ANZCTR search results

Many carers of people with dementia develop affective symptoms of depression and anxiety as a result of their carer role. The START program has been shown to be effective in the UK context in improving these symptom in carers. This study seeks to: 1. Examine the acceptability of the START program in an Australian context as reported by therapists and carers of people with dementia including examination of: a) Adherence of therapists to the treatment manual and their perceptions about the value of the program and potential generalisability in the Australian context; b) Carers perceived acceptability of the program as reflected by their self-report and completion of all 8 sessions; c) Benefit to carers as measured by a decrease in depression, anxiety and carer burden, relative to the control (CBT) group. 2. Examine the feasibility of the START program in an Australian context by examining the practicality and viability of intervention delivered by provisionally registered psychologists from within an Australian university psychology clinic.

The aim of this research is to investigate the functional impact of compression therapy (to manage chronic oedema) for adults who have chronic oedema and a history of recurrent cellulitis in a lower limb or limbs who access health services within the ACT. Reducing cellulitis recurrence could decrease the burden on the healthcare system and may positively influence the quality of life (QOL) of individuals experiencing recurrent episodes of cellulitis. Whilst this study will be performed in adults receiving healthcare services in the ACT, it is hoped the results may provide insight for cellulitis management within Australia. Research Objectives For adults with a history of chronic oedema and recurrent cellulitis who are accessing healthcare services within the ACT, we plan to investigate if use of compression therapy: (1) prevents recurrence of leg cellulitis (2) prevents cellulitis-related hospital admissions; (3) reduces affected leg volume; and (4) improves quality of life (QOL). Research Hypothesis: Addition of compression therapy to manage chronic oedema will prevent recurrence of cellulitis

This research study aims to evaluate the level of implementation support required to achieve adherence to the Clinical Pathway for the Screening, Assessment and Management of Anxiety and Depression in Adult Cancer Patients. Who is it for? Cancer services in New South Wales may be eligible to participate in this study. Study details Cancer services enrolled in this study will be randomised (allocated by chance) to one of two sets of strategies and resources which they must use to implement a Clinical Pathway. The Clinical Pathway describes how cancer patients with anxiety and depression should be identified, supported, referred to appropriate care, and monitored over time. Strategies and resources 1. The Portal: an online management system for registering cancer patients for screening, assessment, referral and monitoring. The Portal alerts staff when screening and re-screening is due, and to the appropriate level of stepped care for the patient. The Portal has patient pages where patients may log-in and complete screening as well as access information and online therapy for depression and anxiety. The Portal links to online cancer-related anxiety and depression screening education and training modules for staff. All sites will receive full access to the ADAPT Portal and training to use the Portal resources and systems. The study arms will differ as to the extent to which they receive the following implementation strategies (interventions): 2. Academic Detailing and Support: Initial staff training and support about the Clinical Pathway and use of the ADAPT Portal. Tailoring of the ADAPT Portal set up to fit individual service requirements, service and staff profile. 3. Awareness Campaigns: Roadshow and poster campaigns to inform cancer service staff about the Clinical Pathway and the Portal. 4. Champions: ADAPT program staff will work with sites to identify and support local Clinical Pathway and Portal Champions. 5. Education: Staff will be trained to use the Portal, in face-to-face training and also by engaging with User Guides and by seeking the support of the Local Champion. 6. Reporting: Reports will be provided to site Leads and Champions regarding use of the Portal and the Clinical Pathway issues and concerns. This study will enable us to determine the level and type of support required by cancer services to introduce the Clinical Pathway, the costs associated with the resources required and the levels of identified anxiety and depression in patients with cancer.

