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Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS)
About 1 in 3 stroke survivors experience an emergency presentation or unplanned readmission within 90 days of discharge from hospital. Unplanned readmissions are associated with poorer quality of life, depression and poorer functional status. In addition to the impact of hospitalisation on survivors and their families, there is a substantial economic impact. While the factors precipitating an unplanned readmission are complex, common precipitating factors include: poorer mental health, poorer functional status, and infections. These factors are related to poor preparation of survivors and their carers for the transition from hospital to home; and a lack of ongoing support to assist with self-managing the sequelae of stroke. Methods: Randomised controlled trial to assess the impact of an innovative dischagre support program comprising (a) standardised goal setting prior to hospital discharge plus (b) integrated e-health self-management support, to reduce unplanned presentations/ readmissions among survivors of stroke within 90 days. Significance: This will be the first adequately powered and rigorous trial of an e-health intervention to improve discharge care and support. Findings will be important nationally and internationally, for all adults discharged from hospital with a newly-acquired disability, not just survivors of stroke.
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Individualised yoga for burnout and traumatic stress in junior doctors.
We conducted a randomised, controlled pilot trial of individualised yoga, compared to group-format fitness, to assess the feasibility, acceptability, and effectiveness of these interventions on symptoms of burnout and traumatic stress on junior doctors at a Sydney metropolitan hospital.
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Home-based occupational therapy for adults with both Down syndrome and dementia and their caregivers
Dementia is a major global health problem for ageing adults with Down syndrome. Almost all adults with Down syndrome are prone to develop dementia as early as 40 years of age. Dementia in adults with Down syndrome causes progressive loss of cognitive skills impacting daily functioning, thus escalating caregiving responsibilities for their informal caregivers. This study examines whether home-based occupational therapy interventions can optimise functioning in daily activities for adults with both Down syndrome and dementia and reduce caregiving strain for their informal caregivers. Three participants with a diagnosis of both Down syndrome and dementia and their informal caregivers living in their own homes with their informal caregivers, or living in close proximity to informal caregivers who provide daily care and support will be invited to take part in this study. The study will have three phases (A-B-A)[ (A =baseline phase with no intervention), (B=intervention phase) and (A=follow-up phase with no intervention)]. Occupational therapy interventions will be client-centred and tailored to meet meaningful goals of the participants. These interventions will be provided by a qualified occupational therapist with previous clinical experience in neurological rehabilitation.
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Sleep in Pregnancy Pilot Trial
This trial will test whether advice alone compared to advice and a pillow device best supports non-supine sleep using the Night Shift as an objective measure of both sleep duration and position. This design could also be employed in the future for a roll out of sleep position interventions, but crucially the optimum intervention would need to be properly validated, which is what this trial aims to do.
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Single Ascending Dose Study to Evaluate the Safety and Tolerability of LPT99 Administered to Healthy Adult Subjects
This is a randomized, double-blind, placebo-controlled, parallel-group, single ascending dose study in healthy subjects. LPT99, the study drug is an Apaf1 inhibitor that can permeate the cochlea. LPT99 is being developed as a locally administered otoprotective agent that would specifically block apoptosis in the ear without interfering with anti-tumor activity of the platinum-based chemotherapeutic agent delivered systemically. There are four sequential doses: 25 µg (200 µM), 50 µg (400 µM), 75 µg (600 µM) and 100 µg (797 µM). Approximately 32 healthy male and female subjects with normal baseline hearing will be enrolled, with 8 subjects planned for each dose cohort. Each Subject will receive a dose of LPT99 or matching placebo by transtympanic (TT) administration. In all subjects, study drug will be unilaterally delivered (ie, 1 ear will remain untreated, serving as the control ear for that subject). The study will include sentinel subjects in the initial cohort and all subsequent dose escalation cohorts.
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Facing Clinical Trials - Unlocking facial clues
The project team, including computer analysts and expert clinicians, will refine and continue to develop facial analysis tools using precise 3-dimensional photography to develop ways to assess treatment response. The hypothesis is: Subtle facial changes associated with treatment response can be assessed and measured by 3D facial analysis
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Giving patients back the blood that they lose during surgery: Does this impact their immune system?
