ANZCTR search results

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

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32103 results sorted by trial registration date.
  • MindYourHead web-app: a randomized controlled trial of the effect of online personalised mental wellbeing feedback on help-seeking among Chinese international students

    This study will evaluate the impact of a personalised mental wellbeing web-app on help-seeking, mental health literacy, self-stigma, and wellbeing among Chinese international students in a randomised controlled trial. Participants are randomised to the intervention (enhanced MindYourHead app), which provides personalised symptom feedback, tailored psychoeducation on symptoms and interventions, and tailored links to external resources and local mental health services; or the attention-control arm (standard MindYourHead app) with an identical web-app design but without the personalised feedback and tailored psychoeducation. Assessments occur at baseline, 1 week post-intervention and 6 weeks follow up. It is hypothesised that participants receiving the intervention will have higher help-seeking intentions and attitudes than those in the the control group.

  • Randomised hybrid implementation-effectiveness trial of a school-based mental health program in Australian schools

    Implementation of evidence-based programs in school settings can be challenging and these challenges undermine the benefits these programs deliver for children. The primary aim of this study is to assess the potential effectiveness of an implementation intervention designed to enhance the adoption of the PAX Good Behaviour Game in New South Wales (NSW) primary schools. A secondary outcome is to investigate the impact of the PAX Good Behaviour Game on children’s mental health in the Australian context. The study uses a cluster randomised hybrid III effectiveness-implementation design and will involve 60 NSW primary schools. Randomisation will occur at the school level. All NSW public schools trained in the PAX Good Behaviour Game are eligible for participation. The intervention is a multicomponent implementation strategy that has been iteratively co-designed by the research team and local stakeholders. Intervention schools will have access to multi-component implementation support strategy in addition to the coaching received as usual care to assist with implementation challenges. Primary and secondary implementation and effectiveness outcomes using self-report online surveys with teachers, support staff and parents at baseline until 6-months follow up, and where relevant, from baseline to 12-months follow up. Qualitative interviews with teachers, support staff and principals will be used to examine which implementation strategies worked for whom and under what conditions.

  • Cost effectiveness of routine histology for haemorrhoidectomy specimens

    This study aimed to determine the cost-effectiveness of routine histology for haemorrhoidectomy specimens in a regional Australian hospital, as a way of detecting incidental anal cancer. The secondary aim was to determine the proportion of specimens that were sent for histology over the study period and whether individual surgeons had a significant preference for whether to send for histology.

  • Bipolar early interventions using new digital technologies (BLEND): a feasibility trial

    Currently, specialised early interventions are not accessible for a majority of youth with Bipolar Disorder who seek care. We have developed a specialised clinical intervention model (BLEND) integrating evidence-based psychological strategies delivered through digital and face-to-face sessions; psychopharmacological interventions; relapse prevention and online social networking. We will conduct a randomised trial to evaluate the acceptability, safety and feasibility of this intervention, compared with an enhanced model of care currently delivered at the clinic (Enhanced Standard Care or ESC). We will include young people aged between 15 and 25 years, seeking specialised help for the first time for Bipolar Disorder types I or II. After informed consent, we will randomise 20 such young people (2:1) to BLEND or ESC. Interventions will be delivered over 6 months and assessments will be conducted at baseline, 3 and 6 months. This study will help adapt the intervention(s) to improve acceptability, feasibility or safety and enable the next steps in evaluating the efficacy of the BLEND model.

  • Implementing the Tailored Activity Program in Australia.

    The Tailored Activity program (TAP) is a structured, occupational therapist-led intervention for people with dementia and their care partners living in the community. It has been shown to be effective in reducing behavioural and psychological symptoms (BPSD) in people living with dementia and carer stress and improving quality of life. TAP is provided by Occupational Therapists (OTs) in up to eight home visits over 3-4 months. The OT assesses the person’s capabilities and strengths, and teaches carers to tailor and adapt meaningful activities (any activity that is important or personally meaningful to the person with dementia), use effective communication strategies, generalise these skills to other activities of daily living, understand environmental triggers for BPSD, and utilise stress reduction strategies for themselves. Despite evidence of its effectiveness, however, TAP is not currently available in Australia. We plan to bring a modified version of the program to Australia where it will be called TAP-Australia and will be provided in 6 sessions, We aim to train up to 100 OTs across Australia who will then be able to provide the program to people living with dementia/ probable dementia and their carer living in the community.

