ANZCTR search results

Central hypertension leading to early vascular remodelling is an independent predictor of major cardiovascular events. Aorta is not only a conduit artery but also act as a vascular buffer to each ventricle contraction. Overtime, this stretch leads to decrease aortic compliance resulting in aortic stiffness. Ageing and HTN are the predominant attributable risk factors leading to premature aortic stiffness. Central HTN can be computed by pulse wave morphology or velocity assessment. Central pressure indices including systolic, diastolic, pulse and augmented pressure along with augmentation index can be derived by central pulse wave morphology. Although evaluation of central haemodynamics can potentially flag the early phase of vascular remodelling but the precise component of central pressure indices predicting risk as per age is under considerable debate. Aortic stiffness is recognised as a surrogate for central arterial hypertension and its non-invasive estimation by pulse wave velocity (PWV) is considered “gold standard” by European Society of Cardiology (ESC) 2013 guidelines. Non-invasive central pulse wave morphology and velocity assessment is not being validated during atrial fibrillation (AF) . In addition, there is paucity of data revealing central pressure indices, including PWV appraisal as an independent predictor of outcome in AF. 1 Purpose of the study Raised central pressure is more closely associated with cardiovascular outcome as compare to peripheral HTN. There is evolving evidence that central HTN is underdiagnosed leading to inadequate treatment resulting in early vascular ageing. We propose a staged prospective investigation by designing two perspective studies to validate and incorporate central pressure indices (central systolic, diastolic and pulse pressure with augmentation index and PWV) respectively in AF risk stratification with a view to titrate treatment as per central pressure to study clinical outcome in AF. 2 Aims In this validation study we will compare invasive versus non-invasive central pressure indices appraisal including pulse wave morphology and velocity assessment in AF. Through this study we seek: I. To validate widely used non-invasive methods to assess local, regional and systemic central pressure indices while the subjects are in atrial fibrillation (AF). We will compare the non-invasive appraisal of central pressure with an invasive enumeration in our paroxysmal/persistent atrial fibrillation (PAF) cohort in atrial fibrillation and post restoration of sinus rhythm during elective pulmonary vein isolation (PVI). II. We will review the shift in central pressure profile with rhythm control in our PAF cohort to identify the early changes in central pulsatile load as well as conduit artery compliance with restoration of sinus rhythm. and will draw a comparison between invasive and non-invasive evaluation

Functional dyspepsia (FD) affects a considerable proportion of Australians and results in significant personal and economic cost. There is as yet no cure for this condition and current treatments are only satisfactory in a subset of patients. New insights into the pathophysiology of FD have found that activation of both mucosal and systemic immune responses are important and have been shown to be linked to symptoms in patients with FD. Specifically, increased mucosal permeability has been linked with mucosal inflammation and our pilot work has shown increased mucosal permeability occurs in FD. In this study we aim to define the effects of pharmacologically induced changes of intestinal permeability on immune activation, upper gut function (sensory & motor function) and symptoms in healthy controls and patients with FD. FD patients and controls will be randomised to receive a nonsteroidal antiinflammtory drug (aspirin) which is known to increase FD symptoms and mucosal permeability or a probiotic (Vivomixx), which is known to reduce the severity of dyspeptic symptoms, and intestinal permeability. In addition recent evidence suggests that that the intestinal microbiome plays a critical role in mucosal inflammation but to date this has not been properly investigated in FD. We aim to define the role of the intestinal microbiome in response to treatment with aspirin and the probiotic Vivomixx using a novel device we have developed and patented that allows targeted aseptic biopsies to be obtained from defined areas of the gastrointestinal mucosa utilising routine endoscopic tests. We will also compare the microbiome in intestinal biopsies from patients with FD and healthy controls to study the link between the diversity of the microbiome and mucosal inflammation. To do this study we will recruit 90 patients with functional dyspepsia and 90 age and sex matched controls without GI symptoms undergoing endoscopy for assessment of iron deficiency with a normal upper endoscopy. They will be randomised to receive either aspirin, Vivomaxx or placebo. They will undergo pre and post treatment testing including fill in questionnaires, donate a blood sample, donate a tissue sample (at baseline only), breath test and a standard nutrient drink challenge. This study will significantly advance the pathophysiology of FD and has the potential to pave the way for future cure of the disease.

Primary aim: To examine whether participation in the online parenting program significantly reduces father- and mother- reported dysfunctional parenting, parenting conflict and child behavioural problems from pre- to post-treatment, and whether these reductions are maintained at 3-month follow-up. Secondary aims: 1. To examine whether participation of fathers enhances the outcomes of the intervention for families in terms of reductions in child behaviour problems. 2. To examine the variables that predict father engagement in the online parenting program. 3. To examine moderators and mediators of program effectiveness (the factors that determine when and how the program works). Hypotheses: It is anticipated that participation in the program will lead to improvements in child emotional and behavioural adjustment, reductions in parental disagreements about parenting, reductions in dysfunctional parenting and improvements in positive parenting.

