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Australian families with preschool/school children have been experiencing significant distress during the COVID-19 pandemic and it is estimated that 1,600,000 Australian families will experience financial hardship during the pandemic. The associated economic recession is resulting in widespread job losses and financial stress, adding further distress. An extra three quarters of a million children are now living in families experiencing employment stress with three suburbs from South West Sydney (SWS) in the top 10 communities impacted3 and marginalised families in rural communities have been further isolated as well. Parental mental health difficulties consequent to the pandemic will adversely impact children’s development and well-being. Specifically, families from priority populations such as from culturally and linguistically diverse (CALD) and rural/regional backgrounds are particularly at risk of poor health outcomes. This has been compounded by the closure of Child and Family Health Nurse (CFHN) services for in-person consultation which has substantially reduced access to resources for vulnerable families during the pandemic. The Watch Me Grow – Electronic (WMG-E) Platform is an innovative technology that will provide a unique opportunity to reach vulnerable families at their homes, critical during the current pandemic. WMG-E has been evaluated for child developmental monitoring and we now propose to expand this to screening and addressing parents’ mental health and unmet psychosocial needs (e.g. financial support, housing) - optimising the family’s wellbeing. We will use this "virtual care approach" to focus on a predominantly CALD community (Fairfield in SWSLHD) and a regional/rural area (Murrumbidgee LHD). We will utilise the opportunistic contact for routine CFHN checks to engage and empower parents (including those who would otherwise not engage with health services), normalise and de-stigmatise mental health and psychosocial screening, and provide urgent targeted interventions.

The number of Australians living with diabetes is increasing and so is the cost of healthcare for these people. Many people living with diabetes are managed by Australian diabetes centres. These centres are members of the National Association of Diabetes Centres (NADC) and include a mixture of primary, secondary and tertiary care facilities. The clinical management provided by these Centres is evaluated by the Australian National Diabetes Audit (ANDA), an annual benchmarking activity where de-identified patient data for a range of process and clinical outcomes is collected, collated and compared for all participating sites. A previous qualitative study sought opinions from clinical staff regarding the acceptability and utility of the audit feedback currently provided. This study has informed redevelopment of the feedback provided to participating sites and development of the cointerventions in this trial.. Providing these enhanced feedback and community of practice interventions in a cluster randomised trial will allow us to evaluate the utility and acceptability of the feedback and cointerventions provided, and also the effect on selected clinical outcomes. We hypothesise that delivery of redesigned audit feedback and educational and peer support resources to diabetes centres will improve the utility and acceptability of the Australian National Diabetes Audit (ANDA) feedback to participating diabetes centres. We also hypothesise that the interventions will lead to improved clinical outcomes including mean HbA1c. This project will contribute to the body of knowledge about how to bring about practice change in diabetes centres in Australia. The outcomes of the study have the potential to improve the health outcomes of the many people with diabetes managed by participating diabetes centres.

Preliminary evidence suggests that low-carbohydrate (LC) diets appear safe for use in type 1 diabetes (T1D) and may be effective for certain subgroups of this clinical population. However, the available body of research is limited and there is still a lack of consensus regarding the efficacy of LC diets for improving T1D management. Since there are a multiplicity of lifestyle factors impacting T1D management, and with consideration that all individuals have their own personal needs and preferences, an interventional study that uses participants as their own controls and investigates a patient-led dietary approach will be of important clinical relevance. Therefore, a within-patient interventional study investigating a LC diet with an adaptive carbohydrate prescription (25-75 g/day) will be undertaken in adults with T1D in an outpatient setting. The aim of this research is to assess the efficacy of a LC diet in adults with T1D. Our primary objective is to determine the effects of a LC diet (25-75 g/day) on clinical markers of T1D management including HbA1c, glycaemic variability, frequency of hypoglycaemia, total daily insulin, and quality of life. We expect that a LC diet will result in improved T1D management compared to habitual diets higher in carbohydrates.

In this pre-post Implementation-Effectiveness trial, we are extending an existing Australian football themed evidence-based men’s health behaviour change and weight management program to regional areas in Western Australia. We aim to recruit up to 150 men (aged 35-65 years, BMI>28) from across three regional sites. Aussie-FIT is a 12 week long program, with weekly sessions including education covering principles of healthy eating, behaviour change techniques and motivational principles; and tailored physical activity. There is a strong evidence base supporting the effectiveness of Aussie-FIT program based on; the Aussie-FIT pilot in Metropolitan Perth, the UK-based ‘parent’ program Football Fans in Training (FFIT), and other FFIT-related projects. Therefore, the primary outcomes for this trial relate to implementation of Aussie-FIT in regional contexts. These include recruitment and reach; engagement; and retention of men in regional towns. In addition, physical health (e.g., weight), health behaviour (e.g., diet) and psychological wellbeing outcomes will be assessed. Mixed-method (pre-post) evaluation will be undertaken. Assessment methods include participant self-report questionnaires (baseline & post-intervention), attendance/retention rates, post-program participant focus groups, participant withdrawal surveys and post-program coach interviews. The Aussie-FIT program can help men to lose weight and improve their health but has not been tested in regional areas of Australia. This study will test if the program can run successfully in regional Australian towns.

