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Online treatment for depression in people with osteoarthritis: a randomised controlled trial
The aims of the current study are to evaluate the efficacy of a validated internet-based cognitive behavioural therapy (iCBT) program (CRUfAD's Sadness Program) for depression when delivered to individuals who meet criteria for a major depressive episode comorbid with osteoarthritis (OA). This study will recruit 100 people with depression and OA and randomly allocate them to 1 of 2 conditions: OA treatment as usual (TAU) + iCBT for depression or OA TAU + delayed iCBT for depression (TAU waitlist control). The primary outcomes will be to determine the impact of online CBT for MDD on depression symptoms and remission rates, as well as on OA-specific outcomes. We will also measure adherence to the course material and satisfaction with the intervention generally.
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The Fluid Translation of Research into Practice Study (Fluid-TRIPS): An International Cross-Sectional Survey of Fluid Resuscitation Practice in Intensive Care Unit Patients
The objective of this project is to describe international trends in the prescription of intravenous fluids for fluid resuscitation in intensive care and to determine the major drivers of choice.
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Novel brain biomarkers of performance impairment in sleep apnea
Obstructive sleep apnea (OSA) is a common cause of daytime sleepiness, impaired cognition, and has a 3 -13 times increased risk of motor vehicle crashes and double the rate of work accidents. This neurobehavioural dysfunction has a critical impact on health and society. One of the major challenges in dealing with this problem is the difficulty in clinically assessing neurobehavioural dysfunction such as impairment in driving ability. Many patients underestimate their impairment and there is wide inter-individual variability in how patients are affected by sleepiness and its consequences. For example, patients with sleep studies showing severe OSA may report few symptoms while others with apparent mild disease exhibit severe sleepiness. Unravelling this problem of inter-individual variability demands better assessment tools as conventional metrics such as sleep studies are uninformative. What is urgently needed are biomarkers, measured at a single or very limited time points that better reflect the individual risk of vigilance failure such as impaired driving. In this study, simulated driving and other performance tasks will be administered during a load of prolonged wakefulness extending throughout the night to unmask variation in neurobehavoural function in OSA. Performance under these conditions will be related to practically deployable biomarkers (or combination of biomarkers) measured at baseline. We have compelling preliminary data on brain bioenergetics (magnetic resonance imaging), quantitative electroencephalogram (qEEG) and cortical activation (event related potentials) as candidate biomarkers for neurobehavioural impairment in OSA. Such biomarkers would also be potentially valuable as tests to monitor treatment effectiveness or a phenotyping tools in molecular and genetic discovery in OSA.
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Cancer Coping Online: evaluating the efficacy a self-guided internet intervention for reducing cancer-related distress.
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Evaluation of psychological treatments for depression following traumatic brain injury
This project is part of a larger body of work evaluating non-pharmacological interventions for depression following traumatic brain injury (TBI). In this project we intend to evaluate specific psychological strategies by applying a single-case experimental design (SCED), also referred to as an n-of-1 trial. The participants will be two people with a history of TBI who are referred to a clinical psychologist in private practice. These individuals will be subject to standardized forms of psychological assessment during a baseline phase. They will then undergo a comprehensive psychological intervention following treatment protocols developed with non-TBI patients. Following this time they will both be assessed during a follow up phase.
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A Randomised Controlled Trial of Daily Weighing in Pregnancy to Control Gestational Weight Gain, Incorporating Self-Reported Activity Levels of Pregnant Women Presenting to a Secondary Level Maternity Unit.
The research aim is to ascertain the activity levels of pregnant women who present for antenatal care to a secondary maternity unit as they progress through their pregnancy, and the effect of daily weight monitoring on gestational weight gain. This RCT will determine whether daily selfmonitoring of weight has a beneficial effect on achieving target maternal gestational weight gain, and will explore factors which influence the amount of weight gained during the pregnancy, including dietary advice, selfreported exercise, socioeconomic status and ethnicity. The study is a randomized controlled trial. All patients presenting at 14-20 weeks for antenatal care at Redcliffe Hospital would be eligible for enrollment. Consent will be obtained by a treating clinician at the medical booking in visit (approximately 20 weeks gestation), with participants randomised to one of two groups (daily measurement group and nondaily measurement group). Consent will include the postnatal collection of data pertaining to the health of the mother and the neonate. Exclusion criteria shall include lack of proficiency in English, preexisting diabetes, preexisting hypertension, preexisting renal disease, multiple pregnancies, minors under 18 years of age. Participants and clinicians would be blinded to treatment allocation. Dietary and exercise advice is standardized and comprised of published Australian exercise and dietary guidelines. This information is to be provided in handout form at the visit at which the participant is enrolled, and referred to at each subsequent visit. Those patients in the treatment arm shall also be provided with a set of scales and a record book in which they are to log their weight daily. They shall be provided with instruction to weigh themselves as close to the same time each day as possible. Clinicians are to weigh the participants at the booking in visit (approximately 20 weeks gestation), the 36 week visit and as close to delivery as possible (eg when comes into labour in birth suite). In addition, women will be asked for their prepregnancy weight which is routinely recorded in the pregnancy health record. At enrollment and at the 36/40 summation visit, participants in both treatment groups complete a Kaiser Physical Activity Survey, to assess their levels of activity. At the enrollment visit, they shall also complete a KPAS retrospectively assessing their pre pregnancy activity levels.
