HHTU News Roundup

DOORstep wins poster award

Dr Charlotte Kelly and Dr Mahe Haji Sadeghi attended the first Women’s Health Conference and won the publicly voted first prize was awarded to the poster for the DOORstep study, a Hull Health Trials Unit managed study funded by Yorkshire Cancer Research. DOORstep is a study looking at whether offering free transport to breast screening appointments increases attendance rates. Huge congratulations to the entire DOORstep team, including Charlotte and Mahe who are pictured here with the winning poster.

The Women’s Health Conference 2026 took place at the University of Hull and brought together leaders in research, healthcare, policy, and community support, all dedicated to improving the health and wellbeing of women and girls. It was extremely well received by everyone from the HHTU who attended.

Congratulations once again to the DOORstep team on this fantastic achievement.

MOI-A team attends conference

The MOI-A study team was delighted to attend IDR26, the International Drug Repurposing Conference in Brussels, represented by Amy Wilkinson (Trial Manager), Judith Cohen (HHTU Director), Professor Nick Bishop (Chief Investigator), and Charlotte Heath (Sponsor Representative).

Over two inspiring days, delegates from across the globe—including researchers, clinicians, patients, and parents—came together to explore the current landscape and future potential of drug repurposing, particularly for rare diseases. The conference showcased exciting developments in the field, including the growing role of artificial intelligence in identifying new therapeutic opportunities and highlighting ongoing studies driving innovation. As the MOI-A study investigates the repurposing of losartan as a potential treatment for osteogenesis imperfecta (OI), a rare genetic condition, it was especially valuable to engage with the wider drug repurposing community.

MOI-A is proud to be one of the demonstration projects within the REMEDi4All consortium, which organised this excellent event. The conference highlighted the significant progress being made across the field and reinforced the importance of collaboration in accelerating access to new treatment options for people living with rare diseases.

RE-SCAIT is open!

RE-SCAIT is a 6 stage study that has recently opened with the first work package (WP). WP 1b involves co-design workshops with healthcare professionals from participating NHS Trusts. The aim is to develop an effective implementation strategy to increase the chances of successful implementation of a waking salivary cortisone (WSC) test for the diagnosis of adrenal insufficiency into routine clinical practice. Recently the first 2 sites in WP1b have been greenlighted and the workshops are being arranged.

These are the first steps in this interesting study and we look forward to seeing how the study progresses over time.

Other May project headlines:

You can find more about each project here.

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HHTU News Roundup

Yorkshire Cancer Research walk

Researchers, people affected by cancer and charity supporters are taking part in a Yorkshire-wide baton relay as part of this year’s We Walk for Yorkshire challenge. Throughout May, the Baton for Yorkshire will pass through 35 locations across the region, symbolising the 35,000 people diagnosed with cancer in Yorkshire each year.

We have 4 current clinical trials funded by YCR and another 4 data analysis studies in the Data Safe Haven. NeoRehab is one of the clinical trials and is exploring how improving fitness in people with lung cancer can influence their surgical outcomes.

It was an honour for Team NeoRehab to help kick off the baton relay, with Chief Investigator Dr Cecilia Pompili receiving the baton from the Active Together team at the start of this month‑long journey. Dr Pompili and NeoRehab Trial Manager Grant Constable then completed the next leg of the relay, handing the baton on to Yorkshire Cancer Research supporters Smailes Goldie.

IMPACT-W Update

IMPACT W is led by Laura Hermann a HHTU based PhD staff member and the study is aiming to improve the recruitment of women to clinical trials. The study continues to recruit well, with two additional staff focus groups completed, bringing the total to nine staff participants and 14 participants from the general public recruited to date. There are now five sites actively identifying participants for the study across primary, secondary, mental health and community healthcare settings. These participants are clinical staff members and also people that have declined to take part in research. We are really interested to see what the results of Laura’s investigations are.

Results paper published

A results paper from the Lincolnshire POACHER study, for which our Director Judith Cohen was a co-applicant, has now been published. HHTU also supported the study by providing the electronic data capture platform through REDCap Cloud.

