ANZCTR search results

Chronic liver disease (CLD), characterised by complications such as ascites, encephalopathy, variceal bleeding, and hepatocellular carcinoma, is a major health concern in Australia. While effective evidence-based therapies exist, delivery of this care has been proven to be sub-optimal. Smartphone-based technologies represent a promising tool for effective disease management and improving patient engagement. Indeed, real-time data collection has demonstrated feasibility and acceptability in a variety of conditions—from schizophrenic disorders , to diabetes, to some promising initial work in liver health . However, in the context of ascites management, there is a need for real-world trials to explore the feasibility and utility of this technology. The objective of this study therefore is to determine the feasibility of a smartphone-based application in the management of ascites in CLD patients in our hospital and community setting.

The overall aim of this study is to assess the acceptability, feasibility and potential impact of CALM in people with advanced NSCLC treated with novel therapies. The specific objectives of this project are to: Assess the feasibility of the CALM intervention, outcome measures, and study design to guide the development of a Phase 3 RCT; Explore the acceptability of CALM to patients with advanced NSCLC treated with novel therapies and to CALM therapists; Provide preliminary evaluation of the potential impact of CALM in this population. Study Design: A mixed methods design will be used for this pilot study.

Pre-treatment rebleeding following aneurysmal subarachnoid hemorrhage (aSAH) independently increases the risk of death and a poor neurological outcome. Over three-quarters of re-bleeds occur within 12 hours so it is recommended that aneurysm treatment occur as ‘soon as feasible’. However, additional factors such as aneurysm location, size, clinical grade, radiological grade, systemic arterial hypertension, systolic blood pressure over 160mmHg, hydrocephalus, intracerebral hematoma (ICH), subdural haematoma (SDH) and intraventricular hemorrhage (IVH) have also been associated with rebleeding. There is likely to be a complex interplay between the time-to-treatment and these other factors as even with reduced treatment times, re-bleeding still affects between 2 to 10% of patients. Several models have been recently described attempting to estimate the risk of pre-treatment rebleeding but none demonstrate a low risk of bias, high clinical applicability and useability. Even the most rigorously formulated model suffers bias from inconsistent predictor ascertainment and the use of historical patient data for model formulation not reflective of current practice which aim to treat ruptured aneurysms within 24 hours termed ultra-early treatment using predominantly endovascular methods. The model also uses as predictors age, sex, aneurysm irregularity and pre-treatment cerebrospinal fluid diversion despite the lack of evidence for an association between these factors and rebleeding whilst it neglects other validated factors such as ICH, IVH and SDH at the time of diagnosis. The model also calculates probability but without elucidating the threshold for altering patient management. In this study we seek to address these limitations using machine learning techniques, referring to types of artificial intelligence which can be trained to automatically detect complex nonlinear relationships between multiple competing factors in the prediction of outcomes of interest. In this study we aim to train a supervised machine learning model using our 14-year cohort of consecutive aSAH patients with ruptured saccular aneurysms managed using an endovascular-first, ultra-early paradigm in accordance with current best-practice guidelines. We will use as inputs a number of routinely available, individually validated clinical and radiological predictor parameters together with the time to re-bleeding or treatment as an outcome to develop this predictive model. This model will be capable of resolving the complex interaction between the time-to-treatment and other re-bleed predictors. Ultimately, it will provide clinicians with actionable information in the form of an optimal time period for the treatment of any individual patient with a ruptured saccular aneurysm to minimise their risk of pre-treatment re-bleeding.

This research project will be based at La Trobe University Albury-Wodonga (LTU-AW) and Eating Disorders Victoria (EDV) and embeds a professional psychology placement program for postgraduate psychology students within a research program examining evidence-based eating disorder assessment and treatment. (Master Research Agreement attached) This is a pilot and feasibility RCT with two primary aims: (i) to explore the viability of running a full RCT to compare treatment efficacy and cost effectiveness of two brief eating disorder interventions; Ten Session Cognitive Behaviour Therapy (CBT-T) and Ten session Guided Self Help (GSH-T), and (ii) to explore the feasibility of providing specialised training in eating disorder treatment and access to treatment via a community-university partnership that embeds professional psychology training in an ongoing research and treatment program. It is expected that eating disorder symptoms will be significantly reduced from pre- to post-treatment in both CBT-T and GSH-T. It is also expected that those allocated to the CBT-T group will have significantly lower eating disorder symptoms post-treatment compared to those allocated to GSH-T.

To date, there have been no comparative studies of retention methods post-expansion. This study aims to address this gap in the literature, comparing the effects of fixed and removable retention methods following rapid maxillary expansion; placement of a Hawley retainer and maintenance of a fixed expander appliance. Records obtained from prior to expansion, immediately posttreatment and then again at 12 month review will be analysed and interpreted in order to determine the best retention method.