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Effects of dual-task functional power training on falls in the elderly? An 18-month community-based randomised controlled trial
Falls are a major public health concern because they are associated with injury, pain, impaired function, loss of independence and even death. Reduced muscle power, or the ability to produce a rapid movement such as a quick step to recover from a loss in balance, is a strong predictor of disability and falls in older adults. In this population, the requirements to produce rapid movements often occurs whilst simultaneously performing other attention demanding cognitive-motor tasks such as walking while talking or negotiating obstacles. This study will evaluate whether a community-based, dual task functional power training (DT-FPT) program can reduce the rate of falls and improve risk factors for falls in elderly women at increased risk of falling. Secondary aims are to: 1) evaluate the efficacy of a 'step-down' maintenance program on fall rates; 2) assess the cost-effectiveness of the program; 3) evaluate the effects of the program on neural and cognitive health and function. This is an 18-month randomised controlled trial involving 6-months of supervised DT-FPT, a 6-month 'step-down' maintenance program, and a 6-month follow-up. Elderly women (n=300) at increased risk of falling will be randomised to: 1) DT-FPT plus a 6-month step-down program or 2) a usual care group. The primary outcome measure will be the number of falls throughout the study. Secondary outcomes will include: lower limb muscle power, gait, reaction time and balance under single and dual task conditions; falls related self efficacy, cognitive function and quality of life. All measures will be assessed at baseline, 6, 12 and 18 months. We expect that the results from this trial will guide the development and implementation of future community-based falls prevention programs that specifically focus on optimising muscle power, gait and function and reducing falls risk in the elderly under ‘real-life’ conditions. We also expect that the ‘step-down’ program will provide new information about the efficacy of a less intensive maintenance program for reducing the risk of falls over an extended period.
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A study to evaluate whether the glucose-lowering efficacy of vildagliptin is influenced by the rate of intraduodenal glucose delivery in type 2 diabetes
After meals, the small intestine is stimulated to release a number of hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). These two hormones play an important role in regulating blood sugar concentrations (by stimulating insulin secretion). The effects of these hormones in the body can be prolonged by a drug called vildagliptin, which is known to improve blood sugar control in people with type 2 diabetes. Because secretion of the hormones GLP-1 and GIP is influenced by how rapidly glucose enters the small intestine, we want to investigate whether the ability of vildagliptin to reduce blood sugar levels is also affected by the rate of glucose entry to the small intestine. Because the preservation of GLP-1 and GIP by vildagliptin may affect heart rate, blood pressure and abdominal blood flow in response to glucose infusion into the small intestine, we also want to measure heart rate, blood pressure and abdominal blood flow (using ultrasound scanning) during the study.
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Stereotactic Ablative Fractionated Radiotherapy Versus Radiosurgery for Oligometastatic Neoplasia to the Lung: A Randomised Phase II Trial
This study is evaluating the safety and effectiveness of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of lung tumours. Who is it for? You may be eligible to join this study if; + you are aged 18 years or above + have 1-3 lung metastases from any non-haematological primary tumour + you are medically inoperable, high risk or have decline surgery + you have not had any previous high-dose radiotheradpy to the chest region Study details: SABR is an exciting novel radiotherapy technique that is delivered over very few sessions. In the case of limited lung metastases, SABR can result in long-term survival. It is non-invasive and associated with high rates of tumour control and relatively low toxicity. Additionally, the large doses of precision radiotherapy involved may evoke a strong immune response to recognise and attack any remaining tumour cells. There are two SABR techniques emerging in Australia; fractionated and single fraction treatments. Participants in this study will be randomly (by chance) allocated to receive either multi-fraction SABR (4 fractions over 2 weeks) or single fraction SABR (1 fraction only). All participants will be assessed at regular intervals post treatment in order to evaluate the toxicity, Quality of Life, clinical efficacy and cost effectiveness of single fraction SABR compared to multi-fraction SABR. The follow-up visits occur every 3 months in 1st year post treatment, then every 4 months in the second year and then 6 monthly until study closure (2 years after the last participant finishes study treatment).
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Evaluation of mental health training for managers
Managers and supervisors play a key role in the welfare of the workforce and in the prevention of long-term disability. There is evidence that managers within the emergency services feel under-skilled in dealing with sickness absence, particularly when absence is due to mental illness. We seek to test the effectiveness of a novel program of manager education which combines mental health literacy and sickness absence management training within Fire and Rescue NSW. The program will be rolled out over a six month period to all Duty Commanders as part of a NSW Fire and Rescue training initiative. We aim to evaluate the effectiveness of the program in increasing mental health literacy, reducing stigma around mental illness, increasing manager knowledge of their role in sickness absence management as well as increasing confidence and encouraging early communication with employees on sickness absence leave. Importantly, we will also investigate the potential impact of the training in reducing overall sickness absence rates within Fire and Rescue NSW.