ANZCTR search results

Diabetes mellitus affects an estimated 451 million adults worldwide, and costs health systems US$850 billion annually. A cornerstone of effective diabetes management is maintaining optimum blood glucose control. However, less than half of people with diabetes reach their target ranges for blood glucose control. A relatively safe and low-cost therapy that is emerging as a promising treatment for diabetes is Olive Leaf Extract (OLE). While findings from laboratory studies indicate OLE may act on multiple metabolic pathways to improve blood glucose control, robust clinical research is needed in order to support the use of OLE in clinical practice. Researchers from the National Centre for Naturopathic Medicine (at Southern Cross University) and Torrens University Australia are embarking on a ground-breaking study to generate this much-needed evidence. The 6-month clinical study will explore whether OLE is safe and effective at improving blood glucose control, diabetes-related distress and quality of life, in adults living with type 2 diabetes. If OLE is shown to be a suitable treatment for diabetes, it may help support individuals living with the condition to reach their blood glucose targets, and in turn, help reduce the impact of diabetes on their lives.

Following surgery for weight loss, the size of the stomach is considerably reduced and food passes through to the small intestines faster. When food passes through the small intestines, various ‘hormones’ that are thought to assist with weight loss enter the bloodstream. While this seems to be a useful effect, some may experience complications such as having a low blood sugar level (post-bariatric hypoglycaemia) or low blood pressure (post-prandial hypotension) after eating and we think this may happen due to increased production of these ‘hormones’. Currently, the treatment options for these conditions are limited. One of the more common types of weight loss surgery is called the Roux-en-Y gastric bypass. From previous studies, one particular hormone called glucagon-like peptide-1 has been consistently found to be elevated following a meal post-surgery and it is elevated to a greater extent in patients with post-bariatric hypoglycaemia. More recently, a newer surgical technique called the one anastomosis gastric bypass has been developed, however, we do not know whether the rate of passage of food and the hormonal changes occur to a similar extent as with the Roux-en-Y gastric bypass. This study will follow up on participants before and after surgery and we will analyse how hormonal profiles and how the speed of the passage of food changes. We will be able to compare the effects of Roux-en-Y gastric bypass and one anastomosis gastric bypass surgery. This understanding may assist in the development of newer therapies for post-bariatric hypoglycaemia and post-prandial hypotension.

UDIVERT is a study designed to evaluate the outcomes following robotic removal of the bladder (radical cystectomy) for bladder cancer. The procedure is split into two main parts. Firstly, there is removal of the bladder +/- prostate (male) or gynaecological organs (female) as well as lymph nodes. The second part involves reconstruction of a new urinary tract (urinary diversion) using a section of small bowel attached to the ureters to drain urine produced by the kidneys. The main objective is to investigate whether performing the urinary tract reconstruction part of the operation is better if done fully robotically (intracorporeal), or whether it is preferable to make a larger incision and perform this using a traditional open surgery approach (extracorporeal). Who is it for? You may be eligible for this study if you are aged between 18 and 80 years, and are undergoing an elective robotic radical cystectomy for bladder cancer or for a non-functioning urinary tract due to bladder cancer treatment. Study details All participants will undergo a cystectomy using robotic surgical techniques. However, participants will be randomised (i.e. allocated by chance) to either undergo urinary diversion robotically or using an open approach. For the robotic surgery (intracorporeal) group, this will involve using the robotic equipment to perform the diversion within the abdomen without making another incision, and is anticipated to take approximately 6 hours to complete. For the open surgery (extracorporeal) group, this will involve performing the urinary diversion from outside the body through an incision in the abdominal wall (known as open method), and is anticipated to take approximately 5 hours to complete. For all participants, the duration of hospital stay after completion of the procedure will be recorded. Participants will additionally be assessed for their recovery, functional outcomes, and quality of life using a number of questionnaires for up to 1 year post-procedure. Lastly, the cost of the two different approaches will be assessed. It is hoped that this study may demonstrate that intracorporeal urinary diversion following robotic cystectomy reduces hospital length of stay, and improves recovery and quality of life compared to an extracorporeal approach.

Spinal cord injury patients are at high risk of catheter associated urinary tract infections (CAUTI), including infection by multidrug resistant organisms. This has severe consequences for their quality of life, including life threatening infections. Such infections also represent a significant cost to hospitals and a source of drug resistant organisms that can spread throughout hospitals. Overall, this project aims to develop diagnostic technologies to facilitate treatment decisions before full-blown symptoms appear as well as evaluate intervention strategies to expand options for how to protect this high risk patient population including the use of non drug based approaches. This projects plans to develop a new catheter coating that could be used in high risk patients. The benefits would be improved quality of life, reduced moralities, reduced spread of drug resistant bacteria and significant cost savings to hospitals. A key issue is that physicians do not act until a UTI is diagnosed. Part of the solution would be better monitoring of patients to predict when they are at increased risk of CAUTIs. A predictive diagnostic would enable physicians to intervene earlier and to employ a wider range of strategies, rather than relying solely on the use of antibiotics. This project will expand on our preliminary data and develop a robust, simpler and cheaper methodology to monitor the microbial community for changes in composition. This would represent an early warning that the patient may be moving towards an infected status. The project will also develop a mixed species biofilm system for laboratory evaluation of interventions aimed at controlling or eradicating biofilms on catheters. We will further use this laboratory system to investigate the mechanisms used by pathogenic bacteria to invade otherwise nonpathogenic microbial communities to cause infections. This will lead to new strategies for infection control.

