ANZCTR search results

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.

This study aims to explore the relationship between adherence to four key components of the PIVC Clinical Care Standard: use of extension tubing, adequate securement, use of a semi-permeable dressing, and avoidance of areas of flexion where possible. It also aims to explore the relationships between these factors and patient-reported sleep quality and sleep disturbance. We hypothesise that pain and sleep disturbance experienced by patients may be lower and sleep quality higher if compliance with CCS indicators related to PIVC placement and securement is high.

The overarching aim of this quality improvement project is to assess whether an Integrated Model of Osteoporosis Management (the Model) improves GP investigation and management of patients determined from radiology reports or a hospital-based Fracture Liaison Service to have a potential osteoporotic fracture. The study design is a Cluster Randomised Controlled Trial (cRCT) with randomisation at the GP practice level, to compare outcomes amongst practices allocated to the Model versus usual care. Specifically, this study hypothesises that GP practices randomised to the model (intervention group), compared to GP practices randomised to the control (usual care) group, will: • Refer a greater proportion of patients with a potential osteoporotic fracture for a bone density scan and/or prescribe a greater proportion of patients with osteo-protective pharmacotherapy within three months of an initial diagnostic report. • Refer a greater proportion of patients with a potential osteoporotic fracture for a blood test related to bone health within three months of the initial diagnostic report. • Initiate a chronic disease management plan for a greater proportion of patients should investigations confirm the fracture being due to osteoporosis. • Prescribe osteo-protective pharmacotherapy for a greater proportion of patients with a potential osteoporotic fracture at 10 months post initial diagnostic report.

This study aims to find out if adding the medications olaparib, or olaparib + durvalumab together, to standard chemotherapy given to premenopausal women with HR-positive, HER2-negative, HRD-positive breast cancer before surgery will do a better job of controlling the cancer. Who is it for? You may be eligible for this study if you are a pre-menopausal woman between 18 and 44 years of age, have been diagnosed with HR-positive, HER2-negative early breast cancer, and a sample of the tumour is shown to be HRD-positive. Trial Details. Researchers will test the cancer to find out if it is HRD-positive. Being HRD-positive could make the tumour more sensitive to the treatments in the main OLIO study. Only about 20% of cancers are expected to be HRD-positive. Whilst the sample is tested, participants will have standard treatment (4 cycles of anthracycline-based chemotherapy). Participants with HRD-positive tumours will be randomised 1:1 to receive: Arm A: An olaparib tablet twice per day with water for 12 weeks, plus have an infusion of paclitaxel into a vein once per week. Arm B: An olaparib tablet twice per day with water for 12 weeks, plus have an infusion of durvalumab into a vein once every 4 weeks for 3 infusions (Week 1, Week 5 and Week 9), plus have an infusion of paclitaxel into a vein once per week. Participants will have surgery within 6 weeks after their last dose of study treatment. The following biological samples will be collected: * Tumour sample at surgery, if any tumour remains * Blood samples before starting study treatment and just after surgery. All participants will be regularly monitored throughout treatment to evaluate their health. There will be end of treatment visits 30 days & 90 days after the last dose of study treatment. Follow-up visits will occur every 6 months after surgery for years 1-3 years post-surgery (6 visits), then every 12 months for years 4-5 (2 visits). Further treatment will be at the discretion of the participant and their treating clinician. It is hoped this research will provide new treatment options for young women with HR-positive, HER2-negative breast cancer, particularly among those selected for a high HRD score.

The aim of this RCT is to investigate whether a written self-compassion intervention can improve affect and pregnancy wellbeing in women with GDM. For this study, participants will be randomly allocated to either the self-compassion or positive distraction group. It is anticipated that participants allocated to the self-compassion reflective writing task (using expressions of self-warmth and self-kindness) will report lower levels of affect, and enhanced pregnancy wellbeing at post-intervention relative to participants allocated to the positive distraction group. The outcome measures will include self-compassion, positive and negative affect, pregnancy wellbeing, and intentions to engage in self-care and help-seeking behaviours.