ANZCTR search results

Despite the strength of evidence about the benefits of medicines for the prevention of cardiovascular events, particularly in those at high-risk, there are substantial evidence-practice gaps. This study will test the hypothesis that an integrated intervention combining three evidence based approaches: (1) a CVD polypill (fixed dose-combination of generic blood pressure lowering and lipid modifying, with or without antiplatelet drugs), (2) a GP focused point-of-care electronic decision support and (3) a pharmacy-led medication adherence intervention will increase prescription and long-term use of recommended medications, leading to improvements in CVD risk factor levels compared to usual care. This will be done using a pragmatic cluster randomised control trial of 70 general medical practices.

The primary purpose of this trial is to evaluate the efficacy of an internet program, iCanADAPT, for depression and anxiety in adults diagnosed with cancer. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, suffer from anxiety or depression and have an early stage cancer, or have survived an early stage cancer in the past. Study details All participants enrolled in this study will be randomly allocated (by chance) to receive the iCanADAPT program soon after enrolment or 16 weeks later. The iCanADAPT program is a 16 week online program which involves learning about tackling depression with a form of therapy called Cognitive Behavioural Therapy (CBT). CBT looks at improving how we manage our thoughts, actions and feelings. There are 8 lessons, each one taking up to an hour to complete, with the recommendation to do a new lesson every 1 – 2 weeks. There will also then be additional activities to do for around 3 hours per week. The program is tailored to unique aspects of the cancer context, such as fear of cancer recurrence and adapting to illness, side effects, and survivorship. Participants will complete a number of important questionnaires to assess their depression and anxiety levels among other psychological factors, at the beginning of the program, mid-way through, then again at the end of the program and the last time is 3 months after finishing the program. Participants will also be asked to complete a short questionnaire before every lesson. It is hoped that the findings of this trial will provide information regarding the efficacy of the iCanADAPT program in reducing depression and anxiety in cancer patients and cancer survivors.

Diabetes is one of the most common chronic diseases in the world, affecting over 8% of the global population and is associated with a life-time risk of foot ulcers of 12-25%. Foot ulcers lead to high morbidity, increased associated healthcare costs and are the most important risk factor for lower extremity amputation. Elevated forefoot plantar pressure is a risk factor for foot ulceration and has been linked to reduced ankle dorsiflexion range of motion (equinus) in people with diabetes. Calf muscle stretching has been demonstrated to improve ankle joint range of motion across both the young and older adult healthy populations, and a pilot trial has demonstrated a reduction in plantar pressures following range of motion exercises in people with diabetes. Calf muscle stretching may be a simple, non-invasive and inexpensive method of increasing ankle joint range of motion resulting in decreased plantar pressures and a reduced risk of plantar ulceration in people with diabetes. The aims of this trial are 1) To determine if an 8 week calf stretching intervention will be effective in increasing ankle joint range of motion in people with diabetes and ankle equinus. 2) To determine if an increased ankle joint range of motion in people with diabetes and ankle equinus results in an associated reduction in forefoot plantar pressures.

People can have many risk factors, but when a combination group together at the same time, including high blood pressure, obesity, blood glucose (sugar) and lipids (cholesterol and triglyceride), it forms what is called the “metabolic syndrome” and exposes individuals to diabetes and cardiovascular disease. People living in regional areas have higher levels of these risk factors than people living in metropolitan areas. One reason for this is less access to health care. Therefore, a health and lifestyle intervention program led by nurses for participants with metabolic syndrome may be beneficial for preventing these diseases. The aim of this study is to develop a regional health care program that reduces the risk of developing diabetes or cardiovascular disease (such as a heart attack or stroke) by managing risk factors that cause these diseases better.

The primary purpose of this study is to evaluate the safety of a new cancer drug, ACT001 which has not yet been tested in humans. The study will also look at the amount of drug in the blood to evaluate the way the body processes the drug and the way the drug acts on the growth of tumours in cancer patients. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, and have been diagnosed with advanced or metastatic solid tumor, including glioblastoma, with no standard treatment options. Study details All participants in this study will receive a specified dose of ACT001 each day for 56 days (two 28 day cycles). The first set of participants will start on the lowest dose level, with the next highest dose only commencing in the next set of participants once the safety of the first dose has been confirmed. Researchers will take a number of blood samples on days 1, 2, 3, 17, 18 and 29 of dosing in each participant to examine the rate that the body processes the drug. Further blood samples, as well as CT and MRI scans will be taken before treatment and at the end of treatment to look for changes in tumour growth. Participants will also be assessed for side effects throughout the study period. It is hoped that the findings of this trial will show whether ACT001 can be safely given to cancer patients, and provide information on the rate of processing of the drug in the body. Using this information, researchers hope to find the best dose to use for further testing of ACT001 in cancer patients.

Emergency doctors are required to complete a range of administrative tasks including typing medical notes, ordering imaging and blood tests, following up on results and corresponding with external departments. These administrative tasks do not require advanced clinical training and so the medical skillset of the emergency physicians is being underutilised. The Emergency Department also loses money due to under-billing patients when at the end of the patients’ attendance by forgetting to include some billable items (e.g. an ECG). A medical scribe completes administrative tasks for the emergency physician so that more time can be spent on medical tasks. The scribe is also responsible for completing billing requirements and can bill for events as they happen, reducing the likelihood of under-billing. While it is important to improve the efficiency of the Emergency Department, it cannot be done at the detriment of patient comfort. However, there is no research in Australian patients’ perceptions of having a non-medically qualified staff member present while being examined by an emergency physician. The current study aims to identify patients’ views and thoughts on medical scribes and uncover any problems that might arise from having additional staff in the room while a consultation takes place.

