ANZCTR search results

Background: ‘At-risk’ patterns of alcohol use are prevalent in many countries with significant costs to individuals, families and society. Screening and brief interventions (SBI), including with web delivery, are effective but with limited translation into practice to date. Previous observational studies of the Hello Sunday Morning program have found that their unique participatory health communication approach has resulted in a reduction of at-risk alcohol use between baseline and three months. This study will systematically evaluate different versions of the site and support resources in reducing at-risk alcohol use. Design/Methods: New participants enrolling on the Hello Sunday Morning website will be eligible to be randomised to receive either i) the “Daybreak” program or ii) the “Daybreak” program plus online coaching support. We will recruit 467 people per group to detect an effect of f=0.10. The primary outcome measure will be the reduction in Alcohol Use Disorders Identification Test-consumption scores. Secondary outcomes include: mental health (Kessler’s K-10), alcohol consumed measured with a seven day drinking diary in standard 10g drinks, days out of role (Kessler), and alcohol related harms (CORE alcohol and drug survey). We will collect data at baseline, three and six months and analyse them with random effects models, given the correlated data structure. The Daybreak program provides evidence-based information on how to change drinking patterns combined with a supportive online environment, with all content produced by participants. Conclusions: A randomised trial is required to provide robust evidence of the impact of the Hello Sunday Morning website, including over an extended period.

New approaches to enhancing Aboriginal and/or Torres Strait Islander mental health are clearly needed. This study aims to development of a culturally relevant and appropriate model of mental health that addresses some of the core issues of disconnection, disrupted attachments and trauma experienced by so many Aboriginal people. We propose adapting compassion-focused therapy (CFT) so that it is culturally appropriate for Aboriginal clients; and will evaluate its effectiveness. As such, this is a pilot study. Our aims are as follows: 1. To develop an Aboriginal-adapted culturally appropriate form of CFT, based initially on feedback from an Aboriginal health professional group. It is anticipated that there will be some further modifications as necessary over the course of the project. 2. To determine if this Aboriginal-adapted form of CFT is viewed as an acceptable and promising approach by Aboriginal health professionals and Aboriginal clients. 3. To conduct a preliminary evaluation of the impact of CFT within the constraints of the timeline, the service contexts, the absence of available control groups and an acceptable evaluation design that meets AHRMC and other ethical guidelines The participants will be clients of three different services: Namatjira Drug and Alcohol Rehabilitation Centre, Bunjum Corporation and Rekindling the Spirit. Different groups will be held in each of the services for their respective clients.. The clients of Namatjira Haven are in the early stages of drug or alcohol rehabilitation and are in-patients; The clients of the other two services live in the community, and may or may not have current mental health problems. People who are assessed as having severe mental health problems (e.g. psychosis, current suicidal ideation) will not be included in the groups.

The Premier's Youth Initiative (PYI) is an endeavour by the New South Wales Government to prevent young people transitioning from out-of-home care (OOHC) from becoming homeless. This study intends to assess the effectiveness of PYI in preventing or delaying homelessness among young people leaving OOHC. Overall, the evaluation will consist of three strands, (i) an outcomes evaluation, (ii) a process evaluation and (iii) an economic evaluation. The outcomes evaluation will use a Randomised Controlled Trial (RCT) to provide robust evidence of the effects of PYI on youth homelessness in the target population.

The purpose of this study is to establish and validate new laboratory techniques required for accurately classifying newly diagnosed central nervous system (CNS) tumours (including brain and spinal cord tumours) in children. Who is it for? You may be eligible to join this study if you are aged 0 - 21 years old and have been diagnosed with a CNS cancer and undergone surgical resection. Study details All participants will have blood and tumour samples sent to Monash Health in Clayton, Victoria, where molecular profiling will occur. Concurrently, participants will have standard diagnostic radiology and pathology diagnostic testing at their centres. If the molecular diagnosis matches diagnosis achieved at the local centre, a report will be sent to the study sponsor (ANZCHOG) and the local treating oncologist. If the results are discrepant, these cases will be subject to central pathology analysis and an expert Tumour Board will review all the results and reach a consensus diagnosis. Participant health records will be assessed yearly to record treatment approaches and responses for up to 10 years. This study will provide valuable data for personalised treatment decisions to optimise survival outcomes and minimise long-term complications

The proposed study will help resolve a long-running controversy in women’s health. For the first time in Australia, it will provide longitudinal (12-year) data abut the relationship between the rate of increase in arterial stiffness in women (a known risk factor for cardiovascular disease) and the withdrawal of oestrogen through the menopausal transition

