ANZCTR search results

The aim of this project is to evaluate the superiority of the Inroads integrated web-based anxiety and alcohol intervention for youth, compared to an active alcohol-feedback intervention. This trial extends an earlier trial of the Inroads program combined with psychologist support (ACTRN12617001609347), which demonstrated significant reductions in hazardous alcohol use and anxiety symptoms for up to 6 months compared to an active control condition [1]. The current trial extends this work by evaluating the efficacy of an adapted, self-guided version of the Inroads anxiety and alcohol intervention, which uses rule-based response algorithms to provide feedback, troubleshooting, accountability, and motivational support via customised, auto-messaging. To maximise adherence, the web-based program will be supplemented by low intensity technical and adherence support from a non-specialist lay technician. The proposed trial will test the efficacy of the self-guided Inroads program compared to an active alcohol control intervention. In addition, the trial will address key gaps in the existing evidence-base by investigating the long-term and cost-effectiveness of the intervention, and incorporating a standardised diagnostic assessment to examine benefits of the intervention in prevention progression from hazardous drinking to alcohol use disorder. The primary aim of this trial is to evaluate the superiority of the Inroads integrated anxiety and alcohol intervention, compared to an active online alcohol-feedback intervention. Specific hypotheses are: • Concurrently targeting anxiety, alcohol use and the interrelationship between them will achieve greater reductions in anxiety symptoms and hazardous alcohol use at 2-month (primary endpoint) and 6-month follow up, compared to an active alcohol-feedback intervention. • The integrated intervention is expected to also achieve superior improvements on secondary outcomes: frequency of binge-drinking, depression symptoms, alcohol consequences and quality of life. • The integrated Inroads intervention will prevent progression to disorder, with lower rates of anxiety and alcohol use disorders at 6-month follow-up compared to alcohol-focused intervention. References: 1. Stapinski LA, Prior K, Newton NC, Biswas RK, Kelly E, Deady M, Lees B, Teesson M, Baillie AJ. Are we making Inroads? A randomized controlled trial of a psychologist-supported, web-based, cognitive behavioral therapy intervention to reduce anxiety and hazardous alcohol use among emerging adults. EClinicalMedicine. 2021

Background: With increasing numbers of people requiring follow-ups for their fractures, the burden on outpatient fracture clinics with limited resources has also increased, causing long clinic wait times, and productivity losses for patients and carers from missing school or work. Published studies have shown that virtual fracture clinics can manage patients with simple fractures, but robust evaluations of their safety, effectiveness and cost-effectiveness are lacking. Aim: To determine whether virtual care is non-inferior to in-person care for people with simple fractures through a prospective two-arm, parallel group randomised controlled trial, using a non-inferiority design; with nested economic and process evaluations, and semi-structured qualitative interviews with subset of patients. Primary objective: To determine whether virtual care produces non-inferior physical function outcomes compared to in-person care for patients with simple fractures at 12-weeks follow-up, measured using the Patient-Specific Functional Scale (PSFS). Secondary objectives: To compare the effects of virtual care and in-person care on pain (Numerical Rating Scale), patient-reported health-related quality of life (EuroQol 5D 5L), patient-reported experience (Generic Short Patient Experiences Questionnaire), cost-effectiveness, healthcare utilisation, medication use and safety (number of adverse events, number of serious adverse events) at 6- and 12-weeks follow-up. Study procedure: All patients referred to the virtual fracture clinic with simple fractures who agree to receive a follow-up at Royal Prince Alfred will be screened for eligibility. Participants who consent to the study will be randomised to receive follow-up fracture care through one of two existing clinics – a virtual fracture clinic (intervention group) or an in-person fracture clinic (control group). The intervention group will receive a standard fracture management fact sheet and have their follow-up care via phone or video calls with a physiotherapist. The in-person clinic (control group) will receive follow-up care at the in-person clinic with an orthopaedic doctor. All participants will complete a series of surveys as part of their clinical care. This study has received ethics approval and will commence recruitment in September 2023.

