ANZCTR search results

Guidelines recommend continuous glucose monitoring (CGM) for all ambulatory pregnant women with Type 1 diabetes (T1 DM), and insulin-treated pregnant women with Type 2 diabetes (T2 DM) and hypoglycaemic risk. However, evidence for efficacy and safety of CGM in a hospital setting is lacking. Aim: To determine CGM accuracy and potential clinical risk of using CGM compared to the reference (capillary blood glucose level, capillary BG level) in pregnant women with T1 DM or T2 DM during acute hospitalisation. Method: Prospective cohort study. CGM glucose was compared to paired capillary BG during hospitalisation. Concordance was assessed using paired values distribution, mean absolute relative deviation (MARD), Clarke Error Grid (CEG) Analysis, and the FDA standard for new integrated Contiguous Glucose Monitoring (iCGM) accuracy.

The current trial will assess the implementation of CFT in real-world clinical settings. This includes evaluating patient outcomes, and determining the feasibility and up-scaling of training physiotherapists in the delivery of CFT. HYPOTHESIS: We hypothesise that CFT will be effective and cost-effective compared to usual physiotherapy practice in reducing disability for patients with chronic disabling LBP. Primary Objectives: To assess the clinical and cost-effectiveness of CFT compared to usual physiotherapy practice to reduce disability for patients with chronic disabling LBP. Secondary Objectives: To assess the implementation of CFT, including the feasibility of delivering CFT in clinical practice and the scalability and effectiveness of the clinician training program to upskill clinicians to deliver high-quality biopsychosocial care (i.e., CFT).

Liver transplantation is the only curative treatment option for patients with advanced liver disease. It is a prolonged and highly complex operation, during which many patients require medication to maintain their blood pressure at a safe level. Complications following this invasive (but life-saving) surgery are common. For example, approximately four in ten patients experience reduced kidney function, which can impact quality of life and life-expectancy. Many previous studies have sought to identify the risk factors for impaired kidney function following liver transplantation. There is evidence that both low blood pressure as well as the medication commonly used to raise blood pressure (noradrenaline) may increase the risk of kidney problems. However, a relatively novel medication, known as ‘angiotensin-II’ may offer a more kidney-friendly alternative, improving blood pressure with less risk of harming the kidneys. Our study will compare angiotensin-II to noradrenaline as a blood pressure support medication during liver transplantation. It is a small ‘pilot’ or ‘test’ study, with the aim of assessing the feasibility of a future larger trial. Our primary goal is to explore different assessments of study practicality, which will inform the running of the future study. In addition, we will compare various side-effects and safety outcomes between the two drugs, including the occurrence of kidney impairment, among others.

Prolonged sedentary behaviour (SB) has been linked to serious health conditions, including cardiovascular disease, diabetes, and poor mental health—even in individuals who meet exercise guidelines. Reducing sitting time and incorporating light physical activity, such as walking, into daily routines can significantly improve health outcomes and serve as a foundation for sustained behaviour change. The SLAMM (Sit Less And Move More) intervention uses a mobile app and wearable activity trackers (e.g., Fitbit) to help participants reduce sedentary behaviour and progressively increase physical activity. Based on real-time tracking and self-reported activity, users are classified via a risk assessment matrix (the Sit-Act Matrix) and will then be provided with tailored behavioural messages or semi-personalised exercise coaching. Contextual factors such as weather, time of day, and work schedule are used to adapt prompts dynamically. The study aims to evaluate the feasibility, usability, acceptability and preliminary efficacy of this 12-week intervention. Outcomes include changes in sedentary time, activity levels, and user perceptions, informing future large-scale trials.

This is a single-center safety and feasibility study of a new device designed for the ablation of uterine tissue. The study will enrol subjects planning to undergo a surgical procedure where the new device will be used and tissue analysed after extraction. This is NOT a powered study, so there is no formal hypothesis. This research is an early feasibility study and will determine whether use of this new system is safe and feasible.

This study explores how advanced hearing aids using artificial intelligence (AI) can help children with auditory processing disorder or related conditions like autism and ADHD to better understand speech in noisy environments. The research will compare these advanced devices to traditional hearing aids by testing how well children hear and identify the location of sounds in a laboratory setting and during a four-week trial. The goal is to determine whether AI-hearing aids provide better speech clarity and listening comfort in complex situations. The findings will help improve recommendations for children with listening difficulties, ultimately enhancing their learning and communication. Families participating in the study will contribute valuable insights into the daily challenges of listening in noisy environments.

Patients with severe acute stroke may experience blood pressure (BP) fluctuation outside targeted range when mobilising. Intermittent BP monitoring may not detect change in a timely manner. This pilot study aims to explore the value of a continuous BP prototype to provide real time BP information matched to patient movement activities during usual care (mobilisation). BP prototype data from 10 participants will be compared to intermittent BP readings, and clinician judgement of BP stability and patient effort. Findings may guide optimal clinical practice in acute mobilisation following severe stroke.

This feasibility study primarily aims to assess the suitability of a strength and fitness exercise program designed for women living with Parkinson's disease. It will be held at gymnasiums with close supervision by exercise trainers educated in delivering exercise to people with lived experience of Parkinson's disease. Women aged 18-75 with idiopathic Parkinson's disease will be eligible to receive the intervention of 1-hour, twice-weekly exercise programs for eight weeks. We will measure the feasibility, including safety and adherence, as well as individual changes in disability, quality of life, wellbeing and strength over the program.

Older adults and people living with dementia in assisted living facilities often feel lonely. In 2017 (pre- covid) it was suggested that 40% of residents seldom or never receive visits from family or friends. Staff workloads are frequently high leaving staff little time to chat to residents. Residents may not have anyone to speak to or have conversations with for long periods of time. In one study less than a third of residents had a friend in the care facility and residents living with mild cognitive impairment or dementia may find it difficult to sustain relationships or engage meaningfully with other residents. This may lead to more feelings of loneliness with associated impact being depression, anxiety, emotional distress and high blood pressure, obesity, heart disease. We have developed an embodied, screen-based, artificial intelligence (AI) and lived experience supported, digital companion to interact with people and support naturalistic conversations. The digital companion for this study has been developed using lived experience data from older adults, and people living with MCI and dementia. We will carry out a pilot study in an assisted living facility making the digital companion available to residents on large iPads on adjustable movable stands positioned at head height (so the iPads do not have to be held and allow for natural face to face interactions) and also a large human-sized screen in a common area. Based on iterative testing throughout development and existing user testing, we expect to see that people find it easy to speak to the AI character, and that these conversations reduce feelings of loneliness, depressive symptoms and changed behaviours (such as agitation) over time.

The STRIKE trial is a single-centre, investigator-initiated pilot study assessing the efficacy, feasibility and safety of infliximab in patients with artificial stone-associated complicated silicosis. Participants will receive 5 mg/kg intravenous infliximab at weeks 0, 2, and 6, followed by maintenance infusions every 6 weeks until week 24. The primary outcome is a composite measure of changes in inflammatory activity using PET scan, lung function parameters (FEV1, FVC, DLCO), and health-related quality of life. Secondary outcomes are adverse event rates, serum biomarkers, and HRCT findings. The trial is being conducted at Alfred Hospital and is sponsored by Alfred Health.