ANZCTR search results

This prospective interventional study will collect data pertaining to demographics, pre-injury factors, injury circumstances and concussion symptomology via online platforms for consenting participants who meet the inclusion and exclusion criteria. These data elements will be correlated with recovery, particularly time to symptom resolution, using machine learning approaches. The output from the machine learning models in the first phase of this project, will be used to revise care recommendations provided through the app. To evaluate the efficacy of the revised care pathway, the time to symptom resolution from the original HeadCheck recovery pathways will be compared to the revised care recommendations in the second phase of the project. Ongoing data collection will form the AUS-mTBI Registry that will enable additional research projects to be undertaken using the collected data to inform clinical decision making, patient care and optimal healthcare for people with mTBI.

Anaemia affects nearly a quarter of the world, and is common in surgical patients with a third of patients presenting with preoperative anaemia and three quarters of patients discharged from hospital with anaemia. The World Health Organisation defines anaemia as an insufficient circulating red cell mass, with a haemoglobin (Hb) concentration of < 130 g.l-1 for men and < 120 g.l-1 for women. Peri-operative anaemia is associated with increased postoperative complications and delayed patient recovery leading to increased post-operative morbidity and mortality. Anaemia also leads to an increased use of allogenic blood transfusions, which is an independent risk for poorer patient outcomes. The most common cause of preoperative anaemia is iron deficiency, which can be caused by reduced or impaired dietary iron absorption, chronic blood loss, or disruption of normal iron metabolism due to co-morbidities or inflammation, aetiologies commonly seen in patients undergoing major abdominal surgery, which causes an increase in hepcidin production resulting in functional iron deficiency, and reduced red cell production. Surgical anaemia can be due to chronic disease, blood loss at operation or secondary to surgical inflammation. Cytokines (particularly IL-6) upregulate hepcidin, the master regulator of iron homeostasis, which prevents iron transport leading to failure of dietary iron absorption, and sequestration of iron within macrophages. This leads to functional iron deficiency and subsequently anaemia of chronic disease. The efficacy of intravenous iron therapy may be impacted by the balance between the inflammatory modulation of iron sequestration and bone marrow suppression with the hypoxic drive for erythrogenesis. Although efficacy of intravenous iron was shown in the IRONMAN trial - performed in patients following ICU admission - and the PREVENTT trial in preoperative patients, the one size all approach may not be precise. Consequently, in the surgical pathway, the optimal timing and modality is unknown. The outcome of this research will provide evidence on the efficacy of post-operative iron administration to treat anaemia in surgical patients. The study will also provide feasibility data to help support a larger future trial.

Memory problems in Alzheimer's disease (AD) are linked to disruptions in the connections between brain regions. In a recent study we demonstrated that Theta Burst Stimulation (TBS), a type of brain stimulation, can alter the connections between brain regions and improve memory in patients with AD. We now propose a randomised controlled trial to examine whether TBS can lead to lasting improvements in 168 individuals with mild to moderate AD. We plan to compare active vs sham (placebo) TBS. Treatment will involve a 6-weeks of daily treatment (Monday – Friday) followed by a 6-weeks of once-weekly treatment. Treatment will be individualised for each participant. This means that stimulation will be based on the individual participant’s brain activity, recorded using electroencephalography (EEG). Additionally, the treatment will be delivered to four areas of the brain, the locations of which will be identified for each participant using a brain scan: a functional magnetic resonance imaging (fMRI) scan. We will examine changes in brain activity, memory and other symptoms of AD before and after treatment, as well as at 3, 6, and 12 month follow ups. If effective, individualised TBS could be used as a new therapy for AD.