The aim of this study is to determine whether it is safe to administer a type of personalized immune cell therapy made from the white blood cells of patients with blood cancer (lymphoma and leukaemia). Who is it for? You may be eligible for this study if you are aged 18 or older and have been diagnosed with a CD19-positive B –cell blood cancer, including non-Hodgkin lymphoma or leukaemia, that has not responded to other treatments or has relapsed after previous treatments. Study Details. This study will enrol only a small number of participants as the therapy is still in the early stages of testing. All enrolled participants will undergo a comprehensive medical assessment. Participants will then have white blood cells collected over 4-6 hours via a special machine. These collected white blood cells will be used to make Chimeric Antigen Receptor (CAR) T cells which takes twelve days. Participants who are able to safely undergo chemotherapy will be given three days of intravenous chemotherapy prior to the CAR T cell infusion, which is given as an inpatient. Participants will need to stay in hospital for a few days before and after the CAR T cell infusion and attend regular follow-up visits after hospital discharge for up to 15 years. It is hoped that this research will show that this type of CAR T cell therapy is safe in patients with blood cancers. This treatment may then be used to improve access to CAR T cell therapy and improve health outcomes of future patients with similar types of blood cancer.

Gout is a common condition, associated with significant illness, and costs to the community and the health care system. However, people with gout generally don’t get good treatment, the health system is failing to provide appropriate care for these people using the routine health care systems in Australia. We aim to develop an educational programme to be delivered in the patient’s home, along with escalation of medicines, to see if this improves the treatment of people with gout.

This is a 17 to 57-week open-label study to evaluate the safety and efficacy of full-spectrum medicinal cannabis plant extract containing only 0.08% THC (FEN164) in children with Autism Spectrum Disorder (ASD). The purpose of this study is to determine how safe and effective FEN164 is in patients with ASD when treated with 20mg/kg/day for an 8 week period. Participants will commence treatment with a daily dose of 5mg/kg of FEN164. This will gradually increase over a four-week period until the maximum tolerated daily dose or 20mg/kg per day is achieved (Up-titration phase). Participants will continue to receive their respective maximum dose for eight (8) weeks (Treatment phase). Participants who wish to continue receiving their maximum tolerated dose beyond the 8-week Treatment phase may do so for up to fifty-three (53) weeks (Extension phase). At the end of the Treatment or Extension phase, participants will be gradually decreased by 5 mg/kg for a period of 4 weeks until the end of their participation (Down-titration phase). Safety will be measured and monitored by performing full blood examinations and liver and renal function tests throughout the study. Efficacy will be measured and monitored by performing participant- and psychologist- led questionnaires specific to measuring changes in the behaviour of patients with ASD.

Patients undergoing cardiac surgery will be the subject of this research. They require administration of heparin and reversal with protamine. This is administered by the anaesthetist, not the cardiac surgeon and as such forms part of the anaesthetic process. The study is designed to test the assumption that calculation of a heparin:ACT dose-response curve at the time of initial administration of heparin allows an estimate of the circulating amount of active heparin from the ACT measured at completion of surgery and after the patient is rewarmed. This then allows an estimate of the dose of protamine required to reverse the heparin. By measuring the clotting times with and without heparinase using viscoelastic testing, it will be possible to determine whether this assumption. is correct.

The MHFA Conversations about Suicide course is a specialised four-hour course focused on recognising and supporting people with suicidal thoughts. It aims to improve participants’ confidence and skills in supporting someone in their social network, such as a friend or family member, who is feeling suicidal. The course is based on suicide prevention best practice guidelines and is delivered by instructors who are trained and accredited by MHFA Australia. The current study is a cluster randomised controlled trial to investigate the effectiveness of the course in Men’s Sheds across Australia. It is expected that the course will lead to an increase in recommended helping intentions and a decrease in non-recommended helping intentions in the intervention group.

This is a prospective, multicentre pragmatic, randomised trial. The primary objective is to examine the impact of the TCC-Cardiac solution compared with usual standard care alone on 6-month unplanned hospital readmission rates in patients who have recently been discharged following an acute cardiac event including myocardial infarction and decompensated heart failure. Participants will be allocated to 1 of 3 cohorts, using predefined criteria according to their access to technology in a pragmatic design, including 1) TCC-Cardiac randomisation, 2) TCC-text randomisation, or 3) usual care registry. Cohort 1 patients will be randomised at point of hospital discharge in a 1:1 ratio to the TCC-Cardiac program in addition to usual care, or to usual care alone. Cohort 2: patients will be randomised 1:1 to receive supportive text messages (TCC-Text) in addition to usual care, or to usual care alone. Cohort 3 is a registry of patients discharged home per usual care. We will aim to recruit 2500 patients aged above 18 years, comprising 1000 patients in the main randomisation (Cohort 1), 1000 patients randomised in cohort 2 and 500 patients in the cohort 3 registry. Based on a pilot study’s results, it is hypothesised that the Teleclinical Care (TCC) app will lead to a reduction in readmission rates and improvement in clinical indices associated with clinical outcome in patients with myocardial infarction and decompensated heart failure.