Hospital emergency departments (EDs) treat a high proportion of older people, many as a direct consequence of falling. Many of these people have fallen in the past year and are a high risk of future falls. At Sir Charles Gairdner Hospital (SCGH) ED, at least 1500 patients are diagnosed with a ‘Fall’ per annum. This accounts for nearly 3% of ED diagnoses at SCGH, although many more patients present ‘at risk’ of falls. The SCGH ED Care Coordination Team (CCT) which includes Occupational Therapists and Physiotherapists, primary aim is to assess and provide early interventions to patients who have presented with a fall. The CCT plans discharge by determining if the patient is able to safely return home and refers to hospital and community falls services. Studies show patients who have presented to ED with a fall are at high risk for recurrent fall and that they do not generally receive the care required avoid further falls. Additionally priorities within the ED dictate that the immediate clinical and functional consequences of a fall are dealt with and there is limited time available to consider future falls and injury prevention strategies. The CCT are targeting falls risk factors, providing education and referring patients to be followed up with Falls specific services. However the outcomes of these patients and the effectiveness of this falls risk assessment and education is unknown. This study aims to review the efficacy of a simple, quick to administer screening tool for discriminating between future fallers and non-fallers that is feasible for use in the busy ED setting. Additionally this study may allow us to gain insight into the effectiveness of falls education in the ED environment. Patients would be randomised to receive additional feedback on their falls risk assessment score and increased falls prevention education versus usual care. It will measure the effect by describing difference in the proportion and number of falls during the six month follow up period (measured with monthly phone calls), changes in physical status, medical history and community service use.

This pilot study aims to test if an iron infusion to iron-deficient patients planned for surgery for colorectal cancer who are anaemic versus not anaemic will improve physical fitness. Who is it for? You may be eligible to join this study if you are aged 18 years and above, have histologically confirmed colorectal cancer and Ferritin of less than 100mcg/l or between 100-300mcg/L with a transferrin saturation of less than %20. Study details Consenting participants will be randomly (by chance) allocated to either receive an infusion enriched with 1000mg iron (Ferric Carboxymaltose) or saline solution of similar appearance. All participants will receive maximum of 250mls of 0.9% saline solution with or without iron (depending on group) over a 15 minute period. All patients will be monitored for 30 minutes following completion of the infusion. No further blood tests will be required on the day of the infusion. This project is a pilot study, and if feasible, may be extended to a larger study in the future. This project is being conducted at Peter MacCallum Cancer Centre and Epworth Health Care.

Sleepiness and fatigue are frequent debilitating problems following traumatic brain injury (TBI). Medications have not provided long-term solutions for these symptoms and there is little research into psychological treatments. Cognitive Behaviour Therapy (CBT) is a well-established treatment for insomnia and chronic fatigue in those without a brain injury. The Monash-Epworth Rehabilitation Research Centre is conducting a world first study to investigate whether CBT can be effectively adapted to reduce symptoms of fatigue and sleepiness after TBI. A randomised controlled trial is used to compare participants receiving 8 sessions of CBT with a neuropsychologist to waitlisted participants who receive routine care as usual.

One in seven women will experience depression or anxiety after the birth of their baby; however 60% of cases will go undetected. The identification of postnatal depression (PND) or anxiety is not part of the routine care provided by health care systems, meaning that only 10% of women experiencing these difficulties will receive treatment. This is mainly due to not screening for, and identifying, postnatal depression or anxiety. Although methods to identify PND exist, they are inconsistently carried out, and are prone to error as primary care professionals lack time as well as a clear system when making decisions on how to manage depression. We have co-developed a tablet-based application (e-screening tool) to screen for postnatal depression and to conduct a broad assessment of a woman’s well-being. This tool will help health professionals to identify postnatal depression and/or anxiety easily, accurately and consistently and provide best-practice guidance tailored to women’s responses. To determine whether our e-screening tool will be useful for health professionals in identifying PND, we will compare it to the existing method of screening and identification that is currently used by health professionals. The success of the new system will be measured by its capacity to deliver real improvements to the healthcare system. The new e-screening tool aims to be quicker, more accurate, involve less staff time and resources, be used more frequently, and lead to improvements in treatment and recovery rates for depressed women. Ultimately, this trial could lead to a cost-effective and sustainable new system.

