ANZCTR search results

This interventional pilot and feasibility study will use a multiphase mixed methods process and outcomes evaluation, reported in line with the CONSORT checklist. Prescriptions for Connection, a social prescribing program, will be co-designed and implemented in six Australian primary care practices and three council areas. Implementation outcomes will be evaluated using the Reach, Effectiveness, Adoption, Implementation and Maintenance Framework. Qualitative data collection, via focus groups for health and social care providers and interviews for older people, will be based on the Consolidated Framework for Implementation Research to explore barriers and facilitators, and explain outcomes.

Chronic Obstructive Pulmonary Disease (COPD) is a severe condition causing millions of deaths annually, with late diagnosis and progressive lung damage making current treatments only symptomatic. The trial focuses on the pre-COPD phase, a critical period when lung function begins to decline but before permanent damage occurs, offering an opportunity for intervention. Inhaled Triple Therapy (fluticasone furoate, umeclidinium, and vilanterol) may slow lung function decline and prevent progression to COPD. This double-blind, randomized, placebo-controlled trial will involve 500 participants from the Tasmanian Longitudinal Health Study (TAHS) to evaluate the therapy's effectiveness and cost efficiency. If successful, this groundbreaking study could shift COPD management to prevention, reduce its global burden, and lay the foundation for future research and drug development.

Emestedastat was created to decrease the production of cortisol by the brain. This drug has been previously tested in nearly 400 people, including healthy adults and people with Alzheimer’s Disease and depression. The research project will test what the body does to emestedastat, such as how quickly it enters, moves through, and leaves the body. In particular, the research project will test if eating food has any effect on what happens to emestedastat in the body. If this and other clinical research projects are successful, the treatment being studied may be approved to treat people with Alzheimer’s Disease or depression in the future.

In children, protracted bacterial bronchitis (PBB) and chronic suppurative lung disease (CSLD) represent chronic respiratory diseases on an overlapping continuum that can progress to irreversible bronchiectasis. Early management, principally through appropriate antibiotic treatment can prevent progression of disease in many children. Airway clearance techniques, prescribed by a physiotherapist are used routinely in children with chronic respiratory disease, such as cystic fibrosis and bronchiectasis to aid in sputum removal and have been shown to improve health outcomes and mortality. Increasingly, these techniques are being used in children with PBB/CSLD. However, there is no current evidence that addition of airway clearance techniques is efficacious in this cohort. Therefore, the aim of this study is to determine if airway clearance, as an adjunct to antibiotic therapy is efficacious in children with PBB. That is, does the addition of airway clearance to standard care reduce the length of the exacerbation? Our study is a single site randomised controlled, parallel clinical trial. Participants will be randomised to standard care (antibiotic therapy) or standardised care plus airway clearance during exacerbations and for 1-week post cough resolution. The primary outcome will be the proportion of children with cough resolution by day-10. Secondary outcomes will be change in (measured via parent-proxy cough-related Quality of Life) PC-QoL scores from day 1 to day-10 and 28 (post commencement of antibiotic therapy), and time to next exacerbation. We hypothesise that addition of airway clearance will result in a greater proportion of children with cough-resolution at day-10, improved PC-QoL, and longer time to next exacerbation.

The “BRAVE-CHIP” pathway is a novel, multidisciplinary model of care designed to accelerate the transition of patients with rib fractures into virtual care through a combination of contemporary rib fracture management and the early utilisation of regional anaesthesia, via a serratus anterior plane block placed in the ED. The project aim is to study the introduction the “BRAVE-CHIP” pathway into Royal North Shore Hospital by assessing whether it can have an impact on hospital length of stay whilst preserving pain management and respiratory function for our patients with rib fractures.

The study aims to evaluate the safety and efficacy signals of AST 004 as an acute intervention in athletes who sustain a sports related concussion during match play on game day. Adverse events, blood protein biomarker improvement, and clinical improvement will be analysed and neuropsychological testing assessed.

This study will conduct a randomised controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of the program to reduce suicidality, depressive symptoms, and improve quality of life, among trans people on a waitlist for initiating GAHT. Participants in the intervention condition will attend 7 x 1.5hr weekly sessions of the peer support program over seven weeks, co-facilitated by two trans people. Participants in the control group will remain on the standard care waitlist and will not receive the intervention. Participants in both groups will be required to complete 3 x 20min online health surveys. If proven feasible, acceptable, with preliminary evidence of efficacy, this program may represent an implementation-ready and readily scalable solution to address the mental health support needs of trans people on GAHT waitlists across Australia.

This study aims to determine the tolerability, safety and efficacy of fibre supplementation to reduce side effect symptom severity and promote maintenance therapy adherence in people with breast cancer Who is it for? You may be eligible to join this study if you are aged 18 years or older, currently receiving systemic maintenance therapy (including chemotherapy, endocrine therapy and/or targeted therapy) for breast cancer, at 6 to 18 months following initial diagnosis, experience side effects to your maintenance therapy and are able to provide informed consent to all trial related procedures. Study details All participants who meet the eligibility criteria in this study will be randomised to either the intervention or control group. In the intervention group, all participants will be provided with a fibre supplement daily for 3 months, whilst on maintenance therapy for breast cancer. The control will continue with their current maintenance therapy and standard care. They will be offered the fibre supplement 1 month after the intervention has been completed. During and post intervention, participants will be assessed for side effects, dose modification, adverse events, gut microbiota, and brain structure. It is hoped that this research project will provide the first evidence supporting the beneficial role of fibre in reducing breast cancer treatment side effects, informing larger scale trials to produce the knowledge required for clinical implementation of fibre as a supportive cancer care strategy.

The study is designed to reflect a real-world scenario where an exercise physiologist may deliver small group breathwork sessions online whilst providing participants materials to perform self-directed practice at home. Additionally, the study will begin the process of developing protocols for safe and effective telehealth breathwork sessions. This includes screening, orientating participants to the telehealth environment, providing technical support, setting online group class etiquette and structure, optimising the home practice environment, promoting social engagement support, and providing opportunities for feedback. The research will be used to inform future studies

This project aims to embed a new technologically based approach for the screening of delirium into the Emergency Department with the goal of improving accuracy and timeliness of diagnosis of delirium in all patients presenting to ED over 65 years of age. The new tool, named DREAM, will be used in parallel to the current clinical screening standard, 4AT, and a diagnostic "gold standard" diagnosis in 100 patients above the age of 65 presenting to ED. Order of testing will be randomly assigned and prospective consent will be obtained from all participants or their primary decision makers. The primary study outcome is diagnostic accuracy of DREAM, which will subsequently lead to implementation into clinical practice. This implementation will provide future opportunities to combine DREAM with existing, electronic delirium aetiology tools to enhance clinical decision support for delirium diagnosis. Early and accurate diagnosis and treatment will significantly improve patient outcomes, such as shorter hospital length of stay, fewer re-hospitalisation, and reduced morbidity and mortality.