The Fetal Kicks is a novel device developed by Monash MIME to monitor fetal movement. For the following study, the current phase entails a proof of concept in women antenatally to assess the quality of signals obtained on Fetal Kicks. For this, Fetal Kicks will be utilised together with the conventional cardiotocography (CTG) to ascertain the equivalence of Fetal Kicks with conventional fetal movement counting Aims 1. Accurately corroborating maternal perceptions of movements on the CTG (via sensor imprints) to device captures of fetal movements 2. Accurately corroborating maternal perceptions of movements on the ultrasound (via sensor imprints) to device captures of fetal movements Research design The following study is a cross sectional survey with a cohort design. The following design has been chosen as it is considered to be the design of choice in evaluating a diagnostic test- in this case, Fetal Kicks. Utilising the following design, measurements of test accuracy and precision will be carried out on Fetal Kicks in comparison to CTG and conventional fetal movement countings. Primary Outcomes 1. Correlation between the signals obtained from Fetal Kicks and routine cardiotocography over a similar time period. This will be done electronically utilising cross correlation. 2. Correlation between the information obtained from Fetal Kicks and CTG as interpreted by clinicians. This will be measured on a CTG reporting tool designed specifically for the study. Secondary Outcomes: 1. Patient view on Fetal Kicks (i.e pros, cons, will they recommend it, areas for improvement etc.). This will be measured through a questionnaire designed specifically for the study

Elevated blood glucose levels are common in many acute diseases, resulting in worse clinical outcomes for patients. Hyperglycaemia in acute ischaemic stroke (post-stroke hyperglycaemia [PSH]) occurs in up to 50% patients, reduces the efficacy of stroke thrombolysis with increased risk of haemorrhage, increases infarct size, and results in worse clinical outcomes and death. Insulin-based therapies have not proved beneficial in treating PSH: they are difficult to implement and maintain, cause frequent hypoglycaemia, may cause increased infarct size, and have not shown to reduce mortality or improve clinical outcomes. An alternative, simple to use treatment for PSH may therefore have a significant impact not only for acute stroke care, but in other acute diseases. Exenatide is a commonly used diabetes drug (a synthetic glucagon-like peptide-1 receptor agonist) that amongst its effects increases insulin secretion. Importantly, this action is glucose dependent - as blood glucose levels decrease, its stimulatory effect on insulin secretion subsides, with a very low risk of hypoglycaemia. A previous pilot study of 17 consecutive, unselected patients (i.e. regardless of their admission glucose level) with acute ischaemic stroke compared subcutaneous Exenatide 5 micrograms for 5 days versus routine standard care. Blood glucose levels remained consistently lower (and less variable) in the treatment group, most noticeably in those stroke patients with known diabetes. Exenatide was safe and well tolerated by all patients, with no symptomatic hypoglycaemia. TEXAIS is a 3 year Phase 2, multi-centre, prospective, randomised, open label, blinded end-point trial comparing subcutaneous Exenatide (5 micrograms) to Standard of Care. The number of patients to be recruited is 528 patients (264 in each arm) with a primary end point of early neurological improvement at 7 days, and secondary end points of recovery at 90 days. Continuous glucose monitors will track the intra-day dynamic variability of glucose in acute stroke in all trial patients (treatment and standard care).

This intervention study will test the effectiveness and explore appropriateness of a Chinese multi-session culturally-tailored diabetes group education program which is designed to carefully match with the Chinese people’s preferred learning style and include Chinese-specific strategies to motivate and sustain healthy behaviour change. The research will involve recruiting 50 Chinese Cantonese-speaking people with type 2 diabetes into this study. Participants will attend a 6-session group education program delivered in Cantonese by a dietitian, physiotherapist, podiatrist and diabetes nurse. The program will then be evaluated on its effectiveness and appropriateness via pre- and post-program anthropometric and biochemical measurements, questionnaires and qualitative participant-observation. This research is expected to provide new practice ideas to enhance diabetes education, especially for the culturally and linguistically diverse populations.

