ANZCTR search results

Treatment of end-stage kidney disease for more than 2 million people worldwide, including 13,000 Australians on dialysis is extremely costly ($1.1billion per year) yet results in poor survival (45% at 5-years), lower than all cancers combined. Health-related quality of life for people managed on haemodialysis is low, around 60% of full health. Both women and men on haemodialysis frequently experience symptoms of severe or overwhelming pain, fatigue, nausea, cramping, itching, trouble sleeping and depression which contributes to a poor quality of life. The problem is standard dialysis care does not focus on patient-centered outcomes like health-related quality of life or symptoms; instead the focus is on the management of biomarkers (e.g. urea, potassium, phosphate). This has resulted in missed opportunities to intervene and improve symptom management and overall quality of life. New data from other areas suggest symptom monitoring may not only improve quality of life, but also improve overall survival. The Symptom monitoring WIth Feedback Trial (SWIFT) is a novel Australia & New Zealand Dialysis and Transplant Association (ANZDATA) registry-based cluster randomised trial to improve the lives of people on kidney dialysis. We will test the hypothesis that: symptom monitoring using the IPOS-Renal with feedback to clinicians, improves health-related quality of life (measured by the EQ-5D-5L) and cause specific mortality among participants receiving haemodialysis. The SWIFT pilot study will assess the feasibility of electronic capture of patient reported outcomes using tablet computers, and feeding back this information to clinicians, for discussion in clinical consultations.

Low energy availability is a major topic in sports nutrition. The increased risk of illness and injury associated with Low energy availability interferes with athlete availability and directly contributes to sub-optimal adaptation and competition performance. We now recognise an increased array of problems associated with chronic and/or severe Low energy availability in male athletes. Therefore, greater knowledge of the effects of reduced LEA on various body systems is required to allow better education, prevention and management of damaging scenarios, while assisting athletes to be able to include shorter periods of tolerable reductions of EA within their programs. The Supernova 4 research camp will investigate the effect of low energy availability and its reversal on a variety of markers of body systems at rest and in interaction with exercise on a cohort of elite male endurance athletes (race walkers).

The purpose of the proposed study is to estimate the accuracy of point of care ultrasound in the prehospital setting. Specifically, the proposed study will assess the utility of extended-Focussed Assessment with Sonography in Trauma (eFAST) ultrasound performed by prehospital physicians. Pre-hospital ultrasound findings will be compared to hospital-based imaging (either computed tomography (CT) scans, eFAST scans or surgical findings) for adult trauma victims presenting to major trauma centres in Sydney, Australia.

People with attention deficit hyperactivity disorder (ADHD) may also have developmental coordination disorder (DCD), which is not always recognised. Individuals with combined ADHD and DCD have increased likelihood of developing anxiety and depression. Evidence detailing early identification and treatment is limited. This project aims to characterise a screening pathway for children with ADHD to diagnose DCD. It will use an established DCD treatment, the cognitive orientation to daily occupational performance (CO-OP) approach, to see if the mental health of those with both ADHD and DCD improves. There will be two linked studies, with children identified with DCD in the first study invited to participate in the second.

Abstract: Background: Australia is one of many nations struggling with the challenges of delivering quality primary health care (PHC) to an increasing number of refugees. OPTIMISE is a project that builds on the collaboration of 12 organisations involved in delivering PHC to refugees. This trial relates to an outreach facilitation based quality improvement intervention, directed towards improving the quality of PHC received by refugees within Australian general practices. Methods: Our mixed methods study involves a quasi-experimental design and is set in 3 regions of high refugee resettlement in Australia. We began by creating Regional Partnerships Teams (RPTs) consisting of policy advisors, clinicians, academics, health service managers and community members. Following a regional needs assessment, stakeholders participated in a deliberative process to reach consensus on four core areas for the general practice based intervention. These were: recording of refugee status; use of interpreters; conduction of comprehensive health assessments and timely referral to refugee specialised services. The intervention involves training expert refugee health staff in outreach facilitation techniques enabling them to engage primary care practices in quality improvement activities. Facilitators will aid practices to identify and address gaps in current routines relating to the four core areas. We aim to recruit 36 general practices with no prior involvement in a refugee health focused practice facilitation. Practices will be randomly allocated into early and late intervention groups. The primary outcomes will be changes related to the four core areas identified. Changes in practice performance relating to these outcome measures will be evaluated using multilevel mixed effects models. Quantitative collection will comprise of (i) a provider survey (ii) two practice surveys: one documenting internal systems of the practice; the other assessing the practice’s current approaches to delivery of care to refugees; and (iii) de-identified data from medical records. Data collection time points are baseline, post-intervention and at 6 months follow up. Qualitative data collection includes semi-structured interviews with intervention participants, reflective diaries and document analysis. Discussion: OPTIMISE will test whether a regionally oriented practice facilitation initiative can improve the quality of PHC delivered to our vulnerable refugee population. Findings have the potential to influence policy and practice in other primary care settings.

