ANZCTR search results

This study aims to test the acceptability and feasibility of a text message program (TEXT4HealthyHeart) on reducing overweight and obesity for people referred to the Shoalhaven CRP, as well as to assess the preliminary effect of TEXT4HealthyHeart on body mass index (BMI), waist circumference, blood pressure, heart rate, nutrition and physical activity including step count. Participants will receive specifically selected automatic daily text messages for 6 months on weight reduction, nutrition and physical activity. They will also receive a step recording calendar and will be supplied with a step counting device if they do not have one. Objective and self-report measures will be collected directly from the participant at baseline, 3 months and at 6 months.

The major aim of this project is to test the effectiveness of Cardiac Prehabilitation aimed at reducing anxiety, depression and distress in patients with aortic stenosis undergoing either sAVR or TAVI as cardiac interventions. This will be assessed by comparing each group against their control arm of cardiac patients in the surgery waitlist. In addition, we will examine whether prehabilitation has been more effective in either sAVR or TAVI. It is expected that those undergoing sAVR will demonstrate higher rates of baseline psychological distress than those undergoing TAVI. A secondary aim is to gauge whether undertaking a web-based intervention has resulted in higher rates of cardiac rehabilitation uptake than is usually seen in this population. This research will contribute to the current lack of research in the area of early interventions in cardiac patients with aortic stenosis.

The primary purpose of this research is to evaluate the feasibility, acceptability, and efficacy of integrating mentalization principles into a cognitive behavioural intervention for childhood anxiety. In light of the evidence that reflective functioning enhances parenting self-efficacy, coupled with the evidence on the effectiveness of CBT in reducing and managing anxiety in children, it is hypothesized that this integrated cognitive behavioural intervention will demonstrate: (a) feasibility, acceptability, safety and tolerability (b) a reduction in clinical levels of anxiety and anxiety symptoms in children and, (c) an increase in self-reported parental self-efficacy in managing their child’s anxiety.

This is a FIH, randomized, double-blind, placebo-controlled, dose-escalation study to investigate the safety, tolerability, PK, and PD of ENN0403 after single and multiple oral dose administration in healthy adult subjects. The study will include 2 parts which will proceed in a parallel staggered manner: Part A, a single ascending dose (SAD) study and Part B, a multiple ascending dose (MAD) study. Approximately 80 healthy adult subjects will be enrolled at a single site in Australia, in up to 6 cohorts in Part A (SAD study), including a Food Effect (FE) study, and up to 4 cohorts in Part B (MAD study). Part A is for the single dose use of IP, while Part B is once daily use for 14 consecutive days. Each cohort will include 8 subjects (6 receiving ENN0403 and 2 receiving placebo). Each subject will be enrolled in only 1 cohort and receive only one dose regimen in this study. Dosing will be escalated in a sequential fashion, contingent on a review of safety, tolerability, and available PK data of the previous dose level by a Safety Review Committee (SRC). The proposed dose levels/dosing frequency of ENN0403 may be adjusted over the course of the whole study and cohorts may be added or removed depending on the emerging safety, tolerability, and available PK data.

Indigenous children and adolescents experience profound levels of preventable dental disease. These impact on Indigenous children and young people’s ability to eat, speak, socialise and learn. It is a leading cause of child malnutrition and overall poor quality of life and SEWB. Trajectories of dental disease among Indigenous children/adolescents are increasing at a rate far greater than for non-Indigenous children/adolescents, with severe cases requiring care under a hospital-based general anaesthetic. Poor oral health in childhood is the leading cause of poor oral health in adulthood, and has associations with other systemic conditions including diabetes, cardiovascular disease and chronic kidney disease. Effective interventions to reduce dental disease among Indigenous children and adolescents are rare, and certainly not included in the current suite of management recommendations for the health and wellbeing of this vulnerable population. This study will test the hypothesis that Indigenous children and young people in 6 Australian states and territories can be provided with appropriate dental care in local Indigenous settings using the AgF approach, without specialist intervention and avoiding the need for treatment under hospital-based general anaesthetic. Our study has 6 major strengths: (1) it will evaluate the extent, prevalence and severity of dental disease in Indigenous children and young people in each state and territory; (2) it will test the efficacy of a simple and culturally safe AgF initiative, which could be easily implemented into the training program of Indigenous Health Workers to be included in their remit of care; (3) we will have capacity to comprehensively assess the cost-effectiveness of the intervention, meaning uptake into clinical guidelines will be much swifter than if no cost-effective analysis was undertaken; (4) the intervention will likely lead to SEWB improvements in Indigenous children and young people; an important strategic priority given current commitments to improving child health and wellbeing, with the Australian Government launching, in Oct 2021, the world’s first National Children's Mental Health and Wellbeing Strategy;1 (5) we have engaged and consulted considerably with the 9 participating ACCHOs, using their feedback to shape the research questions; (6) our researchers are world-class experts in their respective specialties and have experience working with Indigenous child and adolescent populations. Half our study team are Indigenous and include the CEOs and research officers of all ACCHOs involved. Our findings have potential to change the way in which the oral health of Indigenous children and young people is managed, with desired impacts including cost-savings on expensive dental treatments; improved SEWB, nutrition, social and learning outcomes; and improved quality of life for both children/young people and their carers/broader Indigenous community.

