Active Trials‌

‌We form part of the research group within the Department of Health Sciences and our expert team conduct rigorous randomised trials, provide academic leadership in trial design and support to external trials with an aim to improve healthcare, education, and crime and justice.

If you can't find the trial you are looking for, it is possible that it is no longer active and is now part of the list of completed trials.


Online Reading Support Abracadabra (ABRA)

A full-scale effectiveness randomised controlled trial of the ABRA intervention, a 20-week online literacy programme composed of phonic fluency and comprehension activities based around a series of age-appropriate texts designed to improve literacy outcomes for Year 1 pupils.

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Brushing RemInder 4 Good oral HealTh: the clinical and cost-effectiveness of a Short Messaging Service behaviour change programme to improve the oral health of young people living in deprived areas (BRIGHT)

The BRIGHT trial aims to investigate how effective a lesson in school about dental health followed by a series of text messages is in reducing tooth decay, increasing how often (and how well) young people brush their teeth and how much this would cost to run. 

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EAL in the mainstream classroom

This project, led by Louise Tracey in the Deparment of Education, is a CPD programme for teachers aimed to support EAL pupils in the mainstream classroom, with a particular focus on academic language. It is designed to enhance teachers’ language skills and enable them to provide more focused classroom provision for EAL pupils, thus reducing the need for specialist teachers and support staff for this cohort.

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EasyPeasy: Learning through play

This EEF-funded, two-arm, cluster randomised controlled trial aims to evaluate the effectiveness of the EasyPeasy intervention on the language and communication development of nursery-aged children.  EasyPeasy is a smartphone app for parents of pre-school aged children. The design of the app encourages positive habits of play and interaction at home by sending tailored prompts, encouragement, and reminders to parents.  A total of 102 schools have been randomised into the trial.

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Evaluating ‘Enhancing Pragmatic LAnguage skills for Young children with Social communication disorder’ (E-PLAYS): A feasibility study

The E-PLAYS project aims to evaluate the feasibility of delivering a full-scale randomised controlled trial of the E-PLAYS intervention, a computer based game for young children with social communication disorders. 

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Grammar for Writing (Effectiveness Trial)

This project, led by Louise Tracey in the Department of Education, will investigate how effective Grammar for Writing is in improving the writing skills in Year 6 pupils. Grammar for Writing is a way of teaching writing that helps pupils to understand how linguistic structures convey meaning, rather than teaching grammatical rules in the abstract. The teaching of the grammar is therefore explicit, but embedded in the context of teaching about writing genres (e.g. narrative fiction, persuasive writing). The aim is to improve pupils’ “metalinguistic awareness” – an understanding of the language choices they make when they write. The evaluation of Grammar for Writing involves Year 6 pupils in 155 primary schools across England.

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Independent Evaluation of using self-regulated strategy development (SRSD) and memorable experiences to improve writing quality (Calderdale 2)

The SRSD evaluation is a scaled up effectiveness trial which aims to build on insights learned in undertaking the efficacy trial. The study will evaluate two pragmatic cluster randomised controlled trials of the self-regulated strategy development (SRSD) and memorable experiences programme to improve writing quality in children leading up to their KS2 assessments. 

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Lexia, a computer-based independent learning system (ILS), was originally developed in the US to help pupils with dyslexia. Lexia Reading CORE 5 is designed for wider use and provides personalised, adaptive learning for all levels of ability. The aim of this efficacy trial is to assess how effective Lexia Reading CORE5 is in improving the reading skills of struggling readers in Year 2. The trial is being conducted in collaboration with the Department of Education.

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Maths Champions

This project will evaluate the effectiveness of Maths Champions on the mathematical development and skills of children aged 3 and 4 years who attend nursery for a minimum of 15 hours per week. It will also assess the impact of introducing and implementing the intervention on practitioners’ confidence and practice in Private, Voluntary and Independent (PVI) nursery settings.

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Project-Based Learning

Project-based learning is an approach to instruction in which all lessons and activities are organised around a single complex enquiry or project. For example, pupils might study the development of water-mill technology (combining history, physics, and applied mathematics), or create a presentation on whether a local business should expand during a recession (a task involving English, economics, and mathematics). By integrating different subjects and tying learning to real-world problems, the approach aims to make school more engaging and meaningful for pupils. The approach also seeks to make students more accountable (by requiring public displays of finished work) and to improve the quality of feedback that pupils receive (by requiring multiple iterations with a formal review after each). This programme is being delivered by the Innovation Unit, with input from partners at High Tech High and Buck Institute.

