ANZCTR search results

The aim of this study is to test the impact of different messages about COVID-19 vaccines in parents of children aged 5-11 years on intention to take their child for a COVID-19 vaccine. The hypothesis is if persuasive messaging affects intention to vaccinate, then mean intention to vaccinate will be higher in persuasive messaging conditions than the control. Participants will receive 1 of 4 information conditions or a control. The 4 information conditions will focus on: the personal health impacts of vaccinating; family and community health impacts of vaccinating; non-health benefits of vaccinating; and personal choice and control associated with vaccinating. The control will be text about eligibility for paediatric COVID-19 vaccines. Analysis will compare the primary outcome measure (intention to vaccinate child aged 5-11 years for COVID-19) between intervention groups and the control (4 comparisons) using an ANOVA test. Secondary analyses will compare secondary outcome measures (beliefs about COVID-19 vaccines) between intervention groups and the control using an ANOVA test.

The Syncope Stopper trial is a randomised controlled trial which will enroll patients hospitalised with unexplained syncope who have additional high risk features for recurrent syncope. Participants will be randomised 1:1 to either insertion of a permanent pacemaker or to standard care. Participants will be followed up for 12 months and will be assessed for the frequency of a composite primary endpoint comprising cardiovascular death, recurrent syncope, bradycardia resulting in pacemaker insertion or device-related complications. Our overall study hypothesis is that early pacemaker implantation (a ‘Syncope-Stopper’) is the safest and most cost-effective strategy for managing high-risk patients with unexplained syncope, with the novel DROP score able to identify patients at highest risk of bradycardia.

Children with developmental language disorder (DLD) struggle with the learning, use and/or understanding of grammar. This project examines the efficacy of a theory driven empirically based grammar intervention approach, graduated input type variation (GITV), for young English-speaking children with DLD. The aim is to compare participating children’s performance on both the trained grammar target, and the control grammar item which they will not receive treatment, before and after intervention. During intervention, children will receive input of 30 exemplars provided using two evidence-based procedures, recast and focused stimulation, in which the speech-language pathology student uses a special way of commenting on what is going on and responding to the child’s communication attempts of the target in meaningful contexts during fun activities. Both procedures are typically included in the standard-of-care of children with DLD during language intervention. The relative frequency of the verbs in the input exemplars is manipulated such that in the skewed input stage, one verb appears in a disproportionally higher number of the exemplars, whereas in the balanced input stage, all the verbs appear in similar frequencies. Children will participate in 16 sessions of intervention, twice a week for eight weeks. It is predicted that children will make significant gains in the production of the trained grammar target but show no change in the control grammar item. Children will also demonstrate learning of another grammar item that is structurally similar to the trained grammar target, and maintenance of learning of the target 3 weeks after intervention ends.

Aneurysmal subarachnoid haemorrhage (aSAH) is a devastating form of haemorrhagic stroke, that results from bleeding from an intracranial aneurysm. A common complication of aSAH is hyponatremia with a reported prevalence of between 35% to 77%.Our group has recently demonstrated that patients in whom the sodium concentration decreases over the ICU stay have a higher likelihood of a worse outcome at 6-months compared to those patients in whom the sodium concentration remains steady. Fludrocortisone is a synthetic adrenocortical steroid possessing activity which produces significant sodium and fluid retention. Previous studies of fludrocortisone have demonstrated a reduction in hyponatraemia and fluid loss, but these studies were underpowered to show a clinical outcome benefit. Fludrocortisone therefore has the potential to prevent the onset of hyponatraemia in aSAH and lead to improved outcomes; however, this has never been tested in an adequately designed trial. This proposal is for a Phase 2 trial to examine the effect of fludrocortisone administration on serum sodium concentrations, fluid balance and clinical outcomes measures in patients with aSAH.