The study is designed to assess the safety, tolerability, plasma concentration and efficacy of ABI-2280 Vaginal Tablet, self-administered to participants with intravaginal applicator Part A of the study is consists of 3 Cohorts (A1, A2 and A3) Each cohort will enroll 3 participants Total of approximately 9 participants will be enrolled. The study includes Screening, Baseline Visit, Safety follow-up visit.

Running mitigates many common barriers to physical activity as it is time efficient, inexpensive and easily accessible (Hespanhol et al. 2015; Ainsworth 2011). Running has a positive impact on longevity, reducing the risk of premature mortality by 30% compared to non-runners (Lee 2014; Lee 2017). Yet despite its broad appeal, there are a variety of barriers that can hinder long-term participation, with novice runners most at risk of drop-out (Fokkema 2019; Menheere 2020; Vidbaek 2015; Berelsen 2017). Running-related injury and lack of motivation are two main reasons for discontinuation (Dallinga et al. 2015; Middelweerd et al. 2014). Despite motivation being a known reason in determining running adherence, little is known about how this should be addressed. Online interventions to promote exercise participation in conjunction with activity tracking have been used extensively in health research. Compared to face-to-face interventions, online interventions tend to be low cost and can target a broad population. This study will explore the feasibility of a 12-week online intervention comprised of evidence-based education and relevant behaviour change techniques and strategies to improve running adherence, promote motivation, and increase sustainable running participation.

BEAT CF is a national, multi-site project which aims to learn and implement , which of the antibiotics commonly used to treat lung infections are best. There is no single standard of care for managing CF pulmonary exacerbations. Standard care comprises a range of interventions and varies across and within CF treatment centres and may evolve over the course of the PEx Treatment Platform. At the time of initiation of the PEx Treatment Platform Protocol, management of pulmonary exacerbations generally involves the use of one or more intravenous (IV) antibiotic therapies. Most Australian clinicians manage pulmonary exacerbations with an antipseudomonal beta-lactam or carbapenem, combined with a non-beta lactam antibiotic - most typically the aminoglycoside tobramycin given intravenously (IV). Tobramycin can also be given via inhalation. Inhaled tobramycin is widely used for outpatient management, it is rarely used as part of inpatient management of PEx. This particular domain to the BEAT CF PEx treatment platform aims to find out if there is any gain in providing tobramycin in addition to ‘backbone’ antibiotic therapy. Also, it will assess there is any difference in giving tobramycin by the IV or inhaled route, and whether no tobramycin is non-inferior to the IV or inhaled tobramycin. Some clinicians reserve the use of IV aminoglycoside for patients known to be colonised with Pseudomonas aeruginosa. Some, but not all, clinicians use the results of microbiology and in vitro susceptibilities to guide antibiotic selection. Many centres provide additional antibiotic cover targeted to specific pathogens, but only if identified on sputum microbiology, e.g. for Stenotrophomonas maltophilia or Staphylococcus aureus. The duration of IV antibiotic therapy is typically 14 days, and generally ranges from 10 days to 21 days. A recent RCT found evidence that 10 days was non-inferior to 14 days of IV antibiotics therapy in those with a rapid treatment response, and found no evidence that 21 days was superior to 14 days of IV antibiotics in those without a rapid treatment response. The primary objectives, outcomes and endpoints for the PEx Cohort were informed by a systematic review of the literature and involvement of key clinical and consumer stakeholders.

With the general ageing of the population attributed to Baby Boomers and the increase in life expectancy, attention of health consumers is turning from simply the treatment of chronic illness to increasing the span of good health (healthspan) as people age. The inflamma-ageing hypothesis proposes that much of the ageing process per se as well as chronic disease, even in healthy persons, is underpinned by chronic low-level inflammation. In pilot human studies undertaken by NatMed Research looking at their proprietary green-lipped mussel-based products as an anti-inflammatory treatment of osteoarthritis, the observation was made of changes in body composition in those persons receiving active medication. The current proposal is to undertake an open-label trial in middle-aged healthy women (without osteoarthritis) to determine if improvements in body composition and strength can be determined.

This study is designed to show that using a subcutaneous indwelling catheter to administer enoxaparin (Clexane) is safe and effective for patients requiring long term treatment at both treatment doses and prophylactic (preventative) doses. This will be assessed by measuring peak drug activity levels, regular nursing and medical reviews, and assessing participant satisfaction and preference for using the subcutaneous catheters as compared to subcutaneous injections. If successful, this will provide reassurance to clinicians and patients and allow access to use of subcutaneous catheters as part of standard practice for those requiring extended durations of enoxaparin (Clexane) treatment.