This is a 3-arm study using psilocybin-assisted psychotherapy. A randomised controlled, multi-arm design will be used with the same control group all the way through the 57 weeks of the study. Potential participants will be screened to ensure suitability for trial inclusion, and 160 participants will be accepted into the trial upon completion of informed consent. The schedule for all participants will consist of two courses of therapy separated by 4 weeks, each course is comprised of a dosing session plus preparatory and post-integrative psychotherapy sessions with a co-therapist dyad that will generally consist of one female and one male therapist. After the 3-month face to face follow-up session, a third course of therapy (preparatory, dosing, post-integrative) will occur. Participants randomly allocated to the treatment arm will receive an active dose of psilocybin during the first two dosing sessions. Participants in the treatment arm will then be randomly re-allocated to receive either active psilocybin (Arm 1) or an inactive placebo (Arm 2) for the third and final dosing session. Participants allocated to the control group (Arm 3) will receive an in-active placebo at all three dosing sessions. Self-report follow-up assessments will be conducted for all participants every 4 weeks after the first dose-session until 12 months after the second dosing session. Face to face follow-up sessions will occur at 3 months, 6 months and 12 months after the second dosing sessions.

A large proportion of stroke survivors return to living in the community with chronic and complex health needs that are often left unmet. This can have a devastating and long-term impact on their health and productivity. Current stroke rehabilitation is typically hospital-based, time-limited, and applies standard therapy despite variable outcomes. However, there is a gap in transfer of gains to activities the person needs and wants to do at home, and individual recovery trajectories are often disrupted by the lack of tailored professional services to support mid and long-term recovery. This study aims to bridge this gap. We propose a solution to address the individual complexity of recovery over time, delivery therapy at the time of need in the community, and utilise new technologies to monitor and give interactive feedback, to enhance productivity goals. Our approach utilises 3 key points of innovation which are operationalised for persons with stroke living at home. First is monitoring the person in real-time in their home environment, using personalised wearable sensors and an application to survey the experience of engaging in daily activities, in order to determine biopsychosocial markers of recovery and rehabilitation and to inform personalised needs and capacity. Second is the provision of bursts of evidence-based therapies in the community that are personalised, goal-directed for real-world activities, and enhanced to give feedback through a therapist avatar. This is the formation of a centralised hub with an interactive database informed by artificial intelligence. This hub will be supported by a network of sites and up-skilled therapists to support delivery of personalised best practice therapy: at the right time and right place. Our target is improved performance in real-world activities and quality of life of persons with stroke living in the community. Significance lies in establishing evidence for a shift in practice that guides personalised rehabilitation in the long-term, at home, and supported by new technologies to stay connected. We hypothesise that individuals with stroke living in the community will demonstrate significant improvements in their performance of self-selected, real -world activities following bursts of personalised rehabilitation that includes the use of technology-enhanced remote feedback.

Dietary macronutrient composition (amounts of fat and carbohydrate) can be manipulated to manage body composition and alter fuel availability and metabolic energy production for the optimisation of athletic performance. A high carbohydrate intake (>60% of daily energy intake) is generally recommended as an optimal diet and fuelling strategy for most athletic pursuits. However, there is growing interest in the potential performance benefits of high fat dietary approaches such as ketogenic-low carbohydrate high fat (K-LCHF, carbohydrate <10% of daily energy intake) diets for endurance-based activities. Performance in endurance-based activities is underpinned by a high maximal oxygen consumption (VO2MAX), the ability to sustain work at a high percentage of VO2MAX, and good economy or efficiency of movement (oxygen cost at a given velocity). Diet and competition fuelling choices are important determinants of endurance performance by directly or indirectly affecting these physiological traits, along with body composition, fuel substrate utilization (burning fat or glucose), recovery, limiting the negative effects of gastrointestinal symptoms (runners’ gut) from high carbohydrate intake, and the ability of athletes to avoid fatigue-inducing hypoglycaemia (colloquially know as ‘bonking’ or ‘hitting the wall’). Many athletes, coaches, and practitioners continue to experiment with K-LCHF diets to determine whether performance benefits exist. Despite the popularity of ketogenic low carbohydrate diets and some good evidence supporting their theoretical benefits for performance and health, we currently only have data from a few scientific studies. These studies are generally small (underpowered to draw conclusions) and are relatively short duration. In addition, participants in most previous studies of K-LCHF diets have self-selected their diet intervention group. This introduces confounders that could bias conclusions. Finally, very few studies of K-LCHF diets have used real-world measures of endurance performance because contrived race distances and intensities are typically easier to manage in research settings. To address the limitations in previous studies and the need to offer stakeholders high-quality research to guide evolving practices, we aim to conduct a randomized controlled trial to assess the impact of a chronic (6 month) ketogenic low carbohydrate, high fat diet in competitive marathon runners. Our primary endpoint will be real-world race performance as measured in the Sydney Marathon. Secondary endpoints will be measures of exercise metabolism, running economy, body composition, blood lipid profiles, and glucose kinetics during diet adaptation, training and competition.

