ANZCTR search results

To determine if a silver impregnated wound dressing has any clinical benefit over using a similar silver free control dressing, when managing individuals with diabetes-related foot ulcers. Wound healing rates, signs of infection, and need and duration of antibiotic therapy will be compared between the cohort of individuals receiving a silver based dressing and those receiving a similar silver free dressing. Outcomes will also be assessed regarding any clinical benefit in using a silver impregnated wound dressing as compared to a similar silver free control dressing on wounds that are both (1) clinically infected (purulent discharge or 2 or more of redness, pain/tenderness, swelling, warmth) at the outset as well as (2) those that have no signs of infection.

The primary aim of this study is to determine the effectiveness of bubble­-PEP device compared to the active cycle of breathing technique (ACBT) or no intervention in clearing secretions in people with non­-CF bronchiectasis. The hypothesis is that the bubble­PEP is not inferior to the ACBT and is superior to no intervention in clearing secretions. Secondary aims will be to evaluate the acceptability and perceived benefits of the bubble­PEP device by participants.

This project is a pilot study that aims to evaluate the accuracy of digital X­ray radiogrammetry (DXR) in determining bone mineral density (BMD), as compared to BMD by dual energy X­ray absorptiometry (DXA). Participants will be women aged fifty years or older who are postmenopausal and are attending for a follow up mammogram. DXR is a method that can be used to estimate BMD from plain digital hand X­ray images. It assesses BMD from images of the mid 2nd, 3rd and 4th metacarpals. The data is then transmitted in deidentified fashion to Sectra, a Swedish company that has developed the ‘OneScreen’ technology, that combines both mammography and digital X­ ray radiogrammetry. A BMD in g/cm2, a T­score and a Z­score are then transmitted back within minutes. A number of studies have demonstrated that T and Z­scores derived from such DXR examinations correlate closely to values derived by DXA, which is considered the gold standard for screening or follow up bone densitometry. BMD by DXR has been shown to predict fracture risk, similarly to DXA. Women over the age of 50 who are postmenopausal may already have low BMD and are at risk of further BMD reductions. Women who attend for follow up mammography are, in addition, a group who may require breast surgery and possibly aromatase inhibitors that eliminate sex steroid production and increase fracture risk. The addition of a digital hand X­ray for DXR analysis to the mammography examination requires no additional equipment and takes only a few seconds. If DXR is shown to correlate closely to DXA in our local population, it has potential to be used in osteoporosis screening for women who may require aromatase inhibitors. If cost effective, it might even be considered as a screening tool when women attend for routine mammography, because women screened for breast cancer are the same group who may benefit from awareness of low BMD. After ethical approval of this study and after participants have provided informed consent, data will be collected from women over the age of 50 who are post­menopausal and who present for a second mammogram after having a positive screening mammogram in the community. The women will complete a short questionnaire following which DXR of the hand will be performed immediately after mammography and the DXR images will be transmitted for analysis. This de­identified data is generally returned within 5 minutes with BMD Z and T­scores. Participants will also undergo a DXA examination of the forearm, hip and spine to allow a comparison of the DXR measurements. Participants with results by DXA that indicate a BMD in the osteopaenic range will be provided with a letter which can be taken to their general practitioner for further discussion. Any participant with a BMD in the osteoporotic range will be given a letter for their general practitioner who will also be informed of the result by telephone. For participants with T­scores less than ­3 (indicating osteoporotic­range BMD at or greater than 3 standard deviations below the mean), referral to a specialist will also be suggested. While physicians associated with this study will be available to discuss any result with a participant, they will not be involved in ongoing management for ethical reasons. To date, DXR using the Sectra system has not been used in Australia, but has undergone evaluation at single sites in the UK, Sweden and the USA. If the technique proves accurate for BMD evaluation in this pilot study, wider application for BMD evaluation in women undergoing mammography might be considered. Compared to DXA, it would be more simple and convenient, is lower radiation and may be cost effective enough to consider as a screening tool in either specific circumstances (such as follow up mammography) or for general postmenopausal evaluation.

This project aims to evaluate the 'real-world' implementation of a digital health program that is aimed to improve type 2 diabetes self-management. The trial will determine: i) the program’s reach, adoption, implementation and maintenance amongst persons with diabetes (PWDs) type 2; ii) clinical, psychosocial, and behavioural outcomes for PWDs provided with the program; and iii) the costs and value for money of the program.

The PADDI Trial is a large (8,880 patients) international, multicentre, prospective, randomised, double blind, placebo-controlled, parallel assessment, stratified, non-inferiority safety and effectiveness study. It’s purpose is to establish the safety of the administration of 8mg of dexamethasone to adult patients undergoing non-urgent surgical procedures under general anaesthesia of at least two hours duration and requiring at least one night’s stay in hospital postoperatively. Patients will be stratified according to whether or not they are known to have diabetes. The primary outcome is the incidence of surgical site infection at 30 days postoperatively. Secondary outcomes include infection at other sites, and the incidence of chronic post-surgical pain at one year postoperatively. The influence of diabetic status and the quality of control of diabetes on all outcomes will be specifically explored.

