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Ivabradine in the Prevention of Cardiac Injury in patients undergoing major Orthopaedic surgery.
Expand descriptionDuring or after a major operation (such as bones or joints operations, also known as orthopaedic operations), our body increases its heart rate as a response to the stress of the surgery. As the heart pumps faster to manage the stress, it can sometimes damage itself in the process. As previous study observed that up to 52% of patients undergoing major orthopaedic operations demonstrated some evidence of injury to the heart, and these patients have poorer clinical outcomes. This has led to previous studies examining the benefits of heart rate lowering agents to prevent damage to the heart after surgery, to improve clinical outcomes. Unfortunately, many heart rate lowering agents have a common side effect of lowering the blood pressure as well. Hence, whilst these trials demonstrated promising benefit in reducing damage to the heart, they caused significant problems with low blood pressure. Ivabradine is an agent that reduces heart rate, but does not drop blood pressure. It is currently approved for use in Australia for another condition called chronic heart failure. But given its unique properties, we postulate that it can reduce damage to the heart after a major operation as well, without the negative effect of causing low blood pressure. As a result, this trial was conceived to examine this effect.
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Postprandial effect of high fat foods with different structures on plasma triglyceride levels in healthy adults
Expand descriptionFasting plasma triglycerides are currently one of the most used measures to determine the risk of cardiovascular disease. However, we spend 18 hours or more of our day in the post absorptive state and elevated postprandial plasma triglyceride levels have also been linked with increased risk for atherosclerosis and consequently cardiovascular disease. Dietary choices have been demonstrated to modulate postprandial lipemia. Furthermore, manipulation of food structure and composition has the potential to increase or reduce postprandial triglycerides. Therefore, food choices are important targets in the improvement of postprandial lipemia. In this project we aim to determine the effect of three food products with different structures and similar nutrient composition on postprandial blood triglyceride levels. This is a pilot project for the development of a tool to measure the effect of different food products on postprandial lipemia. Healthy adults will be recruited from the community in Newcastle (NSW, Australia) and in Palmerston North (Manawatu, New Zealand). Following an overnight fast participants will attend our clinical facilities and have blood samples collected using finger prick; subjects will then consume a single high fat test meal. Blood samples will be collected again 30, 60, 120, 180, 240 and 360 minutes after meal consumption. After one week wash out, participants will attend our clinical facilities again and repeat the procedure following consumption of the alternative test meal. Blood samples will be assessed for glucose levels and lipid profile (triglyceride, total cholesterol, high density lipoprotein cholesterol and low density lipoprotein cholesterol) using a portable whole blood test system. Participants will also provide information on their medical history, physical activity, usual food consumption and eating attitudes at the start of the intervention.
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Building Resilience in Adolescence: Investigating the Efficacy of a School-Based Skills Training Program on Social and Emotional Learning.
Expand descriptionUsing a non-randomised design, this project will investigate the effectiveness of a universal, primary prevention program (WISE Teens) based on principles of the existing DBT STEPS-A Framework to promote greater social and emotional well-being amongst young people. Between four to six high schools from NSW will participate in the trial with each school providing a year group to complete the intervention, with another year group serving as the control condition (class as per usual). The primary aims of the current study are as follows: a) To examine the effectiveness of applying DBT principles within a universal, primary prevention approach to promote academic, social and emotional resilience in addition to greater quality of life and psychological well-being in Australian high school students. The study will also investigate the following secondary aims: a) Does level of program compliance (via completion of homework tasks and practice) affect social and emotional outcomes? b) Are the effects of the program mediated via increased levels of emotional awareness, more positive beliefs about emotions and reduced emotion dysregulation? c) Are the results of the program moderated by initial levels of clinical severity as determined at baseline? The following outcomes are hypothesised: a) The WISE Teens program will be effective in promoting more positive social and emotiona outcomes in addition to greater academic resilience compared with participation in PDHPE class as per usual. b) This effect is expected to be mediated by increased emotional awareness, more positive beliefs about the role of emotion and reduced emotion dysregulation. c) This effect is additionally expected to be moderated by clinical severity status, with those showing greater clinical severity of symptoms showing more marked improvements on social and emotional outcomes relative to those showing reduced clinical severity of symptoms.
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Warm humidification for prevention of hypothermia during liver transplantation
Expand descriptionThe Victorian Liver Transplantation Unit at Austin Hospital is a collaborative service providing liver transplant services to residents in Victoria, Australia. Retrospective intra-operative data collection from our institution shows that 72% of patients undergoing liver transplantation are hypothermic prior to reperfusion of the donor liver, despite intense and standardised measures taken to maintain temperature homeostasis. This study is a prospective, single centre, blinded, randomised pilot trial to test the feasibility and efficacy of whether, in addition to the standard temperature measure undertaken to prevent intra-opeartive hypothermia, the additional use of the Fisher & Paykel Humigard (Registered Trademark) Open Surgery Humidification System will prevent hypothermia in adult patients undergoing orthotopic liver transplantation. Adult patients undergoing orthotopic liver transplantation will be included. The primary end point will be core temperature measured five minutes immediately prior to reperfusion of the donor liver.
