ANZCTR search results

The primary aim of this study is to pilot test the feasibility of a randomised trial that compares the effectiveness of new generation securement and dressing products for peripheral intravenous catheters. The RCT aims to (i) identify clinical, cost-effective methods to prevent catheter failure due to infection, phlebitis, occlusion, and dislodgement; (ii) compare usual care dressings with a novel method; (iii) evaluate the acceptability of these devices to patients and health professionals; and (iv) study adverse effect profiles. You may be eligible to participate in this trial if you are a medical or surgical patient over the age of 16 and are having a peripheral venous catheter inserted as part of your therapy (which is expected to remain in place for at least 24 hours). All participants enrolled in this trial will be randomly allocated (by chance) to receive one of two PVC dressing/securement options. This will be either the standard bordered polyurethane dressing; or an integrated securement device. The allocated dressing will be applied from device insertion until the time of device removal. Participants will be asked to rate the acceptability of the device and dressing, and the device will be observed closely to examine side effects, device failures and infections. It is hoped that the findings of this trial will provide information on which PVC securements and dressings are most effective in preventing PVC failure.

The proposed study aims to evaluate the impact of an intervention targeting perfectionism and self-compassion on children’s psychological health. It will further develop Fairweather-Schmidt and Wade’s (2015) pilot study, by having greater power, one more lesson that the previous protocol (i.e., 3 instead of 2), having a longer follow up period, and aim to include schools with lower SES to increase generalisability.

Whole of Systems Trial Of Prevention Strategies for childhood obesity: WHO STOPS childhood obesity The goals of this grant are to: 1) strengthen community action for childhood obesity prevention, and 2) measure the impacts of increased action on risk factors for childhood obesity. This proposal addresses the lesson that the impact of previous successful interventions would be optimally sustained by increasing community ownership (community-built interventions), using existing community funding (avoiding the state and federal feast/famine of prevention funding), and building on existing community assets (systems and networks). We propose that permanent reductions in childhood obesity are possible if the complex and dynamic causes of obesity are well understood and addressed through increased community ownership and responsibility. Working with local partners this research tests whether new ways of embedding best practice for obesity prevention into existing community systems (e.g. health, workplaces, local council, schools) will achieve efficient and effective implementation and sustainability. In our development work we have evolved a facilitated, community engagement process which; creates an agreed systems map of childhood obesity causes for a community; identifies intervention opportunities through leveraging the dynamic aspects of the system; and, converts these understandings into community-built, systems-oriented action plans. Throughout this process systems data are collected for measuring systems changes over time. Our experience to date has been that this process rapidly increases capacity of community leaders to use systems thinking for community-wide obesity prevention. Consequently we have seen changes at multiple levels of systems (e.g. a council policies banning sugar sweetened beverages and improving water quality and application of systems thinking for health across ACT primary schools and among 30,000 members of a state emergency service). We will conduct a stepped wedge cluster randomised trial in ten communities in the GSCRV. Five communities will be randomised into the study in year one and all communities will be included in year 3. An additional group of 13 external communities from other regions of Victoria with no specific interventions will provide an external comparison and will help assess the potential diffusion of the intervention between regions within this trial. We will assess whether the adoption of systems change interventions rapidly increases community capacity to apply evidence-informed action across community systems. The primary outcome is childhood obesity prevalence and this will be collected by the community-led monitoring system. It is hypothesised that a systems intervention for childhood obesity will be effective in its impact, efficient in its implementation, scalable in its delivery, and sustainable in its longevity.

Polyphenols contained within the cocoa in chocolate are thought to be beneficial to some aspects of health. However, no study has investigated the effect of different types of chocolate (and the associated variation in polyphenol dose) on appetite and energy intake, in postmenopausal women. This research aims to investigate the acute effect of chocolate consumption (80% cocoa [dark] versus 35% cocoa [milk] versus 0% cocoa [white]) on appetite and energy intake in postmenopausal women. The results will have implications for weight management.

Double-blind, randomized, placebo-controlled, clinical trial with the primary objective to determine the efficacy of omalizumab given to children aged 6-12 years during an acute asthma exacerbation to prevent asthma exacerbations in the subsequent six months. Subjects include male and female children aged 6-12 years presenting to Princess Margaret Hospital for Children (PMH) Emergency Department with moderate to severe acute asthma. The ‘treatment’ group (n=64) will receive one dose of omalizumab at the enrolment visit (Visit 1). The ‘placebo’ group (n=64) will receive one dose of a placebo at the enrolment visit (Visit 1). However, in accordance with the dosing table (described in the Xolair (Registered Trademark) (Omalizumab) Product Information Sheet), each participant with sufficient body weight (kg) and total IgE levels to require a second dose of Omalizumab, will need to have a second dose of either Omalizumab or placebo two weeks later. The treatment drug, omalizumab, (or placebo) will be administered at least 12 hours after the patient presents to hospital, at the enrolment visit and following treatment, the patient will be monitored for a minimum of two hours by an experienced paediatrician. All children will also receive standard asthma therapy according to the PMH Clinical Practice Guidelines. This study consists of 3-4 visits over six months (including the first enrolment and treatment visit) and 1 follow-up telephone interview at 12 months.

