ANZCTR search results

This project aims to test a comprehensive clinical approach to reducing cardiovascular risk in patients with severe mental illness. Alarming as it is that people with severe mental illness (schizophrenia, schizoaffective disorder, bipolar disorder, depressive psychosis) have 13-30 fewer years of life expectancy than the rest of the population, of even greater concern is that this gap is widening. Most deaths in this group are from chronic physical illnesses especially cardiovascular disease. Guidelines on identifying and managing physical health risk factors are available but poorly implemented. The problem lies at the disjuncture between mental and physical illness. Mental health services do not routinely focus on the physical health of their patients, partly because they do not have clinical systems to integrate physical and mental health and primary care likewise. Similarly, patients have limited access to services and motivational interventions whose focus is to address physical health in the context of complex psychosocial issues. Our research team has used a rigorous process, including extensive piloting, to develop an intervention which delivers recommended physical health care to reduce cardiovascular risk and improve quality of life. Components of this intervention are integrated using the Flinders Program of chronic condition management which places the patient at the centre of their care and provides a recovery-oriented framework. The first project aim is to use a randomised trial to evaluate the effectiveness and cost-effectiveness of the intervention. The main outcome measures will be cardiovascular risk and quality of life. Patients will be recruited from the SA state clozapine register and psychiatric clinics. The second aim is to identify essential components, enablers and barriers at patient, clinical and organizational levels for national sustained implementation of recommended physical health care delivery to people with severe mental illness.

This study aims to evaluate the safety of nivolumab for relapsed or residual haematological cancers after blood or bone marrow transplantation Who is it for? You may be eligible to join this study if you are aged 18 years or above and have confirmed relapse or persistent haematological malignancy post allogeneic transplant. Study details All participants in this study will be administered a drug called nivolumab every 2 weeks for up to 48 weeks. Each time you will receive the same dose (3mg/kg) intravenously (through a vein). Assessments will be carried out throughout the 48 week period to evaluate occurrence of graft versus host disease and to measure tumour response to nivolumab therapy. Study significance There is a lack of effective treatment for relapse or persistence of haematological cancer after allogeneic transplant. This study will investigate a promising new approach to treat cancer for these patients, by using the harnessing the immune system to eliminate cancer cells.

An initial RCT undertaken by us in 2014 (N = 308) and a follow-up RCT undertaken in 2015-2016 (N = 557) investigated mindfulness with Year 8 students in Adelaide schools. We used a UK based 9-week mindfulness curriculum with lessons once per week (40-60 minutes). Surprisingly, we were unable to replicate promising findings from a controlled (but not randomised) trial using this programme (Kuyken et al., 2013) which found improvements in wellbeing, stress and depression that lasted for 3 months following the intervention. Our pilot trial has been published (Johnson, Burke, Brinkman and Wade, 2016) and the larger follow-up trial is currently under review. We hypothesised that the programme might have been too brief for the ideas to sink in, and that there might not have been enough practice in class of the meditations, relying too much on home practice (which was invitational). We also wondered if Year 8s might be too young to appreciate the relevance of these emotional tools given that they hadn't yet hit some of the increased stresses and strains of mid-late adolescence. Therefore, we are testing these ideas in the current RCT We will substitute an alternative, Belgian programme, which recently found both treatment and prevention effects for depression which lasted for 6 months in adolescents aged 13-20 in a school setting (Raes et al., 2014). This programme, which has just been translated into English, runs for a similar number of weeks (8) but has longer lessons (75-100 minutes weekly) allowing more time for guided practice in class (rather than relying on home practice), plus expanded opportunities for discussion and application to real-life scenarios. We will test this across three age groups (Year 8, mean age 13.5;Year 10, mean age 15.5; Year 12, mean age 17.5) to expand our investigation into whether the mindfulness approach operates differently within adolescent age bands. This will have direct relevance for where to insert these curricula in the school journey for maximum effect. Research Objectives 1. To examine the efficacy of an alternative curriculum (Mindfulness for Teens) on anxiety, depression, eating disorder risk factors, wellbeing and different facets of mindfulness 2. To investigate whether age affects these outcomes (i.e., are mindfulness programmes more effective at certain ages during adolescence?) 3. To investigate whether mindfulness programmes operate via different mechanisms according to stage of neurocognitive development (i.e., do we need to emphasise different components at different ages?)