The primary objective of this study is to run a randomised controlled trial to evaluate Shift, a novel smartphone application designed to support the mental health and wellbeing of doctors in training in Australia. Specifically, we will see if those who were provided access to the app had reduced depression symptoms. This will be the first app of its kind, in that it is specifically designed for doctors in training who would like to learn about how to improve or maintain their mental health while entering the workforce in the demanding medical profession. The app uses therapeutic elements (cognitive-behavioural, mindfulness, and psycho-educational contents) designed to alleviate or prevent the worsening of mental health symptoms and encourage help-seeking behaviours. We will conduct a nationwide RCT of the app, in which half of the participants will be assigned to an experimental condition (they can use the app as soon as they register), and half of the participants will be assigned to a waitlist control condition (they can only use the app three months after registration). This will enable us to accurately test at scale whether access to the app effectively reduces depression and other mental health and functioning symptoms in doctors in training, and whether Shift can help encourage early help seeking.

Long COVID-19 is a multisystemic condition comprising symptoms that follow an acute infection. This research will compare a multi-session, goal-oriented, chronic disease self-management treatment approach compared to a single-session of a modified version of the same approach. The research questions are: • What is the effect of providing a multi-session program for people experiencing long COVID-19 compared to a single session of the same program on health outcomes at the 3-months? • Are these changes sustained at the 6-month follow-up? • What is the difference in health outcomes between groups at the 6-month follow-up time point? • How do these health outcomes relate to the perception of the therapeutic relationship from the perspective of both the student and the participant? Treatment programs and measurements will be delivered by students under the supervision of clinical placement supervisors

This study aims to investigate whether 3 newly developed brief online interventions are acceptable to young people with chronic health conditions, and pilot the methods for a larger scale randomized control trial. Young people (aged 18-25) with chronic conditions will choose one of three modules to complete and provide feedback on. Each module teaches a different skill (self-compassionate, self-efficacy, and optimism) that has been linked to healthy emotion regulation and mental health in young people with chronic conditions. Modules run for less than 60 minutes, are self-guided and designed to be completed in a single setting. Modules contain a mixture of video content, stories from other young people, psychoeducation on the targeted skills, and interactive activities including guided self-reflection. The trial will assess whether young people perceive changes in their skills and emotions from pre-to-post module completion, as well as their feedback on the module content. It will also explore which modules young people choose to complete, rates of completion across modules, and changes in mental health using validated measures.

Type 2 diabetes mellitus (T2DM) is a chronic disease, the prevalence of which is rapidly growing world-wide. As a result of historical concerns of the safety of available glucose-lowering therapies, cardiovascular outcome trials (CVOTs) were mandated by the Food and Drug Administration (FDA) in 2008 to ensure that new anti-diabetic therapies coming onto the market were safe from a cardiovascular perspective. Out of the recently studied drug classes, GLP-1 receptor agonists (GLP-1 RAs) and sodium-glucose co-transporter 2 (SGLT2) inhibitors have both shown to provide cardiovascular benefits, not just safety/non-inferiority compared to the more traditional glucose-lowering agents they have been compared to. Both are currently recommended in guidelines for use in patients with a cardiac history, however, it is not clear whether one would confer a greater benefit than the other in patients who have recently had an acute coronary syndrome (ACS), nor whether they can slow plaque progression, as a possible mechanism of their cardiovascular benefit. Given patients in Australia can only access one therapy at a time on the PBS, any information regarding their direct comparison in this patient population would be useful. This will be a prospective, randomised, open, blinded end-point (PROBE)-designed trial that will evaluate the effect of semaglutide and empagliflozin on coronary plaque, as assessed by computer tomography coronary angiography (CTCA) at baseline and following 12 months of treatment with either semaglutide or empagliflozin in participants with diabetes and known coronary artery disease who have presented with an acute coronary syndrome. We hypothesise that participants prescribed semaglutide will have a slower progression in coronary plaque development as compared with participants on empagliflozin.