ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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33058 results sorted by trial registration date.
  • POWER: Prevention with OM-85 of wheezing exacerbation recurrence trial..

    The proposed project aims to show that immunomodulation (IM) using a bacterial lysate can deviate the immune system towards more natural responses and away from those that lead to wheeze and do this by reprogramming key response pathways. We plan to use a state-of-the-art, systems biology methodology to precisely identify the responses involved as the basis of establishing IM as a safe, practical and scientifically-sound therapy. We will recruit “high-risk” wheezing preschool children and give a 12 months course of bacterial lysate with the inclusion of a placebo arm so that we can accurately determine how bacterial lysates perturb these responses. To ensure that the immunological data relate to a clinically relevant change, the study is designed to achieve a parallel clinical outcome. The knowledge this project will obtain is essential to understand how current IM agents deviate the immune system away from responses leading to wheeze and asthma. In turn, this information is essential to allow this field of research to develop to improve health translation by identifying the key regulatory checkpoints that can be targeted for novel asthma therapies as well as the development of more focused and efficient IM preparations with potentially permanent effects.

  • Effects of saffron on sleep quality in healthy adults with self-reported unsatisfactory sleep.

    In this randomised, double-blind, placebo-controlled study, 50 adults who are currently experiencing unsatisfactory sleep will be randomly assigned to receive tablets containing either a saffron extract (28mg a day) or placebo for 28 days. We will assess change in sleep habits, sleep quality, severity of insomnia, restorative effects of sleep, and depression, anxiety, and stress scores via several validated self-report measures (to be completed at various time points throughout the study).

  • CogSCAN: Evaluation of computerised cognitive tests in healthy older adults, mild cognitive impairment and mild dementia

    Dementia is a major health problem with 200 Australians diagnosed every day and at least as many having mild cognitive impairment which often precedes dementia. Early diagnosis is seen as critical for interventions yet many older adults at risk do not receive a timely diagnosis. Objective assessment of cognitive abilities is essential for accurate diagnosis at mild or early stages. Traditionally, this is performed by specialist neuropsychologists using lengthy pen and paper neuropsychological test batteries, but these services are limited and associated with high healthcare costs. Computerised neuropsychological assessments (CNAs) have received considerable attention in recent years. Potentially CNAs are more time- and cost-effective, scalable, accessible, precise and can be administered by people with less expertise. But can CNAs improve timely diagnosis of dementia over pen and paper tests? There is limited information about the usability of these tests, and their validity and reliability in the older population. This type of information is critical before we can use these tests in the clinic. CogSCAN will be the first study to systematically evaluate and compare several of the most prominent and widely used CNA batteries in healthy older adults. CogSCAN will evaluate suitability and user-experience in older adults and examine relationships between test performance and the individual’s level of computer familiarity and attitude towards computers. CogSCAN will investigate how CNA test results compare to traditional pen and paper neuropsychological assessment results as well as how CNA results compare when retested at different time points. CogSCAN will assess the validity of the CNAs in people with different cognitive classifications (cognitively normal, mild cognitive impairment and dementia). It will also examine the relationship between demographic and clinical variables (e.g. age, years of education, occupation, premorbid IQ, anxiety and depression symptoms) and CNA test performance. CogSCAN will measure agreement amongst CNAs for categorisation of normal or cognitively impaired as determined by internal norms provided by the CNA developers. We anticipate this study will move the field forward and have a major impact on the practice of cognitive testing in older adults.

  • The development and pilot evaluation of an online mental health education program for physician supervisors

    Our research team is part of a group that has been awarded a grant to establish the Prevention Hub Mental Health Research Program. The Prevention Hub will focus on implementing and evaluating preventative strategies for anxiety and depression in workplace, school, and healthcare settings to achieve the greatest possible impact and reach. This pilot study covers one part of the overall research program; the pilot evaluation of a comprehensive online training program for physician supervisors to enable them to better manage the mental health and work environment of doctors-in-training. Medical students and doctors are often exposed to high levels of stress and trauma, and many experience mental health conditions such as anxiety and depression. This training will be based on two types of manager mental health training that have been shown to be effective in other industry groups, but in a modified format suitable for this high-risk workforce. Research Aim: To develop an online, mobile responsive, education program for physician supervisors that enhances their confidence in supporting the mental health needs of their trainees and promote managerial behaviour most likely to result in a more mentally healthy workplace Research objective: To ascertain the feasibility and acceptability of this tailored online training program among physician supervisors. The findings from this pilot study will inform the content for a future evaluation of the effectiveness of physician supervisor training through a randomised controlled trial.