Cricket is the most participated summer sport in Australia. It has increased in popularity over the past decade with the Twenty20 cricket rising as the most popular form. There is growing evidence that the injury rates in junior and amateur cricketers are higher as compared to professional cricketers. Yet, at the community level there are no standardized cricket specific injury prevention programs. Other sports such as Soccer, Rugby, AFL, Basketball, etc. all have implemented such programs at community level. Soomro et al 2016. showed that injury prevention programs (IPPs) are an effective tool to help reduce injuries in adolescent team sports. The pooled analysis of over 100,000 athletes in this study showed that IPPs reduced the risk of injury by 32%, Injury rate ratio (IRR = 0.68, 95% CI = 0.54-0.84, p <0.05). These programs reduce injury risk by improving neuromuscular strength, agility and limb coordination with a combination of strength, plyometric and balance exercises. Since majority of cricket injuries are of non-contact origin and concentrated around soft-tissues, therefore exercise based interventions and improvement of players’ fitness through appropriate training has been suggested to reduce such injuries. IPPs have been shown to improve strength ratios, thus reducing another contributing factor i.e. strength imbalance from the injury etiology. Considering the overwhelming evidence on the efficacy of IPPs, the development, implementation and clinically validating cricket specific IPP may potentially assist in reducing cricket related injuries.

Background: This NHMRC funded project (2016-2019) will address the fundamental lack of knowledge regarding the brain structure and function responsible for aphasia recovery and determine the best predictors of language improvement and treatment response in the sub-acute phase of brain recovery. Aims & Method: The specific aims of this research are to (1) Identify changes in brain activity from sub-acute to chronic phases in response to naming treatment versus usual care (2) Determine whether subacute brain activity predicts subsequent language recovery and successful treatment (3) Determine structural predictors of language recovery and treatment response (4) Develop a machine learning algorithm that accurately identifies individual patients who will recover language and make significant improvements. 90 participants with post-stroke aphasia will be scanned (at Herston Imaging Research Facility, RBWH campus) and tested on a battery of language tests at the sub-acute stage (1 month post-onset), then assigned to 8 weeks (3 times per week) naming and language treatment versus usual care and then scanned and retested at 3 and 6 months post-onset. 25 healthy older control participants will also be recruited and scanned. Outcomes: Using state-of-the art imaging techniques together with clinically meaningful markers of language function, this research will test for the first time whether brain structure and function in sub-acute stroke can reliably predict the recovery of specific language functions and treatment response.

This research study is testing the safety, tolerability and pharmacokinetics (looking at the amount of drug in your blood to evaluate the way the body processes the drug) of ABI-1968 Topical cream delivered to the cervix by intra-vaginal application. In this study, a total of 40 participants will be enrolled over 5 dosing groups/cohorts with each cohort consisting of 8 people – 6 will receive the active drug, and 2 will get placebo. Participants will be randomly assigned to receive either the active drug or placebo (a ‘dummy’ topical cream that looks identical, but contains no active drug). Participants will have a 75% chance of receiving study drug and 25% chance of receiving placebo. The study drug (or placebo) will be administered as a topical cream to the cervix by intra-vaginal application by the Gynecologist. No participant will be a member of more than one cohort. This study is a dose escalation study meaning that the first cohort will receive the lowest dose of study drug. The dose of study drug will increase with each subsequent cohort. Results will be reviewed by a safety monitoring committee after each dose strength has been tested to make sure that it is safe to continue with testing in the next cohort. The next cohort will not be enrolled until the safety monitoring committee have confirmed it is safe to do so. The study can be stopped at any time, based on evaluation of the side effects of the study drug. The five different dose strengths planned for this study are 0.01, 0.03, 0.1, 0.3 and 1.0 % by weight, applied as a topical cream via a single-use graduated applicator which delivers an approximate 2g dose. During this study, it is possible that the strengths may be reduced, repeated or increased; however, 1.0 % is the highest dose that will be given. Participants will not have a choice as to which cohort or dose level they are assigned (randomised) to, with each cohort enrolled on a first eligible basis. The participant and the study staff will not know if the they are assigned to receive the active study drug or the placebo, although in an emergency the study staff can find out. The first cohort will have 2 ‘sentinel’ volunteers; one will receive the active drug, the other the placebo. These individuals will receive the study drug (or placebo) approximately 24 hours before the rest of the cohort. Participants will be told if they are assigned to the sentinel cohort.

