ANZCTR search results

Many people with cerebral palsy (CP) have communication difficulties. Communication is a vital skill for life, with communication difficulties often leading to social, emotional and educational challenges. Research shows that children with CP who are not talking by 2 years of age, are more likely to have permanent communication problems. We know that early targeted training is helpful for infants with CP to learn how to move and walk, but it is less clear when it comes to communication skills. We want to understand if teaching parents communication strategies before their infant is 12 months old leads to better communication skills at 2 years. We will be comparing It Takes Two to Talk® (ITTT) – The Hanen Program® to a usual care group. ITTT teaches parents how to create communication opportunities, to encourage and respond to their infant’s early communication attempts, and to incorporate these strategies into play and their everyday routines. Hanen programs are effective with other groups of young children with disability including Autism Spectrum Disorder, but there is very little high-quality research on any program focusing on early communication in infants with CP. We will be measuring each infant's communication skills, problem-solving, play, social-emotional skills, and parent- infant interactions. We will complete assessments before the intervention begins, and when each infant is 2 years old, to measure if any change has occurred. This study will help us understand the value of early communication intervention for infants with CP and their parents, to provide future guidance regarding effective early communication intervention. We hypothesise that, for infants with or at risk of CP, early parent training with ITTT will be more effective than usual care to improve: Primary Hypothesis [i] Child communication skills on the Communication and Symbolic Behaviour Scales (CSBS), indicated by a difference between groups of 0.5 standard deviations. Secondary Hypotheses [ii] Receptive and expressive communication skills on the Rossetti Infant Toddler Language Scales and/or the Bayley Scales Infant Development (BSID-IV) language scaled scores; [iii] Cognition measured by Bayley Scales Infant Development (BSID-IV) cognitive scaled scores; [iv] Social and emotional development measured by BSID-IV social emotional questionnaire; [v] Parent-infant interactions as measured through detailed video coding and the PaRRis scale at two years of age.

This study aims to evaluate a telehealth cognitive behavioural therapy intervention for insomnia (CBT-I) in Vietnamese-speaking cancer survivors, delivered by a Vietnamese-speaking psychologist. Who is it for? You may be eligible for this study if you are aged 18 years or over and can speak and read Vietnamese, and have completed curative treatment (e.g., surgery, chemotherapy, radiotherapy) for head and neck cancer and are now experiencing clinically significant insomnia symptoms. Study details Participants will undergo a six-session CBT-I intervention delivered weekly over telehealth. Upon completion of the intervention, participants will be asked to complete a few questionnaires regarding acceptability of the treatment and changes in their insomnia. It is hoped that this study will help provide evidence for CBT-I delivered for a Vietnamese population and help address inequalities in accessing evidence-based health care for people from Vietnamese-speaking backgrounds.

The Registry of Stroke Care Quality (RES-Q) is a global stroke registry used to collect stroke quality of care metrics with benchmarking at both hospital and national levels. RES-Q provides real-time feedback to participating hospitals via reports on demand and dashboards. Providing feedback on the registry data to hospitals and clinicians helps them identify and prioritize areas for stroke care quality improvement. Findings from our recent survey of hospitals participating in RES-Q showed that feedback of RES-Q data to hospital staff and department heads about progress in stroke management was suboptimal. Although there was a high awareness of RES-Q hospital reports and dashboards, staff downloads and views respectively, were low. Current RES-Q feedback mechanisms are passive and rely on the active role of users, which is only partly successful. For RES-Q data to be more effective in driving clinical practice change, evidence-based performance feedback mechanisms are needed. Hence the aim of this study is to evaluate the effectiveness of a feedback prompt intervention involving a ‘push’ email, comprising a message encouraging use of RES-Q data for quality improvement with a link to the RES-Q hospital report and dashboard, sent to the RES-Q hospital coordinators in improving report generating, dashboard viewing and stroke care processes. A randomised controlled trial will be undertaken. Hospitals participating in RES-Q will be randomised to the feedback prompt intervention or a control group. All hospitals registered with RES-Q and entering data to the RES-Q database up to 31st July 2024 will be eligible for inclusion in the study. The study findings have the potential to increase hospitals’ use of RES-Q data to drive practice change within their stroke unit/service.