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This project aims to evaluate the effectiveness of ReflectED on maths and reading outcomes for pupils in both KS1 and KS2. ReflectED is a whole school intervention that was developed by Rosendale Primary School, it focusses on teaching metacognition skills to support student attainment. 

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This project will evaluate the impact of a game-based approach to whole-class teaching, developed by researchers at the University of Bristol and Manchester Metropolitan University (MMU), which uses uncertain rewards. Games are integrated with class teaching in science lessons to test pupils’ learning, with pupils working in teams.

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Tutor Trust Primary Tuition

This project aims to evaluate the effectiveness of the Tutor Trust tutoring programme for improving maths attainment at Key Stage 2 for children who are performing insecurely at or below age expected norms.

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Health Promotion

A randomised controlled feasibility trial of the Active Communication Education programme plus hearing-aid provision versus hearing-aid provision alone (ACE To HEAR).

The ACE To Hear study aims to evaluate a group intervention programme (ACE) designed to improve the communication of hearing impaired adults and their family members. This feasibility study aims to establish the feasibility of delivering ACE to unsuccessful new hearing-aid users three-months post-fitting.

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A randomised controlled trial investigating the feasibility and acceptability of high-intensity interval training and moderate-intensity continuous training in adults with inactive or mildly active Crohn’s disease

An evaluation of an out-of-court community-based Gateway intervention programme

This mixed methods study aims to examine the effectiveness of Gateway, out-of-court community based intervention, for improving the health and well-being for youth offenders aged 18-24 in a large City Policing District. Victim satisfaction and recidivism will also be explored.

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Gentle Years Yoga Trial (GYY)

This study aims to determine the clinical and cost-effectiveness of an adapted yoga programme (Gentle Years Yoga) for older adults with multimorbidity. The study includes an embedded process evaluation and four methodological Studies Within A Trial (SWATS).

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Muslim Communities Learning About Second-hand Smoke in Bangladesh (MCLASS II): An effectiveness-implementation hybrid study (MCLASS II)

The aim of the MCLASS II project is to develop and test the effectiveness and cost-effectiveness of a community-based intervention called 'Muslims for better Health', with or without Indoor Air Quality (IAQ) feedback, in reducing exposure to second-hand smoke in homes in Dhaka, Bangladesh.

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RCT and meta-analysis testing effectiveness and cost-effectiveness of a tailored text message programme (MiQuit) for smoking cessation in pregnancy

This study aims to determine whether or not a text message, smoking cessation self-help support programme (MiQuit) is effective when offered in addition to standard behavioural support for pregnant smokers.

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Patients At Care Transitions (PACT) Patient Panel

The aim of this research is to improve the safety and experience of care for elderly patients as they move from hospital to home, sometimes via intermediate care (support from health and social care services). This period is known as the 'transition'. Patients now spend less time in hospital than they did 10 years ago (5 days compared to 8 days). This can benefit both patients, who prefer to be at home, and hospitals, who can treat more patients if patient stays are shorter. However, this also means that patients leave hospital sicker with ongoing treatment needs (e.g. they may need wound or catheter care or changes to their medication). Therefore, the transition period can be a risky one, particularly for elderly patients with complex needs and who may be anxious, confused and disorientated. Elderly people are the highest users of the NHS and, with the number of people in the UK aged 75 and over set to double in the next 30 years, this group of patients is an important target for support to improve transitions of care. Government policy, described in the NHS Outcomes Framework 2015/2016, focuses on improving the experience of patients and the provision of safe patient care. In this programme of research we will try to understand and improve the experience, and safety, of care for elderly patients during transitions and, by doing so, reduce readmissions and NHS costs. We will do this by undertaking a programme of six inter-linked studies (described as work-packages (WP).

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Pharmacological and non-pharmacological interventions for non-respiratory sleep disturbances in children with neurodevelopmental disorders: a systematic review

Tobacco cessation within TB programmes: A ‘real world’ solution for countries with dual burden of disease

Double-blind, placebo controlled randomised trial to assess the effectiveness and cost-effectiveness of cytisine when added to behavioural support for tobacco cessation compared to behavioural support alone on tobacco cessation in pulmonary TB patients who smoke tobacco on a daily basis. The trial plans to recruit 2388 patients from TB health centres across Bangladesh, Nepal and Pakistan.

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Mental Health and Addiction

CASPER PLUS: Collaborative care in screen positive elders with major depressive disorders.

In this study we will conduct a large scale randomised trial of the effectiveness of screening and low intensity psychosocial interventions for older people (over 65s) with moderate to severe depression.

