ANZCTR search results

This study will be a randomized controlled trial including children aged 2-16 years and adults >16 years of age, with newly diagnosis type 1 diabetes (< 7 days). Participants will be randomized 2:1 to Omnipod®5 automated insulin delivery device OR standard care (multiple daily insulin injections and continuous glucose monitoring [CGM]). Participants will receive the treatment for 12 weeks. Over this time their CGM data will be analysed, along with HbA1c and psychosocial outcomes from questionnaires and cost to the health system and the participant. We think the participants using Omnipod®5 from diagnosis of type 1 diabetes will have better glycaemic and psychosocial outcomes (such as less distress, more confidence and improved sleep) compared to those using standard care.

Stroke remains a leading cause of disability. Rural Australia has higher prevalence of stroke and reduced access to services. The purpose of this study is to evaluate an intensive stroke recovery program, delivered as a hub-spoke model, targeting areas of need in rural South Australia. The intensive burst of training will target arm recovery after stroke.

The purpose of this study is to investigate the safety and tolerability of 3D printed intranasal splints in healthy participants. Who is it for? You may be eligible for this study if you are a healthy adult, without a history of surgeries to the nose. Study details All participants in this study will be asked to wear a splint in the nose continuously for 10 days and will be followed up for 30 days to see if there have been any side effects It is hoped this study will help determine if these splints are safe to use for a future randomised trial looking at whether these devices can be helpful in nasal skin cancers

Shoulder pain affects 15-27% of adults and is the 3rd most common musculoskeletal complaint seen by general practitioners in Australia. Rotator cuff (RC) tendinopathy is the most common cause of shoulder pain and people affected have impairments in work and self-care activities, with 40% having ongoing disability beyond 12 months. Clinical practice guidelines and consensus statements suggest 12 weeks of first line management (activity modification, medication advice, clinician guided exercise) for RC tendinopathy prior to considering imaging or surgical referral. In contrast, our team and others have shown high rates of non-guideline indicated (‘low-value’) imaging (up to 80%) and surgical referral (about 20%). Video conferencing-delivered care is cost effective, convenient, and able to reach people in rural and remote regions. However, video conferencing rely on synchronous contact with a health professional, which is both time and labour intensive, and costly. Providing first line care directly to patients in their homes is now possible via digital voice assistant (DVA) or voice-controlled intelligent personal assistants (VIPAs) like Amazon Alexa (“Alexa”). Our group pioneered this technology for delivering exercise interventions for elderly people. We have now developed an Alexa program that delivers high-quality first-line exercise and education to people with RC tendinopathy. Our program includes behaviour change strategies as well as asynchronous interaction with a health professional via the user’s voice responses. The proposed study aims to test the feasibility of a randomized trial comparing DVA care (via Alexa) to telehealth (via Zoom video conferencing) and active control. If successful, this will lead to a full-scale randomized trial in Australian primary care that has the potential to develop evidence for a high quality and efficient internet-delivered intervention that could benefit millions of Australians who suffer with shoulder pain.

This clinical investigation aims to evaluate the performance and safety of the microICSI device, an investigational product designed to improve the specialised in vitro fertilization (IVF) process of intracytoplasmic sperm injection (ICSI) by reducing physical trauma to oocytes during insemination. The microICSI device uses cutting-edge micro-3D printing technology (2-photon polymerization) to create a micron-level resolution 3D receptacle, minimizing the need for the conventional (glass) holding pipette and suction, which often causes distortion to the oocyte’s shape. This innovation seeks to enhance fertilisation and embryo development outcomes, while also reducing variability associated with traditional ICSI procedures. The primary hypothesis is that microICSI will demonstrate non-inferior performance to cICSI regarding fertilization outcomes.

Trans and gender diverse adolescents face heightened physical and mental health challenges, with elevated rates of depression, self-harm, and suicide attempts (Strauss et al., 2020). Potential risks to cardiometabolic health also exist due to gender affirming medical therapy and unhealthy behaviors (Spanos et al., 2020). Given the well acknowledged benefits of physical activity for physical and mental health (Biddle & Asare., 2011), exercise presents a novel but underexplored strategy to mitigate some of the adverse mental and physical health symptoms and contribute to improve overall health and wellbeing of trans adolescents (Storr et al., 2021). The WA Gender Diversity Service is an outpatient service located at Perth Children’s Hospital that provides adolescents with a multidisciplinary approach to the assessment, care, and management of gender diversity. Currently there are no exercise services part of standard care within the WA service, nor is exercise incorporated as standard care in any gender services across Australia. The "Movement Program" is a twelve-week exercise intervention for adolescents within the GENder identiTy Longitudinal Experience Cohort (GENTLE cohort; RGS320). In collaboration with stakeholders, we aim to create and assess an evidence-based exercise intervention for bettering health, physical activity, and well-being of trans adolescents. The study will enable us to understand the impact exercise can have on trans adolescents’ health and wellbeing and whether providing such support during key developmental stages will also support trans adolescents in developing healthy (or healthier) physical activity behaviours. We propose to deliver the program over 2025 and anticipate up to 20 GENTLE adolescents participating in the intervention. We aim to enhance service delivery and address a significant gap in international research by developing this project within the GENTLE Cohort. Our goal is to determine whether this evidence-based exercise service can complement the current health services of the WA Gender Diversity Service.

To evaluate the feasibility of a brief psychological intervention, OMED Assist in practice for patients with chronic non-cancer pain who may be at risk of potentially harmful prescription opioid use in a prospective non-randomised pilot study.

We need to answer key questions about the efficacy of apps that have been based on proven therapeutic approaches (can they reduce suicidal ideation and improve wellbeing compared with a control, are effects portable from one country to another?), and to understand if these apps are acceptable (are these apps engaging for youth, including rangatahi Maori), and safe (do they cause unintended harms). Answering these questions is the aim of this world-first international trial. We hypothesise that the use of all of the test apps (but not the control app) will result in reduced suicidal ideation. We also hypothesise that apps developed in NZ will be better for NZ young people and the same for Australian apps for Australian young people.

This study is evaluating a new technology called intracardiac echocardiography (ICE) to assess if tumours are compressing, or invading the major abdominal blood vessel, the inferior vena cava (IVC). Who is it for? You may be eligible for this study if you are an adult with a retroperitoneal sarcoma who has radiological evidence (CT/MRI) demonstrating compression or involvement of the IVC, and are scheduled for tumour resection at Sir Charles Gairdner Hospital in Perth, Western Australia. Study details Participants will undergo ICE which is a day case procedure performed under local anaesthetic, involving passing a small catheter into the IVC to assess the degree of involvement of the tumour. It is hoped that by accurately distinguishing between patients with true IVC invasion and those with compression preoperatively will allow us to reduce unnecessary additional invasive procedures in patients that they do not ultimately need. This approach will allow for more effective scheduling of the operative lists and improve efficient use of theatre resources, including staff.

The AFL Brain Health Initiative is a prospective, longitudinal clinical research program designed to monitor player brain health across the lifespan, and explore both protective contributors and risk factors for long-term brain health. The research design therefore aims to answer key questions regarding the prevention, diagnosis and management of sport-related concussion (SRC) and repetitive head impacts, and potentially enable identification of players at risk of poorer outcomes following retirement to inform education and intervention to reduce risks.