ANZCTR search results

The purpose of this study is to investigate the safety, tolerability and effectiveness of pharmaceutical grade cannabis for the management of pain. Who is it for? You may be eligible for this study if you are an adult who has been prescribed NanaBis™ for either cancer-related or non-cancer related pain. Study details All participants will be followed up by their doctors on a monthly basis for 12 months. These follow ups will involve completion of surveys and provision of information regarding the administration of NanaBis™. Participants will not be asked to undergo any procedures or tests as part of this study. It is hoped that this study will help determine whether pharmaceutical grade cannabis is an options for pain management.

Limited health literacy has great impact on patient health outcomes; poorer knowledge of disease is linked with suboptimal self-care, reduced treatment adherence and increased use of emergency services. Studies conducted to assess health literacy and patient understanding amongst patients living with chronic hepatitis B (CHB) have revealed gaps in disease-specific knowledge. Despite this, there are few studies evaluating strategies to improve patient knowledge of hepatitis B. The 'teach-back' strategy is a communication tool that has been shown to be successful in improving disease-specific knowledge in other areas of health. 'Teach-back' ensures the health provider checks for understanding with patients and then allowing opportunity for clarification. This study hypothesises that there is a poor baseline understanding amongst patients living with CHB and that the teach-back method will improve disease-specific knowledge. This would form the foundation for future studies to evaluate how improved understanding translates into greater health outcomes.

Childhood inattention has been linked with poor academic outcomes, as well as increased risk of social, occupational and psychological problems later in life. Children with an Acquired Brain Injury (ABI) are particularly susceptible to attention deficits following their injury and may benefit from interventions aimed at enhancing attention. Training Attention and Learning Initiative (TALI Train), an adaptive cognitive training program, is a novel approach to improving attention capacity in young children. The impetus to develop this training program came from both the lack of suitable non-invasive, non-pharmacological treatments for young children with attention difficulties, and mounting evidence that targeted training can have a positive lasting impact on cognitive functions. TALI Train is yet to be trialled in children with an ABI and as such, its efficacy in this group is unknown. The primary objective of this study is therefore to evaluate whether the TALI Train program is able to reduce attention difficulties in children with an ABI. It is hypothesised that the training intervention will promote greater gains in cognitive attention (selective, sustained and attentional control) than the active control program. Secondary objectives include assessing comparative effects of the intervention and active control program on untrained areas including academic achievement, working memory and social functioning. In addition, this study will examine the potential predictors of training outcomes in children with an ABI including baseline attention abilities, the family environment, socioeconomic status, and parental mental health. Participants in this double blind, randomised controlled trial will be children with an ABI, aged between 4 years and 9 years 11 months. They will be randomly allocated to either (a) TALI Train (intervention group) or (b) an active control group using a program that is non-adaptive and has limited attention training potential. Both programs are delivered on a tablet, and children complete one 20 minute training session at home five times a week for a five week period. The efficacy of TALI Train compared to the placebo program will be assessed at pre-training and post-training, as well as at a 3-month and a 6-month follow-up.

Just over 180,000 people in Australia are living with chronic hepatitis C (CHC) and at risk of liver disease, liver cancer and death. Since 2016, medicines for CHC can be prescribed by GPs, which cure >95% of patients and prevent ongoing liver damage. So far 10% of GPs in Australia have prescribed CHC medicines, but to meet World Health Organisation targets for hepatitis C elimination all GPs will need to identify patients in their practice with the disease and recall them for treatment. NPS MedicineWise has developed an educational intervention delivered by their field force of clinical service specialists (CSS) to general practice staff to support GPs in the diagnosis and management of CHC. The intervention includes a 1-hour educational small group meeting at the general practice, a personalised ‘audit and feedback’ report from the MedicineInsight program, that includes data specific to their practice, benchmarked against all practices, and an online audit tool. The intervention aims to raise awareness, provide education and increase confidence in management of CHC, as well as facilitating links between GPs and specialists who can provide approval for treatment and support GPs while they increase their experience in CHC management. During the 1-hour meeting, in addition to discussing the feedback reports, the education will include a case study, educational materials developed by ASHM, and an action sheet completed by the CSS during the visit. The intervention also includes encrypted patient lists from MedicineInsight identified as requiring follow-up at the practice. This cluster randomised controlled trial will evaluate whether the NPS MedicineWise educational intervention, with data-based insights from MedicineInsight, is effective at improving case finding, assessment and treatment of patients with CHC. We will test the hypothesis that compared to control practices, those practices randomised to receive the NPS MedicineWise educational intervention will have a higher number and proportion of patients with CHC initiating direct acting antiviral (DAA) therapy and a higher number of patients being tested with an HCV (hepatitis C virus) RNA PCR test for diagnosis. Data will be evaluated using the general practice data program, MedicineInsight. MedicineInsight is a leading large-scale primary care data set of longitudinal de-identified electronic health records (EHR) used for quality improvement and research. The results of this trial will help inform future initiatives in Australia as well as internationally to continue the treatment momentum to help eliminate CHC.