Ageing is associated with a physiological reduction of appetite and energy intake, which has been called the “anorexia of ageing”. Dietary supplementation with liquid protein preparations is now used frequently to increase energy and protein intake in older adults in both institutionalized and community-dwelling populations. Although the latter would appear a logical approach, evidence for success of increased energy intake in older individuals is limited. Urgent investigation is warranted to determine the optimal load of protein that can be incorporated into their diet to assist in sparing muscle mass without reducing their appetite. Moreover, weight loss protein-rich diets are often recommended for obese older adults in the same manner as for younger adults. In young adults, obese individuals exhibit a less precise compensatory response to ingested energy than lean individuals. Although only a limited number of studies have examined the effects of state of nutrition in elderly on the regulation of appetite, there is persuasive evidence of substantial differences between undernourished and healthy older people, which may potentially represent an outcome of and/or contribute to the undernourished state. A common strategy to increase energy intake and body weight in undernourished elderly is the use of nutritional supplements, and this is now almost standard practice. Usually such supplements are provided as mixed macronutrient high-energy drinks. Because of the increasing awareness of the major muscle loss that preferentially accompanies weight loss in older people, and its particular adverse effects, there has been a recent, marked, increase in the preferential administration of protein in these supplements and the use of protein-enriched supplements in an attempt to preserve, or even increase, muscle mass, in both institutionalized and community-dwelling populations. Such recommendations and use are, however, largely empirical. Our understanding of the feeding responses, and mechanisms underlying them, of undernourished and obese older people to protein is very limited and will be increased greatly by the proposed study. To aim of the study is to characterise in undernourished and obese, young and older individuals, the effect of different oral protein loads on energy intake, appetite, antral area, gastric emptying, plasma concentrations of amino acids, hormones (i.e. CCK, PYY, ghrelin, GLP-1, GIP, glucagon and insulin) and glucose, and to determine the relationship between the suppression of appetite and energy intake by protein with ‘intragastric’ and ‘small intestinal’ mechanisms.

Pre Exposure Prophylaxis eXpanded (PrEPX) is a new study that will expand the provision of PrEP to 2,600 Victorians who have a high chance of acquiring HIV. Alfred Health is responsible for conducting the study. Associate Professor Edwina Wright from the Department of Infectious Diseases Alfred Health, Monash University and The Burnet Institute will be the Chief Investigator of this study. The study is sponsored by the Victorian Department of Health and Human Services and, co-sponsored by Alfred Health and the Victorian AIDS Council. The chief research partners are The Burnet Institute and the Centre for Social Research in Health, UNSW. The aims of PrEPX are to: -Reduce the incidence of new HIV infections in Victoria, -Expand access to PrEP in Victoria, including rural and regional locations -Build capacity in the Victorian Health Service system so that the use of PrEP will become a routine option for preventing HIV infection PrEPX will start enrolling people on 26th July 2016 and run for 21 months. We will monitor the rate of new HIV infections in Victoria for a period of 36 months after the PrEPX study commences.

The diagnosis of a chronic physical disease can present multiple and significant challenges. It frequently requires adjustment to new and changing circumstances, limitations and treatment regimens that can have a profound impact on all aspects of life. Reflecting this, there is significant comorbidity between chronic physical disease and mental health disorder, particularly anxiety and depressive disorders. Research shows that anxiety and depressive disorders are at least twice as common in people with chronic physical diseases. Chronic physical diseases are one of the strongest risk factors for anxiety and depression and anxiety and depression are some of the strongest modifiable risk factors for deteriorating physical health. Psychological treatments teach patients the skills to understand and manage symptoms and to limit their impact on functional abilities and quality of life.More than sixty years of research has proven cognitive behaviour therapy (CBT) to be effective in treating anxiety and depression. There is strong evidence that suitably tailored CBT significantly reduces disability and improves mental health in adults with chronic physical diseases. Australian epidemiological studies indicate that fewer than 20% of Australians with anxiety and depression access any mental health treatment. Common barriers to treatment include direct and indirect costs, stigma, insufficient numbers of appropriately trained mental health professionals and the decreasing availability of specialist services outside of metropolitan areas. The organisation and limited resources of health services means that mental health is not routinely considered alongside the management of chronic physical disease. Primary health care providers desperately need somewhere they can refer large numbers of patients with the chronic physical diseases for effective mental health treatment. Thus, there is an urgent need for psychological treatments that are accessible, acceptable, efficacious and cost-effective. The proposed project has three primary aims: (1) to evaluate the short-term and long-term clinical efficacy of a new internet-delivered and transdiagnostic psychological treatment, the Chronic Disease Course, in reducing disability and improving emotional wellbeing and quality of life among adults with different chronic physical diseases; (2) to evaluate the treatment cost per patient and the cost-effectiveness of the treatment over the short-term and long-term; and (3) to explore the demographic, disease and patient-related predictors and moderators of treatment response. The hypotheses include: 1. The treatment will result in significant improvements in mental health and improvements in quality of life and disability at the completion of treatment. 2. The treatment will be cost-effective from the health services perspective at the common willingness-to-pay thresholds per Quality-Adjusted Life Year (QALY