ANZCTR search results

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

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31373 results sorted by trial registration date.
  • Multidisciplinary Team-based approach to guide secondary risk prevention for cardiovascular and limb outcomes in patients with Peripheral Artery Disease (TEAM-PAD): A Randomised Controlled Trial

    People with advanced Peripheral Artery Disease (PAD) require costly, complex surgery, and often have heart attacks, strokes, and amputation. Preventative care is poorly provided, and many people with PAD miss out on medications that improves long-term health and avoid complications. We hypothesise that involving a range of expert doctors in team-based care will improve recognition and treatment of cardiovascular risks compared to current care practices. This project aims to improve prevention of adverse cardiovascular outcomes in people with peripheral artery disease by providing multidisciplinary team-based care that is targeted to an individual person’s health needs. To do so, we will compare the cardiovascular risks of people treated according multidisciplinary team recommendations (measured using the SMART-REACH model) to those who receive current standard care. We will also measure patient and clinician experiences, and costs associated with the new team-based model of care.

  • Conscious sedation vs Axillary or Brachial plexus block in Interventional Radiology (SABIR) for endovascular fistula treatment in adults.

    Aim: To improve the quality of care in interventional radiology (IR) by determining the optimal form of anaesthesia for fistula interventions whilst optimising resources for Liverpool Hospital and SWS LHD. Primary objectives: To assess the efficacy and safety of regional anaesthesia for fistuloplasty in IR compared to conscious IV sedation. Secondary objectives: To assess proceduralist and patient satisfaction with regional anaesthesia compared to conscious IV sedation. Hypotheses: We hypothesise, based on anecdotal experience, preliminary data and evidence in the literature in other clinical settings, that regional anaesthesia (axillary or brachial plexus block) is safer and more effective than intravenous sedation for anaesthesia/pain relief during fistula interventions. We also propose that this will lead to improved proceduralist and patient satisfaction and reduced burden on resources.

  • Comparison clinical sensitivity and specificity of self-collected vs practitioner-collected samples from patients attending for colposcopy.

    SCoPE2 is evaluating different methods of self-collection to determine is alternative methods can be used with new HPV nucleic acid based assays to facilitate a wider range of options for HPV-based cervical screening. There is a lot of evidence demonstrating that self-collection is as good as clinician-collected for HPV-based cervical screening. SCoPE2 is looking to assess whether the method in this study produces similar results showing that self-collection is equivalent to clinician-collected samples for HPV-based cervical screening.

  • Using a Motivational RehabChat App for Brain Injury Rehabilitation

    It is important that people with brain injury and stroke engage in rehabilitation activities outside of their clinical appointments to maximise their recovery. Issues with memory, motivation, and therapy engagement can make it difficult for clients to undertake activities between appointments. We have developed RehabChat – a motivational chatbot app - to assist with goal setting and achieving goals. RehabChat was co-designed with clients with brain injury and brain injury rehabilitation clinicians. RehabChat is easy to use and helps clients be motivated and involved in their rehabilitation to complete their practice activities and reach their goals. It is designed to be used alongside usual care by a client with brain injury or stroke, with their therapist providing clinical oversight. The client-clinician pair use RehabChat at weekly appointments to enter key rehabilitation information about the client’s goals and practice activities. The client then uses RehabChat independently in-between appointments for motivational cues and reminders which support the client to complete their prescribed practice activities. Results from earlier testing of RehabChat suggest that RehabChat supports client motivation and therapy engagement. This study aims to appraise how feasible and easy it is to use RehabChat alongside usual rehabilitation care. Each participant will first receive 1:1 training to use RehabChat. Client and clinician pairs will then use RehabChat for up to six weeks and provide feedback of their experiences and perceptions. The findings from this study will inform the development of a larger clinical trial.

  • Development and evaluation of the myTBI online psychoeducation platform on psychosocial adjustment to traumatic brain injury from acute to chronic injury

    Traumatic brain injury (TBI) is a complex chronic disease process with survivors facing unique and ongoing challenges over different recovery stages. Post-injury psychosocial and emotional adjustment problems are common and can reduce quality of life, functional recovery, and increase healthcare costs. The myTBI study aims to develop an online psychoeducation platform to improve psychosocial adjustment to TBI and enable continuing psychosocial support for individuals across acute, post-acute, and chronic phases of recovery. We hypothesise that psychoeducation will improve psychosocial adjustment after TBI and will have a significant impact on overall functional recovery and quality of life after TBI and reduce length of stay. Online education represents a cost-effective and scalable solution that can be directly and immediately implemented within existing health services without requiring highly specialised clinicians, and may be particularly effective for engaging the predominantly younger male TBI population.