To properly manage type 1 diabetes (T1DM), individuals are required to measure blood glucose levels regularly and adjust the amount of insulin to be given accordingly. This is done by matching the insulin doses to the carbohydrate content of a meal. Recent studies have shown that meals high in dietary protein may cause postprandial hyperglycaemia. The paediatric diabetes research team at the John Hunter Children’s hospital published a study demonstrating that meal protein content can significantly affect postprandial blood glucose levels. More recently, our group have published a further study, looking at the impact of pure protein- independent of carbohydrate and fat- on postprandial blood glucose levels in T1DM. We are now in the process of completing a further study that was designed to investigate the effect of consuming protein with carbohydrate only (no fat) on postprandial blood glucose levels and have demonstrated a dose response to increasing amounts of protein when consumed with carbohydrate. These findings have led to recommendations to give additional insulin for meals high in protein to avoid postprandial hyperglycaemic excursions. However, at the present time there is still insufficient data regarding how to safely and effectively calculate and deliver mealtime insulin doses for protein. Therefore, we need to conduct further research in order to determine a safe and effective insulin dosing algorithm for meals high in protein.

Many Australian families are unable to access evidence-based psychological treatments for their child’s Disruptive Behavioural Disorder (DBD) due to their geographical location and limited availability of appropriate mental health services. For these families, Internet-delivered treatment may be a promising means of overcoming these barriers. The aim of this study is to test the feasibility, acceptability, and efficacy of Internet-delivered Parent Child Interaction Therapy (I-PCIT), as compared to standard, clinic-delivered Parent-Child Interaction Therapy (PCIT), using a non-inferiority, randomized control trial. It is expected that I-PCIT children will show non-inferior reductions in ODD/CD rates, and in oppositionality, aggression, noncompliance, and hyperactivity, relative to standard PCIT children. It is also expected that I-PCIT parents, relative to standard PCIT parents, will show (i) non-inferior increases in the use of effective commands, labeled praise for child compliance, behavioural descriptions, verbal reflections, and household consistency and follow-through, (ii) non-inferior reductions in the use of criticisms and indirect commands, (iii) non-inferior improvements in family functioning, and (iv) non-inferior reductions in parental stress and depressive symptoms. Families are eligible to participate if their 2-7 year old child meets clinical criteria for a DBD, parent(s) are fluent in English, not intellectually disabled or with a history of severe physical or mental impairments, and own a computer. Eligible parent-child dyads randomly allocated to I-PCIT will receive 14 weekly one-hour PCIT therapy sessions delivered over secure online videoconferencing software by a trained PCIT therapist under the supervision of a Master Trainer. Dyads allocated to the standard PCIT condition will similarly receive 14 weekly one-hour PCIT therapy sessions delivered in-clinic at the UNSW Parent-Child Research Clinic. All participating dyads will complete four identical 1.5 hour assessment sessions over videoconference or in-person at pre-treatment, mid treatment, immediately post-treatment, and 3-months post-treatment. These sessions will involve coded observations of parent-child interactions, computer-based questionnaires completed by parent(s), and a clinical interview with a research assistant blind to treatment condition.

1.To demonstrate the feasibility of conducting a RCT using omega-3 supplementation with a community sample of impulsive, repeat-violent offenders. Secondary objectives 1.To collect information about the effectiveness of omega-3 supplementation on 3-month behavioural measures of impulsivity, anger, depression and irritability in impulsive, repeat-violent offenders. 2.To collect information about the effectiveness of omega-3 supplementation in reducing self-reported offending among impulsive, repeat-violent offenders.

Preterm infants are highly susceptible to bacterial late-onset sepsis (LOS) and necrotizing enterocolitis (NEC), both are major causes of systemic inflammation and contribute to brain injury and long-term disability in premature infants. Treating LOS and NEC are essential for survival, but suppressing systemic inflammation can also help reduce mortality, hospital stay and disability due to brain injury. The current treatments for NEC and LOS are limited to antibiotics, supportive care and surgery in some NEC cases, all of which do not aid in reducing systemic inflammation, therefore there is a need to reduce systemic inflammation. Pentoxifylline is a safe, low-cost, non-steroidal drug with potent immune-modulating activity with the potential of suppressing systemic inflammation induced by LOS or NEC. A recent Cochrane Review of 6 randomised controlled trials (RCT) suggests that PTX, given with antibiotics in neonatal sepsis, reduces mortality and length of hospital stay. We will enrol and consent 23 preterm infants (<29 weeks gestational age) and intravenously administer Pentoxifylline, adjunct to standard care, for 48hrs within 6 hours of the onset of symptoms suggestive of sepsis or NEC. After 48 hours treatment will cease if diagnosis is refuted or will continue for 4 days if diagnosis is proven. To measure the pharmacokinetic profile of Pentoxifylline a series of four small blood samples will be taken prior to starting treatment and during treatment. The pharmacokinetic profile will allow us to model the optimal infusion frequency and duration, which will be used as a guideline in larger randomised controlled trials that will assess white matter injury and long-term disability.