You can narrow down the results using the filters
-
The Childhood to Adolescence Transition Study (CATS): Health Risks in the Pubertal Transition
Expand descriptionRecent studies have suggested that the transition through puberty is marked by an increased risk of behavioural and emotional health problems. These include common emotional problems such as depression and anxiety; substance use; eating disorders; self-harm; antisocial behaviours, and functional somatic disorders such as headaches and irritable bowel syndrome. Previous studies have not adequately answered whether differences in social, lifestyle and biological transitions during puberty may explain the emergence of these difficulties. This is despite the evidence that adolescent mental and behavioural disorders have become more common in recent decades with the reasons likely to lie in changes in the social and lifestyle context of development. The aim of this study is to prospectively examine the factors that may influence the onset and course of pubertal-onset health problems. This study will provide the most comprehensive quantification of the association between puberty development and the major health problems that become prevalent in early adolescence. Participants will be 1239 grade 3 students (age 8-9 years) at public, Catholic and independent schools in metropolitan Melbourne. There will be annual assessments, over a nine-year period. Participants will complete web-based questionnaires covering a range of topics including mental and physical health, pubertal development, social context, activities of daily living and emotional style. Additionally, participants’ height, weight and waist circumference will be measured. A saliva sample will also be collected from each student in order to measure saliva hormone levels (another measure of pubertal stage). Parents and teachers will also be asked to complete a questionnaire. Parents will provide information regarding socio-demographics, family background, child behavioural and emotional adjustment and parental health and lifestyle. Teachers will be asked to complete a very brief questionnaire about the strengths and difficulties and academic attainment for each student.
-
Trialling the feasibility and acceptability of physical activity self-monitoring and supervised exercise interventions for adults with mental illness
Expand descriptionThis pilot study will be a randomised controlled trial of two physical activity (PA) interventions for adults with mental illness: i) PA self-monitoring using technology (wrist-worn Garmin Vivofits, which provide real-time feedback on the face of the device), and ii) supervised exercise intervention at a community gym. As a pilot study, the primary outcomes will be 1) feasibility of the trial, and 2) feasibility and acceptability of the interventions. Secondary outcomes will be the impact on PA behaviour change (assessed using accelerometers and self-report questionnaires), PA motivations, physical health (weight, waist, blood pressure) and psychosocial wellbeing (self-reported sleep quality and psychological distress). The interlinked aims of this pilot study are to: i) Assess the feasibility of the trial ii) Assess the feasibility and acceptability of the PA interventions iii) Compare the change in PA participation in response to interventions that either promote PA motivation, or provide PA opportunity. Additional aims are to assess: i) The utility of the 6-min walk test, wrist-worn accelerometry, and questionnaires on physical activity, sedentary behaviour and sleep. ii) The impact of the intervention on mental and physical health. It is hypothesised that: i) The trial will be feasible to conduct on a larger scale. ii) The PA interventions will be feasible to implement in the mental health service iii) There will be a qualitative difference in the acceptability of the interventions, dependent upon how they influence capability, opportunity and motivation to promote behaviour change. Inclusion criteria: i) Current adult consumer of Metro North Mental Health Services and Metro South Addictions and Mental Health Services (other than acute care teams) ii) Aged 18-65 years iii) Willingness to provide written informed consent. Exclusion criteria: i) Diagnosed with an eating disorder (assessed by referring clinician) ii) Identification of medical risk factors on the Adult Pre-exercise Screening Tool, and NOT cleared to participate by a medical professional iii) Physically active, defined as more than 300 minutes/week of self-reported moderate-to-vigorous PA (assessed using the Active Australia questionnaire)
-
Pregnancy outcomes when adding a progesterone pessary dose amongst women who are receiving frozen embryo transfer with hormone replacement therapy, compared with placebo.
Expand descriptionFETs using HRT stimulation occur with no corpus luteum. This means endometrial growth, maturation and maintenance is entirely dependent on the effect of HRT for at least the first 2-5 weeks post-transfer. By 10 weeks post-transfer the placenta is producing adequate hormone to support the endometrium. Although intramuscular progesterone treatment is popular in North America, in Australia and Europe vaginal preparations are preferred. Natural and HRT FET cycles have been compared and show equivalent live birth rates on meta-analysis. The local experience at Monash IVF is different, with a significantly lower live birth rate for HRT compared to natural FETs (14.5% vs 22.4% - OR 0.59 (0.55-0.62)) for all comers. This difference is maintained when 20 potential confounding factors are allowed for using logistic regression (patient age; number of embryos transferred, embryo maturity etc) with an adjusted odds ratio of 0.55 (0.48-0.64). A recent publication from Yovich (2015) showed a significantly higher live birth rate in women undergoing HRT FETs, where the mid-luteal phase serum progesterone was >50 nmol/L. Review of the Monash IVF dataset investigating serum progesterone concentrations after 14-18 days of treatment in HRT FETs confirmed a significantly higher live birth rate (26.4% vs 11.3%). A shortcoming of measuring progesterone both at mid-luteal and Day 14-18, is that the opportunity to change management and improve outcome has potentially already passed. A further retrospective review of Monash IVF HRT FET cycles investigating progesterone dosage, Day 14-18 serum progesterone and live birth rates, suggested that dose frequency may be as important of actual dosage. This study aims to investigate “at risk” women with low serum progesterone (<50 nmol/L), but measure this after 2 days of treatment and then assess the effect of adding an extra dose of progesterone each day upon the live birth rate.
