ANZCTR search results

We believe that the combination of midazolam and droperidol will be superior in efficacy and safety to droperidol alone or olanzapine alone for patients with acute agitation

The overarching aim of this study is to decrease the incidence of depressive symptoms for people with aphasia and their caregivers. The specific aims are to determine whether a tailored, early intervention program (Aphasia ASK) leads to better mood and overall quality of life outcomes than an attention control (a secondary stroke prevention intervention) at 12 months post-stroke in both patients with aphasia and their caregivers.

This study investigates the feasibility and safety of inspiratory muscle training for patients with early spinal cord injury. Patients with spinal cord injury are at high risk of respiratory complications. Inspiratory muscle training is a technique that can be used to improve the respiratory function of patients with spinal cord injury but, to date, research published about its feasibility, safety and effectiveness has only included patients who are some weeks or month post-injury. The purpose of this interventional study is to investigate the feasibility and safety of inspiratory muscle training for patients with acute spinal cord injury. The specific aims are to document, in patients with acute spinal cord injury: the feasibility of inspiratory muscle training by recording the number of physiotherapy sessions where the criteria to participate in inspiratory muscle training are met and the number of physiotherapy sessions where the criteria to participate in inspiratory muscle training are not met (and reasons why); the safety of inspiratory muscle training by recording parameters such as haemodynamic stability, oxygenation, breathlessness and respiratory complications; the effect of inspiratory muscle training on lung function parameters such as inspiratory strength and lung volumes.

Young 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.

The 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.

Implementing 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.

We are evaluating the effectiveness of a tablet computer application (app), which provides SMS and calendar reminders, in encouraging on time immunisation.

Peripheral 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.

Oxidative 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.

This 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.