The randomized controlled trial investigated whether organic disease may be masquerading as irritable bowel syndrome (IBS). IBS is a chronic relapsing disorder for which there are currently limited diagnostic investigations when patients present with IBS-like symptoms. However, around 50% of patients do not improve following the standard diagnostic approach, suggesting that alternative underlying conditions may be missed.

Participants in the study were randomized to receive either standard care based on National Institute for Health and Care Excellence guidelines or an intervention. The intervention involved research nurse-led structured investigations designed to identify organic pathology including treatment protocols targeting abnormal investigation results.

The study found that among 74% of intervention participants who completed the intervention, appropriate treatment of alternative diagnoses led to sustained clinical improvement.

BREEZE-2 recruitment competition

And finally we couldn’t not share the very cute spring version of BREEZE-2 recruitment competition. Well done to the Wolverhampton site for securing first place. We are already looking forward to seeing what the summer recruitment competiotion will look like.

Other April project headlines:

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HHTU News Roundup

ProACTIVE update

The proactive study is a 4 stage work package evaluating Alcohol Care Teams (ACTs). It is funded by NIHR Health and Social Care Delivery (HSDR) and sponsored by the University of Southampton. Prof Tom Phillips at the University of Hull and Prof Julia Sinclair at the University of Southampton are the chief investigators. ACTs are specialist services within hospitals that provide care for people with alcohol-related problems. Not all hospitals in England have an alcohol care team and there is limited evidence about the effectiveness of ACTs for the people who receive care from them.

ProACTIVE Work Package 2a (WP2a) is assessing the effectiveness of alcohol care teams by comparing the outcomes of people with alcohol-related problems who attended hospitals with alcohol care teams, Optimised Alcohol Care Teams (OACT) to those who attended hospitals with none, Non Optimised Alcohol Care Teams (NoACT).

Total recruitment in WP2a to date is 472 participants. OACT sites have completed recruitment with 244 participants and they are now closed to recruitment. NoACT sites are still open to recruitment and have recruited 228 participants to date. This includes 8 participants recruited in March.

The study is following up patients for six months to evaluate the impact of ACTs on patient and service outcomes. A total of 433 six-month follow-ups have been completed, representing a completion rate of over 70%. 16 follow-ups were completed in March.

DAMPen-D 2 study update

Around one third of people have delirium on admission to a Palliative Care Units (PCUs) and another third develop it during their stay; delirium causes distress, functional decline, higher care needs and unplanned hospital admissions. National guidance exists but it is hard for PCUs to implement because delirium care is complex and involves many people (Staff, family, carers). 

We are aiming to improve the Detection, Assessment, Management and Prevention of Delirium through our intervention training with PCU staff. We have developed this intervention and are now looking to roll this our across PCUs in the UK.

We are working with 20 Palliative Care Units across England, Scotland and Wales where 10 will have this Intervention and 10 will continue with usual care. 

The study is funded by the National Institute for Health Research. The study design has an initial pilot phase to identify any issues that would point to the study design not working. We are delighted to have passed this pilot phase and are now underway with the main study. 

As of April 2026, we have 15 sites up and running with two further sites very close to being greenlighted. Recruitment is going to finish at the end of year but there has been an excellent start.

New Data Manager

We are delighted to welcome a new member to the team. Deepika Reddy joins us as a Data Manager. Deepika joins us with a background working in large Contract Research Organisations (CROs), bringing valuable experience in professional services support within complex research environments.  She will be working across the portfolio to support the delivery of high-quality clinical trials and research studies. We’re excited to have Deepika on board and look forward to working together.

HHTU are taking part in FACTS

We are underway with Flourishing As Clinical Trial Staff (FACTS) where we are adopting a number of working practices to promote wellbeing within the Trials unit. FACTs is a Nottingham Clinical Trials Unit managed study which aims to target the unique challenges brought by working within clinical trials within the UK. The study is looking at how their guidance (developed from survey data collected 484 participants from UK Clinical Trials Units and focus groups) is implemented in our Clinical Trials Unit. This includes social activities and challenges for our staff. Look out for further updates on this throughout the year.