Background: While World Marrow Donor Association Standards ensure consistency in the assessment and care of unrelated haematopoietic stem cell (HSC) donors, no such criteria exist for related HSC donors. Unlike unrelated donors, related donors are actively involved in the transplant process and witness first-hand the changes in their relative’s health. Their lived experience is thus likely to be very different from that of unrelated donors and it is important to understand and address their needs. Aim: The aim of this PhD project is to identify potential predictors of psychosocial distress and unmet needs of adult related HSC donors, to develop information resources for health professionals and develop and pilot test a psycho-educational resource for donors. PHASE I Participants are adults undergoing HSC donation for a related recipient at the RBWH and Westmead Hospital, Sydney. Donors complete 3 interviews and provide 3 samples of saliva (as a measure of stress): (1) 2 weeks pre-HSC collection; (2) within 24hrs of HSC collection and; (3) 30 days post-HSC collection. An interview with BMT Nurses will explore the nature of their role, their perceptions of the psychosocial needs of donors and their role (if any) in responding to donor distress. Hypotheses: As research into adult related donors is limited, findings from research with younger related HSC donors and adult bone marrow donors were used to make the following predictions: 1. Donor perceptions of the closeness of the relationship with the recipient will be associated with post-donation reactions such as guilt, responsibility and stress. 2. Perceived adequacy of preparation and emotional support will correlate with post-donation reactions such as concern for own health, physical pain/discomfort, guilt and responsibility. 3. Donors with poorer self-evaluated health-related quality of life will report more negative reactions throughout the process. 4. Donors of recipients who experience adverse clinical events (such as development of graft versus-host-disease) will experience increased distress and anxiety. 5. Donor reactions such as stress/physical pain will correlate with high salivary a-amylase levels throughout the process. PHASE II Key indicators that identify risk of HSC donation-related distress will be used to develop a paper-based psycho-educational resource that seeks to reduce related HSC donor distress and may be appropriate for integration within the health system. We aim to assess acceptability, feasibility and potential efficacy and inform the development of a large post-doctoral study which will be required to validate the tool.

Understanding emotions, understanding that other people think or feel things differently to ourselves, and thinking and feeling from another’s perspective are all skills associated with social cognition. There are many reasons why some people find it more difficult to do these things, and having a brain injury is one of them: the regions in the brain that can be damaged through injury often affect the areas we know are important for social cognition. What is less well understood is whether it is possible to treat social cognitive deficits after such an injury. This is because very little research has been done trialling these kinds of treatments for people with a brain injury, and there have been no trials that have ‘comprehensively’ targeted the interrelating process of social cognition. The aim of this study, therefore, is to trial a novel social cognition treatment (SIFT IT), a therapy that has been developed considering the needs of those living with a brain injury, yet still informed by treatments developed in other clinical populations. SIFT IT: The Social Thinking Therapy has been designed as a group program that will run for 14 weekly sessions, each 90-120 minutes. It combines principles of cognitive behavioural therapy (CBT) with cognitive remediation to help participants understand the breadth of processes involved in social cognition and then to apply them to their everyday lives. As SIFT IT is a new psychotherapeutic group intervention, the focus of this study is on whether it is possible to treat social cognitive deficits in this way in this population: i.e. to examine the intervention’s feasibility. Feasibility will be examined by looking at the demand for the therapy, how well the therapy can be implemented, the acceptability of the treatment, and whether it looks like the therapy is helping people improve their social cognitive skills. The study will run as a randomised controlled trial. Participants with a brain injury who have scored lower than expected on at least one social cognition assessment measure will be randomly allocated to the SIFT IT therapy group or to a waitlist control. Testing will take place after initial recruitment to gather baseline performance, then again after the SIFT IT therapy group has finished, then again after a further three months. The participants in the waitlist control will be offered to take part in the therapy group after the second round of testing. All participants will be asked to take part in a semi-structured interview after they have taken part in the therapy group to find out more detailed information about how they found the program. Data gathered from the trial will be analysed in a mixed methods approach. Some data will provide descriptive information about the participants and feasibility outcomes. Some data will allow for examination of changes in outcomes pre- to post-intervention. Other data will be analysed for common themes from feedback to examine therapy acceptability.

