ANZCTR search results

In the study we trialled the effectiveness of a diabetes-related smart phone application to improve self-management and glycemic control in adult patients with T1DM. Specifically the aims of the project were to (i) trial the effectiveness of the ‘Glucose Buddy’ self-management application in improving glycemic control in adults with T1DM, (ii) trial the effectiveness of the ‘Glucose Buddy’ self-management application in producing relevant health behaviour change outcomes in adults with T1DM and, (iii) to examine the relationship of utilisation of the ‘Glucose Buddy’ application, patients engagement with the application and the level of self-care and glycemic control.

Chronic low back pain is a major public health problem. Antidepressants are one commonly prescribed treatment for low back pain, and are used not only to treat depression and insomnia, but chronic pain. Their use is rapidly increasing, despite lack of supportive evidence and conflicting recommendations from clinical guidelines. Aims: In community-based adults with chronic low back pain, we aim to determine: 1. If low dose amitriptyline (tricyclic antidepressant) is more effective than an active placebo in the management of pain 2. If low dose amitriptyline is more effective than an active placebo in improving disability and reducing work absence and hindrance. Methods: A double-blind, randomized, placebo-controlled trial will be conducted. We will recruit 150 subjects with chronic low back pain. Participants will receive low-dose amitriptyline or an active placebo for 6 months. Pain, disability and work absence and hindrance will be assessed at baseline, 3 and 6 months using valid measures. Implications: If antidepressants are found to be effective, it will provide high quality evidence for their use, potentially enabling this treatment option to be considered by more individuals with chronic low back pain. If we do not find antidepressants to be effective, then this trial will provide strong evidence to review international guidelines that recommend their use and to evaluate the extensive use of tricyclic antidepressants for chronic low back pain.

Crohn’s disease is a lifelong condition with symptoms of abdominal pain, diarrhoea, lethargy, vomiting due to an underlying inflammation of the gastrointestinal tract. This is thought to be mediated via elevation of compounds called inflammatory cytokines. There are other health effects not localised to the gut like growth problems and poor bone health (osteoporosis) which may be a consequence of the underlying disease process itself or the use of medication to treat the disease. Often potent steroid medication like Prednisolone are used to control the disease. Whilst this is an effective form of treatment, steroids can have a range of side effects. Growth failure leading to significant short stature, poor bone health with cases of fractures with little or no injury and fracture in the spine have been reported in these groups of children. These of course lead to significant morbidity in the growing years. Statins like atorvastatin have been shown to have a potent effect in lowering cholesterol levels and preventing heart disease from large scale adult studies. Statins have also been used to treat paediatric patients with inherited reason for their high cholesterol. There is some suggestion that statins may have an effect directly at the inflammatory process independent of the level of lowering of cholesterol level. It is thought that statins can lower the level of inflammatory cytokines. As inflammatory cytokine levels are elevated in crohn’s disease and if statins may lower inflammatory cytokine levels, there maybe a role of statins in the treatment of crohn’s disease in children. There are already animal studies and some adult trials that show that statins may help in crohn’s disease and other inflammatory disease like arthritis. In our study, we aim to recruit 60 children with newly diagnosed crohn’s disease (30 in each group) aged between 8-17 years, randomly assigned to either receive atorvastatin or Prednisolone (which is the usual form of treatment in our centre).The study is for a period of 8 weeks. The study aims to show that atorvastatin is no worse than Prednisolone as a medication for induction of remission in reducing actue inflammation in newly diagnosed children with crohn's disease. Patients will attend the study follow-up at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks after diagnosis. At all of those time points, blood tests will be obtained to assess the inflammatory process, growth factors and bone markers. Faeces will be collected to look at the level of inflammation in the gut. At all those time points, the paediatric crohn’s disease activity index will be obtained and also a quality of life score specific for this population of children. IMPACT-III. At baseline and 8 weeks, an assessment of the child’s state of development (puberty) will also be done. Children will also be asked to self assess their development (puberty) based on validated forms. We hypothesis that statin has an effect on the inflammatory process and will be no worse compared with Prednisolone treatment.

This trial assessed the effectiveness of a Chinese herbal medicine to normalise blood glucose and insulin levels. Participants were randomly divided into two groups. Group 1 received the Chinese Herbal Formula and Group 2 received a placebo which had no treatment effect.

