ANZCTR search results

The aim of this project is to evaluate the implementation and effectiveness of delivering the Small Steps for Big Changes diabetes prevention program in the Australian context. The program, developed in Canada, provides training to health coaches (which can be lay persons or peers) to deliver the 6 sessions of 1-on-1 counselling and supervised exercise. The program will be trialled in five sites in South-East Queensland, with a target of 500 clients. It is part of a larger funded evaluation of the program, which is been rolled out across Canada. It is hypothesised that the program will reach a broad range of clients, be effective in changing physical activity and dietary behaviours, be able to be successfully implemented, and be sustainable.

This study aims to compare the impact of Personalised Exercise Rehabilitation for people with Multimorbidity (PERFORM) with traditional cardiac/pulmonary rehabilitation (CPR) on the quality of life of individuals who have both cardiac or pulmonary disease and other additional health conditions. Who is it for? You may be eligible for this study if you are a male or female age 18 or older independently ambulant, with multimorbidity and cardiac or pulmonary disease. Study details Participants will be randomised to receive either PREFORM intervention or pulmonary/cardiac rehabilitation as per guidelines (Alison JA et al. Respirology 2017 and Woodruffe S et al. Heart Lung Circ 2015). The PREFORM intervention involves an 8-week in-person supervised program at a rehabilitation centre, with sessions held twice weekly. Each session will last 2 hours and consist of one hour of exercise training (Move and Improve) and another hour focusing on patient self-care support and education (Health and Wellbeing sessions). After completion of the intervention, participants will be tested for quality of life, exercise capacity, mental health, physical activity, treatment burden, fatigue, pain, breathlessness, adverse events and adherence. It is hoped that findings from this study will help managing these patients effectively with a multidisciplinary approach to address complex disease interactions.

Resection and Plication (RAP) is a new endoscopic procedure that has been shown to improve reflux symptoms. This study aims to compare oesophageal physiology and reflux-related oesophageal acidification as well as symptoms before and after RAP. This work will help to strengthen current understanding of the efficacy of this procedure. Patients must be clinically appropriate and willing to undergo the Resection and Plication endoscopic procedure. Baseline testing (pH studies, manometry and questionnaires) will occur before RAP and 3-6 months post-RAP, to measure change in patient symptoms and physiology.

The purpose of this project is to assess the feasibility, safety and tolerability of synchronous intravesical instillation of gemcitabine and docetaxel for this cohort of patients. Who is it for? Participants are eligible for this study if they are over the age of 18 with confirmed fully resected, high-risk, non-muscle-invasive bladder cancer where BCG treatment has been unsuccessful or cannot be given. Study details Participants will undergo synchronous intravesical administration of gemcitabine and docetaxel. The planned treatment schedule is once a week for six weeks. Participants will then be tested weekly for completion, adverse events, patient-reported outcome, and 3 months recurrence. Translational studies on a small sample of blood collected after the first weekly treatment and on existing bladder tumour specimens will be performed if consent is given. It is hoped that findings from this study will help improve the health outcomes for people with high risk non muscle invasive bladder cancer by providing an alternative treatment option to removal of the bladder when BCG is unsuccessful or cannot be given.

The aim of this study is to find out if transesophageal echocardiography (TOE) is useful for assessing shock in patients with serious injuries, and helping with treatment and resuscitation of shocked patients. The images of the heart taken by the TOE device may help doctors in diagnosing and treating shock, and therefore in resuscitation efforts.

You are invited to participate in a study using TXI, which is a new imaging software in colonoscopy. This has recently been incorporated within the machine used to process pictures of your bowel during colonoscopy and is available for use in our hospital. TXI enhances the colour and texture characteristics of the bowel lining, making subtle changes and abnormalities more noticeable during colonoscopy. This technology can highlight the contrast between a polyp and the surrounding normal tissue, potentially aiding in the detection of small or flat polyps that may otherwise be missed. Our recent experience with this technology suggests it may increase the ability of endoscopists to detect polyps in the bowel and help us make a decision about which ones may need to be removed. Since you are undergoing a colonoscopy to detect or exclude polyps in your bowel, we would like to invite you to participate in this study.

Hypothesis: Infants and young children 4 months to 5 years of age who are commenced on ETI or IVA will have improved and sustained growth and nutritional outcomes, exocrine pancreatic function and sweat chloride levels. Primary aim: To evaluate longitudinal patterns in growth and nutrition in children 4 months to 5 years of age with CF during the first 2 years of treatment with ETI or IVA. Secondary aim: To describe changes in pancreatic function, clinical outcomes and nutritional interventions in children 4 months to 5 years of age with CF during the first 2 years of treatment with ETI or IVA. Longitudinal, ‘real world’ studies are required to better understand the breadth and significance of CF exocrine pancreatic involvement in children with CF who are exposed to early CFTR correction as infants and children and to better understand the nutritional implications.

Current conservative treatment approaches for persistent low back pain are effective, but significant waiting periods and healthcare resource strain is common. Virtual reality interventions are showing clear potential in individuals with low back pain populations and could facilitate early self-management. Our previous cohort study demonstrated that combining virtual reality with pain education using cognitive behavioural principles (VR-CBT) leads to clinically significant short-term reductions in pain and fear of movement. While these results are promising, the study lacked a control and was conducted over only 2 sessions. This project addresses the next stage. We will undertake a feasibility RCT (VR-CBT and homebased VR gameplay and mindfulness vs usual care) over a longer intervention period (up to 16 sessions over 4 weeks) to determine the feasibility and primary outcome measure of a future, fully powered RCT evaluating the clinical and cost-effectiveness of longer-duration VR-CBT in the management of persistent low back pain.

A multi-center, double blind, placebo controlled, randomized pilot study is proposed to evaluate the effects of daily dapagliflozin given within 3 hours of arrest in comatose out-of-hospital cardiac arrest survivors for 30-days post cardiac arrest. The primary end point selected is the safety of dapagliflozin, measured as the total number of in-hospital adverse events. Adverse outcomes will be a composite of in-hospital mortality, ketoacidosis, need for renal replacement therapy, hypoglycaemia, and genitourinary infection. Secondary end points include post-arrest changes in biomarkers (neurofilament light chain, caspase 3, HIF-1a, VEGF, TNF-a, CRP) at 72 hours from baseline, CT-brain defined HIE changes and infarct size, 30-day mortality, and CPC (cerebral performance score) at time of discharge among survivors. This pilot study will aim to include 120 patients, half (n=60) assigned to the dapagliflozin group and half to the placebo. We expect this study will demonstrate the use of dapagliflozin in this population to be safe and effective at reducing biomarkers associated with hypoxic brain injury, allowing for further larger scale trials to explore the potential clinical benefit in reducing hypoxic brain injury in cardiac arrest.

POSTFIT is an exercise intervention that aims to help women who have recently given birth and want to return to exercise to regain their strength and optimise their long-term health and wellbeing. Specifically, we would like to develop a battery of exercise tests to screen for common postpartum musculoskeletal health issues and examine the effectiveness of a 12-week postpartum specific supervised exercise program that aims to improve pelvic floor function, increase core function and strength, and reduce musculoskeletal pain. Women from the general population are not routinely guided on how to return to exercise safely following birth which puts them at risk of sustaining lifelong irreversible injuries, such as pelvic organ prolapse and incontinence. A multidisciplinary approach to postpartum care with the inclusion of an Accredited Exercise Physiologist could ensure a woman’s return to exercise is safe and effective in treating and preventing these common postpartum related musculoskeletal issues. The results from this study can contribute to evidence based postpartum exercise guidelines to improve the care that postpartum women receive when returning to exercise.