ANZCTR search results

This is part of a combined cluster randomized controlled trial and individually-randomized controlled trial with embedded clinimetric study. Trial Part 1 is a cluster randomised controlled trial delivering pain education to adolescents attending Australian secondary schools. The cluster randomized controlled trial (1:1 ratio) will be conducted in grades 7-10 in Australian secondary schools. Schools will be randomized to receive 1) a pain education module integrated into the Personal Development, Health and Physical Education (PDHPE) curriculum, or 2) no education. Schools randomized to receive no education will receive the module one year after the study period. A cluster-randomised design, with the school as the unit of randomisation, was chosen to minimise cross-group contamination through staff and student communication.

This study aims to improve treatment for alcohol use disorder (AUD) by matching brain stimulation interventions with brain imaging informed neural network profiles (or subtypes). Using a novel neuroimaging-informed approach, we will identify which brain network is most affected in each individual and provide a subtype-matched brain stimulation intervention targeted to that network. We will assess changes in drinking behaviours through self-report and biological markers (blood and hair samples). We will also measure changes in brain activity, and cognitive, affective, and decision-making skills to better understand how the intervention works. We hypothesise that matching the intervention to the individual’s brain network subtype will lead to better outcomes than a one-size-fits-all approach.

Infants born very preterm have a high mortality rate and are at increased risk of worse neurodevelopmental outcomes and health-related problems. In recent years, convincing evidence has led to improved care and novel interventions for stabilisation of the newborn in the first 10 minutes of life, which may have a long-lasting impact on neonatal outcome. Non-invasive, continuous positive airway pressure (CPAP) immediately after birth of a very preterm infant (“VPTI,” <32 weeks’ gestational age at birth) is currently recommended as the standard of care during the stabilisation of preterm infants following birth. ) After birth, the infant must rapidly transition from a fluid filled lung, and dependence on the placenta for oxygenation and the elimination of carbon dioxide, to an aerated lung that successfully exchanges gases. CPAP supports the transition from fetal to newborn physiology by providing a distending pressure to the lung, thus maintaining a functional residual capacity (FRC) and enabling oxygenation and ventilation. While the rationale of most cord clamping studies has previously been based on the effects of placental transfusion, more recent studies in preterm lambs have demonstrated that delaying cord clamping until after ventilation onset prevents a rapid decrease in cardiac output. The observed large fluctuations in systemic and cerebral haemodynamics, and concomitant bradycardia and hypoxia frequently observed in preterm infants after ICC, could be avoided by delaying cord clamping until after aeration of the lung When a baby stops breathing or fails to establish normal breathing pattern positive pressure ventilation via a face mask is commenced to provide respiratory support while transitioning. The clinician attempts to create an air-tight seal on the infant’s face, with the nose and mouth inside the internal diameter of the mask. An adequate seal is difficult to achieve and the use of a facemask has the additional adverse effect of high compressive forces being applied to the infant’s face and head during resuscitation regardless of which brand of facemask is used, and even with the use of adjunct respiratory monitoring. Studies have shown that the majority of VPTI born less than 32 weeks completed gestation have a good respiratory drive immediately after birth. Ninety percent of VPTIs will initiate spontaneous breathing by 1 minute after birth. In this feasibility study we will recruit 40 very preterm neonates born from 24+0 weeks to 31+6 weeks completed gestation. We will provide nasal respiratory support to the participants at birth prior to umbilical cord clamping. We will provide CPAP (Continuous positive airway pressure) and if they baby is not spontaneously breathing will provide non-invasive ventilation to the baby. The aim of this study is to enable a longer period of delayed umbilical cord clamping (DCC) and improve cardiopulmonary transition in the neonates.

The Royal Hospital for Women (RHW) in Randwick is implementing a new model of maternity care for women with pregnancy complications such as: a diagnosis of gestational hypertension, threatened premature labour (TPL) and/or premature pre-labour rupture of membranes (PPROM) called ‘Virtual Maternity Ward’. Women who have traditionally required inpatient admission, will be offered the opportunity to be care for at home by midwives and obstetricians from the RHW. The ‘Telemonitoring Simulation Study’ will simulate a telehealth clinic within RHW, aiming to establish the usability of a telemonitoring technology with a small cohort of inpatient women, obstetricians and midwives. The purpose of the study is to explore the feasibility and acceptability of a fetal telemonitoring device we may use in the future in the Virtual Maternity Ward. If the device we are evaluating in this study is found to be feasible and acceptable, we can commence work on developing interoperability with RHW technical infrastructures.

