Physical Health Studies

Full Title: HEALTHY LIVING AND TYPE 2 DIABETES SCREENING UNDERSTANDING AFTER GESTATIONAL DIABETES

Brief summary

Women with a history of gestational diabetes (diabetes first identified during pregnancy) are more likely to develop type 2 diabetes than women who do not have gestational diabetes whilst pregnant.  The aim of this study is to explore the views and understanding of:

• Women with a history of gestational diabetes
• Partners of women with a history of gestational diabetes
• Healthcare professionals who provide a service/care for women with a history of gestational diabetes

To better understand their views and knowledge around:

• the risk of developing type 2 diabetes following gestational diabetes.
• screening for type 2 diabetes following gestational diabetes.
• how to reduce the risk of developing type 2 diabetes after having had gestational diabetes – particularly around the adoption of a healthy lifestyle.

What is involved?

• A discussion with a member of the research team about the study and to answer any questions you may have.
• Signing a consent form, if you interested and happy to participate.
• Completing a short questionnaire.
• Being interviewed by a researcher – this can be face to face, virtual via Microsoft Teams or on the telephone.  This interview will be audio recorded and will last approximately 1 hour.
• A small group of participants will be invited back for a second interview, 1 year after their first interview.

Interested?

To take part you must meet the following criteria:

• Women who gave birth following a pregnancy complicated by gestational diabetes

      OR

• Partners of women with a history of gestational diabetes

OR

• Healthcare professionals who provide a service or care for women with a history of gestational diabetes

AND

• Age 18 years or older
• Live, access a service or provide a service within the CRN Wessex geographical boundary
• Ability to give informed consent
• Willing to be interviewed (either face to face, virtually or telephone) and for the interview to be recorded
• Ability to comprehend and communicate in English

If you would like to take part or want more information please contact the study lead:

Chantelle Moorbey

Email: chantelle.moorbey@southernhealth.nhs.uk

Tel: 07920 834848

A short 5-day course compared to a longer 7-day course of oral flucloxacillin antibiotic for

cellulitis in the leg.

What is involved?

This is a double blinded trial in which patients are randomised to receive either 7 days of flucloxacillin or 5 days of flucloxacillin with 2 days of a placebo for the treatment of cellulitis.

Interested?

Clinicians in participating practices will identify eligible patients during a routine consultation and invite them to participate if they meet the inclusion criteria.

1.    Adult (age _>18 years) with symptoms suggestive of cellulitis (pain, tenderness, redness, or other skin colour changes and warm to the touch) in one leg for 10 days or less, and where the clinical impression is of cellulitis as the most likely diagnosis.

2.   Pain rated _> 3/10 on a numeric rating scale (0-10) at baseline assessment.

3.   Able to complete trial procedures in English language (could be through the assistance of an interpreter).

If you would like more information, please contact the study lead:

Vanessa Amey

Email: vanessa.amey@southernhealth.nhs.uk or research@southernhealth.nhs.uk

Tel: 02380 475943

Full Title: VenUS 6: A randomised controlled trial of compression therapies for the treatment of venous leg ulcers.

Venous leg ulcers are a common, recurring open wounds on the lower leg. Care is mainly delivered in the community by Nurses.

What is involved?

Once you sign the consent form, we will take a photo of one of your leg ulcer(s) and ask you some questions about your general health. You will then be randomly allocated to one of three groups. This means you will have an equal chance of receiving one of the compression treatments under investigation. There is no reason to feel disadvantaged or disappointed by which treatment you are allocated to. All three treatments are regularly used in the NHS however we are running this study because at present there is not enough information to show that either treatment is any better than the other.

Compression wraps	Four-layer bandage	Two-layer hosiery	Two-layer bandage

Interested?

To take part you must meet the following criteria:

. has at least one venous leg ulcer

. can tolerate full compression.

. over 18 years of age

If you would like to take part or want more information, please contact the study lead:

Study Contact: Vanessa Amey

Email: Vanessa.amey@southernhealth.nhs.uk

Tel: 02380 475943

Full Title:

UK Early Detection Initiative for Pancreatic Cancer (UK-EDI)

Brief summary:

The UK-EDI study is a project, with the overall aim of improving detection of pancreatic cancer in high-risk groups, using a variety of different methods.

Most cases of new-onset diabetes mellitus are due to lifestyle or genetic factors, but in a small subset of individuals diagnosed with new onset diabetes mellitus (approximately 1 in 100 people (1%)), the diagnosis of diabetes is believed to be an early sign associated with the development of pancreatic cancer (which should actually be categorised as type 3c diabetes).