Atrial fibrillation (AF) is the most common heart arrhythmia, affecting 1 in 4 adults worldwide, and at least 240,000 Australians. Prevalence rises with age from approximately 1% of the whole population to 5% in those over 65 years. People with AF are up to seven times more likely to have a stroke than the general population. Almost one in every three strokes is AF-related, and AF-related strokes are likely to be more severe, with a whole of life cost of each stroke estimated at $103,566. However, strokes in AF can be effectively prevented using oral anticoagulants. Unfortunately in Australia oral anticoagulant prescription is only about 60% even in those patients with known AF who are therefore at high risk for stroke. This gap has been difficult to close despite having therapeutic management guidelines. Many people in the general population are unaware that they have AF, with first diagnosis being made when they are admitted to hospital with a stroke or transient ischaemic attack. The diagnosis of unknown AF can be easily made using a 30 second ECG rhythm strip obtained with a TGA approved smartphone ECG (iECG). Using this device, unknown AF can be identified and treated, thus reducing the number of strokes due to AF. We have previously shown that community screening for AF to prevent stroke is likely to be cost-effective, but the magnitude of the benefit in terms of numbers of strokes prevented, is determined by the proportion of the population screened. This study therefore explores screening for AF in rural primary care, by performing iECG screening for patients attending their general practice. Screening will be offered by practice nurses during annual influenza vaccination (currently administered to over 70% of patients aged 65 or over in general practice) and during annual chronic care assessments such as Diabetes Cycle of Care and Health Assessment for People Aged 75 and Older. General practitioners will also opportunistically screen patients. This opportunistic method of screening, through its reach, could approximate systematic population screening for AF. Screening will be performed in 10 practices across rural NSW to gauge and efficacy and cost effectiveness of community-based AF screening. In addition to the handheld iECG device, this study will also implement the electronic decision support software called HealthTracker-CVD. A special AF module has been designed as part of this software to automatically calculate the stroke risk score for patients with AF, and provide individualised advice on evidence-based management of AF. An automated tool such as this available to both general practitioners and practice nurses is ideal to facilitate closing the gap in oral anticoagulant prescription for stroke prevention in patients with diagnosed AF.

Venous leg ulcers and stasis ulcers are chronic wounds associated with poor circulation in the leg. Despite treatment some of these wounds fair to heal, or persist over many weeks, months or years. This pilot study aims to assess feasibility of a larger study investigating the use of a silver eluting cellulose/collagen matrix (PROMOGRAN PRISMA®) on hard to treat wounds. Patients with venous leg or stasis ulcers that is slow to heal will be treated with PROMOGRAN PRISMA® in conjunction with compression therapy and standard wound care weekly for 6 weeks, and followed up for a further 6 weeks. The study will measure the number of patients recruited in a 4-month period, number of patients competing the study, number of healed wounds after 12 weeks of follow up, wound surface area reduction over 12 weeks, change in percentage of the wound covered by slough, change in ankle and calf measurements and the amount of pain patients have at clinic visits.

OME is the most common cause of hearing loss in childhood. When persistent, and particularly bilateral, the hearing loss resulting from OME has been associated with language delay, poor educational achievement and behavioural and developmental concerns. Aboriginal and Torres Strait Islander children have the highest rate of persistent, severe and complicated otitis media described in the literature. Persistent bilateral OME is the usual reason for surgical insertion of tympanostomy tubes (‘grommets’), the second most common cause of surgical admission to hospital for children in Australia. The net cost of otitis media in Australia in 2008 was estimated to be over one billion dollars. Given the high health and cost burden of OME, a simple low cost management option is urgently needed. Standard care for OME is initial observation, followed by referral for hearing assessment if bilateral OME persists at 3 months, surgical management with tympanostomy tubes (‘grommets’) and treatment for hearing impairment are considered. Unfortunately, in addition to being costly, tympanostomy tubes have lower success rates in Aboriginal children and can be associated with chronic ear discharge in up to 50% of this group, resulting in more hearing loss than prior to surgery. Long term antibiotics are another treatment option for prolonged OME, but have low efficacy and carry the significant risk of promoting antibiotic resistance. This study proposes the use of Otovent® nasal balloon autoinflation device, as a low cost, simple means of mechanically treating OME. High pressure exhaled air, forcibly opens the Eustachian tube (connecting the middle ear and the back of the nose), by blowing up a balloon through each nostril with the mouth closed. This re-introduces air into the middle ear space and allows the fluid to drain away. It has recently been recommended by the Royal Australian College of General Practitioners for use in OME, whilst results in non-Aboriginal children are inconclusive, the Otovent has never been tested in Aboriginal and Torres Strait Islander children. The INFLATE Trial will use RCT evidence to determine whether nasal balloon autoinflation increases resolution of OME in Aboriginal and Torres Strait Islander children at 1 month. The test group will use Otovent® 3 times daily as recommended by the product manufacturer. Duration of treatment in this study will be for a minimum of 1 to maximum of 3 months (if OME persists), in accordance with the current recommended treatment period, The comparator group will consist of standard care, that is, observation only, followed by referral for ENT assessment if reduced hearing or bilateral OME is detected at 3 Months.

