ANZCTR search results

Over half of Australians fail to reach the physical activity guidelines necessary to reduce the risk of cardiovascular disease, diabetes and cancer. Due to rising levels of chronic disease placing a significant burden on Australia’s health care and economy, there is a need for effective population-based physical activity interventions. The internet provides a practical platform to deliver physical activity interventions as it can reach large numbers of people at low cost. Whilst the short term effectiveness of web-based interventions has been established, participant engagement and retention into the intervention have been identified as problems affecting population-level reach and long term effectiveness. This project will measure the effectiveness of brief online coaching provided via Skype versus personally tailored advice alone will be examined in terms of improving website usage, retention and physical activity outcomes. Overall study findings will inform the next generation of web-based physical activity interventions effective in improving physical activity levels in a large range of Australians, and reducing the prevalence of disease in Australia.

Obstructive sleep apnoea (OSA) is characterised by repeated upper airway obstructions during the night. OSA is associated with excessive daytime sleepiness, lower health status and studies suggest obstructed breathing and snoring in sleep are independent risk factors for high blood pressure, heart disease, stroke and mortality. Thus OSA is a serious and costly public health problem that is growing in prevalence because of population increases in both obesity and ageing. Continuous positive airway pressure (CPAP) therapy is the current treatment of choice for patients with OSA. CPAP is effective in decreasing sleepiness and improves quality of life in patients with OSA. Treatment of OSA with CPAP is cost-effective if worn, but CPAP is poorly tolerated by many patients who find the mask and pressure claustrophobic and uncomfortable. OSA can be effectively treated but poor treatment compliance is a major clinical problem and thus many patients are under treated or not treated at all. Upper airway surgery for OSA is widely used and reported in observational studies but there are few rigorous and randomized clinical trials to provide and validate these studies. The clinical effectiveness and cost effectiveness of this surgical intervention need to be validated. This study is a national, multi-centre, randomised, controlled trial with a recruitment target of 102 participants. Participants with OSA who have failed standard OSA treatments will be randomised into two groups: Group 1 will receive reconstructive surgery of the upper airway and Group 2 will receive the standard non-surgical care for OSA. Participants will undergo follow-up for 6 months. Study participants will be tested for OSA, daytime sleepiness levels, and quality of life improvements before the treatment and at 6 months follow-up. Magnetic resonance imaging of the upper airway will also be used on participants randomised to Group 1, before the surgery and at 6 months, with the aim of developing a prediction model for future patients who will benefit the most from surgery. The study will be carried out at five sites across Australia to examine the universal effect of this standardised surgical protocol. AIM: To establish for the first time whether or not upper airway surgery is clinically effective, safe and cost effective for patients with symptomatic OSA who have failed medical management HYPOTHESIS: Surgery will deliver a better treatment outcome than ongoing medical management of symptomatic OSA as measured by the improvement in Apnoea Hypopnea Index (AHI) and subjective and objective daytime sleepiness in patients who have failed CPAP treatment despite persistent, supervised attempts.

Prospective observational study 3,6,12 and 18 months post discharge using quantitative surveys to assess health related quality of life and mental health followed by a limited number of semi-structured qualitative interviews with patients and relatives.

Falls by older people in the community are frequent and are a major concern worldwide because of their association with disability, institutionalisation and mortality. Older people presenting to the Emergency Department (ED) following a fall have often fallen previously, indicating a failure in secondary prevention. This may be due to a lack of engagement in prevention strategies. There is evidence that suggests only a minority of older people who present to the ED after a fall follow recommendations provided by ED staff. This randomised controlled trial (RCT) will test the RESPOND program which is designed to improve older persons’ participation in falls prevention activities through delivery of patient-centred education and behaviour change strategies. . It will involve 528 patients from two hospitals across Australia; 264 patients will be randomised to the intervention group and will receive the RESPOND program while the other 264 will receive standard care. The RESPOND program incorporates: (1) home-based risk factor assessment and risk stratification; (2) education on risk factor management, goal setting around 4 specific high level evidence interventions, coaching and follow-up telephone support; and (3) healthcare provider communication and community linkage. Primary outcomes are falls and fall injuries per-person-year and ED re-presentations occurring over 1 year. It is hypothesised that falls, fall injuries and ED re-presentation rates will be reduced by at least 30% in the 12-months post-implementation of the RESPOND program for intervention compared with control participants.

Mounting evidence indicates that cognition-based interventions for people with mild cognitive impairment (MCI) are effective in maintaining independence and increase patient satisfaction. Studies to date have primarily focused on clarifying intervention parameters associated with greater efficacy, such as duration and frequency. Less is known, however, about the contribution of health related variables to the outcome of cognition-based treatments. Neuropsychiatric symptoms (NPS) are highly prevalent in people with MCI and are associated with greater impairment, excess disability, and worse outcomes. Despite this, studies evaluating the efficacy of cognition-based interventions in persons with MCI tend to exclude patients with NPS. Understanding the contribution of NPS to the outcome of such interventions is important in terms of their application in clinical settings. A double-blind randomised controlled trial design is proposed to compare the efficacy of a cognitive training intervention between individuals with MCI, individuals with MCI and NPS, and individuals with NPS and no MCI. The outcomes of the study will inform the selection of candidates that have the greatest potential to benefit from cognition-based interventions, with implications for clinical practice.

