You can narrow down the results using the filters
-
Tools for resilience: A mobile phone and web-based intervention for improving mental wellbeing and reducing distress in adolescents and young adults with Type 1 diabetes
Expand descriptionYoung people with Type 1 diabetes are at greater risk of mental health problems and poor psychological wellbeing than their counterparts without diabetes. Young people are high users of mobile and internet-technology, and increasingly use these tools for health information and support. The project’s primary objective is to test the hypotheses that psychological well-being will be significantly improved, and that symptoms of psychological (i.e., depression, anxiety and stress) and diabetes-related distress will be significantly reduced, in participants who use a mobile phone and web-based mental health intervention, myCompass, for seven weeks compared with those in a placebo control group. The project’s secondary objective is to test the hypothesis that diabetes self-care, work and social functioning, glycaemic control (glycosylated haemoglobin, HbA1c), and quality of life will be significantly improved for participants who receive the myCompass intervention.
-
A play-based intervention to improve the social play skills of children with Attention Deficit Hyperactivity Disorder (ADHD)
Expand descriptionThe purpose of the 10-week play-based intervention is to improve the social and communication skills of children with ADHD. We aim to do this by using: the context of play, parents, children's typically-developing playmates and therapist supported clinic sessions. We suspect, that both children with ADHD and their playmates will demonstrate significant improvements in their social and communication skills following the intervention and that these skills will also be observed in the home environment. We suspect parents may also find the intervention a supportive approach that assists them to develop their child's social and communication skills which are needed for friendships.
-
A pragmatic randomised trial of an intervention to increase childcare service implementation of healthy eating and physical activity promoting policies and practices
Expand descriptionImplementing initiatives to promote healthy eating and physical activity in childcare services has been identified as a priority to prevent excessive child weight gain. Despite this, few trials have been conducted to assess the effectiveness of interventions to support population-wide implementation of such initiatives. The aim of this study is to assess the effectiveness and acceptability of a performance review and feedback intervention, targeting childcare service staff, in increasing the implementation of healthy eating and physical activity promoting policies and practices.
-
vaxSMS: A randomised controlled trial of text messaging and calendar reminders for improving immunisation timeliness in areas of low immunisation coverage
Expand descriptionWe are evaluating the effectiveness of a tablet computer application (app), which provides SMS and calendar reminders, in encouraging on time immunisation.
-
Pathogenesis of long bone fractures in Vitamin D deficient children
Expand descriptionPeripheral quantitative computed tomography (pQCT) is a novel tool that has the ability to assess trabecular bone independently of cortical bone, and to evaluate various measures of macroscopic bone geometry, which can be combined into indices of bone strength. A randomised, placebo control trial of vitamin D treatment versus placebo will be performed. Muscle strength and cross sectional muscle area will also be assessed at each follow up time point for all eligible patients.
-
THE HEP573 STUDY: A randomised, double-blind, placebo-controlled clinical trial of silymarin alone, and silymarin combined with antioxidants in chronic hepatitis C
Expand descriptionOxidative stress (OS) is a key mechanism by which liver injury occurs in chronic hepatitis C (CHC) virus infection. For this Study, it was hypothesised the use of antioxidant compounds would reduce OS, hepatic necroinflammation and hepatic fibrosis in CHC patients. To test this hypothesis, a randomised, double-blind, placebo-controlled clinical trial (termed the Hep573 Study) was conducted in three Australian teaching hospitals in New South Wales. One hundred and eighteen participants were recruited through the liver outpatient clinics at the hospitals from July, 2003 to March, 2006. They were randomised to treatment in blocks of six to one of three groups: placebo; silymarin (720 mg silybin/day); and silymarin with antioxidants (720 mg silybin plus 12 other ingredients). Study duration was 48 weeks: 24 weeks on active treatment or placebo, and 24 weeks follow-up post treatment. The primary outcome measure was the proportion of patients with alanine aminotransferase (ALT) normalisation at Week 24 (Fisher's exact test). Secondary outcome measures were the percentage change from baseline to Week 24 in F2-isoprostanes, and to Week 24 and Week 48 in ALT, HCV viral load (HCV RNA), FibroTest and Hepascore (Linear Mixed Effects). Results were analysed on an intention-to-treat basis. In patients with compensated CHC, the use of silymarin and antioxidant compounds achieved a higher rate of ALT normalisation than placebo (P=0.02) or silymarin (P=0.003) at Week 24. This result could not be attributed to alcohol, diet or caffeine, as intake across the groups did not change throughout the Study. In addition, there was a significant improvement in the overall mental-health score (Mental Component Summary), QualityMetric Hepatitis Quality of Life Questionnaire Trademark (HQLQ) in the silymarin and antioxidant (SOX) group (P=0.002). This novel randomised, double-blind, placebo-controlled trial of oral silymarin and oral antioxidants has shown a reduction in hepatic necroinflammation and an improvement in overall mental-health status in a specific CHC population.