"Changing the Focus" program addresses two significant health problems of older Australians: (a) Dementia. The incidence and prevalence of dementia in Australia is projected to grow from 459,000 in 2020, to 1,076,000 by 2058. While the major direct impacts of dementia are cognitive impairment and progressive cognitive decline, onset and progression of dementia are also associated with other health problems that have significant negative personal and carer impact, and add resource and economic cost to health and care systems. Impacts to the individual include reduced independence, physical function, balance, mobility, and community participation, poor mental health, and increased falls. (b) Low levels of physical activity. Older people generally have low physical activity levels, with only 25% of Australians aged >65 years meeting physical activity guidelines. People with dementia have even lower activity levels. Further, physical activity reduction post dementia diagnosis is associated with accelerated cognitive decline. For older people, higher physical activity levels reduce the risk of chronic disease and falls, and improve balance, mobility, function, psychological health, wellbeing and quality of life. Systematic review evidence supports that various forms of physical activity can be implemented safely, and achieve similar outcomes for people with dementia and improve or delay decline in cognition and structural brain changes. Other benefits include improved activities of daily living and reduced social isolation. No systematic approach exists for identifying physical activity needs, or promoting physical activity in people with dementia, despite growing evidence of physical activity benefits along the dementia pathway. This research addresses this major unmet need for an early, systematic approach to identify physical activity needs for people with mild dementia, and embed referral pathways/training opportunities for exercise leaders to support improved physical activity options. Effective management of physical inactivity is required to improve outcomes for the person with dementia and their carer before later stages of dementia, when problems become greater and less amenable to intervention.

The aim of this second study is to test different combinations of written strategies for debunking misinformation about COVID-19 vaccinations and fertility in Australian adults to see whether they are effective at reducing agreement with misinformation compared to a control. We will recruit adults who have concerns about serious side effects of COVID-19 vaccination. Participants will receive an information intervention or a control. The control message will provide correct information. Intervention 1 will provide correct information + information on misleading techniques. Intervention 2 will provide correct information + information on untrustworthy sources. Intervention 3 will provide correct information + information on misleading techniques + information on untrustworthy sources. Analysis of the primary outcome variable (agreement with misinformation about COVID-19 vaccinations and fertility) will use a linear model with predictors of randomised treatment (information on untrustworthy sources (No/Yes), information on misleading techniques (No/Yes)) and their interaction, adjusted for baseline level of agreement with misinformation. Analysis of secondary outcomes will use similar methods.

Skeletal muscle cramping is a common and bothersome symptom for patients on maintenance dialysis therapy. Although initially considered to be an intradialytic phenomenon associated with rapid fluid removal during haemodialysis, accumulating evidence indicates that dysfunction of the renin-angiotensin-aldosterone system (RAAS) may play a significant role in its pathophysiology. This is a multicentre, phase 2, placebo-controlled, randomised crossover trial of the safety, tolerability, and efficacy of angiotensin II in chronic haemodialysis patients who regularly experience cramps. We hypothesise that angiotensin II will be safe, feasible, and effective at reducing cramping.

Purpose: Research indicates there is an unmet need, to test an individualised obesity management approach for people with asthma that addresses nutritional and physical activity inadequacies, while also considering patient preferences, behaviours, and comorbidities. The purpose of this study is to address this unmet need, by testing the first individualised obesity management approach for adults with asthma. The study will seek to achieve this through the provision of medical nutrition therapy and personalised physical activity prescription, and by assessing the efficacy, mechanisms, acceptability, and cost of this intervention. Hypothesis: Obesity-associated asthma is driven by excess adiposity, poor diet quality, physical inactivity, and poor metabolic health. An individualised obesity management intervention, utilising medical nutrition therapy and a personalised physical activity prescription, will improve diet quality, physical activity levels and metabolic health in obese adults with asthma, resulting in better asthma control and lung function.

A six-month study comparing usual clinical care (face to face appointments every 3 months) to usual care plus an SMS-based diabetes support program. HYPOTHESIS: We hypothesize that an SMS-based support program (SMS4T1D) will be feasible in the RPAH Diabetes Centre type 1 diabetes population and that this SMS-based program will facilitate a greater decrease in diabetes distress than standard clinical care over a six-month period. AIM: The primary aim of this study is to assess the feasibility of an SMS-based, diabetes distress support program in the RPAH Diabetes Centre type 1 diabetes population. The secondary aim is to estimate the likely magnitude of change in diabetes distress associated with the SMS4T1D program. This data could then be used to inform power calculations for future studies involving the SMS-based support program.