  • My Liver Health App for Ascites

    Chronic liver disease (CLD), characterised by complications such as ascites, encephalopathy, variceal bleeding, and hepatocellular carcinoma, is a major health concern in Australia. While effective evidence-based therapies exist, delivery of this care has been proven to be sub-optimal. Smartphone-based technologies represent a promising tool for effective disease management and improving patient engagement. Indeed, real-time data collection has demonstrated feasibility and acceptability in a variety of conditions—from schizophrenic disorders , to diabetes, to some promising initial work in liver health . However, in the context of ascites management, there is a need for real-world trials to explore the feasibility and utility of this technology. The objective of this study therefore is to determine the feasibility of a smartphone-based application in the management of ascites in CLD patients in our hospital and community setting.

  • Managing cancer and living meaningfully (CALM) in people with non-small cell lung cancer treated with novel therapies: a pilot study

    The overall aim of this study is to assess the acceptability, feasibility and potential impact of CALM in people with advanced NSCLC treated with novel therapies. The specific objectives of this project are to: Assess the feasibility of the CALM intervention, outcome measures, and study design to guide the development of a Phase 3 RCT; Explore the acceptability of CALM to patients with advanced NSCLC treated with novel therapies and to CALM therapists; Provide preliminary evaluation of the potential impact of CALM in this population. Study Design: A mixed methods design will be used for this pilot study.

  • An artificial intelligence model to predict the ideal time for ruptured brain aneurysm treatment to prevent re-rupture of the aneurysm prior to its treatment.

    Pre-treatment rebleeding following aneurysmal subarachnoid hemorrhage (aSAH) independently increases the risk of death and a poor neurological outcome. Over three-quarters of re-bleeds occur within 12 hours so it is recommended that aneurysm treatment occur as ‘soon as feasible’. However, additional factors such as aneurysm location, size, clinical grade, radiological grade, systemic arterial hypertension, systolic blood pressure over 160mmHg, hydrocephalus, intracerebral hematoma (ICH), subdural haematoma (SDH) and intraventricular hemorrhage (IVH) have also been associated with rebleeding. There is likely to be a complex interplay between the time-to-treatment and these other factors as even with reduced treatment times, re-bleeding still affects between 2 to 10% of patients. Several models have been recently described attempting to estimate the risk of pre-treatment rebleeding but none demonstrate a low risk of bias, high clinical applicability and useability. Even the most rigorously formulated model suffers bias from inconsistent predictor ascertainment and the use of historical patient data for model formulation not reflective of current practice which aim to treat ruptured aneurysms within 24 hours termed ultra-early treatment using predominantly endovascular methods. The model also uses as predictors age, sex, aneurysm irregularity and pre-treatment cerebrospinal fluid diversion despite the lack of evidence for an association between these factors and rebleeding whilst it neglects other validated factors such as ICH, IVH and SDH at the time of diagnosis. The model also calculates probability but without elucidating the threshold for altering patient management. In this study we seek to address these limitations using machine learning techniques, referring to types of artificial intelligence which can be trained to automatically detect complex nonlinear relationships between multiple competing factors in the prediction of outcomes of interest. In this study we aim to train a supervised machine learning model using our 14-year cohort of consecutive aSAH patients with ruptured saccular aneurysms managed using an endovascular-first, ultra-early paradigm in accordance with current best-practice guidelines. We will use as inputs a number of routinely available, individually validated clinical and radiological predictor parameters together with the time to re-bleeding or treatment as an outcome to develop this predictive model. This model will be capable of resolving the complex interaction between the time-to-treatment and other re-bleed predictors. Ultimately, it will provide clinicians with actionable information in the form of an optimal time period for the treatment of any individual patient with a ruptured saccular aneurysm to minimise their risk of pre-treatment re-bleeding.

  • Ten Session Intervention in the Treatment of Disordered Eating: A Randomised Controlled Pilot and Feasibility Study (ED10)

    This research project will be based at La Trobe University Albury-Wodonga (LTU-AW) and Eating Disorders Victoria (EDV) and embeds a professional psychology placement program for postgraduate psychology students within a research program examining evidence-based eating disorder assessment and treatment. (Master Research Agreement attached) This is a pilot and feasibility RCT with two primary aims: (i) to explore the viability of running a full RCT to compare treatment efficacy and cost effectiveness of two brief eating disorder interventions; Ten Session Cognitive Behaviour Therapy (CBT-T) and Ten session Guided Self Help (GSH-T), and (ii) to explore the feasibility of providing specialised training in eating disorder treatment and access to treatment via a community-university partnership that embeds professional psychology training in an ongoing research and treatment program. It is expected that eating disorder symptoms will be significantly reduced from pre- to post-treatment in both CBT-T and GSH-T. It is also expected that those allocated to the CBT-T group will have significantly lower eating disorder symptoms post-treatment compared to those allocated to GSH-T.

  • Effects of two different post-expansion retention methods in the mixed dentition

    To date, there have been no comparative studies of retention methods post-expansion. This study aims to address this gap in the literature, comparing the effects of fixed and removable retention methods following rapid maxillary expansion; placement of a Hawley retainer and maintenance of a fixed expander appliance. Records obtained from prior to expansion, immediately posttreatment and then again at 12 month review will be analysed and interpreted in order to determine the best retention method.

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