-
Trends in dietary sodium from food sources in Australian children and adolescents from 2007 to 2011/12
Expand descriptionThe aim of this study was to assess trends in sodium intake from food sources among Australian children and adolescents from 2007 to 2011-12. To do this we have completed secondary data analysis of two existing data sets, the 2007 CNPAS and the 2011/12 NNPAS.
-
TARGET study: Exercise for people with knee osteoarthritis and obesity
Expand descriptionKnee osteoarthritis (OA) is a major public health problem with significant personal, social and economic burden. Being overweight is a known risk factor for the development and progression of symptomatic knee OA. One potential reason may be due to the increased forces placed on the knee joint during weight bearing activities in people that are overweight. The development of targeted treatments for people at high risk of disease progression, such as those who are overweight, is a research priority. Our primary aim will therefore be to evaluate whether people with knee OA and obesity respond differently to two different types of exercise; 1) weight bearing functional exercise and ii) non-weight bearing quadriceps strengthening exercise. Participants will be randomly allocated to one of the two exercise groups. Over 12 weeks participants will attend 5 in clinic physiotherapist appointments. The physiotherapist will prescribe a home based exercise program following the exercise protocol assigned to the participant. The home based exercise program will be completed 4 times a week, in addition to the physiotherapy sessions. Primary outcomes are overall knee pain and physical function measured at 12 weeks. As body mass index is easily measured our findings will potentially provide clinicians with a simple and effective means to tailor their exercise prescription and optimise outcomes for their patients with knee osteoarthritis.
-
Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes (TEACH-PD) - Pilot Study
Expand descriptionThere is an increasing number of people developing end-stage kidney disease in Australia every year. Peritoneal dialysis (PD) is the most cost-effective and user friendly form of dialysis, yet the rate of PD utilisation in Australia has been steadily falling since 2003. A major contributor to low referral rates by physicians to PD and relatively high rates of PD technique failure is PD related peritonitis. Studies in a number of countries have shown that peritonitis rates vary greatly between PD units (between 5 to 20 fold variation). With PD critically dependent on patient self-management, research is required into potentially modifiable peritonitis risk factors, including patient training. The primary objective of the TEACH-PD (Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes) pilot study is to refine the TEACH-PD training modules for PD patients and trainers. TEACH-PD pilot study is an investigator-initiated, single-armed, non-randomised, pilot trial assessing the use of training modules for both PD nurse trainers and incident PD patients undertaking PD training. A total of 10 PD trainers will be enrolled and at least 1 PD patient per trainer and at least 10 English speaking patients (between 10 and 20 patients in total) from PD units at John Hunter Hospital, New South Wales and Logan Hospital in Queensland. PD trainers will complete “train the trainer” modules during the study which have a focus on adult learning principals and be provided with Patient Training Manuals. Once the PD trainers are assessed for competency with the modules, the trainers will then instruct the incident PD patient using the Patient Training Manuals and practical demonstrations. The primary objective of this pilot study is to further refine the TEACH-PD training modules designed for PD trainers and patients. The TEACH-PD training modules were developed by the Home Network, a group of health professionals focused on identifying and addressing barriers to home dialysis. The study is being coordinated by the Australasian Kidney Trial Network (AKTN).
-
Evaluation of fine needle biopsy (FNB) for endoscopic ultrasound (EUS) guided tissue acquisition of pancreatic masses to negate the need for rapid on-site evaluation: a multi-centre randomized control trial
Expand descriptionBackground: Endoscopic ultrasound guided fine needle aspiration (EUS FNA) is a key component for the investigation and diagnosis of solid pancreatic masse. It has a proven track record for being safe with complications and tumour seeding being a rare occurrence. The sensitivity, specificity and diagnostic accuracy for pancreatic lesions in many studies is high and exceeds 85%. Studies aiming to optimize EUS FNA have compared several factors including needle size, the number of needles passes and suction versus slow-pull. Initial studies showed that the use of rapid on-site evaluation (ROSE) had the biggest impact with increased diagnostic accuracy and reduced needle passes. However more recent reports show conflicting results on whether ROSE actually does influence outcome in EUS FNA. ROSE has historically been performed using FNA needles with cytological assessment. The act of smearing specimens (a necessary step for ROSE) to prepare cytology slides using cell aspirates obtained from FNA needles can be done without difficulty after necessary training and experience. The fine needle biopsy (FNB) needle (the ProCore needle) was introduced to further improve upon EUS guided tissue sampling. It is designed to collect a larger amount of core sample tissue by having a reverse bevel near the tip. Several studies favour the EUS FNB needle over the classic FNA needle for obtaining more adequate histological specimens with a high diagnostic yield. Data comparing the performance of EUS FNB without ROSE versus EUS FNA with ROSE is currently lacking. With this in mind, needles that provide histological specimens with an excellent (>95%) diagnostic yield (thus negating the need for ROSE) are the ideal devices for obtaining EUS guided diagnostic tissue. We therefore aim to compare the diagnostic yield of solid pancreatic masses using EUS FNA with ROSE versus EUS FNB without ROSE. Hypothesis: EUS FNB without ROSE will have equal diagnostic accuracy to EUS FNA with ROSE, hence negating the need for ROSE when EUS guided tissue acquisition is performed with FNB needle for solid pancreatic masses. Aim: To compare the outcomes of EUS FNA with ROSE versus EUS FNB without ROSE for solid pancreatic masses. Design: This will be a prospective, multi-centre, randomized control trial involving 600 patients with pancreatic solid mass of more than 1cm. There will be 10 centres participate in the trial, each recruiting 60 patients per hospital. Patients at each site will be randomized to either: Group A, (n=30, total = 300) which will undergo EUS FNA with the standard 22G EchoTip needle with ROSE. Group B (n=30; total=300), which will undergo EUS FNB with the 22G ProCore needle without ROSE.