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Community Pharmacies Mood Intervention Study (CHEMIST): A Feasibility and Pilot Study

The CHEMIST study is being run by researchers in the University’s Department of Health Sciences in collaboration with Durham, Keele, Newcastle and UCL Universities. The study aims to evaluate the delivery of brief psychological support via community pharmacies to people living with long-term health conditions who will be at an increased risk of developing depression.

The first stage of the study will involve training staff from community pharmacies to deliver this brief psychological support (called Enhanced Support Intervention), recruiting a small number of people (maximum of 30) to receive the Enhanced Support Intervention and refining the study procedures and materials in preparation for the larger pilot stage. In the pilot study, up to 100 patients will be randomised to receive either the Enhanced Support Intervention or usual care.

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Connect project: Co-Production of Policing Evidence, Research and Training - Focus Mental Health

Connect is a collaborative project between the University of York and North Yorkshire Police on new approaches to dealing with mental health problems. 

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The Smoking Cessation in Pregnancy Incentives Trial (CPIT III): A Multi-centre phase III Randomised Controlled Trial

CPIT III is a large multi-centre trial which will determine the effectiveness and cost effectiveness of providing financial incentives, in the form of shopping vouchers, to pregnant smokers to engage with smoking cessation services and to quit smoking during and after pregnancy.

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RESPECT: Randomised Evaluation Sexual Health Promotion Evidence for Care and Treatment: A feasibility study of an intervention to promote sexual health for people with serious mental illness (SMI)

RESPECT aims to develop an evidence-supported and co-produced manualised sexual health intervention designed for people with SMI in the UK and assess the feasibility and acceptability of the intervention delivered within mental health services.

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In this study we will conduct a randomised controlled trial looking at the clinical and cost effectiveness of a “bespoke smoking cessation” intervention for people with severe mental ill health such as schizophrenia or bipolar disorder.

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Yorkshire Lung Screening Trial

The Yorkshire Lung Screening Trial will test screening in mobile vans in community settings in Leeds and work out which people should be invited. If lung screening was introduced across Yorkshire, hundreds of lives could be saved each year.

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Does Occupational Therapist led home environmental assessment and modification reduce falls among high risk older people? (OTIS)

OTIS is a multi-centred randomised controlled trial with an economic evaluation and nested qualitative study.  It is evaluating the clinical and cost effectiveness of a home environment assessment and modification, to reduce falls among older people.  

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Screening for osteoporosis in older women for the prevention of fractures (SCOOP)

Screening for osteoporosis in older women for the prevention of fractures.

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Placebo-controlled trial of methotrexate to treat painful knee osteoarthritis (PROMOTE)

A pragmatic, double-blind, randomised, placebo-controlled trial of methotrexate to treat painful knee osteoarthritis.

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Does slip resistant footwear reduce slips among healthcare workers? A randomised controlled trial. (SSHeW)

York Trials Unit (YTU), the University of York and the Health Safety Executive (HSE) are working with the NHS to test the effectiveness of slip resistant shoes for reducing slips and falls in the workplace.  

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STEPFORWARD: Patient acceptability of a novel prosthetic device

A multi-centre, randomised controlled, open feasibility study to evaluate the acceptability to patients and limb centres of randomisation to the two arms, and to assess the acceptability of, and adherence to, the intervention in a group of older patients with vascular-related amputations.

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Screening and Prevention

Cancer Diagnosis via Emergency Presentation Study (EMPRESS)

This study investigates what happens to patients in the period before an emergency presentation. The aim of the study is to determine whether there are differences in the pathway to diagnosis between patients who are diagnosed as an EP compared to those diagnosed via the 2WW pathway for lung and colorectal cancer.

The EMPRESS study is being funded by Cancer Research UK, and the Chief Investigator is Professor Una Macleod from the Hull York Medical School (HYMS) Primary Care and Palliative Care Research Group

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LEISH Sudan: A Phase IIa/IIb clinical trial to evaluate the therapeutic efficacy of ChAd63-KH vaccine in patients with persistent post kala-azar dermal leishmaniasis (PKDL)

Visceral leishmaniasis (or kala azar) is a chronic and life threatening parasitic disease caused by infection with Leishmania donovani and L. infantum. There are approximately 400,000 new cases each year, mainly in Sudan, South Sudan, India, Bangladesh, Ethiopia and Brazil, with a case fatality rate of ~10%.

Although a handful of drugs are available, efficacy varies geographically and emerging drug resistance is a major threat. In East Africa and South East Asia, the lack of complete efficacy of these drugs can also lead to patients developing a chronic and stigmatizing skin disease, called post kala azar dermal leishmaniasis (PKDL). The development of new preventative and/or therapeutic measures to combat this infection is therefore a major international research priority.