Exercise in type 1 diabetes may lead to increased variability in glucose levels and hypoglycaemia. Glucose management around exercise may be therefore challenging for people living with in type 1 diabetes and prevent them from undertaking exercise. At the same time, there was deficiency of easily accessible information to help stabilise glycaemia around exercise and prevent hypoglycaemia in type 1 diabetes. The aim of the trial was to establish whether educational online tool: ext1d may reduce hypoglycaemia following exercise. This educational website was developed specifically for people with type 1 diabetes and was based on current literature recommendations. It consists of several learning modules. The educational modules discussed the glycaemia secondary to exercise and suggested insulin adjustment and carbohydrate supplementation. Topics included: increased insulin sensitivity following exercise and the role of hormones regulating glucose levels around exercise; dose reduction and timing of meal bolus and/or temporary basal insulin for a given exercise, additional carbohydrate type and amount in relation to exercise. Participants were asked to review the learning modules on glucose management in type 1 diabetes in relation to exercise. Participants chose recommendations related to exercise and stabilising glucose, that best suited them and then incorporated those recommendations into their usual exercise routine. Participants were encouraged to utilise the online tool ‘dashboard’ which suggests possible individualised insulin dose tailoring, typically an exercise-related reduction, as well as carbohydrate supplementation amount for a given exercise regimen. The study design was a prospective randomised controlled trial with crossover of the Control group into the Intervention. Following a baseline CGM Study Period (CGM1) participants underwent computer randomisation and were assigned to either the Control or the Intervention group. During the following 5-week period participants in the Intervention group accessed the website and the Control group continued with usual care. Subsequently, all participants underwent a second CGM Study Period (CGM2). This was followed by the second 5-week period during which the Intervention group continued with the website viewing and education and the Control group gained access to the website, in the partial cross-over design. The second five-week period concluded the trial with CGM Study Period (CGM3). During each CGM period participants wore continuous glucose monitoring system (Medtronic iPro2) to monitor for exercise and non- exercise related hypoglycaemia. Hypoglycaemia data was based on continuous glucose monitoring system output. For a primary outcome, the exercise-related hypoglycaemia data, was compared between the Intervention group which already had access to the educational modules for 5 weeks and the Control group, which did not have access to the educational modules in the past 5 weeks.

Clinical management of asthma involves tailoring medication to minimise the frequency and intensity of symptoms and prevent exacerbations. However, management is currently based on subjective patient recall of symptoms, rather than objective and personalised measures of current status and predictors of future risk of exacerbations. A potential solution may be offered by daily home monitoring using Forced Oscillation Technique (FOT), which patients can measure unsupervised at home due to its ease of use compared to peak flow or spirometry. We have shown potential clinical utility of advanced analyses to study the day­-to­day variability in lung function in asthma in a series of retrospective studies, including the ability to predict future exacerbations within a month in an individual. This project aims to adapt such analyses to FOT data as the basis of a home telemonitoring system, and initiate a prospective study investigating the potential benefit of long-­term FOT home monitoring in Australian patients with both well­-controlled and uncontrolled asthma. We aim to show that FOT variability (i) predicts occurrence of exacerbations, (ii) is related to asthma control, and (iii) is sensitive to treatment changes. We will demonstrate this by studying moderate-to-severe asthma patients in a pragmatic, observational study in well­-controlled asthma patients who are being considered for reduction of their inhaled corticosteroid treatment dose. Treatment is initiated by the physician according to Australian guidelines independent of participation in the study, and we will study these relationships regardless of the nature of treatment. We will monitor unsupervised FOT measurements and symptoms over a period of 10-­24 weeks. Data will be uploaded automatically via mobile internet to encrypted servers and regularly checked for quality. We will also monitor exacerbations and asthma control via weekly telephone interviews and questionnaires. From these results, we eventually hope to develop an automated alert system which can signal to the patient whether or not they are about to deteriorate and to initiate self-treatment, enabling them to gain control of their disease.