The aim of this study is to assess the effect of an ergonomics intervention on sonographer work-related musculoskeletal disease. The study will be a randomised cluster control trial. The intervention used will be RESPite, which is an online multimedia ergonomics educational program with simple techniques that sonographers can integrate into their working day. It is hypothesised that RESpite will reduce the musculoskeletal pain and dysfunction of the shoulder and neck in sonographers compared to standard ergonomic guidelines.

Dementia is a leading cause of death in developed nations. Despite an often distressing and symptom laden end of life, there are systematic barriers to accessing palliative care in people dying of dementia. Evidence exists that 70% of people living with severe dementia attend an emergency department (ED) in their last year of life. This randomised controlled trial (RCT) will test a Carer End of Life Planning Intervention (CELPI) co-designed by clinicians, content specialists and consumers to improve access to end of life care for older people with severe dementia, using an ED visit as a catalyst for recognising unmet needs and specialist palliative care referral where indicated.

The aim of the current study is to trial a new psychological treatment designed to improve psychosocial functioning in middle- to older-aged depressed individuals, together with an antidepressant medication. The psychological treatment will target three domains of psychosocial functioning, which when impaired, appear to underlie psychosocial dysfunction in depression. These domains include cognition (e.g. attention, memory), emotion processing (e.g. pessimism), and social cognition (e.g. interpreting social situations). Personalised training that considers the strengths and weaknesses of individuals in these domains is expected to be more beneficial than just standardised training. Therefore, this study will compare an intervention group undergoing a personalised version of the training program, to a control group undergoing a standardised version. The psychological treatment will be combined with the use of an antidepressant medication, Vortioxetine. The use of antidepressants in the treatment of major depressive disorder is very common both internationally and in Australia (Malhi, Bassett et al. 2015). As the psychosocial training program can be rather intensive, the use of an antidepressant may help to alleviate depressive symptoms in individuals undergoing training. Vortioxetine has been shown to have beneficial effects on cognitive symptoms seen in depression and is the only antidepressant listed in the Royal Australian New Zealand of College Psychiatrists (RANZCP) guidelines to show this effect (Malhi, Bassett et al., 2015; McIntyre & Lee, 2016; Nierenberg, Loft, & Olsen, 2019). it is hypothesised that Middle- to older-aged adults will be able to adhere to the study protocols of personalised and standardised cognitive, emotional and social cognitive treatment and that participation will result in improved psychosocial functioning at week 8 (i.e. end of study) relative to baseline.

In Australia, antenatal education programs are mostly unregulated and educators do not require formal qualifications that ensure evidence-based teaching (Downer, Young et al. 2020). In a climate where birth interventions are increasing (AIHW 2018), antenatal education can play a role in helping women to make evidence-based decisions about labour and birth that may improve outcomes for themselves and their baby. Randomised control trials (RCTs) of antenatal education interventions are diverse, and largely weakened by low numbers and poor design. The strongest suggestion so far that antenatal education can improve birth outcomes was an RCT of 176 births in Sydney, Australia where women undergoing a an antenatal program based on the SheBirths® course, compared to controls, had 65% less epidural anaesthesia, 44% less caesarean sections and 50% less medical augmentation/induction (Levett, 2016). In order to make generalisations about the impact of this antenatal education course, the results need to be replicated in other populations. The proposed project will be an open-label, assessor-blind RCT of the online, self-administered adaptation of SheBirths® antenatal education program in Port Macquarie and Coffs Harbour Base Hospitals.

Pregnancy and birth provide a critical window for intervening to improve short- and long-term health and wellbeing for women and their children, yet there is a lack of evidence to guide preventative interventions. At two sites in Victoria, Australia we will conduct a randomised controlled trial comparing midwife-led, group-based pregnancy care model with usual pregnancy care. We will implement and evaluate a midwife-led, group-based pregnancy care model aimed at influencing risk factors and behaviours that result in adverse outcomes in pregnancy and beyond. We aim to decrease the proportion of births by caesarean section, and the proportion of infants born premature or low birthweight. All three are associated with significant maternal and neonatal morbidity. This collaborative model combines continuity of midwife care, education and peer support to address women’s individual needs, support them to make informed decisions to achieve a healthy pregnancy, and improve clinical and psychosocial outcomes.

The COVID-19 (coronavirus) pandemic has led to a large amount of information being made available to the community through a range of mediums. How this information is presented can have a different effect on different people in terms of how much the accept it, and how much it may influence their future behaviours. This research seeks to compare the effectiveness of different approaches that can be used to convey COVID-19 health messages. This will better inform government strategies as to how they might share COVID-19 information as well as information relevant to other future health issues in our community. Specifically this study aims to assess: a) the use of animation versus 'talking head' visual stimulus approaches b) the use of a general practitioner to deliver the COVID-19 relevant information versus a community representative (specific to each subgroup population).