ANZCTR search results

The LiveBetterSA trial has been designed to compare the effectiveness of artificial intelligence (AI) powered digital health coaching to traditional telephone-based health coaching in supporting healthy lifestyle changes. The study aims to evaluate whether the digital health coaching program is as effective as telephone-based health coaching on weight management at 6 months. Participants will be randomly assigned to receive either digital health coaching or telephone health coaching over six months. The study will also examine the effects of digital health coaching on secondary outcomes—including waist circumference, physical activity levels, dietary habits, sleep, and quality of life, compared to traditional telephone-based coaching. In addition, the study will assess key implementation outcomes including participant engagement and program acceptability. Finally, a health economic analysis will be conducted to assess whether the digital health coaching model offers a cost-effective alternative to traditional telephone coaching. This study represents the first large-scale evaluation of an AI-powered digital health coaching model for preventive health. If successful, it could offer a scalable, sustainable approach to improving population health in Australia.

The purpose of this study is to pilot test an automated STS intervention and collect data to support development of a future definitive trial of the hypothesis that patients with heart failure whose routine on-going care includes a nurse-led ASTS intervention will have greater knowledge and better adherence to evidence-based self-care behaviours for their heart failure, with consequently better outcomes (in terms of fewer hospitalisations for acute heart failure episodes, better health-related quality of life and longer survival post-diagnosis) than heart failure patients managed with routine care alone.

A substantial percentage of people with metastatic breast cancer (MBC) experience poor quality of life and elevated distress, yet few interventions address this. The few intervention studies that have been done have mainly focused on high intensity and high burden interventions, such as face-to-face therapies, without consideration of low intensity options, such as digital interventions. Beatty and colleagues were among the first to design an online self-directed intervention for people with MBC; Finding My Way-Advanced (FMW-A). However, the efficacy of low intensity digital interventions may be impacted by low engagement. The purpose of this study is to explore methods of increasing engagement in this population, with the addition of guidance appearing to be promising in digital mental health interventions. Who is it for? You may be eligible for this study if you are a woman aged 18 years or older who has recently been diagnosed with MBC. Study details Participants in this study will be randomly allocated (i.e. allocated by chance) to one of three condition arms: email, phone-call and video-call guidance. Participants will receive a 6-module psychosocial program that addresses commonly experienced concerns raised by women with MBC. Each of the six modules focuses on a different topic, namely (1) Navigating healthcare and making decisions; (2) Living well with a progressing illness (managing fear of progression and coping with uncertainty); (3) Managing physical symptoms (particularly focusing on fatigue and pain); (4) Managing emotional distress; (5) Managing identity and role changes; and (6) Social support: receiving support and supporting family. Module content is provided in a multimedia format, with video and written personal accounts from women living with MBC, educational videos from health care professionals, self-management activities, audio relaxation-mindfulness downloadable files, print psychoeducation with audio-conversion options, and illustrations/imagery throughout. Participants in all 3 conditions will be assessed for feasibility and complete self-report measures of quality of life, psychological distress, cancer specific distress, fear of progression, and self-efficacy at the baseline. They will then be asked to complete the same online questionnaire assessing quality of life, distress, and health service use at 6-weeks and 3 months later. Engagement will be evaluated through objective indicators (e.g. number of modules accessed, duration of human support), and subjective indicators (e.g. self-report/verbal feedback). Participants will also have the opportunity to complete a qualitative interview to provide feedback on their satisfaction with the human support. It is hoped that this research will provide participants with additional information and support to improve their quality of life and wellbeing, and to improve our understanding in the psycho-oncology field on how best to offer guidance for online programs.

