ANZCTR search results

Obesity is common in Aboriginal and Torres Strait Islander communities and increases the risk of type 2 diabetes and heart disease. This WA-based study, designed in partnership with Aboriginal health and community groups, will test whether a medication called semaglutide (already shown to reduce weight and improve blood sugar and heart risk in other groups) can help improve health outcomes in Aboriginal people. The study will involve 200 Aboriginal or Torres Strait Islander participants, who will be supported with healthy eating, exercise, and regular check-ins. Some will receive weekly semaglutide injections, while others will receive a placebo. The study will measure changes in weight, blood pressure, blood sugar, and heart health over two years. This is the first trial of its kind in Aboriginal Australians and aims to guide future care.

The primary aim of this study is to assess the effect of a sensory vest on autistic children’s anxiety. Using a randomised controlled trial design, Autistic children aged 8-12 years will be randomly allocated to an experimental (sensory vest) or placebo vest condition. Study participants will wear the vests for 12 weeks, attend monthly study visits with the research team and complete brief online surveys throughout. Child anxiety will be measured by assessing stress response (electrodermal activity via sweat response) during activity and parent report. The secondary aim of the study is to explore the mechanism-of-action and cost-effectiveness of the sensory vest. Specifically, we will examine a) whether the sensory vest affects anxiety symptoms directly or indirectly via sensory regulation, sleep quality and/or physical activity pathways, and b) the cost-effectiveness of sensory vest wear compared to placebo in terms of health-related quality of life from a societal perspective.

This project aims to evaluate acceptability and feasibility of the implementation of a pressure injury preventing system (PIPS) within a Residential Aged Care service setting. The key objectives will be to: - Evaluate the feasibility and acceptability of the PIPS intervention by Healthcare Workers to understand how it impacts workflow, clinical decision making and prioritisation of clinical care provision. - Secondary outcomes include reporting of preliminary effectiveness data related to pre and post changes in repositioning frequency and cumulative 'at risk' pressure minutes.

The Royal Hospital for Women (RHW) in Randwick is implementing a new model of maternity care for women with pregnancy complications such as: a diagnosis of gestational hypertension, threatened premature labour (TPL) and/or premature pre-labour rupture of membranes (PPROM) called ‘Virtual Maternity Ward’. Women who have traditionally required inpatient admission, will be offered the opportunity to be cared for at home by midwives and obstetricians from the RHW. The midwifery team will consult with women regularly and collaborate with obstetricians and escalate women’s care when required. The new model with combine a midwifery home visiting program and periodic outpatient visits to RHW. Models of this type are common in Europe and have been operating as standard care for up to 10 years. Examples include maternity units in Aarhus University Hospital and Copenhagen University Hospital, Denmark and Utrecht University Hospital The Netherlands - see Lancet publication: Bekker, M. N., Koster, M. P. H., Keusters, W. R., Ganzevoort, W., de Haan-Jebbink, J. M., Deurloo, K. L., Seeber, L., van der Ham, D. P., Zuithoff, N. P. A., Frederix, G. W. J., van den Heuvel, J. F. M., & Franx, A. (2023). Home telemonitoring versus hospital care in complicated pregnancies in the Netherlands: a randomised, controlled non-inferiority trial (HoTeL). The Lancet. Digital Health, 5(3), e116–e124. https://doi.org/10.1016/S2589-7500(22)00231-X This pilot evaluation study will evaluate the feasibility and acceptability of the Virtual Maternity Ward at RHW model to women, their partners, clinicians and managers. It will also pilot methods for a future evaluation of cost (hospital and individual levels) and carbon emissions. The study is fully funded by NSW Health, SPHERE and UTS and has been approved by the HRECs of SESLHD and UTS. Governance approval has been granted by the RHW.