Of the one in four young people who are diagnosed with mental disorders, only 35% seek professional help. There are many barriers preventing young people from seeking help such as: lack of recognition of mental health problems, lack of awareness about appropriate mental health services, readiness to seek help, and the stigma associated with mental illness and seeking professional health. Technological solutions have been identified as one of the key areas that should be utilised to improve treatments and access to care. Young people often seek information about health online and often prefer anonymous sources of help to traditional services. Nevertheless, despite the broad interest and vast amount of online services available to assist young people with mental health problems, evaluation is rarely conducted to determine the impact of online services on help-seeking. Focusing particularly on young adults aged 18 to 25 years, we aim to investigate the effects of a dedicated online tool to facilitate help-seeking in young adults compared to usual search strategies. All surveys and recruitment will be conducted online. Young adults will be asked to complete four surveys at baseline, post-intervention, one month and three months. This project is of international relevance as one of the first dedicated online tool to facilitate help-seeking for young adults and one of the few to evaluate access to care as an outcome. It will also help inform policy and practice with evidence on whether technical solutions can increase help- seeking for young adults using a stepped-care approach.

The aim of this research is to determine the relationship between higher levels of mindfulness on trait self-control and on the intention-behaviour relationship in the Theory of Planned Behaviour. Further, the study will investigate the mechanisms by which mindfulness affects behavioural change outcomes, as indicated by daily fruit and vegetable consumption over a four week period. The hypothesis is that higher levels of mindfulness will be associated with higher levels of trait self control. Further, higher levels of mindfulness will strengthen the intention-behaviour relationship as demonstrated by increased fruit and vegetable consumption in the behaviour/mindfulness change group, compared to the standard behaviour change group: H1: There will be a difference between the standard behaviour intervention (BI) group and the behaviour intervention + mindfulness (BIM) group in terms of behaviour outcome (fruit & vegetable intake). H2: The relationship in H1 will be mediated by trait self-control and levels of mindfulness. H3: Compared to the BI group, the BIM group will report higher levels of mindfulness, which will result in higher levels of self-control.

We are investigating the use of a parent-based Cognitive Behavioural Therapy (CBT) program for treating anxiety difficulties in children aged four to six with Asperger’s Syndrome/High Functioning Autism. Parent-based CBT programs offer an alternative to traditional child-based CBT programs which may be too intellectually demanding for children under the age of seven. Moreover, parent-based CBT programs have be found to effective in treating anxiety in young neuro-typical children and older children with Autism Spectrum Disorders. The design is between groups, repeated measures RCT in which parents will be assigned to one of two conditions: treatment or waitlist control. It is hypothesized that from pre- to post- treatment children of parents in the CBT group, compared to children of parents in the waitlist control group, will demonstrate a significantly greater improvement in emotional awareness and a significantly greater reduction in anxiety. Additionally, it is hypothesized that from pre- to post- treatment, parents in the CBT group, compared to parents in the waitlist group, will demonstrate a greater reduction in parenting stress and parenting distress as well as a greater improvement in parental self-efficacy and parental satisfaction. Finally, it is hypothesized that pre- to post- treatment improvement for children and parents in the CBT group will be maintained or improved upon at 3-month follow up.

Aims and hypotheses: To examine the efficacy of novel versus traditional exercise therapies on metabolic and cardiovascular outcomes in adults with type 2 diabetes. We hypothesize that all exercise interventions will improve abdominal, liver and pancreas fat levels, insulin sensitivity, fitness and cardiovascular health compared with control.

This observational study aims to explore the use of diffusion-weighted magnetic resonance imaging (DW-MRI) and dynamic contrast enhanced MRI (dCE-MRI) in predicting treatment outcome in patients with anal cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with anal canal squamous cell carcinoma (SCC) managed with definitive chemoradiotherapy with concurrent Mitomycin-C and 5-FU. Study details All participants will continue their standard chemotherapy and radiotherapy as planned. Patients participating in this study will have multiparametric MRI's performed at the following four time points: 1) prior to chemoradiotherapy, 2) during the second week of treatment, 3) during the fourth week of treatment, 4) at 6-8 weeks post treatment. Each scan involves the use of an injected contrast agent and is of approximately 45 minutes length. Participants will be followed-up for 6 months to determine treatment outcomes. Correlations between the different types of MRIs and tumour response will determine whether DW-MRI and dCE-MRI can predict tumour response and treatment outcome.