Blood collected from volunteers, also known as allogeneic blood, is donated, processed and made available for patients requiring transfusion, such as during surgery. This is an expensive process; according to the National Blood Authority, the estimated cost associated with blood transfusion in Australia is over $1 billion per year. While the safety of allogeneic blood transfusions has improved over decades, life-threatening risks remain. For example, 617 transfusion-related adverse events were reported in Australia in 2013-2014. These adverse events include wrong blood to wrong patient, transfusion-related lung injury, allergic reaction, infection, cancer recurrence, organ failure and death. Research has linked some of these outcomes to a post-transfusion impairment of the patient’s immune responses. In order to better understand how this happens, the Australian Red Cross Blood Service has developed a series of tests to characterise how transfusion impairs these immune responses. Intraoperative cell salvage is a process where blood lost during surgery is collected, processed and given back to the patient. Use of intraoperative cell salvage may provide a cost-effective and safer alternative to allogeneic blood transfusion. In particular, because patients aren’t exposed to blood from another person, it seems likely that the impairment of immune responses that occurs following allogeneic blood transfusion will be prevented. However, whether or not this assumption is true remains to be investigated. Therefore this research project aims to investigate whether the process of intraoperative cell salvage affects the immune responses of patients. To do so, this research project will use the existing series of assays already developed by the Australian Red Cross Blood Service. This project will be highly significant to the health care system as we anticipate that intraoperative cell salvage, as an alternative to allogeneic blood transfusion, results in better patient care, less harm to patients and a decrease in costs. This important research is led by Dr Michelle Roets, a senior anaesthetist at the Royal Brisbane and Women’s Hospital who has been researching improvements in blood management over the past 10 years. Her work has resulted in authorship of the ‘Guidance for the Provision of Intraoperative Cell Salvage’ National documents with the National Blood Authority in Australia. Dr Roets has teamed up with the Australian Red Cross Service to co-ordinate an expert team and evaluate the association between immune suppression and infection risk after allogeneic blood transfusion compared to intraoperative cell salvage. These results hope to significantly improve current blood administration practice.
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Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM): A 21st Century Approach for Improving the Self-Management of Heart Disease
We developed a smartphone-based cardiac rehabilitation programme that provides participants with 1) real-time exercise monitoring and coaching from rehabilitation specialists, and 2) educational and social support to make heart healthy lifestyle changes, regardless of where they live. This overcomes key accessibility issues that stop many people participating in traditional hospital-based programmes.. This study will compare health effects and costs of smartphone-based and traditional rehabilitation programmes. We expect the accessibility of the smartphone-based programme will increase participation, improve health outcomes, and reduce costs. Exercise training is a central component of global guidelines for the secondary prevention of ischaemic heart disease and traditional programs delivered in face-to-face settings result in numerous health and wellness benefits. However, uptake and adherence to these programs is low. Accessibility barriers are among the key factors limiting participation rates, especially in regional and rural areas. Our trial will assess the effectiveness of a telerehabilitation program that uses mobile and internet technologies to emulate face-to-face exercise supervision and coaching, and deliver education and strategies to support healthy lifestyle behaviours. 220 participants will receive 1) 24 weeks of usual care (i.e. face-to-face) cardiac rehabilitation or 2) 24 weeks of telerehabilitation in addition to usual care. We will compare physical fitness, risk factors associated with heart disease, lifestyle behaviours, program adherence, and costs between these two groups. This telerehabilitation delivery model has potential to improve the reach and accessibility of cardiac rehabilitation services, and satisfy the unique preferences of many people who are currently unable or unwilling to attend face-to-face programs.
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Examining the Effects of One-Month Probiotic Treatment on Mental Fatigue
The aim of this study is to demonstrate the effects of 28-days supplementation with a novel probiotic formulation on mental fatigue following a cognitive load in healthy adults. Half of the participants will receive the probiotic formulation while the other half will receive placebo.
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Plant Sterols and Beta-Glucan for Reducing Cardiovascular Disease Risk (Beta-GAPS Trial)
Cardiovascular disease (CVD) is the leading cause of death worldwide. Dyslipidaemias and insulin resistance have been associated with the development of CVD. In addition, elevated levels of chronic inflammation has also been shown to play a key role in the pathobiology of CVD. Targeting blood lipid levels, insulin sensitivity and chronic inflammation in high risk individuals may help to ameliorate these modifiable risk factors and reduce the overall risk of developing CVD. Phytosterols are well-known cholesterol-lowering agents, resulting in 10% reductions in LDL-C in only 3-4 weeks of supplementation. Oat beta-glucan is a rich source of soluble fibre which has been shown to lower cholesterol levels with implications for glucose control. This project aims to investigate if combined dietary supplementation with plant sterols and beta-glucan reduces blood cholesterol and to a larger extent than either of the treatments alone.It is expected that participants will have improved levels of blood cholesterol as well as an overall reduced 10-year risk of developing CVD.