Other March project headlines:

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HHTU News Roundup

Protocol paper published

The protocol for the STARLIT-3 Study has been published in BMJ Open.

STARLIT-3 is led by Dr Charlotte Elder at the University of Sheffield and managed by Kathryn Date here at the HHTU. It is the third study of the STARLIT programme of work.

The study is evaluating a novel, needle-free approach to diagnosing adrenal insufficiency — using Nasacthin nasal spray and salivary cortisol measurement instead of the injections and blood samples required for the Short Synacthen Test.

This randomised 2-way crossover trial will recruit 32 patients with adrenal insufficiency across Sheffield Children’s Hospital and Royal Hallamshire Hospital. Participants will receive both Synacthen and Nasacthin in a random order across two study visits. Paired blood and saliva samples will be collected at baseline, and at 30 and 60 minutes after drug administration.

The study will then compare glucocorticoid levels to determine whether the Nasacthin test can accurately diagnose adrenal insufficiency, alongside assessing safety, tolerability, usability and patient acceptability.

This work could represent an important step forward in making adrenal insufficiency testing less invasive and more accessible.

The study is funded by the Medical Research Council and sponsored by Sheffield Children’s NHS Foundation Trust.

You can read the full protocol here: https://bmjopen.bmj.com/content/16/2/e112708.full

Researcher recruitment

It’s a busy time for recruiting researchers around here at the moment. 1 post working on DESTIGMATISE has just closed but there are still 3 researcher jobs currently live on the University of Hull Jobs page. These are working for clinical trials that are being delivered in collaboration with the HHTU.

You can read about the 3 roles below and the studies they will be working on below. This will also give you a sneak peak into 4 of our studies currently in set up!!

Postdoctoral Researcher in Implementation Science (Closing date 12 March)

The successful applicant will play a major role in delivering the NEWDAY-ABC process evaluation (60%) and Re-SCAIT work packages (40%), contributing as appropriate in each study to obtaining research governance and ethical approvals, conducting and analysing qualitative semi-structured interviews with study participants, health professionals & managers, non-participant observation and analysis of intervention delivery, and experience-based co-design workshops for implementation strategy development and tailoring/optimisation. Achieving the duties of the post will require active collaboration with the studies’ public involvement members and study leads/partners at the University of Hull, University of Sheffield, and study sites.

https://uoh.wd103.myworkdayjobs.com/en-GB/University_of_Hull_Careers/details/Postdoctoral-Researcher-in-Implementation-Science_JR101994

Qualitative Research Fellow (STEPFORWARD) (Closing date 19 March)

The post holder will undertake the qualitative work within the STEPFORWARD trial. The trial starts with an internal pilot study within which an embedded qualitative process evaluation will run to understand the acceptability of the intervention and trial processes. During the pilot study the postholder will interview trial consenters and decliners to capture their experience of the trial, and with staff to identify barriers and facilitators to recruitment. The postholder will use the data to inform and amend the recruitment strategy as required. The postholder will also conduct interviews with participants after the prosthesis is fitted to understand engagement and prosthesis use.

During the main part of the trial, as part of the SWAT, the postholder will complete semi-structured interviews with site staff and participants to explore the acceptability of using AI technology during recruitment. Towards the end of the trial the postholder will use surveys and interviews with staff to develop an implementation plan using Normalisation Process Theory (NPT).

https://uoh.wd103.myworkdayjobs.com/en-GB/University_of_Hull_Careers/details/Qualitative-Research-Fellow–STEPFORWARD-_JR102077

Qualitative Research Fellow (Neorehab) (Closing date 19 March)

The post holder will undertake the qualitative work within the NEOREHAB trial. This will include focus groups with stakeholders (clinicians, exercise physiologists, patients) to refine the intervention; semi-structured interviews with patients and clinicians in the early months of the trial to pro-actively identify any issues with study processes; further interviews with patients and clinicians to gain an in-depth understanding of trial feasibility and acceptability.

