ANZCTR search results

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.

Diabetes is a major contributor to the mortality gap between Indigenous and non-Indigenous Australians, and the risk and severity of diabetes complications (cardiovascular disease, kidney failure, blindness) are far greater in this population than in non-Indigenous Australians. We address this problem, targeting Goal 5 of the National Diabetes Strategy. We urgently need effective and convenient ways of improving glycaemic management in Indigenous Australians. New technologies that continuously monitor blood glucose are effective in assisting patients to improve their blood glucose levels through driving changes in behaviour (increasing physical activity), lifestyle (healthier eating habits), and therapy. The devices are worn on the arm and provide continuous, real-time feedback on blood glucose levels, but have not been tested in Indigenous Australians. We will assess the effects of one of these technologies (flash glucose monitoring) on glycaemic control (glycated haemoglobin [HbA1c] levels, achieving blood glucose targets, reducing hypoglycaemic episodes) through a randomised clinical trial in this high-risk population. We will also perform a cost-effectiveness analysis. Indigenous Australians with type 2 diabetes on injectable therapy, and with persistent high blood glucose levels, as indicated by HbA1c >7.5% (n=350), will be equally randomised to use a flash glucose monitor or receive standard care (glucose tested by finger-prick) for 6 months. Anticipated primary outcomes will be a lower, clinically significant HbA1c level with flash glucose monitoring. Anticipated secondary outcomes include achieving blood glucose targets, fewer hypoglycaemic episodes, reduced costs, and improved quality of life. The research will likely lead to major, cost-effective health gains for Indigenous Australians, and significantly improved health-service delivery for Indigenous and other high-risk Australians.

The purpose of this study is to determine the effects of sustained-release oral morphine (20mg) on sleep efficiency, breathlessness, and daytime alertness in breathless people with chronic obstructive pulmonary disease. We hypothesize that low dose morphine will improve sleep efficiency.

The CHIPS Trial is a double-blinded, randomised dose-ranging trial designed to determine the minimum effective steady-state penicillin concentrations required to prevent pharyngitis caused by Strep A. This trial will use a world-first fully validated human challenge model for Strep A infection which has been developed in Australia by members of our team as a tool to test different interventions in the fight against acute rheumatic fever (ARF) and rheumatic heart disease (RHD). If the CHIPS Trial determines that the minimum concentration required to prevent Strep A pharyngitis is lower than the currently accepted target of 20 ng/mL, this will transform the penicillin reformulation landscape toward a new long acting penicillin implant and provide opportunities to make data-driven changes to recommendations of currently available penicillin preparations used for secondary prophylaxis of ARF and RHD.