Type 3c diabetes is caused by damage to the pancreas by conditions such as pancreatitis, pancreatic cancer and cystic fibrosis. It is important to distinguish individuals with type 3c diabetes, which includes those with pancreatic cancer-associated diabetes mellitus, from other types of new-onset diabetes mellitus. Currently it is not possible to accurately do this.

We would like to be able to find ways to distinguish between the forms of diabetes so effective screening programs may be developed to detect pancreatic cancer much earlier and hopefully provide better treatment options for these patients.

Full title: Reported Outcomes in COPD with Trixeo in Real world (RECORD)

A non-interventional, multi-centre study to investigate the change in clinical and patient-reported outcomes in moderate to severe COPD patients treated with TRIXEO (Budesonide / Glycopyrronium / Formoterol) under real-life conditions

The RECORD study aims to describe the change in chronic obstructive pulmonary disease (COPD) health status over a 1 year period of patients starting a specific triple fixed drug inhaler (Trixeo) for their COPD. It involves the completion of a number of online questionnaires describing their experience relating to health status, quality of life, patient satisfaction and exacerbations of their condition.

Study contact: Vanessa Lucas - research@southernhealth.nhs.uk

Full Title:

Domestic abuse and life-limiting illness: identifying and supporting adults at risk (DALLI)

Brief summary:

The aim of the study is to co-produce a toolkit for health care professionals working in hospice and palliative care services to screen, identify, and facilitate support for domestic abuse in the context of life-limiting illness, and in doing so foster stronger partnerships between health care, third-sector organisations and local authority agencies.

Full Title

Dealing with Feelings: The Neural Bases of Emotional Processing and Regulation in Bulimia Nervosa

Brief summary

A research study to look at what is happening in the brain while people with and without bulimia nervosa experience and regulate their emotions.

What is involved?

The first part involves filling out an online questionnaire asking about your emotions and eating behaviours amongst other. This should take you about 20-30 minutes.

The second part involves a visit to Bournemouth University which will last around 2.5 hours. There, we will look at your brain activity and you will look a bit like the woman on the picture. This is non-invasive and it does not hurt.

Everyone who takes part will receive £35 plus travel costs to travel to and from Bournemouth.

Interested?

To take part you must meet the following criteria:

Have a diagnosis of Bulimia Nervosa

have no known suicide ideation

between the age of 18 and 40 

NOTE: (don’t have to write anything here, previously people have written “You cannot take part if you are pregnant, vegetarian/vegan or do not meet the above criteria.”)

If you would like to take part or want more information please contact the study lead:

Study Contact: Laura Renshaw-Vuillier:  

Email: laurav@bournemouth.ac.uk

Full Title:

Evaluation of a nutritionally complete, plant-based, high energy, high protein, enteral tube feed in adults

Brief summary:

The aim of this study is to evaluate a plant-based, high energy, high protein tube feed (with or without fibre) in patients who require enteral tube feeding to meet their nutritional requirements. It is hoped that this tube feed will help patients with higher energy and protein needs to better meet their nutritional requirements. Your opinion is valued, and we would like to invite you to try the new plant-based tube feed

What is involved?

• Day 1: Your dietitian will collect information regarding your medical and dietetic history, measure your height and weight, and ask you to recall your dietary intake from the previous 24 hours. You will be asked to record the amount you take, your tolerance, and acceptability of your current enteral tube feed. Your dietitian will then decide which (or both) tube feeds (fibre and/or non-fibre) you take during the intervention period (days 2-29). The prescribed amount will be determined by the dietitian responsible for your dietetic care.
• Day 2: You will begin to take the study product daily for 28 days. Throughout days 2 to 29, you will be asked to record the amount of the study product you took daily and complete some short questionnaires in your ’patient diary’.
• Day 29: Your dietitian will measure your height, weight, and assess your tolerance and compliance with the new study product. You will also be asked to recall your dietary intake for the previous 24 hours. The study is then finished.

Interested?

To take part you must meet the following criteria:

• Male or female
• ≥16 years of age
• Using or requiring an enteral tube feed in the community as part of nutritional management plan
• Expected to receive at least 1000kcal/day (one bottle) from one of the study products

Full Title

HypoRESOLVE Understanding the impact Hypoglycaemica has on people living with Diabetes

Brief summary

The purpose of this project is to reduce the burden and consequences of hypoglycaemia in people living with diabetes.  As part of the HypoRESOLVE project we want to understand how hypoglycaemia can affect the day-to-day lives of people living with diabetes. 

What is involved?

You will be asked to complete the survey. The survey contains questions about you and your experiences. 