An international research team, led by Professor Paul Kaye at the University of York, has developed a new adenovirus-based vaccine for visceral leishmaniasis, which has shown efficacy in animal models and safety and immunogenicity in a human Phase I clinical trial. This new study is funded by The Wellcome Trust, and will allow the team to evaluate the vaccine for safety and therapeutic efficacy in Sudanese patients with persistent PKDL.

The study will first identify a safe dose of the vaccine to use in adults and children with PKDL and then proceed to test whether a single dose therapeutic immunization can stimulate immune responses leading to clinical cure or reduction in symptoms. If successful, these clinical trials will determine whether therapeutic vaccination has the potential to be developed further, as an alternative treatment option for patients with PKDL and perhaps other forms of leishmaniasis.

Surgical Trials

Articular Pilon Fracture Trial (ACTIVE)

The aim of this study is to investigate the clinical and cost-effectiveness of internal plate fixation versus external fine wire fixation for the management of Type C, closed pilon fractures of the distal tibia.

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Dupuytren's Interventions: Surgery vs Collagenase (DISC)

A pragmatic, randomised, non inferiority trial comparing injections of collagenase to surgical correction in the treatment of moderate Dupuytren's contracture.

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FARSTER: Feasibility Study of Early Outpatient Review and Early Cardiac Rehabilitation After Coronary Artery Bypass Grafting: Mixed Methods Research Design.

In the UK, heart operations have steadily increased since 2010. Of 36,134 operations performed in 2013, 17,630 were isolated coronary artery bypass grafting (CABG). Our proposed study will examine the feasibility of bringing forward outpatient review and cardiac rehabilitation, in order to facilitate recovery, physical fitness and quality of life. 

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A Randomised Controlled Trial of the effect of a Two-layer Compression Bandage System on Knee Function following Total Knee Arthroplasty (KReBs)

The objective is to determine the effectiveness and cost-effectiveness of a two layer compression bandage compared to standard wool and crepe bandage post-operatively on patient reported outcomes following total knee replacement surgery.

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L1FE : Lateral Compression Type-1 fracture fixation in the elderly

The aim of this study is to investigate the clinical and cost effectiveness of surgical fixation with INFIX compared to non-surgical management of LC-1 fragility fractures in older adults.

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Occupational advice for Patients undergoing Arthroplasty of the Lower limb (OPAL)

Hip and knee arthritis causes pain which limits physical function and can affect ability to work. Hip and knee replacements are proven to relieve pain and improve function, and help many patients of working age to continue working or get back to work. Currently there is variation in the advice and support given about sickness absence, recovery to usual activities and return to work after these procedures. Earlier, sustainable, return to work improves the health of patients and benefits their employers and society. It is therefore important to better understand what is currently being done and how current care can be improved. 

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Pragmatic Randomised Evaluation of Stable Thoracolumbar fracture treatment Outcomes (PRESTO)

The aim of this study is to establish whether it is feasible to deliver a trial comparing surgical fixation to initial non-operative management for patients with a relatively stable thoracolumbar fracture without spinal cord injury.

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PROximal Fracture of the Humerus: Evaluation by Randomisation Trial no. 2 (PROFHER-2 Trial)

A three-arm randomised controlled trial to assess the effectiveness and cost-effectiveness of Reverse Shoulder Arthroplasty versus Hemiarthroplasty versus Non-surgical care for acute three and four-part fractures of the proximal humerus in older adults.

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Scaling Up Quality Improvement for Surgical Teams (QIST)

Patient safety initiative to reduce complications from surgery by implementing two separate quality improvement initiatives using the Institute for Health Improvement (IHI) Breakthrough Series Collaborative model.

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SWHSI-2 A pragmatic multicentre randomised controlled trial to assess the clinical and cost effectiveness of negative pressure wound therapy versus usual care for surgical wounds healing by secondary intention

A two-arm randomised controlled trial to assess the effectiveness and cost-effectiveness of negative pressure wound therapy (NPWT) versus usual care (no NPWT) for surgical wounds healing by secondary intention.

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Scaphoid Waist Internal Fixation for Fractures (SWIFFT)

Aims to obtain reliable evidence about whether adults with a fracture of the scaphoid waist should receive plaster cast treatment or surgical fixation.

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UK FROST: United Kingdom Frozen Shoulder Trial

UK FROST is a multi-centre randomised controlled trial with economic evaluation and nested qualitative study comparing early structured physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a frozen shoulder (Adhesive Capsulitis).

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