Earlier recognition and better support for children with mental health problems is an urgent priority in Australian mental health research and policy. "Supporting Child Mental Health (SCMH): A comprehensive program for adults to learn how to provide mental health first aid to children aged 5-12 years" is a new training program designed to increase the mental health literacy and first aid skills of parents and teachers of primary school children. We propose an uncontrolled pilot trial with 100 teachers and 100 parents to establish: 1) initial evidence for the safety and efficacy of the program; 2) the feasibility of the program for community-based dissemination; and 3) the appropriate protocols for conducting a subsequent randomised controlled trial (RCT). The outcome of this pilot evaluation will allow refinements of the SCMH program materials, to ensure it is an effective and feasible program, which will then be subject to a randomised controlled trial (RCT) in 2026. The RCT will establish high-quality evidence of efficacy, allowing the program to be licensed to Industry Partners who will disseminate the program nationally, and internationally--with the aim of improve outcomes in child mental health--should SCMH be found to be an effective and feasible program

The overall aim of this study is to evaluate whether our new osteoarthritis eLearning program designed to facilitate the uptake of evidence-based osteoarthritis care, meets the needs of health professionals and leads to better service delivery.

Revascularisation of large coronary arteries (percutaneous coronary intervention, PCI) may improve blood flow to areas of myocardium previously subtended by a chronically occluded (CTO) vessel. Restoring blood flow in this manner may be associated with an improvement in angina, however despite technically successful PCI a significant proportion of patients will continue to experience angina or suffer from future stent failure (in-stent restenosis and re-occlusion. The reasons for this remain unclear and the influence of PCI on the coronary microcirculation is poorly described. However, it is likely that the presence of ongoing local vascular inflammation (at the site of PCI) and/or the presence of CMD may influence the outcome of PCI. In this study we aim to examine the effect of PCI on the coronary microcirculation. Furthermore, to better understand the influence of vascular inflammation, delayed stent healing / early stent failure with CMD, intravascular imaging (IVUS or OCT) will be performed immediately after PCI. Finally, we aim to measure cOCT at the same time as baseline invasive coronary assessment and again at 3 months, so that temporal changes in peripheral (cutaneous) microvascular reactivity and its association with baseline coronary microvascular reactivity may be described.

This study aims to explore whether a low-carbohydrate/ketogenic diet combined with ketone supplementation can improve kidney and metabolic health in adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD). The study will assess safety, feasibility, and changes in quality of life, kidney function, and metabolic markers. Participants will receive dietary support via a smartphone app, take a ketone supplement, and use continuous glucose monitoring. The hypothesis is that reducing glucose availability and supporting nutritional ketosis may slow disease progression and improve overall wellbeing in people with ADPKD.

The ACTIDIET-PRO study aims to evaluate the feasibility of an exercise and diet intervention in Australian men with metastatic hormone-resistant prostate cancer who are treated at a single centre. Who is it for? You may be eligible to join this study if you are aged 18 years and older, have been diagnosed with adenocarcinoma of the prostate, and are receiving ongoing treatment with androgen deprivation therapy (ADT) plus an androgen receptor pathway inhibitor (ARPI) such as Abiraterone/Prednisone, Apalutamide, Darolutamide or Enzalutamide. To be deemed eligible for this trial, you must have a rising PSA with no evidence of clinical or radiographic progression on imaging evaluation, and your doctor must consider that continuation of your current systemic treatment is feasible. Study details: All participants who meet the eligibility criteria in this study will undertake a 12-week lifestyle intervention of intensified physical activity and a controlled dietary regimen. Exercise prescription will be tailored to each participant’s fitness and comorbidities, and will consist of two supervised sessions per week and one pre-instructed home-session, including cardio and resistance training. The dietary regimen will consist of a balanced diet consisting of low total fat, low saturated fat, high omega-3 fatty acids, optimised protein content and low simple carbohydrates. During and after the completion of the intervention participants will be assessed for prostate-specific antigen (PSA), and questionnaires assessing quality of life and fatigue. Changes in lipid and immune signatures will be assessed through serial blood profiling. It is hoped that this research project will help in understanding whether benefits from of diet and exercise prescription in men with early stage of prostate cancer can be replicated in men who suffer from a more advanced stage of disease.

The ACTnow toolkit was designed for health professionals who were developing physical activity programs for survivors of stroke. This toolkit has completed stage 2 (co-design an ‘Adherence Counselling Toolkit’) and is currently in stage 3 (pilot testing in an inpatient and ambulatory stroke rehabilitation services of Flinders Medical Centre – RAP). Participants (health professionals and survivors of stroke) in stage 3 will provide feedback via a survey and semi-structured interview. This stage, stage 4, proposes to test the ACTnow toolkit in a chronic stroke population at the FMC-RAP outpatient Stroke Clinic as a RCT. It is hypothesised that the intervention group will have improved adherence and self-efficacy as they are using the toolkit which will develop individualised and tailored programs.