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A comparison of transversus abdominis plane (TAP) block vs port site infiltration: pain levels and analgesia requirements in women undergoing gynaecological laparoscopy.
Expand descriptionLaparoscopic (‘keyhole’) surgery is used to perform many different types of gynaecological surgery. These include diagnosis of reasons why pregnancy has not been possible, diagnosis of abdominal pain, and treatment of endometriosis (which is painful, abnormal tissue in the abdomen (belly). It also includes procedures using a robot to aid surgery, and removal of organs or abnormal growths. There are several causes of pain after this sort of surgery. One cause of pain is local damage to the wall of the abdomen due to the tubes that run into the abdomen that make keyhole surgery possible. For a long time surgeons have used local anaesthetic in small amounts that is injected into the holes or ‘port sites’ where these tubes are inserted. More recently a different way of giving local anaesthetic has become popular. This is called the ‘TAP block’ which stands for “transversus abdominis plane” block. The name simply means that it is injected alongside the transversus muscle in the wall of the abdomen. Anaesthetists tend to use an ultrasound probe to take a picture and place this at the right depth, but for surgeons to place it laparoscopically while they operate is also a recognised technique. This study will investigate whether the infiltration method or TAP method of giving local anaesthetic is more effective by measuring pain on a scale of 1 to 10 just after surgery and 24 hours after surgery. The surgeon will be instructed to perform either the TAP block or infiltration based on the patient’s randomisation. The anaesthetist, recovery staff, and patient will be blinded, so unaware of what the patient has received. The surgeon, who is not blinded, will not be involved in any measurement of pain scores. Patients undergoing any type of gynaecological keyhole surgery will be accepted. TAP blocks have been looked at in many trials now. There are some aspects to this trial which would be novel in combination and would add to our knowledge base. The surgeon would be giving the block. This approach has been used relatively rarely. By doing away with the need to keep the patient asleep while the anaesthetic performs the block and gets set up with an ultrasound machine, the block can be performed with minimal delay to the list. This is a ‘real-world’ trial which compares two commonly-used techniques, rather than comparing TAP blocks to injection of saline, which means that a convincing result would guide the choice to use one or the other. This trial is not restricted to some subgroup of gynaecology patient; it would look at a cross-section of any day-case or inpatient laparoscopic gynaecology population.
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Effect of a model of GP and pharmacist collaboration in primary care in reducing unplanned hospital readmissions: REMAIN HOME study
Expand descriptionThe transition of patients with chronic and complex conditions from hospital back into the community setting is a critical time with an increased risk of medication misadventure and re-hospitalisation. AIM: The aim of this study is to investigate whether a model of structured GP and pharmacist care reduces unplanned hospital readmissions in patients taking multiple medicines. METHOD: This study will include 2240 people who have been discharged from hospital taking 5 or more medicines and attend an enrolled medical centre. Participants will be recruited at discharge from hospital and the intervention will be in 14 different medical centres across South East Queensland. Depending on when the participant is discharged, they will be placed in the control or intervention phase. Participants in the control phase will receive usual care from their medical centre. This means the patient would consult their GP as per normal standards for that practice for a patient discharged from hospital. Participants in the intervention phase will be followed up after discharge by a pharmacist working in the medical centre they attend. The practice pharmacist will organise a time for the participant to come into the medical centre and to discuss the changes made during their hospital stay and review the participant’s medicines. After a consultation with the pharmacist, the participant will have a consultation with their GP to receive any new scripts they may need and to consider any changes recommended by the hospital or pharmacist. The practice pharmacist will follow up with the participant within five days of the first consultation. The practice pharmacists may also contact other health professionals involved in the participant's care as required. It is hoped that a pharmacist and GP reviewing a patient’s medicines and changes made during hospital will reduce the likelihood of the patient being readmitted to hospital.
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MindExpressTM: trial of a depression prevention program for young people vulnerable to depressive disorders
Expand descriptionMindExpressTM - the skills to build resilience - is an online risk-factor based tailored depression prevention and mentoring App targeting young people aged 16 to 25 years at elevated risk for mood disorders. The App delivery of MindExpressTM with tailoring to personal circumstances is an innovative approach to depression prevention, resilience-building and reduction of chronicity of mood disorders in youth. MindExpressTM was developed at the University of New South Wales in 2011-2013, funded by a beyondblue National Priority Driven Research Program grant. Custom web functions and design relevant to youth culture were developed through focus group consultations with the target demographic. A feasibility pilot study was completed in 2013 involving 30 participants aged 18 to 25 years. The feasibility study found MindExpressTM to be acceptable, useful and helpful to young people and indicated that it may be possible to reduce depression symptomatology by modifying risk factors through best practice cognitive and behavioural change. The results indicated a positive effect on coping skills with a substantial effect size and improvement in depression scores. The tailored design enables individuals to identify personal risk and protective factors and provides support and feedback to implement cognitive and behavioural changes in real life. MindExpressTM is intended as an adjunct to usual care and enables users to be linked dynamically to their support networks such as their support worker, mentor, carer or GP. If proven scientifically valid by the RCT, MindExpressTM can be translated as a primary prevention App for adolescents and young adults at risk for mood disorders.