Informed medical consent is often poorly done; it can be time consuming, there is no clear standard between different medical practitioners, and overwhelmingly, the literature provides support for standardised animations or video consent. Video animations have been shown to improve patient comprehension, take the same amount of time, or can even save time and in most cases there is an improvement in patient satisfaction and comprehension. Videos have been successfully used to consent for colonoscopy, knee arthroscopy, laparoscopic urological procedures, cataract surgery, intravenous fluorescent angiography, vascular procedures, coronary angiography, cardiac electrophysiology, urogynaecological surgery as well as for clinical trials. There are no studies evaluating video informed consent for cardiology procedures in Australia. Given the literature shows improvements in patient understanding and satisfaction, it is anticipated that the video informed consent will lead to enhanced clinical practice, including enhanced knowledge retention by patients, improved patient and physician satisfaction, improved recall of the procedure, as well as saving minutes per consultation. We aim to compare traditional doctor-patient informed consent to a video animation when consenting for cardiology procedures such as a coronary angiogram. We propose that the video consent will be superior to traditional doctor patient consent – patients will have better retention of information, comprehension and understanding and higher satisfaction.

Background: This NHMRC funded project (2018-2021) will determine how music listening impacts on language-related brain activity, brain structure and connectivity in post-stroke aphasia. Aims and Method: The specific aims of this resaerch are to (1) Determine whether daily music listening in addition to usual care will result in superior aphasia recovery compared to usual care only, as measured by standard clinical language and communication assessments. (2) Identify the effect of music listening on cognition and mood and the relationship between these factors and aphasia recovery. (3) Determine the effect of music listening on language-related brain activity, brain structure and brain connectivity using advanced imaging techniques developed for this population. (4) Determine if brain activity and structure predicts aphasia recovery in response to music listening and examine the influence of genetic factors and stress levels in recovery and response to music. 94 Participants with post-stroke aphasia will be scanned and undertake tests of language, cognition, mood, and music processing 2-4 weeks post-onset. They will then receive either usual care only or will listen to music daily (minimum 1 hour) in addition to receiving usual care until three months post-stroke. All participants will be scanned and re-tested at three months and six months post-onset. Outcomes: This approach will provide important insights into the mechanisms driving music-induced recovery of language and will identify potential responders to this treatment.

The aim of this study was to utilise a non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS) to assess it's efficacy in improving symptoms of anorexia nervosa. Eight individuals with anorexia nervosa were randomised to receive tDCS to the inferior parietal lobe of the brain, or sham tDCS, for 10 days over two weeks. They completed assessments pre- and post-intervention including psychological assessments and eyetracking. The study was ceased early due to COVID-19 disruptions.

This open-label, dose-ranging clinical trial which aims to determine the feasibility, tolerability, and safety of oral ketamine (OK) for post-traumatic stress disorder. In this 10-week trial, participants will undergo 6 weeks of active treatment followed by 2 follow-up assessments (week 7; week 10) Participants (N = 50) will be receive a sub-anaesthetic dose of OK once a week over a 6-week period (according to an established titration protocol; 6 ketamine treatments in total); • All participants will be engaged with their treating doctors for the duration of the trial. • Ketamine will be used as an adjunctive treatment, meaning that participants are able to maintain or modify their current treatments under guidance of their physician. Any changes to medication will be recorded by study staff. Primary hypothesis: That a 6-week OK treatment will be efficacious in reducing PTSD symptom frequency and severity. Secondary hypotheses: That a 6-week OK treatment will be efficacious in: reducing stress, anxiety, depression, suicidal ideation; Improving cognitive, social, and occupational functioning; Improving sleep quality; Improving overall wellbeing. Additionally, this study aims to examine the cognitive, neurobiological, and neurophysiological effects of OK treatment in adult participants with PTSD. All changes outlined in this ANZCTR have been approved prior by Princes Charles Hospital Human Research Ethics Committee.

The study will follow a cohort of high risk pregnant women and assess for and treat OSA with CPAP therapy. Maternal blood pressure will be monitored throughout pregnancy and is the primary outcome between the two groups of participants (those with OSA compared with those without OSA). Quality of life will be assessed during pregnancy to determine if treating OSA improves quality of life. Placental vascular health will be monitored via ultrasound assessment at 28, 32 and 36 weeks gestational age followed by pathological examination of the placenta following delivery. Those women with a diagnosis of OSA during pregnancy will be reassessed for persistence of OSA at 6 months post partum.