Given the prevalence of sexual violence and its harmful impacts, there is a critical need for effective primary prevention interventions targeting school settings in Australia. Currently, there is limited evidence of effective primary prevention interventions aimed at stopping sexual violence before it occurs (Our Watch, 2020). Secondary schools represent a promising setting for such efforts, as interventions can reach young people at a pivotal developmental stage—before perpetration may have begun and when norms and values are still being shaped (De Gue et al., 2014; Porat et al., 2024). Consent and healthy relationships education has the potential to prevent sexual violence by equipping students with key skills and attitudes before harmful behaviours emerge. To evaluate the impact of consent and healthy relationships education on sexual violence prevention, this study will employ a cluster-randomised controlled trial (cRCT) involving 12 secondary schools in Tasmania, Australia. Schools will be randomly allocated to either the intervention group (n=6), which will receive the three-session Schools Education Program (SEP), or a waitlist control group (n=6), which will not receive the program during the trial period. For ethical reasons, the control group will be offered the intervention in 2026 after study completion. The primary objective of this cRCT is to assess whether SEP improves Year 9 (ages 13–15) students’ knowledge of sexual violence, including gender equality, consent, healthy relationships, and rape myths. Secondary objectives include evaluating whether SEP enhances students’ attitudes toward gender equality, reduces rape myth acceptance, and increases empathy, as well as behavioural intentions related to consent and bystander intervention. A comprehensive process evaluation and realist evaluation will be conducted alongside the cRCT.

Cardiac amyloidosis is a significant health issue associated with high rates of heart failure and heart rhythm issues, including the need for pacemaker devices. Up to 40% of patients with cardiac amyloidosis need a heart pacemaker at some point, but the best heart rate to set the pacemaker at is not established. In similar conditions, higher heart rate pacemaker settings have been shown to be safe but also improve heart function, symptoms and exercise tolerance. Heart MRI (magnetic resonance imaging) is a technique widely used to understand the mechanisms and changes in flow in many heart conditions and we believe this is the best technique available to study heart function in response to different heart rates. Unlike most medical imaging methods, MRI does not use radiation but instead used magnetic fields and radiofrequency waves to produce images of the internal structure of the human body. We propose to assess MRI findings of heart flow and function at three different pacing heart rates to determine which heart rate provides the best possible heart output.

Many older adults complain of cold feet, but little is being done to alleviate this problem because it is generally not considered limb-threatening. Fabrics functionalised with inorganic additive minerals reflect far-infrared (FIR) rays. Socks made from these ‘FIR’ fabrics have thermo-regulating properties in-vitro. They could reduce discomfort and complications related to cold feet in older adults, resulting in benefits such as improved blood flow to the lower limbs and reduction of thermal injuries from placing cold feet too close to a heat source or falls from wearing thick socks. We hypothesize that ‘FIR’ socks are effective in thermo-regulation and improving the blood flow in older adults.

The BOOST Study aims to assess the staggered implementation of a permanent surgical geriatric service embedded within emergency and elective general surgery, urology and vascular surgery at the John Hunter Hospital. Outcomes measures will include patient outcomes, service implementation measures and healthcare worker satisfaction. This data will assist to provide a framework for wider dissemination of this model of care in a sustainable manner. It will also provide evidence of the impacts of enhanced shared decision making and patient centred care.

Orally administered psilocybin has shown promise as an effective treatment for a range of mental health disorders. Psilocybin is a prodrug that is rapidly converted in the body to its active form, psilocin. As such, the therapeutic effects observed in psilocybin studies are attributable to psilocin. TRP-8803 is a novel, intravenously administered formulation of synthesised psilocin. Previous studies conducted by the study Sponsor demonstrated that a hydrochloride (HCl) formulation of TRP-8803 was safe and well tolerated in healthy adult humans, with an acceptable pharmacokinetic profile. However, a new besylate formulation has been developed to enhance physicochemical stability and reduce hygroscopicity. These properties will support more reliable manufacturing, storage, and intravenous administration, without altering the identity of the primary psychoactive compound or safety profile of TRP-8803. This Phase 1 study will evaluate the safety and pharmacokinetics of TRP-8803 [Psilocin Besylate] in healthy adult participants to inform its further clinical development.

Idiopathic intracranial hypertension (IIH) is a rare condition that predominantly affects women aged 16 to 45 years where high pressure inside the skull, known as intracranial pressure (ICP), which causes headaches, and in some cases, can lead to permanent vision loss. Medications to lower ICP are recommended as part of treatment, but currently there are no medication approved for this condition. This pilot study will test whether sodium glucose transport protein 2 inhibitors could lower ICP in women with IIH.

We hypothesize that Blastx accelerates wound closure rates faster than Aquacel Ag Extra Plus on chronic burn wounds with better scarring outcomes. To test this theory, we will recruit patients with >4-week-old burn injuries and place them on an arm of the study, Comparing results and outcomes with the aid of AI technology and POSAS scores