At the end of the study the post holder will also interview patients and clinicians from different specialities to explore ways care could be redesigned, which clinicians should monitor patients, and how best to support patients.

https://uoh.wd103.myworkdayjobs.com/en-GB/University_of_Hull_Careers/details/Qualitative-Research-Fellow–Neorehab-_JR102074

Other February headlines:

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HHTU News Roundup

CONIFAS2 is live

We’re delighted to share that Co-produced nature-based intervention feasibility for children with ADHD Study (CONIFAS2) is now open to recruitment! This study is led by Dr Hannah Armitt with Kathryn Date managing the trial at HHTU.

CONIFAS2 is intervention is a home-based, family-led intervention delivered with professional third-party telephone support. It encourages daily engagement with nature for at least 10 minutes, including activity cards and supportive psychoeducational elements. CONIFAS2 is ready to be tested in NHS funded neurodiversity services assessing the feasibility and acceptability of a full-scale effectiveness trial.

Protocol Paper Published

DOORStep have a newly published protocol paper in BMJ Open. This study assesses whether offering free, bookable, door-to-door transport to and from breast cancer screening appointments could increase screening attendance. This cluster-randomised GP feasibility trial is funded by Yorkshire Cancer Research, led by Chief Investigator Charlotte Kelly, and managed by Mahboobeh Haji Sadeghi at the Hull Health Trials Unit. The photo below is DOORStep team member outside a breast screening van where attendees were encouraged to complete a travel survey. This stage of the study is complete and analysis is now taking place. We look forward to reading the results paper when it’s ready!

MABEL Video live

Following on from our MABEL Study Spotlight, a new patient information video has now been released. It was co-created with our patient and public involvement group at the University of Hull for people who have been recommended to try low-dose morphine for their breathlessness by their doctor. Using clear animation and narration, the video covers living with breathlessness, why morphine might help, how it is taken, and addresses common concerns in an accessible and reassuring way. The messages in the video are consistent with the evidence from the MABEL study.
 
Chronic breathlessness is often disabling despite best treatments of the underlying condition(s) that cause the breathlessness. MABEL tested if regular, low dose morphine capsules regularly twice a day are better than placebo (dummy) ones for chronic breathlessness and whether morphine improves daily activity. It was found that people taking morphine on average completed about 10 more minutes of moderate-vigorous exercise per day. This was a study lead collaboratively by teams at the University of Hull and the University of Edinburgh and was funded by NIHR HTA.

You can watch the video and also read more about the MABEL study here and the video was created by graphic designer Amymadethis.

Other January project headlines:

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HHTU News Roundup

Recruitment milestone reached

We are thrilled to announce that the MOI-A study has successfully reached its UK recruitment target. A major milestone for this important research programme into a rare disease. This achievement is a testament to the dedication and hard work of the research team here at HHTU, the continued support of our Chief Investigator, Professor Nick Bishop, and the commitment of our recruiting sites. A heartfelt thank you also goes to the participants themselves, whose involvement is helping to advance knowledge and future treatments for people living with osteogenesis imperfecta (OI).

The MOI-A (Matrix-Directed Therapy in Older Adolescents and Adults with Osteogenesis Imperfecta) study is being conducted as part of the broader REMEDi4ALL drug repurposing initiative. It is investigating whether the repurposed drug losartan can reduce bone turnover in individuals with OI, a rare inherited condition characterised by bone fragility and associated complications. The trial aims to identify an effective dose of losartan based on its impact on bone resorption markers.

While the UK recruitment target has now been met, recruitment will continue to enable the study to reach its overall aim of 30 participants, in collaboration with our partner sites in Italy.

In addition to this recruitment milestone, the MOI-A study has recently achieved another significant success with its first publication, which can be read here: https://pubmed.ncbi.nlm.nih.gov/41360460/

This publication is the protocol paper which details the plan for the study and outlines the methods and analysis. We look forward to reading future MOI-A related publications in the future.

BREEZE-2 recruitment competition

To boost participant enrolment and encourage engagement across all trial locations,  a Winter Recruitment Competition was launched on BREEZE 2. Each participating site competed to get the highest recruitment numbers from the 1^st November through to the 19^th December end date. The competition took the form of a sledge race down a snowy hill where each site was represented by sledge, and higher recruiting sites were further down the hill. All sites received regular updates of the leaderboard, with a number of sites recruiting several across one or two days. 