Immunotherapy targeting immune checkpoint molecules (cell markers) is a new treatment option for patients with mesothelioma. The purpose of this study is to use a novel positron emission tomography (PET) imaging tracer to identify tumour cells that are expressing a specific marker (PD-L1) on mesothelioma tumours using imaging. A new non-invasive method of imaging PD-L1 in people with mesothelioma may allow clinicians to better guide immunotherapy treatment that is personalised for each patient. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with either pleural or peritoneal mesothelioma and you have not yet undergone any immune checkpoint therapy (immunotherapy). Study details This study will enrol participants into one of two stages. Participants enrolled in Stage 1 of this study will be asked to undergo 4 imaging scans in total over a 7 day period. On the first day, participants will undergo two different but similar CT scans. Each scan will involve injection of a specific tracer/dye into a vein 20 minutes prior to the scan being undertaken. Each scan is anticipated to take up to an hour, the total time needed to complete both scans is not anticipated to take more than 3 hours. Participants will then be asked to return 3 days and then between 5-7 days after the first scans to undergo two further scans. These follow-up scans are anticipated to take up to an hour. Participants who choose to enrol in Stage 2 of this study will also be asked to undergo 4 imaging scans in total but this will occur over a longer period of time. Prior to their scheduled anti-cancer systemic therapy, participants will undergo two different but similar CT scans. Each scan will involve injection of a specific tracer/dye into a vein 20 minutes prior to the scan being undertaken. Each scan is anticipated to take up to an hour, the total time needed to complete both scans is not anticipated to take more than 3 hours. Participants will then either receive immunotherapy alone or immunotherapy with chemotherapy. Six weeks after the commencement of systemic therapy, participants will undergo another two scans. A follow-up appointment to discuss any adverse events, the cancer response and a general physical examination of health will be arranged at the next appointment in line with standard of care. It is hoped this research will determine whether this new imaging method is able to accurately identify tumour cells that are expressing PD-L1 and whether this imaging is able to show differences in cell expression over the course of immunotherapy treatment for patients with mesothelioma. Any advance in predicting treatment outcomes would benefit mesothelioma patients by avoiding unnecessary toxicity and better personalising therapy. People in whom the new PET imaging demonstrates a very low chance of immunotherapy response may choose to participate in clinical trials or to be trated with chemotherapy.

Pelvic organ prolapse (POP) is a common gynaecological condition which has been observed in up to 50% of women above 50 and has an associated 20% risk of surgery during a woman’s lifetime. Despite impacting the lives of millions of women in our society, there are few options available for preventing or addressing this condition. Defined as the downward displacement of one or more pelvic organs into the vagina, POP can significantly impact the quality-of-life of women with the condition. It has a number of causes including injury from vaginal birth/pregnancy, and is exacerbated by ageing, obesity, genetics, constipation, chronic coughing, heavy lifting, and smoking. Severity is graded using the Pelvic Organ Prolapse Quantification (POP-Q) tool which classifies the degree of descent using the hymen as a reference point. Stages of descent vary from minor descent (Stage 1) to the complete external presentation of the organ (uterus, bladder, bowel) through the vagina (Stage 4). Symptoms include a heavy sensation or dragging feeling in the vagina, a lump in the vagina, a lump which bulges out and can be felt or seen when standing, painful intercourse or loss of sensation, difficulty emptying the bowel or bladder, recurring urinary tract infections, and faecal or urinary incontinence (UI). According to a report by the Australian Institute of Health and Welfare, UI alone accounts for >$200 million each year in healthcare expenditure in Australia, with drastically more women being affected than men for this condition. Current clinical protocols primarily have a passive management focus, which includes lifestyle changes or simple intravaginal pessaries, both of which require long-term (often until surgery or end-of-life) investment and adherence by patients; or a rehabilitation focus where pelvic floor muscle training attempts to strengthen the pelvic floor muscles. On the spectrum of invasive practices, 10-20% of women will undergo surgical intervention. However, surgery carries a number of risks, contraindications, and has the disadvantage that up to a third of women may have a recurrence. Additionally, vaginal mesh procedures introduced to reduce the risk of recurrence caused unacceptable adverse events and are no longer approved. Due to these limitations with current management protocols, there is a demand for novel non-surgical treatments which can improve or cure the condition. IVES could play a role in rehabilitating the pelvic floor muscles of women with POP. It does this by triggering neuromuscular contractions in the pelvic floor which may either increase muscle bulk or tone muscles to improve their ability to support the organs. With research suggesting that IVES may be effective at treating UI and at increasing pelvic floor muscle strength, it is possible that IVES may be an effective treatment for mild-to-moderate POP. This study aims to develop a heat map of the optimal intravaginal regions to target with IVES to improve efficacy of IVES.

Inflammatory Bowel Disease (IBD) is a chronic gastrointestinal disease, affecting approximately 1 in 250 Australians. Ulcerative colitis is a sub-type of IBD. Scientific research exploring the effectiveness of nutritional therapies in adults with Ulcerative Colitis has not yet found many definitive conclusion, therefore more research is needed. In addition, research testing how these nutritional therapies change the gut microbiota may be beneficial at developing anti-inflammatory nutritional therapies that help to manage this burdensome disease. There is a lack of clinical trials that have tested both changes to inflammatory markers and the gut microbiota in adults with inflammatory bowel disease, after taking a microbiota-modulating therapy. Plant athocyanins and probiotics have both been shown to reduce inflammation, however not enough to be effective in adults with IBD. In this study, we plan to test for the first time whether combining both an anthocyanin and a probiotic will result in more effective reductions in inflammation and therefore beneficial disease control. This study aims to evaluate the effectiveness of a multi-strain probiotic intervention provided together with dietary anthocyanins extracted from the New Zealand Blackcurrants on the gut microbiota profile and inflammatory biomarkers in adults with mild-moderate Ulcerative Colitis. We hypothesise that the combination of anthocyanins and probiotics will lead to reduction in gut inflammation in participants (measured through faecal calprotectin), and will alter the gut microbiota. We hypothesise that these improvements will be more significant in participants who take the combined intervention (anthocyanin + probiotic) rather than participants who take the anthocyanin alone or probiotic alone.