Docosahexaenoic acid (DHA) is an n­3 long chain polyunsaturated fatty acid (LCPUFA) which is important for optimum health of the mother and growth and development of the fetus. During the prenatal period, the time before birth, the only source of LCPUFAs for the fetus is from the mother via transfer across the placenta. The last trimester of gestation is the major period of n­3 LCPUFA accumulation in fetal tissues, including fetal fat tissue. The n­3 LCPUFAs inhibit fat cell formation and lipid accumulation in adults and this has led to the suggestion that prenatal exposure to an increased supply of n­3 LCPUFA could reduce the subsequent accumulation of fat tissue in childhood, and hence the risk of obesity and diabetes later in life. However, results of the studies which have attempted to study this question to date have been inconclusive. The DOMInO trial (DHA to Optimise Mother Infant Outcome) was designed to evaluate the effects of supplementing women with 800mg DHA/day during the second half of pregnancy on maternal and infant outcomes. The growth andinsulin resistance follow­up of children in this study was undertaken when they were 3 and 5 years old and aimed to determine whether increasing the amount of n­3 LCPUFA in the diet during pregnancy could reduce the risk of obesity and diabetes in the children. In the present study, we are proposing to extend this follow­up of the DOMInO children to 7 years of age. This is important, since major changes in body composition (the balance of muscle and fat) occur in the first few years after children start school. Capturing the growth and body composition of the DOMInO children at 7 years of age will therefore provide a more complete picture of changes in body composition over this critical period of growth and will enable us to determine the effects of maternal n­3 LCPUFA supplementation on the body fat mass at school age. The body fat mass of children at school age is also a stronger predictor of their body fat mass and metabolic health later in development than fat mass at earlier ages. The primary outcome of the current study is to assess if omega 3 LCPUFA supplementation during pregnancy is associated with a reduced body fat mass later in childhood. This will be achieved by measuring body composition and body mass index (BMI) z-scores in children (n=252) of mother's who were enrolled in the DOMInO trial at 7 years of age. The findings from this study will provide valuable information as to whether maternal n­3 LCPUFA supplementation in pregnancy has the potential to reduce body fat mass in children at school age, and therefore reduce their future risk of obesity.

Obesity significantly increases the risk of developing metabolic syndrome (MS), which is associated with increased cardiovascular morbidity/mortality. Presently, there is fierce debate surrounding the effects of the A1 beta-casein protein variant (A1) in bovine milk compared to the progenitor A2 variant (A2) with respect to their relative impact on MS risk factors. Most milk and milk products available commercially in Australia contain the A1 protein from dairy cows which carry the A1 gene. The A1 variant in Australian dairy cattle is the result of a mutation from the A2 gene in European herds ~5,000 years ago. Alternatively, milk produced by cows specially selected and then bred to produce only the original A2 beta-casein type is also available in Australia, but it is a specialty milk brand. Ample evidence now suggests that A1 milk beta-casein can affect features of MS and so has important public health implications. Given the Australian Dietary Guidelines recommend 2.5-4 dairy serves/day, the effect of milk variety on MS warrants investigation. A1 and A2 protein have differences in bioactivity on digestion, due to the release of the 7-amino acid opioid peptide beta-casomorphin-7 (BCM-7), from the digestion of A1 but not A2. In vitro and animal studies have demonstrated that BCM-7 oxidises low density lipoprotein (LDL)-cholesterol and increases levels of the inflammatory marker myeloperoxidase, both of which are implicated in the development of heart disease. A1 beta-casein and BCM-7 also stimulate inflammatory markers and so may contribute to the overall inflammatory milieu in MS. We have also shown in our recent randomised cross-over study that A1 milk stimulates differences in gastrointestinal inflammatory responses compared to A2 milk. The aim of the current proposed project is to investigate the difference between A1 and A2 beta-casein protein containing milk on cardiovascular and metabolic risk factors in overweight/obese individuals. Simple and affordable nutrition interventions that can positively affect modifiable risk factors for heart disease and T2D in Australian adults are needed. If the predicted differences between A1 and A2 beta-casein containing milk on cardiometabolic risk outcomes are found, it will have important ramification for public health and the prevention of chronic illness like cardiovascular disease. Dairy farmers would be advised to choose A2 semen for their dairy breeding programs to change to the A2 milk type for Australian consumers. We hypothesise that A1, but not A2 beta-casein containing milk, will correspond to shifts in cardiometabolic risk factors mediated via BCM-7 in blood. In contrast, we propose that A2 beta-casein containing milk will have a neutral, rather than beneficial, effect on metabolic syndrome factors. Thus, the hypothesis implies that A2 will do no harm, while the mutated A1 variant may increase the risk of chronic disease at a population health level.