Sports TM after stroke: qualitative study of the trial of Wii TM in stroke (TWIST)

The CUPID Trial – NIHR Journals Library – February 2015
The Cannabinoid Use in Progressive Inflammatory brain Disease (CUPID) trial: a randomised double-blind placebo-controlled parallel-group multicentre trial and economic evaluation of cannabinoids to slow progression in multiple sclerosis

The CUPID Trial – Lancet Neurology – September 2013
Effect of dronabinol on progression in progressive multiple sclerosis (CUPID): a randomised, placebo-controlled trial

The South West Impact of Multiple Sclerosis (SWIMS) Trial – BMC Neurology – October 2010
Patient-orientated longitudinal study of multiple sclerosis in south west England (The South West Impact of Multiple Sclerosis Project, SWIMS) 1: protocol and baseline characteristics of cohort

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