  • Impact of staffing structures on communication and management of unexpected findings in patients with a suspected inflamed appendix

    Lay summary When a patient has their appendix removed (appendicectomy), the specimen is then examined under a microscope in a laboratory. Most show an inflamed appendix (appendicitis), as expected, a few are normal (negative), and approximately 10% show important unexpected findings (pathology). These include cancer, pre-cancerous growths (polyps), abnormally located cells from the womb (endometriosis) or parasites. In 2005, a new structure of care for patients with appendicitis and other emergency general surgery (EGS) conditions. Unlike the previous Traditional arrangements, this acute surgical unit (ASU) model allocated separate teams to elective and emergency patients. Many studies have shown that the ASU model reduces the time spent waiting for the operating theatre, the overall time spent in hospital and complications. However, it is unclear whether this dedicated team for EGS patients leads to better care or communication when unexpected findings occur. Therefore, amongst appendicectomy patients with important incidental findings, we aimed to assess whether introducing an ASU led to better surgeon-to-patient and surgeon-to-general practitioner communication, and better management.

  • Using behaviour change interventions to reduce sedentary time in people with chronic obstructive pulmonary disease

    This is an interventional study where adults with COPD are recruited from Pulmonary Rehabilitation Programs three Perth hospital sites. The study's intervention is behaviour change techniques to reduce sedentary time with adults with COPD and this is conducted over a nine month period.

  • The Future Proofing Study: A School-Based Depression Prevention Trial

    Research has shown that effective psychological prevention programs can prevent depression in approximately 22% of young people at risk. However, a major challenge is delivering these prevention interventions at scale, which have until now been expensive and typically delivered face-to-face. The Future Proofing study will identify how we can use smartphones to deliver effective psychological preventive interventions on a large scale, reaching young people universally by partnering with schools. The aim of the study is to determine whether SPARX – an app-based Cognitive Behaviour Therapy (CBT) program can prevent the onset of depression in Year 8 school students, who will be followed up for five years. The study will also examine the effects of the intervention on a range of mental health symptoms, wellbeing, and drug and alcohol use at 12, 24, 36, 48 and 60 months. The study will also examine the effect of a second insomnia app (‘Sleep Ninja’) on depression in those who show high symptoms of depression 12-months after using SPARX. The Future Proofing study aims to involve 10,000 Year 8 students from across 200 schools in New South Wales. It is anticipated that receiving a CBT prevention program at this developmental stage will significantly reduce the number of young people who go on to experience depression.

  • The Actionable Intime Insights (AI2) Study: Implementing a digital model for timely and needs-based interventions for individuals on anti-psychotic medication in mental health services by applying algorithms to health care data

    We are recruiting healthcare professionals aged over 18 years old to participate in a 1-year internet based study, called the Actionable Intime Insights (AI2) Study . The study aims to explore whether the use of patients Medicare Benefit Scheme (MBS) and Pharmaceutical Benefit Scheme (PBS) claims data held in My Health Record, can unveil more sufficient ways for clinicians and other healthcare professionals to provide optimal health care to patients with a chronic mental illness. Specifically, when people go to visit their doctors, they typically lodge a MBS or PBS claim to subsidise some of the payment costs. However, to date, there has not been a successful way of monitoring and managing the MBS and PBS data. We hope that we can be the first to provide a long-term sustainable solution to this problem, with the implementation of our novel digital application called the Actionable Intime Insights (AI2) application. We believe the AI2 application will help transform the way clinicians and patients interact with each other and ultimately improve patient’s well-being and outcomes.

  • A randomised controlled trial of an efficacious school-based eating disorder risk reduction program: A comparison of 2, 4 and 8 lessons

    Media Smart (MS) is an 8-lesson school-based program that was developed by Dr Wilksch and Prof Wade and has been evaluated in a systematic program of research with over 2,000 participants. MS is now considered the leading ED risk reduction program worldwide for school-based, universal settings (i.e., given to all students regardless of risk status rather than selecting those at high-risk of an ED). However, many schools find 8 lessons difficult to timetable within the busy school program and given competing demands. Therefore the overall aim is to conduct an RCT to assess the efficacy of MS when it is delivered in shortened formats, namely a 2- and 4-lesson version, compared to the full 8-lesson program. The study design will include school class randomisation to: MS–2 lessons (MS-2); MS–4 lessons (MS-4); the full 8-lesson MS program (MS-8) and control group (normal school lessons with provision of a 1-page tip sheet on improving body image). Consistent with previous RCTs, MS will be delivered by trainee psychologists who will receive 5-hours of training in the program. Students will complete measures at baseline, post-program, 6- and 12-month follow-up. Measures will assess disordered eating and ED risk factors. This research is important in assisting with dissemination of the program given greater uptake is likely with a shorter curriculum. The rationale is not to replace MS-8 but to provide schools with informed, evidence-based alternatives for shorter versions that can better fit into the school program.

  • Treating insomnia symptoms using the THIM sleep tracking device.

    This project will be the first to test the effectiveness of the sleep wearable device called THIM for administering Intensive Sleep Retraining in the home environment. We will also examine the ability of THIM to provide effective and affordable treatment for insomnia, improve individual sleep health and general well-being. We predict that THIM-administered Intensive Sleep Retraining intervention condition will demonstrate: • increased total sleep time and sleep efficiency; • reduced sleep onset latency and time awake after sleep onset; • improvements in daytime functioning measures Compared to the Sleep Hygiene Control condition at post-treatment and two-month follow up time points.

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