ANZCTR search results

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

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33204 results sorted by trial registration date.
  • A pragmatic, two-arm, parallel randomised controlled trial comparing a virtual care referral pathway with usual paramedic care for back pain in ambulance service: Redesigning Ambulance Management for Back-pain Outcomes the RAMBO trial

    A collaborative research project to implement and test a virtual care referral pathway for paramedics to manage people with back pain. The project is a collaboration between the Institute for Musculoskeletal Health, and established health services, including Sydney Virtual Hospital and NSW Ambulance. Back pain is a common presentation to Australian ambulance services. Currently, ~30% of patients with back pain who are managed, discharged to stay at home and referred by paramedics to community health services for follow-up care reconnect with emergency health services. Virtual care services are a new alternative to in-person hospital care, providing high-quality care remotely to patients with back pain, to reduce hospital admission. This research program will involve a number of projects including a randomised controlled trial and economic evaluation, and qualitative research. The research project aims; to implement and test a virtual care referral pathway for paramedics to manage people with back pain. The RAMBO trial will evaluate the effectiveness of the virtual care pathway on health service outcomes, such as ambulance transport to hospital (primary outcome), presentation to the emergency department, patient re-contact with ambulance service, re-presentation to the emergency department and admission to hospital. The trial will also evaluate patient outcomes, including pain intensity, physical function and satisfaction with care. The economic evaluation will evaluate the cost-effectiveness of the virtual care referral pathway compared to usual care delivered by paramedics (e.g. transport to hospital) from a healthcare funder perspective. The nested qualitative research will explore; i) the clinician's perspectives of the virtual care referral pathway, and enablers and barriers to its use, and ii) the patient's views and satisfaction with the virtual care that they received for their back pain. The findings from the program of research will be translated into practice, through our partnership with health services and the Sydney Local Health District.

  • The effect of water dousing on heat strain after exercise in trained cyclists

    A common method of cooling used in endurance sports is additional skin wetting (applying water to the skin), including through water dousing (pouring water over the body). Placing additional water on the skin through dousing effectively acts as non-biological sweat which can increase the skin wettedness (% of skin covered by water) of an individual and potentially improve heat loss through a greater evaporative capacity. This study seeks to determine if dousing improves the rate of cooling during recovery from exercise, whilst also directly comparing against cold water ingestion.

  • A Brief Online Imagery Rescripting Intervention Targeting Perfectionism in First-Year University Students

    This study will test whether a brief online guided imagery exercise can help reduce maladaptive perfectionism in first-year university students. Participants will be randomly allocated to complete either an audio-guided imagery rescripting exercise or an audio-guided positive imagery exercise. They will complete online questionnaires before and after the exercise, and again after receiving their academic results.

  • A Pilot Study of the Supporting Child Mental Health Program for Parents of Children from Diverse Cultural Backgrounds

    This pilot evaluation will generate empirical evidence on the efficacy of the SCMH program in supporting parents of children from CALD backgrounds. The findings will also generate critical cultural considerations necessary to optimise the program’s relevance and appropriateness within CALD communities, which may lead to greater uptake of the course and better effects in CALD communities in Australia and internationally.

  • A randomised controlled trial in adults with obesity to evaluate the effects of tirzepatide-induced weight loss, with and without structured exercise, on metabolic, immunological, and imaging biomarkers of systemic and brain inflammation.

    This randomised controlled trial aims to evaluate the effects of weight loss, via treatment with tirzepatide, combined with a personalised exercise intervention on markers of brain inflammation. This study will allow us to explore the link between excessive adiposity-induced systemic chronic inflammation, metabolic abnormalities, and neuroinflammation. We hypothesise that tirzepatide and exercise will result in attenuated neuroinflammation (as measured by neuroimaging), improvements in cognitive function, improvements in immune-inflammatory markers, and improvements in cardiometabolic biomarkers at 6 months compared to control.

  • Implementing an accessible self-management program for quality of life in people living with seizures.

    Adults with epilepsy often face memory issues and reduced quality of life despite medical treatments for seizures, with few evidence-based non-drug options available in Australia. This randomised controlled trial tests if the HOBSCOTCH telehealth program (8 weekly sessions of self-management and cognitive strategies) improves quality of life compared to usual care for people living with epilepsy. We hypothesise that completion of the HOBSCOTCH program will result in improvements in quality of life compared to standard care, and will also result in improvements in self-efficacy, mood, and everyday cognitive function in patients with epilepsy. Furthermore, HOBSCOTCH will be feasible and able to be implemented within existing tertiary epilepsy services in Australia. Finally, we predict that HOBSCOTCH is cost-effective.

  • Investigating the use of non-invasive brain stimulation to improve attention in children following acquired brain injury

    This study aims to investigate whether a safe, non-invasive form of brain stimulation delivered at home can improve attention in children and young people aged 8–24 years following an acquired brain injury. Participants will be randomly assigned to receive one of two types of brain stimulation or a sham (placebo) stimulation while completing a computer-based attention training activity for 20 minutes a day over 10 weekdays. The first and last sessions will take place at the research centre, while the remaining sessions will be completed at home under video-call supervision from the research team. Participants will also complete assessments of attention, hand function, and brain activity before and after the intervention, as well as one week later to determine whether any effects are maintained. We hypothesise that active brain stimulation combined with attention training will lead to greater improvements in attention compared with sham stimulation. The findings from this study may help inform the development of safe and accessible therapies to support cognitive recovery following childhood-acquired brain injury.

  • Evaluating pre-surgical non-invasive brain stimulation for improving post-surgical outcomes in those with endometriosis: A pilot study

    This is a pilot randomised controlled trial study. Twenty participants with a clinical or imaging-based diagnosis of endometriosis who are scheduled for laparoscopic excision surgery will receive a pre-operative course of home-based tDCS (active or sham). The primary purpose is to assess feasibility metrics and obtain preliminary effect size estimates to power a subsequent randomised controlled trial.

  • Translating Cognitive Remediation Therapy into Mental Health Practice: Implementing Computerised Interactive Remediation of Cognition and Thinking Skills (CIRCuiTS) for adults with psychosis in Australian public mental health services

    Guided by the RE-AIM framework, this multi-phase implementation study translates CIRCuiTS into routine mental health practice and examines the reach, adoption, implementation, effectiveness, and sustainability of the CIRCuiTS cognitive remediation therapy program for people with psychosis across four Australian public mental health services.

  • Care during pregnancy and birth and maternal and perinatal outcomes according to model of maternity care for women giving birth in Victoria, 2019-2023

    There are many models of maternity care available in Victoria. The model of care during pregnancy and the model of care at the onset of labour/admission to hospital for the birth is reported to the Victorian Perinatal Data Collection for all births This project will use this population-based dataset to analyse: -characteristics of women using the various models of care (e.g. residential location, age group, Aboriginal status, complexity of their pregnancy); -variation between models of care in the nature of the care provided (e.g. number of visits, maternal vaccinations in pregnancy); -differences in intrapartum care; -outcomes of the various models for women and for babies (e.g. mode of birth, maternal and neonatal complications, early infant feeding). All other models will be compared with private obstetric care.

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