To compare the pharmacokinetics and safety of dihydroergotamine delivered via 2 nasal spray devices: the investigational device versus the Migranal nasal spray applicator. Methods: Single-center, open-label, randomized, single-dose, 2-sequence, 2-treatment crossover study in healthy adults. The 2 treatment periods will be separated by a washout period of at least 5 days. Investigational product, dosage and mode of administration: IPX234. 1 mg DHE solution (1 spray in each nostril; 0.5 mg DHE per spray) administered intranasally via the investigational device.

The primary objective of the proposed study is to test the mechanism of action of two pre-quit smoking cessation medications - varenicline and nicotine patch – in order to learn how best to optimize these pre-quit treatments.

Wernicke-Korsakoff syndrome (WKS), once thought to be a rare condition, is now known to be common in people with nutritional deficiencies or alcohol dependence. The primary cause of WKS is thiamine deficiency, and more than 90% of cases are reported in alcohol dependent patients because alcohol dependence predisposes to severe nutritional deficiency. WKS may lead to significant, long-term brain dysfunction with severe effects on work, personal and social function. Whilst effective treatment may greatly reduce severe disability and the human and social costs of this illness, almost no evidence exists on optimal dosing regimens. This project proposes to develop quality evidence for effective treatment of WKS in an Aboriginal setting. The need for evidence-based thiamine treatment protocols is of great clinical importance for two related reasons. First, in relation to acute symptomatic WKS, a failure to treat immediately or adequately may result in profound and often permanent cognitive and neurological disability. Secondly, the need for evidence-based treatment guidelines is greatly magnified when it is recognised that milder, subclinical WKS may be preventable with adequate thiamine treatment. The aims of this study are to determine the optimal thiamine dose required for: A. Treatment of acute symptomatic Wernicke-Korsakoff syndrome (WKS) among Aboriginal and non-Aboriginal alcohol-dependent patients. B. Reducing or preventing subclinical WKS-related brain damage in at-risk Aboriginal and non-Aboriginal alcohol-dependent patients. Primary Hypotheses 1. Among alcohol-dependent patients with acute symptomatic WKS, higher doses of parenteral thiamine (1500mg) will lead to greater improvements in specific cognition and neurological functions than lower doses (900mg or 300mg). 2. Among alcohol-dependent patients that are at high risk for subclinical WKS-related brain damage, higher doses of parenteral thiamine (900mg) will lead to greater improvements in specific cognition and neurological functions compared to lower doses (300mg or 100mg). Secondary Hypotheses 1. Thiamine deficient patients will show poorer performance on cognitive and neurological measures 2. Patients with concurrent magnesium deficiency will show greater impairment at baseline 3. Nutritional risk and alcohol frequency will correlate with thiamine pyrophosphate levels. 4. Number of previous admissions with thiamine supplementation in the past 3 months will correlate with thiamine pyrophosphate levels.

We aim to explore if the drug ‘denosumab’ is effective at reducing bone loss in the feet/foot in participants with Diabetes Mellitus and Charcot Foot. Bone loss or Osteoponia as it is referred to medically is a recognised feature of Charcot foot. If the bone loss process can be prevented then this may stop the Charcot process in a much quicker time frame.

In Australia, accidental injury represents the most common type of traumatic event experienced by children under the age of 6 years. Recent research has shown that around 10-30% of young injured children will go on to develop chronic posttraumatic stress disorder (PTSD). Parents of injured children are also at risk of PTSD and this is associated with short and long-term consequences for their child’s physical and psychological recovery. PTSD is a complex and serious disorder that is associated with a range of adverse psychiatric and health outcomes; poorer adherence to medical treatment; reduced wound healing; diminished health-related quality of life; impaired parent-child relationships; and can significantly impact psychological, cognitive, social and neurobiological development. Despite the significance of this problem, to date, the mental health needs of injured young children have been neglected. One reason for this is due to the uncertainty and considerable debate around how to best provide early psychological intervention to traumatised children and adults. In particular, there are currently no published studies on early intervention for young traumatised children. The proposed research therefore aims to evaluate the effectiveness and feasibility of a screening and indicated prevention program for injured young children (1-6 years) and their parents. The study will employ a randomised control trial design and children who are screened as ‘high-risk’ for PTSD and their parents will be randomised to either (1) 2-session face-to-face child and family focused intervention or (2) treatment as usual. Assessment will be completed at baseline (2 weeks), 3 and 6 months post injury. The development, evaluation and dissemination of effective indicated prevention programs for young children and parents have the potential for enormous national and international benefit.