Interested?

To take part you must meet the following criteria:

Have diabetes and experience hypoglycaemia 

If you would like to take part or want more information please contact the study lead:

If you are interested in taking part click below to access the survey and find out more details about the research.

(https://tinyurl.com/3jrezjdk)

If you would like to take part or want more information please contact the study lead:

Study Contact: Kelly Carden or James Watson

Email: research@southernhealth.nhs.uk

Tel: 02380 475943

The effect of injectable therapies on health status, quality of life and treatment satisfaction in patients with type 2 diabetes: prospective observational cohort study.

What is Involved?

The study involves three contacts with the research team over a period of six months. These study contacts can either be over the phone or in form of face to face study visits at The Research and Development Department, Moorgreen Hospital, depending on preference. This will involve taking the patients’ medical history, diabetes medications, filling out paper questionnaires about their quality of life and treatment satisfaction and recording their height and weight.

Interested?

Be aged 18+Diagnosis of type 2 diabetes.

Naïve to self – administered SC injectable diabetes therapy at the point of recruitment.

Patients with type 2 diabetes treated with diet or oral medications only, who are planning to start a new oral diabetes medication or injectable diabetes treatments to improve their diabetes control, are invited to take part in this research study.

Study Contact: Liz Houghton

Full Title:

Brief Summary:

To determine if a strategy of intermittent urinary catheter mixed-use is no worse than a strategy of intermittent urinary catheter single (sterile) use only, in terms of incidence of microbiologically confirmed symptomatic and help-seeking UTI over 12 months (post two week learning period) using a randomised controlled trial design.

Full Title:

The impact of detectable anti SARS-CoV-2 antibody on the incidence of COVID-19 in healthcare workers

Brief summary:

COVID-19 is causing a global pandemic. This study aims to find out whether staff working in healthcare organisations who have evidence of prior COVID-19, detected by antibody assays (positive antibody tests), are protected from future episodes of infection compared to those who do not have evidence of prior infection (negative antibody tests). With the introduction of COVID-19 vaccinations for healthcare workers from December 2020, this study will also examine immunity acquired by a vaccine and obtain early estimates of vaccine effectiveness. It will explore both short and long-term effectiveness of a vaccine against infection and immunological response to a vaccine, including potential differences in response associated with factors such as prior exposure and antibody status.

All participants enrolled into the study are being asked to have a regular nose swab every other week to detect mild cases or cases who do not have symptoms. Once the infection is cleared, we cannot detect the SARS-CoV-2 virus in samples. Therefore, we will also ask these individuals to have blood samples taken every other week to determine whether they have antibodies to the infection. Through this study we will provide this very important information which will help to understand the future impact of COVID-19 on the population.

The study is of ongoing importance, performing a surveillance role within the United Kingdom, with new questions surrounding emerging variant. Participants will be offered an opportunity to remain in SIREN until March 2023.

What is involved?

Regular nose swabbing (PCR) and blood testing.

Interested?

This study is CLOSED to new participants

Previous studies of semaglutide have shown that using semaglutide reduced the risk of cardiovascular events in some people with type 2 diabetes. Semaglutide is already approved in some countries at a lower dose, to treat type 2 diabetes. The SELECT study will examine the effect of semaglutide in people with established cardiovascular disease and obesity or overweight. 

What is involved?

Initially, you will go through a screening process at Moorgreen Hospital to ensure that you meet the criteria for being included in the SELECT study. If you do, the study doctor will explain exactly what is expected of a study participant so you can make an informed decision. Participation in the SELECT study will include:

• A once-weekly injection of the study medicine, prescribed by the study doctor
• Attending regular study visits for study-related health checks
• Regular contact with the study nurse or doctor throughout the study

Interested in taking part?

To take part you must meet the following criteria:

• Male or female, age ≥ 45 years at the time of signing informed consent
• Body mass index (BMI) ≥ 27 kg/m2 (overweight)
• Have established cardiovascular disease – previous heart attack / stroke / PAD (peripheral arterial disease)

NOTE: You cannot take part if you had a TIA (Transient Ischaemic Attack) as opposed to a stroke.

Study Contact: Juliette Meek - Senior Research Nurse

Please note: This study is currently paused

Screening of target genes for polymorphic variation which may alter treatment response for airway treatment targets. The aims of the study are to define the extent of polymorphic variation in genes whose products are, or may be, primary targets for treatment of patients with asthma, and to identify if this genetic variation contributes to disease severity or treatment response.

What is involved?

A 20 - 30 minute appointment which will include:

• Conducting a breathing test known as spirometry and peak flows.
• Collecting a blood sample.
• Asking you a few questions about your asthma and medications you take. 

