ANZCTR search results

Approximately one in ten adults in Australia have chronic kidney disease (CKD). In advanced CKD, the kidneys fail to remove waste from the blood, leading to symptoms that reduce quality of life and contribute to >1,700 deaths per year in Australia. Once the kidneys fail, patients can opt for life-extending treatment, such as haemodialysis (HD). However, the process of obtaining consent for HD is not consistently implemented across most Australian healthcare facilities. We hypothesise that quality informed consent improves decision-making and is key to better preparing patients for HD. This project aims to empower patients with advanced CKD to make informed decisions about HD by collaboratively developing a digital information interface called eConsent HD, co-designed with consumers, to present information in a user-friendly manner, catering to diverse backgrounds, languages, and health literacy levels. The effectiveness of eConsent HD will be evaluated through a randomized controlled trial comparing it to the current informed consent practice. Furthermore, an implementation strategy will be assessed using implementation science frameworks, aiming to identify facilitators and barriers to adopting eConsent HD into clinical practice. The project's ultimate goals are to improve patient outcomes, reduce treatment withdrawal rates, and standardize the HD consent process across Australia. The team involved in the project includes a diverse and skilled group of clinicians, researchers, and an industry partner specializing in digital capabilities. The research findings are expected to generate new knowledge, improve health literacy, and deliver a market-ready product to improve the patient experience in decision-making for HD. The project will address the disparities in consent practices, particularly for culturally and linguistically diverse populations, and contribute to evidence-based policies and practices in kidney care.

This study aims to provide understanding of parenting interventions for IGD by providing such an intervention and then testing its effect using a range of measures around the child’s functioning and wellbeing pre- during- and post intervention. The current study will also provide specific data on an Australian population, and examine possible cultural differences in such interventions. In addition, given the rapid advances in technology over the last 5-10 years (smartphone capabilities, devices in schools, faster internet speeds, new video game development etc), this study would provide clarity around the efficacy of assisting parents with technical advice around managing screen and internet access. Finally, whilst physical monitoring of screen time is a common strategy for parents of younger children, it becomes untenable and combative when applied in adolescents. This study will emphasise a model of monitoring internet access as opposed to screen access, and to our knowledge this key differentiation has not been explored to date. Hypotheses: 1. That parents who are able to implement the model for 6 weeks post intervention, compared to those parents who didn’t implement the strategies, will report a decrease in child screen use and an overall increase in their child’s wellbeing as measured by reduced family conflict, improved behaviour, sleep, exercise, social engagement with peers and schoolwork. 2. That children with high levels of problematic screen-use prior to intervention will report an initial increase in family conflict followed by a steady reduction once the parent strategies are in place.

Prolonged stress is known to cause mental and physical health problems such as depression, anxiety and cardiovascular disease (CVD). To date, there is not a gold standard measure of stress. Stress levels are subjectively assessed using questionnaires and having instruments that can evaluate stress levels more directly (i.e., through heart rate variability [HRV]) could help with the early detection of stress, and potentially prevent the onset of stress-related conditions. Wearable devices are popular and have the capacity to collect data continuously, in real-time, which may help monitor stress levels. In the WEARABLE (Wristband hEArt Rate vAriaBiLity to measure strEss) study, we aim to examine whether a WHOOP®-derived HRV, a proposed marker of stress levels, can be a reliable and accurate measure of stress. We will investigate the associations of stress levels (HRV assessed by a wrist strap) with self-reported stress (commonly used questionnaires), HRV assessed using an electrocardiogram (ECG [gold-standard for measuring HRV]) and hair cortisol (biomarker of stress). The outcomes of this pilot study could provide evidence for the use of wrist wearable devices in future clinical trials investigating the role of stress on health outcomes. Additionally, this may encourage improvements with the inclusion of HRV measures in commercially available wrist wearable devices, so there is a broad range of devices that can be used to monitor stress levels in the wider population. Currently there is no gold standard for measuring stress levels. The best measures include self-reported instruments using questionnaires, salivary or hair cortisol and HRV assessed using ECG. Although ECG is the gold standard for measuring HRV, which is related to stress levels, it is unclear whether HRV could directly represent stress levels.