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Evaluating the efficacy of a brief psychoeducation and skills-based group intervention for the carers of individuals with eating disorders: A randomised controlled trial
Expand descriptionResearch has highlighted the high level of burden and distress experienced by individuals caring for a family member with an eating disorder (Treasure, 2008). The present study aims to evaluate a brief, two-session group psychoeducation and skills-based intervention for the carers of individuals with an eating disorder. This intervention aims to reduce carers’ distress levels whilst reducing their perceived burden of care, accommodating and enabling behaviours and level of expressed emotion and improving their knowledge of eating disorders and coping self-efficacy. The associated costs of caring for an individual with an eating disorder highlight the need for interventions to be both time efficient and cost effective (Highet, Thomson, & King, 2005). The brief and manualised nature of the proposed intervention makes it highly feasible and easy to disseminate, maximising access to necessary information and training. Criteria for inclusion in the study will be: a) aged over 18 years; b) able to read and speak English fluently; c) currently caring for an individual with a diagnosed eating disorder (for the purpose of this project, carer is defined as a parent, sibling, friend, or partner). Participants will be recruited directly through the Centre for Clinical Interventions and via interest groups (e.g., Butterfly Foundation) and media advertising (e.g., Curtin fm, social media). This evaluation will be run as a randomised controlled trial (RCT) comparing the intervention to waitlist controls. Participants allocated to the waitlist control group will still receive the intervention within 2 months of agreeing to participate in the project. Running this evaluation as an RCT, as opposed to a single group pre-post evaluation, will allow us to determine the efficacy of the intervention without the potential confounds associated with the passage of time. Each participant will attend two, 150-minute group sessions spaced one week apart. The outcome variables of the study will be: depression/anxiety symptoms, self-efficacy, perceived burden of care, accommodating and enabling behaviours, level of expressed emotion, knowledge of eating disorders, interpersonal caregiver skills. The study will also measure changes in the carers’ interpersonal skills as perceived by the individual with the eating disorder.
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Does song writing enhance wellbeing of people with acquired brain injury or spinal cord injury?: A pilot and feasibility study
Expand descriptionThe aim of this pilot study is to determine the effects of a therapeutic songwriting protocol on a range of wellbeing measures for people who are undergoing inpatient rehabilitation and those who are 0-24 months post discharge from acquired brain injury (ABI) or spinal cord injury (SCI) rehabilitation. A pre-post design will determine whether therapeutic songwriting can assist people who have sustained longterm injuries resulting from traumatic injury (such as workplace or road accidents) to work through issues of identity. This guided therapeutic process may include exploring a new identity that integrates the old preinjured self with a new identity that integrates the residual physical/cognitive/and psychosocial effects of the injury. The main purpose of this pilot project is to test the feasibility of the study protocol, establish the appropriateness of the measures for answering the research questions, and collect data that will capture the factors of efficacy.
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Simulated Driver Rehabilitation Following Brain Injury
Expand descriptionThis study seeks to investigate the effectiveness of simulated driver rehabilitation methods in reducing time taken and success in return to driving following an Acquired Brain Injury (ABI). No commonly agreed best-practice guidelines are currently available to guide the assessment and rehabilitation of driving ability post-ABI in Australia and worldwide. Many current driving assessment and retraining procedures used post-ABI are generic and the reliability, validity and clinical effectiveness of these procedures have yet to be established. In order to develop reliable and valid driving assessment and re-training procedures, a clear evidence-base identifying which specific driving interventions are effective post-ABI is needed. To date, studies investigating rehabilitation methods for driving post-ABI suggest that a functional, top-down approach (involving the full activity of driving a car) generalizes better than less comprehensive to improved driving performance on on-road tests. Due to modern advances in technology, production of and access to sophisticated driving simulators has increased. Given limited and inconsistent evidence surrounding the utility and effectiveness of driving simulators for rehabilitation after ABI, further exploration is warranted. In this study, participants will be recruited from the Epworth HealthCare Occupational Therapy Driving Assessment and Rehabilitation service. Their decision to participate, or not to participate, will not impact on their treatment. All participants will be involved in standard outpatient rehabilitation (as part of their regular clinical care) however participants allocated to the simulator-training group will dedicate 6 extra hours of their time (8 x 45 minute sessions) to complete the simulator program, in contrast to the standard rehabilitation group, who will not complete the program. While we do not anticipate or advocate for simulators to completely replace on-road driving rehabilitation, we propose that simulator-based training may improve pass rates for on-road assessment and reduce the total number of costly on-road rehabilitation sessions required by people returning to driving. Furthermore, simulators may act as a starting block for drivers who either lack confidence or are judged too risky to engage in on-road driving rehabilitation, and facilitate increased engagement in driving rehabilitation as a result.