Interested?

To take part you must meet the following criteria:

• Have asthma for more than one year.
• Be prescribed asthma medication.
• Aged 16 to 60.
• Of European descent.

NOTE: You cannot take part if:

• Known highly transmissible or serious blood-borne infection that would render the whole blood and saliva samples a serious biohazard. This includes Hepatitis B, Hepatitis C, and HIV. If the individual gaining consent or performing phlebotomy has any concerns in this regard they should contact one of the study investigators.
• Anyone unable to comprehend the study and provide informed consent, e.g. insufficient command of English in the absence of someone to adequately interpret.
• Smoking history of more than ten pack years.
• Known lung, chest wall, neuromuscular, or cardiac disease or abnormality that would confound symptom scores and Spirometry.

Study Contact: Qi Zheng

Full Title:

Nursing shift patterns in acute, community and mental health hospital wards: a feasibility study and survey

Brief Summary:

Nursing shift patterns in acute, community and mental health hospital wards: a feasibility study and survey. 

The aim of this project is to support evidence-based decision making about efficient deployment of nursing staff and care staff on acute, mental health and community hospital wards in England.

Understand how shift work may impact on the experience of work and productivity and preferences and constraints around shift patterns through a survey.

Determine the availability of routinely collected data of shift patterns of the nursing and care workforce and patient outcomes in different hospital settings (acute care, mental health and community).

Explore the feasibility of using routine data to measure associations between shift patterns, workforce characteristics and outcomes including sickness absence.

Full Title:

Getting the right classification and treatment from diagnosis of diabetes

What is involved?

The purpose of this research is to determine whether blood tests can help us improve treatment by identifying which patients have Type 1 diabetes, and will need very early insulin treatment, and which patients are unlikely to need insulin treatment at diagnosis. These tests include antibodies against the cells that make insulin (often seen in Type 1 diabetes), and a new test which assesses genetic risk of diabetes.

Interested?

To take part you must meet the following criteria: People were invited to take part in the StartRight study if they were diagnosed with diabetes during the last 12 months, were 18 years of age or over at the time of their diabetes diagnosis.  Taking part in the study may help us discover whether early testing of blood samples can improve diabetes diagnosis and treatment.

Recruitment ended in March 2020 with over 1800 participants consented at 55 UK sites.

Participant follow up at   >3 years post recruitment continues until April 2023.

Full Title:

Strength assessment and strength training in pulmonary rehabilitation: an online survey of services in England

Brief Summary:

A cross-sectional questionnaire-based online survey

Full Title:

The PD Life Study – Exploring the treatment burden in people with Parkinson’s and their caregivers

Brief Summary:

The aim of this study is to understand the experiences of treatment burden and capacity for people with Parkinson’s, and/or those who support or care for someone with Parkinson’s.

We are interested in the effort and day-to-day tasks required to look after the overall health of people who are living with Parkinson’s. Some people will find it easy managing their health, but others may find it more difficult. Some people with Parkinson’s require help from their partner, family member or friends to look after their health. We sometimes refer to this person as a ‘caregiver’.

We may invite them to take part in the study as we are also interested in their experiences of helping to support and care for the health of someone with Parkinson’s. Their participation in this study is through interview with the research team. The results of the study will help us better understand how you look after your health with Parkinson’s.

This study is a phase II, randomized, parallel group, multi-center, dose-finding study of subcutaneously administered BI 456906, compared with placebo and open-label semaglutide in patients with type 2 diabetes mellitus who have insufficient glycemic control despite diet, exercise, and metformin treatment.

What is involved?

If you would like to take part you will be invited to come to the clinic for a screen visit. This visit will take 1 hour to complete. If you’re eligible for the study, your participation in the trial will last approximately 23 weeks and require approximately 13 visits to the trial clinic. If you’re in one of the groups receiving the injection twice a week, you will have about 20 visits to the trial clinic. For your time and inconvenience related to taking part in this study, and to take account of any loss of earnings, the sponsor will pay the costs of £30 per visit (plus £10 if you’re assigned to group which need to come to clinic twice per week).

Interested?

To take part you must meet the following criteria:

• Participant is willing and able to give informed consent for participation in the study;
• Participant is 18 years to 75 years of age on the day of signing informed consent;
• Diagnosis of type 2 diabetes mellitus at least 6 months prior to informed consent;
• Treatment with a stable dose of metformin >=1000mg/day for at least 3 months;
• BMI 25kg/m2 -50kg/m2;

Study Contact: Qi Zheng