SUMMARY Study title: Ex-vivo confocal microscopy: diagnostic accuracy, acceptability & feasibility This study is investigating the accuracy of a new method of analysing skin biopsies using a high-powered microscope to determine the diagnosis (for example, skin cancer, inflammatory skin condition) and whether the lesion is clear of the surgical margins or not. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older, you have one or more skin lesions that need to be investigated and you are willing to have a biopsy (tissue sample) taken, when a biopsy is recommended for you as standard care by your treating doctor.. Study details All participants who choose to enrol in this study will not be asked to provide any extra skin samples that they would not already be providing as part of their standard clinical care. Participants who choose to enrol in this study would give permission for up to three of their skin biopsies to be examined with the new microscope. The skin biopsies will then undergo further preparation for scanning with the new fusion ex-vivo confocal microscope (fevCM) system and will also be assessed by the standard histology (staining of the tissue) analysis method. It is not anticipated that participation in this study will require additional time or travel commitments from patients. It is hoped this research will determine whether the new microscope method of assessing skin tissue is comparable to the standard assessment methods in terms of accuracy and time needed to prepare and analyse tissue samples. If the new microscope system is found to be accurate and quicker than the current assessment methods, use of this technology may be expanded to a greater number of patients.

This study is a mixed-methods study, combining an open-label pragmatic parallel group randomised controlled trial (RCT) with qualitative methodology investigating the effect of different milk proteins on brain, immunity, gut and skin health outcomes. There is evidence that different forms of beta-casein proteins, found naturally in milk, have different effects on health. There is also some evidence of an interconnection between the brain, immune, and skin systems linked by the gut microbiome. This study aims to determine the effect of milk containing only a2 beta-casein protein on brain health, immunity and inflammatory markers, gastrointestinal function, and skin health as compared to conventional milk which contains A2 and A1 beta-casein, in healthy older adolescents and adults (16-65 years) in a real world setting. Participants (n=1000) will be randomised to each study arm. The study period goes for 30 days including a 2 day run-in and 28-day intervention. Outcomes will be measured at the start, middle and end of the intervention period. The first 260 participants will be required to have a saliva sample and faecal sample collected pre and post intervention and complete questionnaires at each time point. The remaining 740 participants will complete questionnaires at each time point only. There will additionally be a short (1 min) survey sent twice a week to monitor for adverse events. Participants from the intervention group will be randomly selected and invited to participate in the nested qualitative study (n=30). The study has been planned in accordance with the Declaration of Helsinki, National Health and Medical Research Council National Statement on Ethical Conduct in Human Research. All staff with direct participant contact have completed Good Clinical Practice Guideline training and certification.

Primary aim: To examine the efficacy of heel lifts versus sham on pain intensity among individuals with mid-portion Achilles tendinopathy at 3 months. Secondary aim: to investigate the acute biomechanical effects of heel lifts among individuals with mid-portion Achilles tendinopathy. The primary outcome measure will be pain intensity (at its worst) at 12 weeks. Study hypothesis: Heel lifts will lead to a superior outcome in the pain intensity measure compared to sham at 12 weeks.

The Daughters and Dads Active and Empowered Program is an intervention which engages fathers in positive lifestyle role modelling and effective parenting strategies to improve the physical activity behaviours, physical confidence, sport skills and social-emotional wellbeing of their daughters. Importantly, the program also targets girls to improve their fitness and physical activity levels, and parenting skills of their fathers. This mixed-methods, observational study is a follow-up of participants from previously registered studies, including: ACTRN12615000022561 (2015), ACTRN12616001270404 (2016), ACTRN12617001450303 (2017-2019) and ACTRN12621000264886 (2020). The purpose is to evaluate the impact of the Daughters and Dads community-based program beyond the initial effects, on longer-term, real-world impacts upon the outcomes mentioned above. Establishing the long-term effectiveness of the program: • would be an important and novel contribution to the literature. • may inform future iterations of the programs. • will help provide evidence as to whether additional scale-up of the program is worthwhile with current and future agencies who may wish to fund the scale-up of this evidence-based program, thus providing greater reach to families across the state, nationally and internationally.