The recruitment during the competition was fierce (particularly in November), being amongst the highest recruiting months since recruitment began with a total of 19 participants in the competition bringing the total recruitment for BREEZE 2 to 68 participants. After a close race, the winning sites (Great Yarmouth, Devon and Hull) all recruited 3 participants each and got a hamper of confectionary just in time for Christmas. 

Other December project headlines:

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HHTU News Roundup

Christmas closure

The Hull Health Trials Unit will be closed from 5pm Friday 19th December 2025 until 9am Monday 5^th January 2026. We will have a skeleton team to ensure safety aspects of studies are covered over this time (except weekends and the bank holidays).

All the team at HHTU wish our colleagues and collaborators a restful Christmas break and a very Happy New Year!

The DAMPen-D 2 study is greenlighted

One-third of people have delirium when they are admitted to a palliative care unit or hospice and a further one-third develop delirium during their stay. People with delirium may see or hear things that aren’t there, say or do things that are out of character, and can’t ‘think straight’. This is distressing for the person, their family, and staff. There is clear national guidance on the actions needed to prevent, detect, assess, and manage delirium. However, it is difficult for hospices to put this guidance into practice because delirium care is complex and involves lots of different people, including family, friends and health professionals. The DAMPen-Delirium 2 team have designed a way to help hospices to overcome these difficulties and follow delirium guidelines better. They have tested this on a small scale and are now running to run a major, national trial to test whether this improves delirium care and reduces delirium in hospices.

This month the first 5 DAMPen-Delirium 2 sites, out of 20, have been greenlighted with data collection to start in January.

HHTU Director at SSA Conference

The Director of the Hull Health Trials Unit is also the Co-Director of the Centre for Addictions and Mental Health Research (CAMHR) in Hull whom we closely collaborate with. Judith and many others of the CAMHR team recently attended the Society for the Study of Addiction annual conference in Newcastle. This is the UK’s foremost gathering of addiction researchers, policymakers, practitioners and experts by experience. This conference was described as an ‘amazing opportunity’, ‘an incredible couple of days’ by members of the CAMHR team and they are ‘looking forward to building on new networks and collaborations’. 

Half year round up

As 2025 draws to a close, we’ve been reflecting on achievements of the last 6 months at the Hull Health Trials Unit.

We opened the IMPACT-W study, led by NIHR Doctoral Fellow Laura Hermann, exploring why women are underrepresented in research. We are also preparing two studies for early 2026: DAMPen-D II, supporting hospices to follow delirium guidelines and CONIFAS-2, a feasibility RCT of a home-based, family-led neurodiversity intervention. Our Data Services Team continues to support the recruiting Pharm-Air Qual Study.

Several key publications were released this year:

• The main MABEL trial results were published in The Lancet Respiratory Medicine, with the Health Economics paper in BMJ Open in November.
• The CANFit protocol paper appeared in BMJ Open in September.
• The NEWDAY-ABC pilot results were published in Pilot and Feasibility Studies in August, ahead of a full multicentre RCT launching in 2026.
• Senior Data Manager Sarah Sumper was a named author on the UKCRC guidance document Data Cleaning and Query Management.

Our Director, Judith Cohen, served on the panel for the annual Allam Lecture at Hull York Medical School, featuring keynote speaker Prof. Sir Stephen O’Rahilly.

In October, members of our Data Management team attended the UKCRC DISOG National Meeting—a valuable day of learning and collaboration, introduced by our own John Turgoose. A vendor showcase also highlighted innovations in data management systems.

Together, these achievements reflect the continued growth, dedication, and collaborative spirit of the Hull Health Trials Unit as we look ahead to 2026.

Other November project headlines:

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HHTU News Roundup

Data team attend DISOG National Meeting

In October, members of our Data Management team attended the UKCRC Data and Information System Operation Group (DISOG) National Meeting – a valuable day dedicated to learning, collaboration, and sharing best practice across the network.

The event opened with a warm welcome from our own John Turgoose (Hull Health Trials Unit) and co-chairs. Their introduction set the tone for a productive and engaging day, followed by an overview of network-wide activities which provided useful context for the sessions ahead.