Cognitive impairment, as experienced in people with Alzheimer’s Disease, a common cause of dementia, is an important factor leading to driving cessation. Making decisions regarding fitness-to-drive based on a diagnosis of dementia or dementia severity alone in the absence of rigorous assessment can lead to premature driving cessation or continuation of unsafe driving. Many people who are suspected of having, or have a new diagnosis of Alzheimer’s Disease, are referred for an occupational therapy driver assessment. While a portion of drivers with early Alzheimer's Disease will need to relinquish driving, there is also a need to support those who can drive safely to continue to do so for as long as possible. Since driving is an over-learned skill, it may be possible for some individuals with Alzheimer’s Disease to continue to drive safely for some time after a diagnosis and undergo periodic re-assessment to ensure the continued safety of the individual and the community. A driving assessment involves both off-road and on-road components. The purpose of the off-road component is to identify strengths and weaknesses that may impact on driving and to screen out clients who are unsuitable to progress to an on-road assessment. During the on-road assessment, an occupational therapy driver assessor observes driver behaviour and performance. The outcome for the purpose of this research is classified as pass or fail. While some people with Alzheimer’s Disease may perform poorly on the unfamiliar (open/standard) test route, performance may be significantly improved if tested in their local area leading to a recommendation for local-area-only licence. Drivers who do not pass an open area assessment may therefore undergo a local-area-only licence. There is little research evidence concerning the performance of drivers with Alzheimer's Disease on initial versus subsequent testing and if improved performance is related to the area the assessment is undertaken in, or related to a practice effect. Additionally, it’s not clear if performance in both these testing locations is affected by whether the client has navigational problems. Clients tested in their local area need to self-navigate. However, clients tested in an open area are generally directed by the driving instructor. This study determined the effect of: (1) location of assessment and ordering of the tests (local area test first or second); (2) opportunity to undertake a second test, and; (3) navigational difficulties on the performance of people with Alzheimer’s Disease on an on-road driver assessment.

The insertion of peripheral intravenous catheters (PIVC) or cannulas for intravenous treatment and venepuncture for blood sampling are common in modern health care. However, difficulty in obtaining successful access is common and patients may undergo repeated attempts. This difficulty results in high costs for health care organisations and distress for patients (Sharp et al. 2014; Robinson Reilly 2015). Successful attempts may be influenced by both the size and the depth of the vein (Witting 2010; Kimori 2016). Clinicians often apply heat to the area and encourage fluid intake to increase vein diameter and make veins more superficial so as to improve venepuncture success (Fink 2009). However, these interventions are based on limited evidence. Existing research about the effect of hydration on the size of veins used for venepuncture and PIVC insertion is scant. No existing research could be identified that has investigated the effect of heat or hydration on the distance of the vein from skin surface. Hypotheses: - Heat and hydration will increase vein diameter - Heat and hydration will decrease vein depth

What is the study purpose? The purpose of this study is to investigate whether a specially-designed hip brace is effective for treating hip impingement. We hypothesise that the hip brace will help alleviate hip pain for people with hip impingement. What does the study involve? Participation in this study goes for six weeks. This type of study is known as a ‘randomised trial’. Since we don’t yet know whether the hip brace is effective in treating hip impingement, we need to compare it to the usual treatment people receive. To do this, study participants are put into two groups: one group using the hip brace as well as the normal treatment their doctor would recommend, and the other group just having the normal treatment their doctor would recommend for hip impingement. To ensure the groups are similar to start with, a computer allocates each study participant into a group randomly, like the flip of a coin. Participants will fill out questionnaires about their hip symptoms before beginning the study, and then also fill out the questionnaires after six weeks, allowing the researchers to compare results between the two groups to see which treatment is better. Here is some further information about each of the two treatments : 1. Treatment with the hip brace The hip brace is a new device that has been designed by Ossur, a company that develops and manufactures non-invasive orthopaedic equipment. The brace has been made for people with hip impingement, with the purpose of reducing their hip symptoms. There has not been any previous study on the effectiveness of this hip brace for hip impingement, so we don’t yet know if it is effective or not. People allocated to receive treatment with the hip brace can still continue with the normal treatment for their hip recommended by their doctor. However they cannot have surgery during the six weeks of the study and cannot start any other new treatments that their doctor has not recommended. Participants allocated to the hip brace gorup will receive the hip brace at no cost to them, and will be free to keep the hip brace after the study is over. 2. Normal treatment Participants allocated to receive normal treatment will be asked to simply proceed with the normal treatment that your doctor recommends for your hip impingement (apart from surgery). Participants allocated to normal treatment will not be given a hip brace to use. All people participating in this study will go for an EOS scan (a special type of low radiation dose X-ray). This will help the researchers to measure the extent of each participant's hip impingement.

This study aims to contribute to the improvement of the general health of young people affected by schizophrenia, bipolar disease and/or major depression. This model of nutrition and health education is likely to influence the high risk of comorbidities that are known to be related to treatment with the newest psychotropic medications in severe mental illness. Obesity is the key risk factor predisposing to the development of metabolic syndrome, exacerbated by the lack of physical activity seen with these patients. The prevention of the development of obesity among these young people is paramount in order to enhance their physical and mental well being. Educating in isolation is not sufficient to alter outcomes in these patients who require additional support. Family or carers, hence, are key players in the education of their young relatives or clients. This study aims to establish firm strategies for motivating young people to change their lifestyle by empowering them with knowledge and realistic skills to put into practice for the benefit of their physical and mental health. It is hoped that this can be achieved via the development of health literacy and nutrition education programs which are not only low cost but highly effective.