  • The effectiveness and value-for-money of an intervention supporting healthy food changes in local government food retail outlets

    This randomised controlled trial (RCT) aims to determine the effect of a 3-year multi-component healthy food retail support model (the Intervention) on sales of healthy and unhealthy foods and drinks, compared to a Control condition, in local government-owned retail outlets in non-seasonal sport and recreation facilities. We hypothesise that the Intervention will be associated with a decrease in purchases of unhealthy food and drinks, and an increase in purchases of healthy food and drinks. Four LGs (approx. 20 facilities) will be assisted to adopt healthy retail practices via: (i) salary support for a dedicated local government project officer; (ii) implementation support and training; and (iii) a retailer-level monitoring system to incentivise progress. Four control local governments (approx. 20 facilities) will not receive any intervention, but will be monitored during the RCT. The study will help inform interventions to support local governments to implement healthy food retail changes, while considering whether such interventions offer 'value-for-money' for local and state governments.

  • CUMULUS: Comparing Ultrasound Markers of Under recruited Lung in preterm infants on respiratory Support

    Preterm infants frequently require mechanical ventilation. This lifesaving intervention is associated with long term respiratory consequences, the most important being bronchopulmonary dysplasia. To minimise this risk, clinicians employ lung protective ventilation strategies. Such strategies require detailed knowledge of the lung volume state. Lung volume is commonly assessed by chest x-rays (CXR). CXRs have disadvantages including not always being readily available, exposure to ionising radiation and only providing a static picture of lung, often at an uncertain point of the respiratory cycle. Lung ultrasound (LUS) is being increasingly utilised in neonatal intensive care units. It has proven utility in the diagnosis of respiratory distress syndrome (RDS), pneumothorax, consolidation and the need for surfactant and mechanical ventilation. Lung ultrasonography offers advantages over conventional imaging modalities: no ionising radiation, less manipulation of the patient and dynamic assessment of the lung. The precision and accuracy of this technique is to detect poor lung recruitment, and it’s correlation with respiratory support requirements in preterm infants warrants further exploration. We designed a prospective observational study to explore these applications. The results of this pilot study will support further clinical studies exploring the utility of LUS in guiding neonatal respiratory support.

  • Pre-treatment dihydropyrimidine dehydrogenase (DPYD) genotyping in patients receiving fluoropyrimidine (5-Fluorouracil or Capecitabine) chemotherapy: A clinical implementation study of the effect of individualised dosing on treatment related toxicity

  • The role of REM sleep fragmentation in treatment for insomnia and separation anxiety

    This research project seeks to answer the following research questions: 1) Is there a relationship between separation anxiety and REM sleep fragmentation in children in middle childhood (aged 7-13) with insomnia? 2) Can Sleep Restriction Therapy reduce separation anxiety, sleep fragmentation, REM sleep fragmentation, daytime sleepiness, and worrying in these children? The study will randomly allocate children to receive either Sleep Restriction Therapy or Bedtime Regularisation. Children’s separation anxiety, sleep, sleepiness, and worries will be assessed using self-report measures as well as polysomnography at baseline and post-treatment. We hypothesize that separation anxiety will be significantly associated with REM sleep fragmentation. We also expect to observe greater reductions in anxiety, REM fragmentation, sleep fragmentation, and sleepiness from baseline to post-treatment in children receiving Sleep Restriction Therapy compared to Bedtime Regularisation.

  • A Comparison of Kneeling Ability After Lateral or Midline Incisions In Total Knee Arthroplasty

    This is a prospective randomized controlled trial comparing the outcome of patients undergoing primary total knee arthroplasty with either a midline or a lateral skin incision. Patient outcomes will be collected and compared between the two surgical cohorts over a 24 month post-operative period, and will include a range of subjective and functional outcomes, and kneeling tolerance. It is hypothesised that there will be no difference in kneeling tolerance between midline or lateral skin incisions.

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