ANZCTR search results

The objectives of this research project are to: (1) identify levels of distress in patients on a waiting list for total joint arthroplasty (TJA), and (2) to determine whether administering an eight-session group mindfulness training intervention prior to surgery will improve the physical recovery of patients undergoing TJA. It is hypothesized that (1) levels of pain will be adversely associated with depression, anxiety and lower Quality of Life; (2) the intervention will lead to better tolerance of symptoms, and improved quality of life. Mindfulness is “the awareness that emerges through paying attention on purpose, in the present moment, and non-judgmentally to the unfolding of experience moment by moment”. Training involves instruction in a number of meditation techniques as well as teaching on how to remain focused on the present moment in day to day activities. There is now extensive scientific evidence showing that mindfulness training leads to an improvement in emotional and physical symptoms in a variety of disorders such as chronic pain, cancer, depression, anxiety and substance use among others. We propose to undertake a 3 year randomised controlled trial in patients with end stage osteoarthritis on the waiting list for TJA. The study will recruit 150 patients and randomly allocate them to receive the current standard of care for TJA or a combination of Mindfulness training (MT) followed by TJA. We plan to measure pain, function, quality of life, coping and mental health via validated questionnaires, as well as the cost effectiveness of a strategy that combines MT and TJA, compared to TJA alone. These measures will be taken prior to surgery and at 3 and 12 months post TJA surgery. Participants will all be followed for one year at which time the benefits in terms of health improvements after TJA will be, compared.

This project will be the first high quality clinical trial comparing two conservative physiotherapy management approaches for anterior shoulder dislocations (ASDs) using reliable measures of shoulder function and re-dislocation as outcomes. This project will also contribute to the research in immobilisation positioning for patients with ASD and will provide further direction on the implications of conservative management versus surgical intervention for this population. The incidence of ASD has been estimated at approximately 1.7% of the population and the consequences of traumatic shoulder dislocation and re-dislocation include loss of work productivity, ongoing loss and limitation of shoulder function and sporting activities, and degenerative arthropathy, all contributing to great cost for the patient and community. The findings of this project will benefit patients, orthopaedic specialists, emergency department specialists, general practitioners and allied health personnel who deal with this frequently seen condition and consequently reduce the significant costs associated.

The aim of the study is to understand the role of endogenous opioids ( the body's own morphine-like chemicals) in regulating breathlessness in people with Chronic Obstructive Airways Disease and to answer the question "Does blocking these endogenous opioids during exercise change the perseption of breathlessness. Trial details Participants with moderate to severe Chronic Obstructive Pulmonary Airways (COPD) disease, if eligible will be asked to attend the clinic up to 5 times over the study period and each visit will take about 2 hours. After a baseline exercise test on a treadmill participants will have 4 subsequent standardised treadmill exercise sessions.Each test will comprise of up to 15 minutes on the treadmill with the aim of walking as far as possilbe at a steady pace. Visits will be weeklyand a doctor and nurse will be present at all times during the proceedure. Bloods will be taken on visit 3 to measure two chemicals that the body routinely makes- beta endorphin and adrenocorticotrophin. 30 minutes before each exercise test the participant will be administered 5mg of salbutamol through an inhaler. On the 3th,4th and 5th exercise test participants will receive a double blind injection on different visits of each of saline, methylnaltrexone and naloxone, in a random ( by chance) order. During the 15 minute exercise tests, participants will be asked to record the intensity and unpleasantness of their breathlessness and how tired their legs feel, every minute by means of a touch pad screen. Throughout each test and for 30 minutes after stopping the participant will be attached to cardiac monitor and their blood pressure will be monitored regularly.

Mental Health First Aid Mental Health First Aid is defined as the help provided to someone who is developing a mental illness or experiencing a mental health crisis. The assistance is given until appropriate professional help is received or the crisis resolves. Mental Health First Aid training is provided to members of the public so that they can learn how to effectively and confidently assist those with mental health problems. The Mental Health First Aid Training Program (MHFA) has been running since 2002 and has trained over 85,000 Australians in how to respond to mental health problems, via a 12-hour training course, which is run in an interactive, group format. Development of First Aid Guidelines Over the last 3.5 years a series of guidelines for providing best practice mental health first aid have been developed by MHFA. These guidelines are based on the expert opinions of panels of mental health consumers, carers and clinicians from Australia, Canada, Ireland, New Zealand, the UK and the USA. Since developing these expert consensus documents, the MHFA program has begun to revise its training course and teaching materials to reflect the new evidence they provide. Purpose of this research Guidelines on providing first aid for eating disorders were developed in 2007 and published in 2008. Because these guidelines are the first ever to provide consensus-based information about how to assist someone who may be developing or experiencing an eating disorder, we would like to gather some feedback from community members about how helpful they are.

The Arthroplasty and Bariatric Surgery (ABS) study intends to examine the clinical outcomes and cost effectiveness of preceding total knee replacement (TJR) with laparoscopic adjustable gastric banding (LAGB) in a randomised controlled trial (RCT). This will be a 4 year multi-institutional randomized controlled trial in severely obese patients with end stage osteoarthritis. The study will recruit 120 severely obese people with osteoarthritis who are on the waiting list for TKR and randomly allocate them to receive the current standard of care for TKR or a combination of LAGB followed by TKR. We plan to measure weight loss, pain and function, quality of life and complications, as well as the cost effectiveness of a strategy that combines LAGB +TKR, compared to TKR alone. Participants will all be followed for one year at which time the benefits in terms of, weight loss, clinical and health improvements, adverse events and costs would be measured.