-
Investigating the effect of a soluble seaweed dietary fibre on gut, metabolic and skin health.
Expand descriptionThe aim of this project is to test the effectiveness of a seaweed dietary fibre extract on gut and metabolic health and, consequential effects on inflammatory related Palmoplantar / psoriatic Keratoderma symptoms. This study will follow the initial Bio-Belly Study 1, where we have already found significant outcomes in an overweight population. Improvements were seen in plasma cholesterol, inflammation and insulin, as well as a case study, anecdotal improvement to a psoriatic skin disorder. Therefore, we aim to demonstrate repeated efficacy of the seaweed extract in an independent sample population, and to increase the power by restricting it to overweight participants only, and not obese, as there was a larger effect size in the overweight population. In addition, we would like to recruit to test the anecdotal effect of improvement to psoriatic skin disorders found in the initial trial. We propose to undertake a randomised placebo controlled crossover trial, with two six week treatment arms. Therefore the trial in its entirety will last 12 weeks.
-
Action: PACT. Be Active. Online. A trial to promote physical activity in young people with cystic fibrosis.
Expand descriptionCystic Fibrosis (CF) is a complex, progressive, life-limiting disease that predominantly affects children and young adults. ‘Flare-ups’ of CF lung disease are common in people with this condition and often lead to admission to hospital and decline in lung capacity, imposing considerable burden on patients, their families and the healthcare system. Physical activity (PA) participation is a low-cost, easily accessible treatment option that has the potential to reduce the impact and progression of chronic lung disease in CF and may help reduce ‘flare ups’ of lung disease. However uptake and adherence to PA and exercise rehabilitation programs by young people with CF is poor. Advances in Internet technology and accessibility have made it possible for people to receive specialist medical care and rehabilitation therapy without attending the hospital. By using a secure website, readily accessible on any smartphone, tablet, laptop or computer it is possible for young people with CF to track their PA participation and receive feedback – at any time and place of their choosing. The aim of this project is to determine whether use of an online program to track PA participation and provide feedback, is more effective than usual care at improving PA participation, exercise capacity and quality of life, and prolonging the time to next hospital admission. People who agree to take part in the study will be randomly allocated to use the online program via the Internet, or to usual post-hospital care. At the beginning and end of the 12 weeks of the intervention phase, and at 3-months post completion of the intervention period, all participants will undergo measurements of PA participation, exercise capacity and health status. At 12 months- post completion of the intervention, hospital medical records will be reviewed to determine the frequency of hospital admission and number of hospital days. It is hypothesized that: 1. The web-based intervention will improve uptake and participation in PA by young people with CF. 2. The web-based intervention to increase PA will lead to improvements in exercise capacity, lung function, quality of life, anxiety and depression and sleep quality in young people with CF and reduced health care utilisation for this group in the 12 months post intervention.
-
An Australian multicentre trial to compare the safety and efficacy of intravenous immunoglobulin replacement therapy with subcutaneous immunoglobulin replacement therapy (Hizentra®) to treat immunoglobulin deficiency in patients with chronic lymphocytic leukaemia (CLL)
Expand descriptionThis study aims to assess whether subcutaneous immunoglobulin (SCIg) replacement therapy is an acceptable alternative to intravenously immunoglobulin (IVIg) replacement therapy in terms of safety and efficacy in chronic lymphocytic leukaemia (CLL) patients with acquired hypogammaglobulinaemia. Who is it for? You may be eligible to join this study if you are aged 18 years, have a diagnosis of chronic lymphocytic leukaemia (CLL) and are currently receiving IVIg. Study details Study participants will be allocated by chance to one of the three groups. One group will continue receiving IVIg monthly for at least 12 months (their usual care). Second group will receive SCIg (Hizentra®) weekly for at least 12 months and third group will receive SCIg (Hizentra®) fortnightly for at least 12 months. Safety and efficacy measures including evaluations of blood samples and completion of questionnaires will be collected over a 12 month period. This study will address whether SCIg is an acceptable alternative to IVIg in terms of safety and efficacy in patients with acquired hypogammaglobulinaemia in the setting of CLL.