This is a randomized, double-blind, placebo-controlled, phase 1 first-in-human study to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of ABBV-CLS-628 in healthy adult volunteers

Concussion is a significant public health concern among Australian children and adolescents. A large population of children who experience a concussion (approximately 30%) will go on to experience persistence post-concussion symptoms for more than 4 weeks following their injury. These symptoms can limit their ability to attend and engage in school, extra-curricular activities and can lead to reduced quality of life. International consensus on Concussion recommends a brief period of physical rest immediately after concussion (24-48 hours) followed by a graduated return to physical activity at a level that does not provoke significant symptom exacerbation . Active rehabilitation involving sub-symptom threshold aerobic activity is a growing area of research with evidence showing reduced symptoms and improvements in recovery following concussion. The primary aim of the study is to evaluate whether a telehealth-supervised sub-symptom, graded return to aerobic exercise program improves recovery for children and adolescents who have sustained a concussion when compared to standard care. This study will be commenced once the Phase 1 - Validation of Modified Shuttle Test has been completed. We aim to see children by 3 months post-injury in the Complex Concussion Clinic: our current wait time is 3 months. While the child is waiting to be seen, PPCS limits physical activity and quality of life limiting their ability to participate in school and recreational activities. The longer symptoms persist the more difficult it is to treat these persistent symptoms and more health-related interventions are often needed to aid the child to return to normal school and sport activities. If the trial is successful, children will be able to return to these activities quicker, with a resultant decrease in the burden of the injury, and improvement in quality of life. A later cost-effectiveness of the intervention will be performed. The projected outcome of the project is to have a fully completed study protocol, with ethics approval, and a completed RCT within the specified timeline (24 months). This project is significant because not only will it impact QPRS, but the results of the study will have a far reach, Queensland wide with a more equitable service able to be provided to patients across the state. Information gained from the study could potentially lead to a change in current practice within QPRS and lead to future studies looking a how to translate this knowledge across QLD and Australia.

This study is investigating cancer-related cognitive impairment, and the impact of a cognitive training intervention. Who is it for? You may be eligible for this study if you are aged 18 years or over, living in or near the Perth/Peel regions of Western Australia, are currently undergoing any treatment for a confirmed diagnosis of cancer, AND are experiencing possible associated cognitive decline. Completion of baseline of this study will determine said eligibility. Study details The intervention of the study requires participants to complete brain training sessions involving puzzles, games, and word problems for 12 hours across 6 weeks. Follow-up tests (1 week and 3 month) investigating memory, attention, executive function, and processing speed will be performed, as well as other psychological factors such as quality of life, sleep, anxiety, and pain. Biological markers implicated in neurogenesis will also be assessed through blood tests, direct questions, and with reference to medical history. It is hoped that findings from this study will assist researchers with optimising daily oncology care.

Paramedics experience high levels of mental ill-health and family and friends are a main source of care and support. However, this caring role can result in significant difficulties. Interventions targeting these challenges among family and friends are therefore important for preventing psychological distress among this group and to strengthen the support they provide to others. Everymind has developed a prevention and early-intervention program for carers of individuals experiencing depression and anxiety, and has adapted it to target carers of paramedics. We are proposing to evaluate the effectiveness and implementation potential of the adapted Minds Together program. We will carry out a feasibility and acceptability trial in which carers will complete pre, post and follow up online assessments.

ECHONOF III is a parallel group, pragmatic randomised controlled multi-centre trial, in which patients presenting with hip fracture are randomised to receive or not receive preoperative focused transthoracic echocardiography (TTE) before surgery. The trial aims to assess whether adding a focused TTE will lead to a reduced composite outcome of at least one of: all-cause mortality, cardiac failure, myocardial injury in noncardiac surgery, acute kidney injury or hospital readmission at 30 days post-surgery compared to patients who do not receive preoperative focused TTE (the current standard of care). A sample size of 2,000 patients has been estimated (1,000 per group). Secondary outcomes include in-hospital medical complications, quality of recovery, independent living and health cost analysis.

The Sonomat is a non-invasive sleep mat which has recently been validated in children. The primary aim of this study is to evaluate the potential clinical application of the Sonomat, in children with Neurodisability. Participants will undergo sonomat monitoring at the same time as having their in lab sleep study (polysonomgraphy - PSG) and then use the mat at home for three nights. We hypothesise that the sonomat will be comparable to an in lan sleep study for the diagnosis of sleep disordered breathing in children with neurodisability.