After arrival in Western Australia resettled refugees undergo an initial health assessment that includes testing for 25(OH) vitamin D. An internal audit in 2007/8 revealed that of the 2400 patients assessed, 45% were vitamin D deficient (25(OH)D:<27.5 nmol/L) and 54% insufficient (25(OH)D:27.5-78 nmol/L). The use of high-dose depot vitamin D therapy is increasing, but there are few data on its use in children. OBJECTIVE: To compare the efficiency and safety of daily versus depot oral vitamin D supplementation in refugee children METHODS: Refugee children aged 0-16 years with 25(OH)D levels <78 nmol/L were recruited through a refugee tertiary clinic and randomized as follows: those with vitamin D deficiency received either vitamin D3 200,000 IU depot or 5000 IU daily and those with vitamin D insufficiency 100,000 IU depot or 2500 IU daily. 25(OH)D measurement was repeated 6-8 and 14-16 an 22-24 weeks later and treatment continued if levels were <78 nmol/L. Other biochemical parameters included calcium and alkaline phosphatase (ALP). Data on sun exposure, season , diet, country of origin and skin pigmentation were collected. RESULTS: A first analysis looking at 84 subjects with complete data sets revealed significant improvements in 25(OH)D between visits (p<0.05) without difference between depot and daily treatment groups. Sun exposure and oral calcium intake were very low. The study is ongoing. CONCLUSIONS: Supplementation with both daily and depot vitamin D3 resulted in similar improvements and could normalize vitamin D levels during the initial treatment phase. Depot vitamin D3 therapy was a safe and well accepted therapeutic option. It was difficult to achieve long term improvement even under controlled conditions. Support by public health initiatives is required.

This randomized comparison trial will test the efficacy of a novel rehabilitation (MiTii: Move it To improve it) which involves the use of a web-based, intensive and individualized, multimodal therapy program with therapists acting as 'virtual trainers', over a 20 week period, and comparing this approach to standard care received in children with congenital hemiplegia.

This research project is aimed at people who have known cancer of the pancreas, who may have symptoms or signs of pancreatic exocrine insufficiency (PEI). Pancreatic exocrine insufficiency (PEI) occurs when diseases of the pancreas prevent it from functioning properly. In the healthy state the pancreas releases substances in into the intestinal system to breakdown ingested fats. In patients with cancer of the pancreas this process can be impaired due to blockage of the pancreatic duct or due to poor function of the pancreas. This means that some patients with pancreatic cancer cannot breakdown fats and so they cannot absorb fats from their food. This results in: - Weight loss - or inability to gain weight - Non-absorption of essential vitamins found in fats (for example vitamin A, D, E and K) - Unpleasant fatty diarrhoea which is frequent, foul smelling and difficult to flush Pancreatic enzyme replacement therapy (or PERT) is a medication that these patients can take which replaces the most important of the body’s natural pancreatic enzymes and therefore allows better breakdown and absorption of fats. This helps patients with pancreatic cancer to maintain a healthy weight, and have reduction in the unpleasant side effects of frequent diarrhoea. This is important for this patient group as it reduces time spent in hospital towards the end of their life due to complications arising from low weight and malnutrition and improves their quality of life. Good nutrition is also important if patients are going to be able to tolerate other treatment, for instance chemotherapy. This research project will involve patients with known cancer of the pancreas. They will be randomly allocated into two groups. Each group will be given a supply of tablets, to be taken at home for a period of 4 weeks. Neither group will know what medication the tablets contain. Group A will receive PERT tablets, and group B will receive a placebo tablet (meaning a completely harmless tablet with no medication in it). The patients will be required to keep a bowel chart whilst taking the medication. Patients will be able to contact a dietician for support if they require it throughout the 4 week period. Both at the start and at the end of the 4 week study period, patients will be weighed, and they will also have their stool tested. The stool testing requires two samples only (i.e. One at the start and one at the end of the study period), and can be done at a time which is convenient for the patient. Patients will also complete a questionnaire relating to their quality of life, both before and after the 4-week medication period. PERT medication is already used to help alleviate some of the unpleasant symptoms associated with pancreatic cancer, however not all doctors prescribe it routinely. The results of this study may support or refute its use in patients with pancreatic cancer, and will therefore give doctors good evidence for prescribing or not prescribing PERT to help their patients with this condition.

This study is a randomised controlled trial to evaluate the safety and pharmacokinetics of a single intravenous dose of the new drug GB221, compared to the drug Herceptin (also known as trastuzumab, Registered Trademark) in healthy volunteers. Who is it for? This trial is open to males aged between 18 and 45 years of age, with additional details listed in the Inclusion Criteria section of this form. The trial has been designed to look at how safe and well-tolerated GB221 is when administered to humans intravenously as compared to Herceptin Registered Trademark. The study will also look at how quickly GB221 is absorbed into the blood, how much of it is absorbed and how long it takes to body to remove it (this is known as the study of pharmacokinetics) when compared to Herceptin (Registered Trademark). You will be randomised to one of two intervention arms, where in one arm you will receive a dose of the new investigational drug being tested, GB221, administered as a single IV injection (8mg/kg) over 90 minutes. In the other arm, you will receive Herceptin (trastuzumab) at a dose of 8mg/kg administered as an IV infusion over 90 minutes. 10 weeks following this intervention, you will be assessed on various safety outcomes to determine the usefulness of the drug.

Participation in physical activity (PA) helps relieve side effects of prostate cancer treatment, reduces depression and anxiety, enhances quality of life and importantly, improves prostate cancer (PCa)-specific survival. There are few existing exercise programs to promote and support behaviour change designed specifically for this cohort and the few available are generally not home-based or widely available. The intervention proposed here addresses these challenges in a cost-effective manner.