Physical Health Studies

What is involved?

The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor)

To take part you must meet the following criteria:

Inclusion Criteria:

• Male or female, age 18 years or above;
• Have type 2 diabetes diagnosed ≥180 days before screening;
• Stable daily dose for ≥90 days before screening at effective or maximum tolerated dose of metformin +/- SGLT2 inhibitor;
• HbA1c 53-91 mmol/mol

BMI of at least 25 kg/m²

You cannot take part if you do not meet the inclusion criteria or have any of the following exclusion criteria:

• Renal impairment (eGFR ≤30ml/min/1.73m²)
• Treatment with any medication for diabetes other than those in inclusion criteria within 90 days of screening

Uncontrolled & potentially unstable diabetic retinopathy or maculopathy

Physical Health Research team, research@southernhealth.nhs.uk

02380 475258 / 475910

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

Study of a single intramuscular dose of nirsevimab in the prevention of hospitalizations due to respiratory syncytial virus (RSV) infection in healthy term and preterm infants during the first year of life

Brief summary

The HARMONIE Research Study is looking at a new medicine which protects against RSV; an antibody injection called Nirsevimab. This study looks at how strongly babies can be protected from serious illness due to RSV infection by comparing a single antibody dose with no intervention.

What is involved?

A single in-person visit, during which participants are randomised into either a single antibody dose arm, or the ‘no intervention’ arm. Medical events, including wheeze data, are then collected for up to two years of follow up.

Interested?

To take part you must meet the following criteria:

• N/a – closed, in follow-up

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

Study Contact: James Watson / Vanessa Lucas

Email: resear@southernhealth.nhs.uk

Tel: 02380 475943

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:

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:

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