This study aims to understand how gum inflammation (gingivitis) may affect the immune system in people with rheumatoid arthritis (RA) or those at risk of developing it. Participants will temporarily stop brushing and flossing for up to three weeks under supervision, allowing researchers to observe changes in the gums and immune responses. The study will compare these changes across three groups: people with RA, those at risk, and healthy individuals. We hypothesise that people with RA will show a stronger immune and bacterial response to gingivitis than healthy individuals. The results may help identify early warning signs of RA and improve strategies to prevent joint flare-ups linked to oral health.

The primary aim of this research study is to investigate the effect of resistance training on body composition in females in or approaching the menopausal transition. The aim of the second study is to investigate if an exercise care management model can maintain physical activity levels in this population. The entire study will be followed by a semi-structured interview to qualitatively assess differences in experiences across the study between participants who finish the trial as either insufficiently active, moderately active and active.

Waiting at least 60 seconds before clamping the umbilical cord ("delayed cord clamping") is recommended in uncomplicated pregnancies to reduce anaemia, death and disability. However, babies with a heart defect diagnosed before birth have not been included in the studies on which these recommendations were based. This study will examine whether delayed cord clamping improves the proportion of red blood cells ("haematocrit”) in the blood of babies born after 34 weeks of pregnancy with a serious heart defect ("critical congenital heart disease") that was diagnosed before birth, compared to early cord clamping. It will also examine the feasibility of a larger definitive trial that would examine whether delayed cord clamping improves health outcomes for these babies in the longer term. Data will be collected to approx. 3-4 months of age, or to approx. 12 months of age subject to further funding. A total of 90 infants will be recruited.

The purpose of this study is to evaluate the effectiveness of an evidence-based peer coaching online parenting intervention (PiP-P2P) as compared to the non-coached self-guided online parenting intervention (PiP) in parents of adolescents aged 12-17 years with emerging mental health problems. The program aims to build parenting skills and confidence by equipping parents with evidence-based parenting strategies that are associated with reduced risk and impact of depression and anxiety disorders in adolescents. The PiP program comprises up to 10 self-guided, online modules covering different topics related to parenting and adolescent mental health. In this trial, we aim to evaluate: 1) the effectiveness of PiP-P2P compared to self-guided PiP in improving parenting skills, parental self-efficacy, parental anxiety and depression symptoms, caregiver strain, carer burden, carer gains, adolescent depression and anxiety symptoms, and adolescent perceived quality of parental support, and 2) whether intervention engagement (percentage of PiP modules and PiP goals completed) mediates the effects of the intervention on parent and adolescent outcomes. We hypothesise that compared to PiP, PiP-P2P will produce greater improvements in parent and adolescent outcomes from pre- to post-intervention and at follow-up. It is also hypothesised that greater improvements in outcomes from PiP-P2P compared to PiP will be explained by greater intervention engagement in PiP-P2P.

This study is testing a new dosing schedule of Lutetium-177 PSMA (177Lu-PSMA), a radioactive treatment for men with prostate cancer that has spread and no longer responds to standard hormone therapy. The aim is to see whether giving 177Lu-PSMA more frequently at the start of treatment can overcome early resistance and improve outcomes. Who is it for? You may be eligible for this study if you are a male aged 18 or over who has prostate cancer that has spread to other parts of the body and is no longer controlled by standard hormone therapy (castration-resistant). You must have evidence of metastatic disease on imaging, a reasonable general health status (ECOG 0–2), a life expectancy of at least 12 weeks, and adequate blood and organ function. Men who have previously received modern hormone therapies such as abiraterone or enzalutamide may be eligible. Study details All participants will be randomisation to either arm 1 or arm 2 with different dosing schedules. Participants will receive 177Lu-PSMA treatment according to either the standard schedule or a more frequent dosing schedule. You will have PSMA PET/CT scans, blood tests, and other routine health checks to monitor your response and side effects. It is hoped that this study will help provide important information on whether a new dosing schedule can improve the effectiveness of 177Lu-PSMA and guide future treatment for men with advanced prostate cancer.

The aim of this study is to evaluate the acceptability and feasibility in a real world setting of a tailored intervention developed to assist CSOs of treatment-refusing or non-help-seeking individuals with gambling problems, to encourage the gambler to enter treatment.