-
A Feasibility Pilot Randomised Control Trial to Compare Failure Rates between Peripherally Inserted Central Catheter (PICC) and Anti-infective Peripherally Inserted Central Catheter (PICC) lines in patients that receive Total Parenteral Nutrition (TPN)
Expand descriptionThis project will address a significant problem in healthcare which is to provide safe, effective and reliable vascular access when commencing a patient on Total Parenteral Nutrition (TPN). TPN is used in patients where the gastro-intestinal tract cannot be used for the ingestion, digestion and absorption of essential nutrition. Two types of central venous access devices (CVADs) are central venous catheters (CVCs) which are inserted centrally into the veins on the neck and peripherally inserted central catheters (PICCs) which are inserted via veins in the arms. PICCs can be associated with central line associated blood stream infection (CLABSI), thrombotic complications (thrombosis) and mechanical complications (catheter occlusion, phlebitis). These complications impact on the cost of care, and have the potential to be a life-threatening adverse event. To help combat this problem PICC lines have been developed that are coated with antiseptics or antibiotics, referred to as anti-infective lines. There are few comparison studies that have analysed the safety and costs of the lines by comparing anti-infective PICCs and standard PICCs in patients that receive TPN. Despite this gap in research, there is an increased use of the PICC line based on perceived time benefit, lower cost and fewer mechanical complications, where there is a lack of scientific evidence to support this choice. The main aim of this study is to determine if there is a difference in the failure rates and costs between the patients who receive TPN via an anti-infective PICC line and a standard PICC line. This feasibility pilot study will be a carried out a single centre. Participants will be patients requiring the insertion of a CVAD for delivery of TPN during the study period that meet the inclusion criteria and sign consent. They will be randomised into one of two groups, we aim to recruit 30 patients per group: * group 1 (Anti-infective PICC) * group 2 (Standard PICC) It is envisaged that findings from this study will provide a foundation for a larger study to explore the failure rates of PICC and anti-infective PICC lines used for delivery of parenteral nutrition, and to develop recommendations for the choice of PICC in patients receiving TPN.
-
The effects of four front-of-pack labelling schemes compared to standard Nutrition Information Panel, on the healthiness of food Purchases among adult Australian consumers.
Expand descriptionA large scale randomised controlled trial conducted using a smartphone application to evaluate the comparative effects of four different forms of front-of-pack nutrition labelling against the current back-of-pack nutrition information panel on the healthiness of foods purchased. The four front-of-pack nutrition labelling formats tested will be: 1. Colour-coded multiple traffic-light labels; 2. Monochrome daily intake guide labels; 3. The "energy stars" based front-of-pack nutrition labels; and 4. Advisory labels. The findings will feed directly into the ongoing policy debate about the format of front-of-pack nutrition labelling to be introduced in Australia.
-
Detailed assessment of risks and benefits of inferior vena cava filters on patients with complicated injuries
Expand descriptionVenous thromboembolism (VTE) is a significant health problem especially in hospitalized patients, with a high associated morbidity and mortality. For most patients, the standard of care is to use prophylactic anticoagulation (heparin) and intermittent pneumatic compression to both lower limbs. There is a group of patients who are at very high risk of VTE but these VTE prophylactic measures cannot be used or considered adequate, either for physical reasons (lower limb fractures / open wounds ) or risk of bleeding from anticoagulants (such as severe brain injury). In these patients, the options are to use no intervention or to insert an Inferior Vena Cava filter (IVCF). Although IVCFs are widely used as a mechanical VTE prophylaxis in patients who have contraindications to conventional VTE prophylactic measures, their effectiveness in this regard has not been established. This phase II / III randomized controlled trial aims to assess the clinical effectiveness, benefits and harms, and also the cost- effectiveness of the early use of IVCFs (<72 hrs of admission after severe injury) for trauma patients who have contraindications to conventional VTE prophylactic measures (pharmacological thromboprophylaxis). This trial has the capacity to influence the management of trauma patients worldwide, and to establish the place of IVCFs in modern medical practice.
-
An open-label, phase 2, single centre, randomised, crossover pharmacokinetic study assessing two application areas of 0.5ml (5mg) of a testosterone 1% cream, ANDROFEME(Registered trademark) in healthy postmenopausal women
Expand descriptionANDROFEME (Registered trademark) cream is currently the only available testosterone product in Australia with widespread use in clinical practice. The available pharmacokinetics indicate the most appropriate dose for women is 0.5ml (5mg)/day. However the absorption of transdermal preparations is known to vary according to the area of application. This was not controlled for in prior studies. Furthermore, the investigators believe the upper arm is not an appropriate site for the drug application as 1) there is a greater risk of transfer of the applied drug to others; 2) contamination when blood is drawn for measuring testosterone levels is common (resulting in falsely elevated levels) and 3) the possibility of increased blood levels of testosterone in the ipsilateral breast. In this study we will evaluate the pharmacokinetics of two application sites of 0.5ml (5mg) of this testosterone 1% cream in postmenopausal women: an area on the upper outer thigh/ lower buttock approximately the size of the palm (approximately 80cm2) and a broad area on the outer thigh/ lower buttock (approximately 300cm2).