The aim of this research project is to create partnerships with Indigenous local community agencies and three local high schools to increase the physical activity levels, educational interests and goals, and life skills of their Indigenous students. Additionally, this will provide University of Sydney preservice physical education teachers with a sociocultural teaching experience that increases and deepens their competence and knowledge of Indigenous youth, their current health, physical inactivity levels and educational goals.

The study involves double blinded randomised controlled trial, the surgeon is blinded to which local anaesthetic is used and the assessor is also blinded to which agent has been used. Pudendal nerve block is performed by the colorectal surgeon prior to preceeding to perform open haemorrhoidectomy

This trial has two aims: 1. To determine the characteristics of children who have poorly controlled asthma despite optimal management. 2. Whether using an electronic monitoring device (Smart-inhaler) which includes a reminder function and which can be used to provide feedback on adherenve improves adherence with preventive medication.

Approximately 50% of preterm children born very early have problems at school. Difficulty remembering things, using something technically known as “working memory”, contributes to these school problems. Working memory is the ability to temporarily store information for everyday activities. It is critical for learning information and developing basic academic skills. This study aims to investigate if an adaptive working memory training program, known as Cogmed, can improve school performance in very preterm children at 7 years of age. It will also be the first study to incorporate advanced neuroimaging techniques in a randomised controlled trial of Cogmed, and will be essential for determining and monitoring the neural changes that occur as a result of adaptive working memory training.

This study is observing changes which occur to bone density and structure, muscle mass, and glucose metabolism (the way that the body converts sugars to energy), after stroke. We are investigating how these outcomes are influenced by physical activity after stroke. This information will be used in future designs of rehabilitation programs aimed at improving stroke patients' health and recovery.

This RCT examined the effectiveness and safety of herbal medicine in conjunction with lifestyle changes, for overweight women with polycystic ovary syndrome (PCOS). PCOS is a common disorder with 11-21% prevalence in the Australian and other populations(1). PCOS is associated with short and long term health consequences including significantly increased risks for diabetes, cardiovascular disease and cancer. Up to 75% of women with PCOS have underlying metabolic disease(3) and women with PCOS have increased risks for infertility, pregnancy and neonatal complications, hyperlipidaemia, sleep apnoea, anxiety and depression(1). The progression of disease is exacerbated by increased body weight and improved by weight loss (1). The evidence based guidelines for the management of women with PCOS, commissioned by the National Health and Medical Research Council indicates that lifestyle intervention including diet and exercise, is first line treatment for women with PCOS (1), The strength of evidence however is limited by high attrition in RCTs and clinical uptake remains impeded by the lack of evidence for optimal dietary and exercise practices. In addition physical and psycho-social barriers are often observed in overweight women, particularly in those with established obesity(1). Many women use complementary medicines (CMs) (4-5). This study investigated one of the CMs, naturopathy in combination with lifestyle intervention for improved menstrual regularity, and other outcomes. Naturopathy was defined as a new herbal medicine regime including five herbal extracts. Herbal medicine is chemically complex and may improve several aspects of PCOS, however the current evidence base is limited (6). This randomized controlled trial will examine the effectiveness and safety of combined herbal medicine and lifestyle intervention in overweight women with PCOS. 1. AAPCOS. Evidence based guidelines for the assessment and management of polycystic ovary syndrome. March 2011, https://www.nhmrc.gov.au/guidelines-publications/ext2 2. ESHRE. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertility and Sterility. 2004;81(1):19-25. 3. Hart R, Norman R. Polycystic ovarian syndrome – prognosis and outcomes. Best practice & research Clinical obstetrics & gynaecology. 2006;20(5):751-78. 4. Williamson M, Tudball J, Toms M, Garden F, Grunseit A. Information use and needs of complementary medicines users. National Prescribing Service. Sydney: Department of Health and Ageing, NSW Government; 2008. 5. .Arentz, S., Smith, C.A., Abbott, J.A., Bensoussan, A. A survey of the use of complementary medicine by Australian women with PCOS. BMC Complementary and Alternative Medicine 2014 14 (1) p.472 6. Zhang J, Li T, Zhou L, Tang L, Xu L, Wu T, Chinese herbal medicine for sub-fertile women with polycystic ovarian syndrome. Cochrane Database of Systematic Reviews 2010 (9)