The aim of this randomised control trial is to evaluate the effectiveness of methods to recruit schools to an app-based nutrition program, called SWAP IT. The trial will evaluate whether recruitment via invitation emails from the app provider, Skoolbag, is as effective as usual recruitment via a Health Promotion Officer employed through the state health department. The trial will run for approximately 4 weeks. 76 schools in the Hunter New England region will be randomly allocated to the intervention (Skoolbag recruitment) or control (usual methods). The trial aims to provide evidence to inform recruitment methods for broader dissemination if the program is deemed to be effective.

This project aims to evaluate the impact of an intervention designed to improve activation on patient outcomes and investigate whether activation levels of patients on haemodialysis change overtime. This study will involve adult participants 18 years and over who are new to haemodialysis and commence at Monash Medical Centre. It will be a single centre, prospective participant blinded randomised controlled trial with 18 months follow up. Participants will be randomly distributed into a control and an intervention group.

Trauma focused cognitive behavioural therapy has long been the standard approach for the treatment of posttraumatic stress disorder (PTSD). Cognitive Processing Therapy (CPT) is a manualised treatment protocol based on a cognitive behavioural therapy approach, typically delivered over 12 sessions. Whilst CBT approaches have good efficacy in the treatment of PTSD, the non-response to treatment and dropout rates remain substantial. In military clients, between 20-30% will drop out of treatment prematurely and 40-64% will fail to lose their PTSD diagnosis by the end of treatment (Forbes et al., 2012; Resick et al., 2015, 2017). This research utilises a flexible adaptation of CPT which individualises therapy based on the needs of the client and allows for deviation from the standard treatment protocol. It is hypothesised that this approach will result in less dropout and better good end-state functioning.

The National Comprehensive Cancer Network guidelines now suggest testing all men with metastatic prostate cancer for germline mutations predisposing to cancer, the purpose of this study is to determine whether this kind of testing is acceptable to patients with prostate cancer. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with prostate cancer. Study details: The study involves having a discussion with a member of your treating oncology team about genetic testing for an inherited gene that may have predisposed to developing prostate cancer. If you agree to the testing, we will collect a saliva sample and send it for testing. The results will be available in about 4 weeks. If your result shows a change in one of the genes that we are testing for, that may have contributed to your development of prostate cancer, then we will refer you for a consultation with the Familial Cancer Service. After your oncologist provides you with the test result, we will provide you with a questionnaire, asking you about your opinion on the testing process. It is hoped that this study will help determine if the testing process is acceptable to patients with prostate cancer.

Good sleep is essential for normal daytime functioning and health and effects of sleep disorders and sensory disturbances such as traffic noise on sleep quality and health outcomes are well known. Expansion of wind farm facilities in Australia has been associated with widespread community complaints regarding sleep disturbance and adverse health effects potentially attributable to wind farms operating in a normally quiet rural environment. Wind farm noise exposure, including audible and potentially inaudible low frequency components, clearly has the potential to adversely affect sleep, health and well-being through two main plausible and inter-related mechanisms; chronic sleep fragmentation from frequent physiological activation responses to sensory disturbances in sleep, and chronic insomnia which could potentially develop more gradually over time in sensitised individuals. However, as outlined in the NHMRC rapid review of the evidence, data from well-designed studies using objective measures of sleep and sound are remarkably lacking and are clearly now needed to definitively establish the sleep disruption characteristics of wind farm noise compared to other noise disturbances in sleep. This project will, for the first time, use direct electroencephalographic (EEG) and cardiovascular measurements to systematically evaluate the sleep disruption and physiological activation response characteristics of wind farm noise during sleep. Groups of individuals with and without prior wind farm noise exposure will be studied in carefully controlled laboratory conditions using pre-recorded and accurately-reproduced wind-farm noise, including and excluding low frequency components and infrasound. Dose-response characteristics will also be evaluated against more ubiquitous traffic noise in sleep. Potential predictors of sleep disturbance responses such as sensory acuity, annoyance and physiological activation response to noise presented during wakefulness will also be evaluated.

Research focusing on frailty in residential aged care services (RACS) is sparse. A better understanding of the relationship between frailty progression, residents’ use of life space and their perspectives on quality of care, combined with residents’ health data will help to better determine the progression of frailty, its associated health outcomes and costs, and assist in developing interventions that could improve the health circumstances of residential aged care residents in the long term. The aims of this study are: 1. To confirm the validity of the FRAIL-AC in comparison to the FRAIL-NH and 66-Item FI 2. To describe the trajectory of frailty and its relationship with factors such as malnutrition, mobility, qualify of life, quality of care, dementia, sleep, activities of daily living, strength and pain 3. To investigate the association between frailty, hospitalisation, emergency department presentations and mortality via data linkage Hypothesis: We have recently investigated the frailty trajectory of older people living in the community and have demonstrated that frailty levels are dynamic with improvement and stability possible. Through this study, we aim to investigate if similar findings are present within RACS. We hypothesise that frailty and its trajectory may be associated with characteristics of the care provided in RACS to older adults.