Delusions are characteristic of people with psychosis. Many of these people do not respond well to current drug treatments and require additional psychological treatment. This project is an investigation into the efficacy of psychological treatments for delusions in psychosis, focusing on a new therapy (MCT+) which combines cognitive-behavioural therapy for psychosis and metacognitive training. Cognitive Behavioural Therapy for psychosis develops an awareness of the implausible content of a patient’s delusion, while metacognitive training targets the problematic thinking styles underlying delusional beliefs. It is expected that MCT+ will be one of the most effective psychological treatments for reducing delusional symptoms. The first aim of the proposed project is to determine the unique contribution of an individually-administered MCT+ program, combining the important facets of MCT and Cognitive Behavioural Therapy, over a standard cognitive remediation program (HAPPYneuron) targeting only neuropsychological cognitive deficits. The second aim is to determine the persistence of any improvements due to MCT+ by including a longitudinal follow-up. In sum, this project will provide the theory-driven evidence base that is needed to inform and influence clinicians to roll-out MCT+ to improve treatment for delusional people with psychosis. Primary Hypothesis: Participants who receive metacognitive training (MCT+) will show a reduction in delusional severity whilst improving clinical and cognitive insight (relative to participants in the cognitive remediation control condition). Participants randomised to the cognitive remediation control condition will show improvements to the “cognitive symptoms” of psychosis, including improved language and memory skills (relative to participants in the metacognitive training condition).

The primary objective of this clinical research is to establish the effects of a standardised green-lipped mussel lipid extract (PCSO-524) in women and men with osteoarthritis (OA) of the knee. The study seeks to determine the effective dosage and will be conducted using an open-label design and is categorised as a Phase II clinical trial. Participants meeting the enrolment criteria will be randomised to either 200mg or 400mg daily for a 12 week period. The primary validated measurement will be the Comprehensive Osteoarthritis Test (COAT) which we developed in previous clinical trials on OA. The results will be used to inform a Phase III randomised controlled study.

As dietary patterns established in early childhood track into adulthood, interventions to improve children’s diets are a key focus of national chronic disease prevention strategies. The World Health Organization recommends the implementation of dietary guidelines in childcare settings to improve child health and prevent the development of non-communicable diseases. As such, most developed countries including Australia have sector specific regulations requiring that foods served to children attending childcare is consistent with national dietary guidelines. Research conducted by the research team, however, shows that less than 5% of Australian childcare services adhere to such guidelines. An online menu planning intervention (integrated into mandatory service operating systems) may represent a potentially effective, low-cost, and acceptable means of providing population-level support to childcare services to improve the nutritional quality of food provided in services. This study will assess the effectiveness of a web-based intervention in increasing adherence of childcare service menus to sector specific nutrition guidelines. The study will employ a parallel group cluster randomised controlled trial design with 54 long day care services in New South Wales. Services will be randomised to receive either the web-based intervention integrated into current childcare management reporting software or the control group. The primary trial outcome is the adherence to the nutrition guidelines regarding provision of fruit; vegetable; grains; milk, yoghurt, cheese (and/or alternatives); meat (and/or meat alternatives) and discretionary foods (foods high in energy, fat and/or salt) as assessed via a comprehensive menu review undertaken by a blinded dietitian or nutritionist. In a nested sample of up to 35 services child dietary intake in care will also be assessed

Water birth occurs when a baby is born fully submerged in water. There is a lack of strong (Level 1) evidence to conclusively agree on the safety or risk of water birth. We aim to determine if it is possible to run a large study that examines the safety of water birth compared to land birth in women with low-risk pregnancies. In this study, we will test recruitment parameters, research processes, and outcome measures (for mother and baby) to assess the feasibility of a main study. If this study proves feasible and funding is obtained, then we will consider an international study across multiple sites (subject to ethical approval) with the primary purpose of testing safety for babies who are born under water.

An non-randomised (single group) trial to test the safety and efficacy of the ARIA Emphysema Treatment System (ETS) for patients with Severe Emphysema and Hyperinflation of the Lung. The ETS device will be implanted in the lung and will remain insitu for the duration of the clinical trial.