ANZCTR search results

The hypothesis for this study is to show that the twice-daily application of a barrier wipe can reduce the incidence of pressure injuries. Studies highlight that pressure injuries (PI) are a healthcare quality indicator and that healthcare workers need to expand their knowledge to adequately manage these wounds using the latest evidence-based information. A focus on prophylactic dressings applied to patients’ skin to prevent PIs has gained some traction in recent years to avoiding PIs however it is often referred to as an adjunct therapy with more studies to prevent PIs needing to be done. Based on the above a new way to prevent pressure injuries needs to be studies. The hypothesis for this study is to show that the twice-daily application of a barrier wipe can reduce the incidence of pressure injuries.

Major Depressive Disorder (MDD) is a common and debilitating condition with high rates of treatment resistance. Repetitive Transcranial Magnetic Stimulation (rTMS) is an established treatment for TRD with few adverse effects. Intermittent theta burst stimulation (iTBS) is a novel and time-efficient form of rTMS with evidence base in the treatment of treatment-resistant depression. The drug D-cycloserine (DCS) is a has demonstrable impact on rTMS and iTBS’s neuromodulatory effects. This study protocol proposes the conduct of a prospective multi-site, parallel-arm design, randomized, double-blinded, placebo-controlled clinical trial to investigate DCS augmentation of iTBS in MDD. We will investigate if adjuvant DCS 50mg or 100mg/day might have superior iTBS antidepressant effects. We hypothesise that iTBS administered 2-hours after ingestion of DCS 50mg or 100mg will be more effective in treating depressive symptoms compared with iTBS administered 2-hour after ingestion of placebo.

Over the first three years of the Voluntary Assisted Dying (VAD) legislation, patients, families and clinicians have experienced significant challenges as they seek information, access and a better understanding of the ethical, legal and clinical implications of VAD. Several anecdotal accounts have been shared across services, but no systematic effort has been undertaken to study the in-depth impact of this legislation. We propose applying several lenses which include a clinical, ethical, psycho-existential focus on: patients, caregivers, health practitioners, and services-as-a-whole. We have assembled an experienced team of palliative and psychosocial care providers, ethicists and service leaders to undertake this review. The setting examines the unique interaction where the legal directive of VAD does not clearly align with the ethical and clinical principles of health care delivery in end of life care and palliative care. By sustaining our focus on the quality-of-care provision to patients and families, this research is not driven by polemics. Instead, its focus is on clinical outcomes that embrace both patients and families and care providers and enables an in-depth analysis of this new model of care to be undertaken. The goal is directed towards optimising palliative care, not the delivery of VAD. The potential for moral distress, impact on care provision and unwelcome bereavement outcomes make this focus of study worthwhile and necessary to sustain the model of palliative care delivery. A mixed-methods approach will be employed using qualitative and quantitative methodology and case reviews. We will retrospectively assess socio-demographic, medical and health utilisation data from the medical records of patients (n=120) who have expressed an interest in or pursued VAD, specifically identifying pertinent clinical issues and the utilisation of palliative care services. A qualitative descriptive approach will be used to analyse interviews (n=120) undertaken with clinicians and family caregivers about their experiences of the VAD process, involvement of palliative care and bereavement support. In addition to thematic analysis, the researchers will use these data to construct anonymised case studies that illustrate or exemplify ethical issues or challenges. These will be shared with expert bioethics collaborators who will comment on the issues themselves and on the potential usefulness of case studies, perhaps modified, for the purposes of medical education. Ultimately this information will be valuable to inform policy, future legislation, education and support for our community around end of life care and palliative care provision.

Upper limb injuries including bony fractures/dislocations, are sometimes deformed and require realignment in the emergency department (ED). Numerous techniques are available to allow this procedure to be painless. Bier block (BB) involves placing a band on the upper part of the affected arm to constrict blood flow, with injection of numbing agent into a hand vein on the same side to make the entire arm numb. An alternative technique is ultrasound guided supraclavicular blocks (UGSCB), which involves introducing a needle under ultrasound guidance to nerves situated just above the collar bone and injecting numbing agent around these nerves to make the arm go numb. However, the effectiveness of UGSCB when performed by ED doctors is unknown and patients might recover more quickly. We aim to conduct a randomised trial to compare UGSCB versus BB for re-aligning fractures/dislocations of the upper limb in the ED. We hypothesise that UGSCB provides safe and effective regional anaesthesia for the closed reduction of upper limb fractures or dislocations that is non-inferior to BB. However, UGSCB is likely to provide superior post-procedural analgesia with reduced opioid requirement and reduced ED length of stay.

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. Participants will be recruited online and via social media advertisements. They will target parents who are concerned about their Childs screen use and would like to be more proactive in setting boundaries.

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.