The primary aim of the current trial is to test the effectiveness of the online Recognise, Respond and Support - A Parent's Guide to Youth Mental Health resource in increasing parent self-efficacy to recognise, respond and support mental health problems and suicide risk in their child. Secondary aims of the trial include assessing the effect of the resource on perceived knowledge and/or skills to recognise, respond and support child mental health, mental health and suicide literacy, mental health and suicide stigma, and help-seeking attitudes, intentions and barriers, The Recognise, Respond and Support - A Parent's Guide to Youth Mental Health resource will be compared to a wait-list control condition, with effects assessed at post-intervention and 12-week follow-up. All participants in the wait-list control condition will receive access to the resource after completion of their 12-week follow-up survey.

This research study is investigating the effectiveness of current cleaning and disinfection procedures used for home non-invasive ventilation (NIV) or continuous positive airway pressure (CPAP) devices. Small organisms (microbes) such as bacteria or fungus can potentially be present on this equipment. The use of routine disinfection processes should remove these organisms. However, there has been limited investigation into whether NIV devices can become contaminated and how effective current cleaning processes are. The objective is to investigate whether microbes, similar to what is in your sputum (lung mucous), are present on or inside the NIV or CPAP device prior to and after cleaning. Most people who use NIV or CPAP at home require the use of a loan pool device in order to trial therapy and/or qualify for government funded equipment. These devices are always cleaned and disinfected by staff between patients. This process includes cleaning all accessible surfaces with special medical grade wipes and changing the filter. For this study, swabs of your NIV or CPAP machine and an air sample are going to be taken before and after the machine is cleaned using our normal cleaning process to test if the cleaning process removes any microbes that happen to be present on or in the device after you have used it. The most important outcome of this study is comparing the number of microbes before and after we clean the device to look at how well the cleaning processes work. Microbes are everywhere in the world and inside your body and are a normal part of our environment. We are not trying to show that your machine is more or less “dirty”. We aim to show that cleaning processes work effectively by demonstrating that less microbes exist after cleaning. We are particularly interested if any microbes which might harm people with lung problems might be present on the devices, or in the air flow after they are cleaned. We do not want you to take any additional steps to “disinfect’ your machine prior to our assessment because we need some normal environmental microbes to be present for this investigation to be useful.

The TRodelvy use in AdvanCed TrIple Negative BrEast Cancer in Australia also known as TRACIE aims to open at approximately 20 sites and include 150-200 patients. This is what is known as a non interventional study where we use patient data that has already been collected in the course of normal medical care. Who is it for: We are looking at adult patients, over 18 with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received at least two prior systemic therapies, including at least one prior therapy for locally advanced or metastatic disease, and who have started treatment with Trodelvy between 1 Oct 2021 and 30 September 2024 Health data that may be collected includes adverse events or side effects noted while receiving trodelvy, access to medical scans and/or blood tests used to determine disease progression/metastases and tumour characteristics identified during biopsy assessments. Participants will not be required to complete any physical assessments or have any visits or contact as part of this observational study. We already know that Trodelvy is safe and effective as a breast cancer treatment when used in clinical trials and hope to be able to show the same results in the real world setting.

For medical technology and advances to be utilised in clinical practice they need to be not only effective and safe but also acceptable to consumers. To achieve this, it is important to invite the users of health technologies, including patients, carers and clinicians to provide feedback on new and emerging technologies. To determine the opinions, motivations, barriers and potential uptake of new technologies for cystic fibrosis care we are inviting paediatric patients, their parents/carers and associated health care workers to provide their opinion on two emerging technologies: XV LVAS imaging and airway gene therapy. It is important to determine the opinions of paediatric patients as well as their care team as in cystic fibrosis lung health in the early years impacts lifelong health and wellbeing for these patients. Mitigation of barriers to existing and emerging health interventions in this group will have a lifelong impact on wellbeing, life expectancy and healthcare utilization. Subjects will be invited to participate in this study based on their experience in the XV Feasibility Study (Protocol No: WCH_XV_001, ACTRN12623000109606). During this study cystic fibrosis affected children were offered an XV LVAS scan which is compared to results of routine Lung Function testing to determine whether this technology is safe, effective and an appropriate addition to paediatric cystic fibrosis care. Those children and their care teams will be interviewed to determine their attitudes towards the new technology and also that of airway gene therapy which is under development. Subjects will be invited to participate in a one-hour semi-structured interview to discuss their lived or clinical experience of cystic fibrosis, XV LVAS scans and understanding of gene therapy. This will be complemented by limited demographic data collection and complimentary data extracted from the XV Feasibility Study (WCH_XV_001).

