ANZCTR search results

The purpose of this research is to define and identify “consumer-navigation stress” and satisfaction of clinical communication experienced by individuals with Inflammatory Bowel Disease (IBD) as they navigate healthcare systems. By identifying and addressing consumer-navigation stress and assessing communication satisfaction, this research seeks to assess whether the availability of a mobile app can augment care, reduce friction to accessing care, and ultimately improve health outcomes for individuals with IBD. This study will use an IBD-centric consumer designed digital application to improve care navigation, leveraging Crohn's Colitis Care, a bespoke IBD electronic medical record system current in use for over 15,000 patients with IBD across Australia and New Zealand.

This study is testing a new service called the Integrated Peer-Supported Physical Health Service (IPPHS), designed to help improve the physical health of adults living with long-term mental health conditions of schizophrenia, psychosis and bipolar disorder. The service will be offered at adult community mental health clinics in south eastern Sydney and Tasmania and includes support from peer workers, physical health checks with a primary care provider, and a mobile app for health tracking and home exercise. The service for better physical health for people living with persistent mental illness by increasing the number of consumers offered, taking up, and continuing with recommended physical health care.

This is a multi-centre retrospective data collection collaboration with Monash University acting as the co- ordinating organisation. People with epilepsy will be assessed for eligibility through screening of seizure clinic attendance lists and hospital medical records by their recruiting organisations. The recruiting organisations will enter the structured clinical information of their people with epilepsy into the cohort dataset. The data will be de-identified before being provided to Monash University for storage in the data warehouse.

Self-harm is a major threat to health and wellbeing, substantially increasing a person’s risk of suicide. Concerningly, rates of self-harm amongst those under the age of 14 have been increasing rapidly over the last five years. As such, it is becoming increasingly important to target prevention efforts in mid- to late-childhood, before self-harm behaviours emerge. Universal prevention programs are needed to reach all children, regardless of risk. However, no effective universal prevention programs targeting self-harm in young people currently exist. To address this gap, we have developed a new universal, primary school-based self-harm prevention program for students in Years 3-6, called Bridge to Better (B2B). The aim of this study is to evaluate the effectiveness and implementation of the B2B program in reducing self-harm and improving psychological wellbeing amongst students. Up to 6,500 students in Years 3-6 from 72 schools will participate in a cluster-randomised trial to assess the efficacy of the program. Additionally, implementation outcomes will be assessed to determine program adoption and fidelity. It is expected that B2B will reduce the onset of self-harm behaviours and improve wellbeing among students following the delivery of the intervention, and at follow-up. It is also hypothesised that risks for self-harm, including emotional reactivity, depression, negative affect, and bullying will decrease as a result of improved emotion regulation skills and social connectedness among students. If successful, B2B will provide the first Australian evidence-based self-harm prevention program for primary schools.

This study will test whether BRP-180 can improve wakefulness or reduce cataplexy in people with narcolepsy. Participants will be randomly assigned to receive either a low dose, high dose, or placebo, taken once daily for eight weeks. The trial includes a screening and observation period, a treatment phase, and a follow-up to monitor effects. Researchers hypothesize that BRP-180 will significantly improve symptoms compared to a placebo.

A proof of concept, open-label, placement of a novel sternal band and plate fixation device with similar mechanics of stabilisation to the current routinely used band and plate system at Royal Melbourne. Evidence of adequate bone healing (proof of concept) will be assessed in the same way as the previous prospective randomised trial was conducted, with early assessment using high-frequency ultrasound imaging of the bone edges, and a CT scan at three months post operative to allow assessment of new bone formation.

This is an observational research study, meaning no investigational drug will be administered and the study involves only gathering data through standard clinical assessments for Geographic Atrophy condition. This study consists of 2 parts. Part 1 is intended to identify potential participants for a separate study and will evaluate changes in Geographic Atrophy characteristics based on optical coherence tomography (OCT) and fundus autofluorescence (FAF) imaging. Part 2 will study the natural disease progression in participants diagnosed with Geographic Atrophy over an up to 18-month period.

This is an exploratory study collecting Cerebrospinal Fluid (fluid in the spinal column) via spinal tap to study the biomarkers of a new product being developed by Evecxia Therapeutics that could help patients with depression. The study is to determine what quantity of EVX-301 (through looking at the biomarkers) after 24 hours of iv infusion can pass through the blood/brain barrier for treatment of depression in patients.

This study aims to determine if specific changes to the National Bowel Cancer Screening Program (NBCSP) increases participation in ‘persistent never screeners’. ‘Persistent never screeners’ are defined as people who have been eligible for at least 3 consecutive screening invitations (sent kits), but never completed an NBCSP screening test. Who is it for? You may be eligible for this study if you are an adult in Australia over the age of 50 who has never returned a bowel screening kit from the NBSCP. Study details The trial will have three arms, with a sample size of 60,000 people (20,000 people in each arm). People in Arm 1 will not be sent a NBCSP kit but will be sent a pre-invitation letter with details about how to order a kit. People in Arm 2 will be sent a revised letter with additional health promotion messages on the outside envelope and in the letter including a QR code link to tips to help overcome known barriers to participation. People in the control arm (Arm 3) will be sent the standard material – letters, the NBCSP kit and reminders. Eligible people who are due for their pre-invitation letter will be randomly assigned into one of the three arms and followed up for six months from the time the last kit has been sent out. We will compare the percentage of people who return the kit between the three arms, to determine the impact of each intervention on kit return. It is hoped that this study will help determine if changes to the way people are invited to take part in the NBSCP kit will have an impact on the number of kits returned for testing.

The MANTRA Study aims to test, via a randomised non-inferiority trial, trauma-sensitive yoga (TSY) for people who have experienced non-consensual sexual experiences to improve their mental health and wellbeing. The project aim to recruit 370 people who have experienced non-consensual sexual experiences and are currently experiencing Complex Post Traumatic Stress Disorder and randomly assign them to participate in either TSY or the comparator, group Cognitive Processing Therapy. We hypothesise that TSY will not be inferior to the control group for reducing Complex PTSD symptoms, mood disturbance and negative feelings while also improving feelings of self-compassion. Further, we hypothesise that TSY will be more cost-effective compared to the control intervention.