A Phase 1 clinical study in healthy subjects to evaluate the safety, tolerability, and plasma drug concentration profile resulting from the administration of single and multiple oral doses of MAXONA Pharmaceuticals MAX-001

A first time in human study to evaluate safety, tolerability, and pharmacokinetics of UA021 capsules compared with placebo in normal healthy adult participants. A single and multiple-ascending dose study to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of UA021 in healthy adult participants. Results of this study will inform dose selection and design of studies to assess the efficacy and safety of UA021 in inflammatory diseases, including psoriasis.

A Phase 1 clinical study in healthy subjects to evaluate the extended-release formulation candidates and assess their associated food effect to select the optimal extended release formulation based on the safety, tolerability, and plasma drug concentration profile of MAXONA Pharmaceuticals MAX-001

An APP has been developed to provide information and guidance to individuals with TBI and RTW/VR providers in ways to prepare for returning to work and to provide strategies to manage potential challenges once back at work. The aim of the project is to compare the effectiveness of the app in improving employment outcomes in a group who access the app prior to and during their return to work as compared with those who don’t. The results will be used to justify use of the app to improve work outcomes for individuals after TBI.

Approximately 150 million people wear contact lenses (CL) globally . Of these, 50% experience discomfort during contact lens wear and 25% of wearers are likely to discontinue wear permanently. The etiology of contact lens discomfort (CLD) is multifactorial and could be due to reduced compatibility between CL and the ocular environment. Intense Pulsed light therapy has been proven to be an effective therapy for improvement of signs and symptoms of dry eye disease, but it has not been fully evaluated as a treatment for contact lens discomfort. This project aims to evaluate the qualitative and quantitative change in signs and symptoms of Contact lens discomfort (CLD) and Meibomian gland dysfunction (MGD) following Intense Pulsed Light (IPL) treatment in Contact lens wearers. The research hypotheses is that Intense pulsed light (IPL) therapy will improve the signs and symptoms of CLD and MGD in contact lens wearers. This study designed as single centre, randomised, double masked trial, and consists of three visits. At the first visit, screening will be performed to determine the eligibility to take part in the study, If eligible, various clinical procedures will be conducted, followed by random allocation to one of the two treatments (Intense pulsed light or sham treatment) with Meibomian gland expression. The primary outcome is an improvement in Contact lens dry eye questionnaire -8 (CLDEQ-8) symptoms score following Intense pulsed light therapy in contact lens wearers. The secondary outcome is an improvement in tear break up time and Meibomian gland expression following intense pulsed light therapy in contact lens wearers .

Deep Transcranial magnetic stimulation (dTMS) is a form of repetitive transcranial magnetic stimulation (rTMS) which has been established as a safe, effective and well-tolerated treatment for depression, especially in patients who do not respond to initial antidepressant medication treatment. Although dTMS, and other forms of rTMS, are effective treatments, only about 50% of patients get a substantial clinical response and for some this can take a considerable period of time. Over recent years we have conducted extensive research developing methods to enhance treatment response to forms of rTMS including exploring whether improving the targeting of treatment into relevant brain areas can improve clinical outcomes. dTMS involves the application of repetitive pulses using a coil that has a deeper and wider area of stimulation of the brain. There are a number of dTMS coils commercially available which allow for stimulation of different areas of the brain. For example, H1 coil is typically used to stimulate a relatively large area of the lateral prefrontal cortex. In contrast, the H7 coil is applied to stimulate medial prefrontal regions. Evidence suggests that meaningful therapeutic benefits in patients with depression can be achieved with stimulation of both lateral and medial prefrontal cortex although there may be differences in the clinical characteristics of patients who respond to treatment at these two locations. The aim of the current research is to explore whether clinical outcomes may be improved using an approach which combines stimulation of these two sites. Specifically, we will compare treatment at the lateral prefrontal cortex with the H1 coil alone (current standard treatment) to a dual approach stimulating both lateral prefrontal cortex with the H1 coil and medial prefrontal cortex with the H7 coil.

Non-ambulant children with cerebral palsy experience more sedentary behaviour, spending up to 96% of their waking day sitting. With limited evidence-based interventions available, this can have a devastating impact on health and well-being. CPMovetime aims to develop wearables and user interface that reduce sedentary behaviour to improve health outcomes.