ANZCTR search results

Insulin therapy is the most effective treatment for diabetes, however, one in four adults with type 2 diabetes (T2D) delay initiation due to negative attitudes towards insulin. Few evidence-based interventions exist to address these issues and none widely available in Australia. The aim of this study is to pilot-test the efficacy of a novel psycho-educational web-based resource for reducing negative attitudes to insulin among adults with non-insulin treated T2D. A two-armed pilot randomised controlled trial will be conducted to assess the feasibility and acceptability of the intervention content and format. Up to 40 adults with non-insulin treated T2D will be recruited through the ACBRD (and affiliated organisations) websites, e-newsletters/blogs and social media. Preliminary evidence for the effectiveness of the web-based resource (intervention) compared to widely available existing resources (control) in reducing negative attitudes towards insulin will also be investigated. Outcomes will be assessed at baseline and 2-week follow-up.

Introduction: Health-related quality of life (HRQoL) is a commonly used health outcome. For many acute conditions (e.g. fractures), retrospective measurement of HRQoL is necessary to establish pre-morbid health status. However, the validity of retrospective measurement of HRQoL following an intervening significant health event has not been established. The aim of this study was to test the validity of retrospective measurement (recall) of HRQoL by using a test-retest design to measure reliability and agreement between prospective and retrospective patient-reported HRQoL before and after an intervening health event (major elective orthopaedic surgery). Method: Participants were recruited from the pre-admission clinic of a metropolitan hospital. Participants were assessed for their HRQoL using the EQ-5D-5L at two time-points; prospectively at two weeks prior to their date of surgery and then retrospectively (recalling their pre-operative health) following elective hip or knee joint replacement surgery. Prospective measurements were compared with retrospective measurements for the five domain scores (nominal data) using intra-class correlation and for the EQ-Index score and the EQ-Visual Analogue Scale (VAS) score (continuous data), using Pearson’s correlation. Agreement was tested in the continuous variables using Lin’s coefficient of concordance (pc) and inspection of Bland-Altman plots.

This is FIH randomized, double-blind, placebo-controlled study in healthy population. Up to 7 single ascending doses (cohorts 1 to 7) will be studied to determine the safety and tolerability of ALD1910. Approximately 96 healthy male and female participants are planned for the study, 64 for Part A and 32 for Part B.

The aim of this quality improvement project is to implement and examine the effectiveness of strategies to support clinical staff in the provision of the preventive care policy within community mental health services in the Hunter New England LHD. An implementation intervention will be co-developed with the service to support clinicians to provide preventive care for tobacco smoking, harmful alcohol consumption, inadequate fruit and/or vegetable consumption, and inadequate physical activity. Evidence based strategies such as education and training, feedback reports, aids to enable care provision, and a designated support person will be tailored, specifically to overcome the impediments to preventive care provision in community mental health. It is hypothesised that clients from the intervention service will receive higher levels of preventive care compared to a control service who will receive no implementation intervention.

This study is primarily intended to investigate the safety and tolerability of platelet-derived extracellular vesicles (PLEXARIS) following intradermal injection around a skin punch biopsy in a healthy participant. PLEXARIS will be directly compared to a matched placebo formulation in each participant. Additionally, the study aims to evaluate the time to wound closure between the treated and control biopsies, and assess the presence of scaring, erythema or infection at the wound site.

The study aims to demonstrate that 400 mls of a preop carbohydrate drink is fully cleared from the stomach 2hours after consumption in pregnant patients fasting for a caesarean section. All elective patients are subject to standard fasting guidelines-6h for food and 2h for clear liquid. In an effort to minimise physiological disruption to patients a carbohydrate drink (as opposed to water) has been given to patients fasting for operations. There is minimal data to in the heavily pregnant patient to demonstrate that a carbohydrate drink is cleared from the stomach.

Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed following musculoskeletal injuries and fractures as an effective method of pain relief. However, there is inconclusive evidence that these NSAIDs may impair bone formation, and therefore impact upon fracture healing, creating delayed union or non-union. It is essential that we have solid evidence to inform clinical guidelines on the use of safe and appropriate analgesia to improve patient care. In order to conduct a large multi-site randomised-controlled trial (RCT) to draw more definitive conclusions about the effects of NSAIDs on bone healing, it is important to firstly ascertain the safety and feasibility of conducting such a study via a pilot RCT. Therefore, the aim of the current study is to determine the feasibility of using a prescribed treatment regime of NSAIDs versus a placebo in people with tibial shaft or femoral shaft limb fractures, and is expected to inform the design of a large multi-site trial.

The primary aim of this intervention research project is to investigate the impact of a neck strengthening exercise program on the incidence of concussion in adolescent (12-18 years) contact sport athletes. A secondary aim will be to investigate whether higher neck strength is associated with reduced head acceleration during purposeful heading in adolescent football (soccer) players. Neck muscle strength data will be collected for all participants at three time points (baseline, 6-week, and 6-months) using a hand-held dynamometer along with weekly completion of a concussion incidence and activity survey. Additionally, for football players only, accelerometry will also be used to capture head acceleration during purposeful heading at three time points (baseline, 6-weeks and 6-months). Anthropometry (neck girth, height and weight) data for all participants will also be collected. If higher neck strength is associated with a lower incidence of concussion this evidence would provide an incentive to include neck strengthening exercise as part of all injury prevention programs within these sports.

There is no medical treatment that has been shown to have clinical benefit in primary sclerosing cholangitis (PSC); a condition affecting the liver and bile ducts. Mesalazine (5-ASA) is a first-line medication used for treatment for ulcerative colitis. Ulcerative colitis has a strong association with PSC. 5-ASA is rapidly metabolised before reaching the liver and bile ducts which may restrict its potential benefit in PSC. This study investigates whether a naturally occurring flavonoid, quercetin, may inhibit metabolism of 5-ASA and lead to improved drug delivery to the liver and bile ducts. This study will also explore the impact of quercetin on the bacterial population in the faeces.

This study is a prospective, interventional study of bone health in children with neuromuscular diseases conducted at The Royal Children’s Hospital, Melbourne. The effect(s) of pubertal induction in paediatric neuromuscular diseases have not been formally studied. Our main aim is to provide evidence as to whether pubertal induction may improve bone health and quality of life in children and adolescents with significant neuromuscular disabilities and reduce burden of care on families. Children with neuromuscular disabilities are often very thin and have poor muscle strength and stability, which increases fall frequency and risk of fracture and often have delayed or arrested puberty. Puberty is a crucial time for bone mass accrual and therefore, an optimal time for clinicians to intervene to improve bone health.