A vendor showcase offered a chance to see what products and services are available to support the important work taking place across our field, highlighting the continued innovation in data management systems.

A highlight of the morning was the panel session on WAgile working — an innovative hybrid of Waterfall and Agile methodologies designed to improve database development processes for clinical trials. The discussion generated thoughtful debate and practical ideas for how centres might adopt similar approaches in their own teams.

In the afternoon, attention turned to MHRA inspections, where colleagues from other CTUs recently inspected shared their experiences and insights. Their presentations provided valuable guidance and practical advice for teams preparing for future inspections.

Overall, the meeting provided an excellent opportunity to exchange knowledge, strengthen collaboration, and reflect on the evolving landscape of data management and information systems within clinical trials. The discussions and shared experiences will undoubtedly help inform future developments across the network.

Our Senior Data Manager authors guidance

Sarah Sumper the HHTU’s Senior Data Manager has recently been a named author on the UKCRC guidance document ‘Data Cleaning and Query Management’ which is available here https://ukcrc-ctu.org.uk/is-data-management/.

The purpose of this document is to provide guidance on cleaning of data collected within a clinical database for clinical research and the management of queries.

Different trial units will have different approaches depending on the tools they are using and the type of data included in the trials. The processes may be manual, automated, or a combination / hybrid approach. This document incorporates recommendations based on the experience of the authors, representing thirteen UKCRC registered clinical trials units, with consideration to regulatory requirements. It is designed to be used as recommendation for good practice and as a starting point for new CTUs alongside their own specific guidance and SOPs.

Other October headlines:

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HHTU News Roundup

Join our team

We’re thrilled to share that, thanks to the success of our Trials Unit in securing funding for new clinical trials, we’ll soon be expanding our team. Over the coming months, a range of positions will be advertised across all areas of the Trials Unit, including data management, statistics, and trial coordination.

The jobs will be advertised on the University website here https://www.hull.ac.uk/about/jobs and we will share new posts as they go live on our LinkedIn page.

BEYOND Frontier live in the DSH

The FRONTIER Programme aims to support the early diagnosis of COPD and the timely initiation of evidence-based interventions to improve outcomes for participants in the Hull Lung Health Check Programme. BEYOND FRONTIER—a newly opened study within the HHTU Managed Data Safe Haven—builds on this work by using FRONTIER data to evaluate the performance of TidalSense Diagnostic Algorithms in identifying COPD and pre-COPD among participants. Led by Professor Mike Crooks, this marks the 32nd study supported by the Data Safe Haven, which continues to provide the secure, accredited environment that enables innovative research to take place

Allam Lecture 2025

The Annual Allam Lecture hosted by Hull York Medical School always proves to be an excellent event with members of the trials unit being able to network with the wider research community across HYMS. The poster session always proves to be a buzz with lots of interesting research and conversations. This year our HHTU Director Judith Cohen was a part of the panel this year judging the oral presentations. The afternoon wrapped up with the keynote lecutre by Prof. Sir Stephen O’Rahilly from the University of Cambridge who gave an insightful lecture titled ‘The causes and consequences of obesity; lessons from the extremes’. We are looking forward to next years Allam Lecture already.

TRE conference

John Turgoose, Information Systems Manager, and Amy Porter, Data Support Administrator, recently attended the Trusted Research Environment (TRE) Community Conference in Leeds. As the HHTU team manages the University of Hull Data Safe Haven—our own TRE—this event was a valuable opportunity to connect with others in the national TRE network. The conference’s main theme focused on federation, encouraging reflection on progress to date and open discussion around current challenges. John and Amy took part in interesting breakout sessions covering information governance principles, risk assessments, SATRE accreditation, and AI output checking, as well as a series of engaging five-minute presentations from across the TRE community.

PRE-DX results meeting

On the 26^th September, an online results meeting was held for PRE-DX  with Principal Investigators from participating sites and members of the research team. Chief investigator Henry Cain shared the results of the study, with lots of discussion around the findings and future work. The results are expected to be shared more widely next year.   

Other September headlines:

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