ANZCTR search results

This study aims to co-design, trial and evaluate an Aboriginal cultural health program in the Northwestern and Far South Coast regions of NSW. A stepped-wedge cluster randomised trial design will be used to implement the program to 120 Aboriginal adults (18+ years) randomly allocated to four clusters (2 in each region). Senior Cultural Health Facilitators will lead the delivery of the program, which aims to improve cultural health and social and emotional wellbeing through in-community and on-Country activities. Effectiveness of the program will be measured against participant reported outcomes of cultural health and social and emotional wellbeing using measures validated for use with Aboriginal people. Participant reported outcome measures will be collected at baseline, then after each cluster receives the program at 2 months, 4 months, 6 months, 8 months, and 10 months post baseline. The evaluation will use quantitative and qualitative process measures to examine the implementation, contexts and mechanisms that shape the delivery of the program using the Consolidated Framework for Implementation Research (CFIR 2.0) design.

We are developing new phenotyping and acoustic techniques to help better identify the mechanisms and sites of airway collapse during both sleep and DISE (drug induced sedation endoscopy) to see if these techniques can be used before and during DISE to more accurately reproduce upper airway collapse during natural sleep. Snoring and complete airway collapse produce characteristic features in breathing and acoustic signals that can be collected during sleep studies and DISE. By testing these new techniques in this study, we will be able to test how well DISE mimics natural airway collapse during sleep and what acoustic and other signal features can tell us about the specific sites of airway collapse identified using DISE. Our overall aim is to develop a new ‘Pheno-DISE’ procedure that can more effectively guide surgical treatment choices for patients with OSA and snoring.

Dietitian-led, open-label program of 3 dietary strategies as adjunctive therapy for Inflammatory Bowel Disease. Dietary therapy will be offered to patients: the Crohn’s Disease Exclusion Diet (if patient has Crohn’s or pouchitis), the Ulcerative Colitis diet (if patient has UC or microscopic colitis), or a less restrictive wholefood diet that excludes ultra-processed food (any condition). PROGRAM HYPOTHESES • Dietary therapy in patients with IBD is practically feasible, well tolerated, and satisfying • Dietary adjunctive therapy will reduce disease activity • Dietary therapy will enhance quality of life • Dietary therapy will modify the enteric microbiota

The purpose of this project is to investigate the effect of a 6-month personalised lifestyle protocol that incorporates recommendations from the Shae platform (nutrition, exercise, sleep, mindset, relationships, environment) and group coaching (to support adherence) on the change in markers of diabetes and pre-diabetes. It is hypothesised that those individuals following personalised lifestyle medicine guidance will experience a meaningful improvement in blood glucose control and markers associated with Type 2 Diabetes risk. Participants will be randomised into two arms: (Group 1) Immediate intervention; (Group 2) Wait-list control. Those in the wait-list control will be monitored for 6 months without intervention while they recieve standard care under the supervision of their personal health care provider.

Medication errors are a significant problem in hospitals. Most hospital patients experience at least one medication error each day, and older people—especially those with age-related illnesses—are most at risk, experiencing three times as many errors as people under 65. A promising approach to reduce these errors is partnered pharmacist medication charting, where doctors and pharmacists work together from the start to decide on a patient’s medicines, instead of identifying problems after they happen. In hospitals that use paper-based prescribing systems, this approach has reduced medication errors from 66% (with doctors prescribing alone) to just 3.6%. However, electronic prescribing introduces different types of errors, and it’s not yet clear whether the benefits of partnered charting still apply in hospitals using these systems—especially for older patients at higher risk. This study will introduce and thoroughly test partnered charting in hospitals that use electronic prescribing. We’ll run a large, multi-site trial comparing this approach with usual care to see if it reduces medication-related harm in older patients. The results will help determine whether this model of care should be adopted more widely across Australia and internationally.

Roxadustat is a first-in-class oral prolyl hydroxylase inhibitor, marketed since 2019 exclusively for the treatment of anaemia in chronic kidney disease. Roxadustat increases hypoxia inducible factor (HIF) signalling, the primary mediator of the body’s normal adaptive response to low oxygen levels. HIF is a transcription factor that influences the expression of over 400 genes relating to energy production when oxygen is scarce (glycolysis), improved tissue oxygen delivery (erythropoiesis and angiogenesis), cell survival under stress and enhanced innate immunity. All of these biological mechanisms play a key role in favourable outcomes after the tissue injury of major surgery and the associated stress response. The HYPE Pilot Study (RGS0000006528, SMHS HREC, ACTRN12624000188538) is a separately registered double-blind phase 2 RCT that is currently recruiting at Royal Perth Hospital to explore the safety and potential benefit of three preoperative doses of Roxadustat 100mg in patients undergoing major noncardiac surgery. It remains unclear to what extent such brief Roxadustat exposure changes gene expression in the key pathways outlined above. The HYPE Volunteer Study (RGS0000007340, Central HREC) will complement the HYPE Pilot Study by improving understanding in this area i.e. will potentially substantiate any clinical effects observed in the HYPE Pilot Study and may support a subsequent phase 3 trial.

Due to gaps in first-person communication with their clinicians, people with communication disability can experience poor health outcomes, lengthier hospital admissions and adverse events including preventable deaths. Despite numerous attempts to integrate augmentative and alternative communication (AAC) into health settings, patient input is often deferred to others, such as parents or carers, or is subject to the ‘best guess’ by healthcare professionals. The Talking Scrubs project aims to form a bridge to AAC by locating key communication icons on scrubs (and scrubs vest) to be used with patients (in and of themselves) and/or to prompt the use of patient individualised communication methods. Our study is propelled by the following hypothesis. A patients health improves, and adverse risk reduces, when the patient’s communication agency is understood and used (reflected back) by clinicians; when s/he has the first-person voice in their own health care; when s/he is no longer ‘spoken for’ but instead indicates their health concerns, feelings and consent.

This Phase 1, randomised, placebo-controlled, double-blind clinical trial will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MZE782 when administered at increasing dose levels in healthy adult participants in Australia. Participants will receive MZE782 or matching placebo as multiple doses.

The study aims to evaluate the toxicity and quality of life outcomes associated with urethra-sparing prostate stereotactic ablative radiotherapy (SABR) for intermediate risk prostate cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have intermediate risk prostate cancer. Study details: Traditional radiotherapy for intermediate risk prostate cancer typically involves four weeks of daily treatment. Recent studies have shown that using fewer but larger doses of radiation, i.e. 5-treatment SABR, is just as effective and safe, and this has now become one of the standard radiation schedule option for men with intermediate risk prostate cancer. The question then is whether we can further reduce treatment-related toxicities while maintaining cancer control. In this Australian phase 2 trial of urethra-sparing prostate SABR, we aim to evaluate the efficacy, toxicity, quality of life outcomes of this treatment

This project will address the significant impact of antipsychotic-induced weight gain among people with serious mental illness (SMI) by co-designing an evidence-based, easily understandable, and low-cost, educational resource on diet and physical activity. This study will use a co-production methodology to co-design the lifestyle resource with individuals with SMI and their treating clinicians. We will identify the key components required for this educational resource, and then develop, and refine this resource by running three focus groups (N = 5 per group) with Metro South Addiction and Mental Health Service (MSAMHS) case-managed out-patients (18-65 years) with lived experience of SMI. We will then pilot this lifestyle self-management intervention with MSAMHS consumers (N=20). We expect that this resource will lead to positive changes in consumer intentions, attitudes, perceived behavior control, motivation and health literacy in relation to their physical activity and nutrition. We also expect that this will lead to a change in consumer health behavior (i.e., increased physical activity and healthy eating).