Residential aged care facilities (RACF) have difficulty accessing timely primary care for their residents. A solution within RACFs is to employ Nurse Practitioners (NPs) to supplement GP services. Evidence suggests that NP models within RACFs positively impact resident well-being. The current research evaluates impact, acceptability, and feasibility outcomes for 5 RACFs where an NP model of care is active. The impact of the NP program is evaluated by comparing resident health outcomes (e.g. hospitalisations, polypharmacy, falls) routinely collected for the 5 intervention RACFs against 5 matched control sites without an NP program, for 12 months prior to and during the intervention. A sample of staff, residents, NPs, and GPs will also participate in qualitative interviews assessing acceptability of the program. It is expected that resident outcomes will be improved for the NP sites during the program relative to prior and compared to control.

Melanopsin is expressed by axons of intrinsically photosensitive retinal ganglion cells (ipRGC) that pass through the optic nerve head, corresponding to the blind spot. Blue light stimulation of the blind spot has been demonstrated to activate melanopsin. The synaptic pathway between ipRGCs and dopaminergic amacrine cells in the retina has implicated these cells in the light-mediated mechanisms regulating eye growth. This human experimental study addresses the hypothesis that the biomarker choroidal thickness increases with repeated daily blue light stimulation of the blind spot over a seven-day period as compared to red light stimulation in myopic children and adolescents.

The purpose of this study is to assess safety, reactogenicity (reactions that occur to the body soon after vaccination) and immunogenicity (the ability of a vaccine to provoke an immune reaction in the body) of an influenza vaccine, MYNFLU001. The MYNFLU001 vaccine will be administered twice via intramuscular injection, 21 days apart. This study will be conducted on healthy men or women, 18-59 years old. This study will compare MYNFLU001 with placebo. A placebo has no active drug in it. One group of participants will receive a low dose of the vaccine (12mcg), one group will receive the high dose (32mcg) and the other group will receive a placebo. The effects seen in participants receiving the study drug will be compared to the effects seen in participants who receive placebo. Each group will involve 15 participants, with 45 participants to be enrolled in total.

Urinary sodium (UNa) enables rapid assessment of the response to diuretic therapy. If inadequate, it allows for rapid escalation of the diuretic dose until adequate diuresis is achieved. Insufficient decongestive therapy in acute heart failure (AHF) is associated with poor outcomes. Hence, spot urinary sodium concentration (UNa) has been proposed as a tool to rapidly assess the response to decongestive therapy and to estimate future outcomes by the Heart Failure Association of the European Society of Cardiology in 2019 and incorporated in the 2021 European Society of Cardiology Guidelines for the diagnosis and treatment of AHF. This recommendation is entirely based on expert opinion, and the efficacy of this approach has not been tested in a randomised controlled trial (RCT). In this prospective RCT, we investigate the clinical utility of spot UNa measures in the treatment of patients with AHF, and its effect on the short-term and long-term clinical outcomes compared with the standard treatment. Primary Aim is to determine if titrating intravenous loop diuretic dosing based on serial spot UNa samples (intervention arm) compared with diuretic dose titration based on the evolution of clinical signs and symptoms (standard care arm) leads to a shorter length of stay in patients hospitalised with AHF. Secondary aims are to determine if Una-guided loop diuretic titration is associated with: (1) Greater weight loss and decongestion at 72 hours. (2) Less adverse effects during admission (3) Improved all-cause mortality and unplanned readmissions at 30 days, 6 months, 12 months, and 2 years (4) Better prediction of the risk of adverse events, death and readmissions compared with standard care.