ANZCTR search results

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

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33027 results sorted by trial registration date.
  • Immune response to a third COVID-19 vaccine dose in people with multiple sclerosis receiving B cell-depleting therapy

    Evaluate immunity provided to people with multiple sclerosis (pwMS) receiving B cell depleting therapy with ocrelizumab by a third mRNA-platform COVID-19 vaccine dose. Immunity was evaluated by comparison with pwMS receiving treatment the non-depleting drug natalizumab and through comparison against a correlate of real-world protection against infection. Peripheral blood immune cells were analysed in order to describe how the altered immune system in pwMS receiving ocrelizumab is associated with vaccine response, and to identify potential predictors of immune response to stratify poor responders for antiviral prophylaxis.

  • Just Say No to the Just in Case Cannula: An Implementation Science Trial

    Background This implementation science trial aims to reduce unnecessary and improve peripheral intravenous catheter (PIVC) insertion in Emergency Department (ED) patients. The intervention is effective locally and recommended by ACSQHC PIVC Clinical Care Standard. This project has received $2.9M funding from the MRFF 2023-2028. Primary Objective To implement best practice for PIVC in Australian ED. Methods 1. Stepped-wedge cluster-controlled trial for clinical effectiveness and safety of the intervention. We will study 9 diverse EDs and implement a package of interventions, three at a time, with 6-monthly steps. We will measure rates of PIVC insertion, use, safety and PIVC-related infections. 2. An adaptive, co-designed intervention based on our previous model/ACSQHC standards, using validated implementation and evaluation frameworks.

  • Testing different ways to explain coronary calcium artery scoring for support of shared decision making in adults who do not have a history of cardiovascular disease

    The aim of this study is to improve knowledge of consumers about new and emerging CVD risk assessment methods, addressing different levels of health literacy; and to improve the uptake of evidence-based risk assessment methods by health professionals by providing them with communication tools that allow them to quickly and automatically apply the evidence to their patients. This project will use a novel approach to: 1) identify the best way to communicate the known benefits/harms and uncertainties of these tests, for patients with varying health literacy levels; and 2) develop novel patient decision aids on these issues to support revised national guidelines before they are implemented.

  • Evaluation of a Virtual, Comprehensive Care Program Before and After Total Hip and Knee Arthroplasty

    This study will assess the outcomes of an integrated program of patient education and exercise before and after total hip or knee arthroplasty. The program will be home-based and remote-monitored, but will include physiotherapy-led home visits, telehealth consultations and tele-messaging. A program of specific muscle strengthening exercises and cycle ergometry will focus on muscle power as the therapeutic target. The cycling program will be fully measured and adjusted based on patient performance and feedback obtained via remote monitoring. Outcomes of the pre-operative phase and early post-operative recovery will be the focus of the study. Specific outcomes will include program completion, hospital length of stay, discharge to hospital rehabilitation and surgery-related readmissions. Physical performance and patient-reported outcomes will be measured at the end of the pre-operative phase and at program completion, six weeks post-surgery.

  • SAFE-HF - tranSlating heArt Failure guidElines into practice in a Nurse Practitioner primary care service

    Current management of HF patients post-discharge is sub-optimal and patients are not receiving the full benefits of evidence-based care simply due to inaccessibility to a heart failure specialist team. The aim of this project is to assess implementation and effectiveness of a HF nurse practitioner primary care service. The HF nurse practitioner service can be integrated within primary care and will reduce hospitalisations and mortality.

  • The effect of manual therapy on ankle dorsiflexion range of motion: A pilot crossover randomised trial

    Ankle stiffness has been identified as a risk factor for lower limb injuries in sport. This randomised crossover control trial will investigate if ankle dorsiflexion can be increased with manual therapy. The participants will be required to attend two sessions of one hour, one week apart. Over the two sessions, participants will receive an intervention to address ankle joint stiffness and one to address calf muscle length. Measurements of ankle dorsiflexion range of motion will be taken before and after each intervention.

  • PROlonged versus Single dose in PEnicillin oral Challenge Testing

    Penicillin allergies are a major burden on patients and health care worldwide. Currently, up to 1 in 4 hospitalised patients admitted to hospital will report an antibiotic allergy, which limits appropriate antibiotic use and leads to poorer health outcomes. In some instances, patients can be given a single or multiple test dose of an antibiotic to determine if a patient is truly allergic. This study will inform whether research to determine if a multiple dose challenge (5-days) elicits more true penicillin allergy than a single dose challenge is feasible. The current Drug Allergy Practice Parameters recommend “against the routine use of multiple-day challenges in the evaluation of penicillin allergy”, providing a “strong recommendation” but with ” low certainty of evidence”. In Europe, a mixture of observational and retrospective studies has suggested that extended challenges ranging from 3 to 10 days may be superior to single dose challenges at excluding delayed immune reactions, however the reported prevalence of delayed reactions is highly variable (5-12% of patients) and many were reliant on patient self-reporting. This is converse to the North American experience where delayed prolonged challenges have been associated with low rates of delayed reactions (0-1.8%). Whilst a study of children demonstrated that delayed reactions may occur <7 days following a single challenge. Therefore, whilst oral challenge is the well-defined gold standard for penicillin allegro-immunological investigation, limited controlled evidence is available regarding the safety and efficacy of single dose versus prolonged oral challenge. Blinded randomized placebo-controlled trials have not been previously used in any drug allergy trials. The aim of this double blinded placebo controlled pilot randomised control trial is to evaluate the feasibility of placebo controlled trial and safety of oral penicillin challenge (5-day) versus single dose challenge penicillin challenge (followed by 5 day placebo) for evaluation of immune-mediated penicillin allergy in the inpatient and outpatient setting to inform the design of a definitive trial.

  • Return to Country: A national platform study to return Aboriginal and Torres Strait Islander renal patients home

    End-stage kidney disease (ESKD), when dialysis or a kidney transplant is required to maintain life, has a devastating impact on Indigenous patients and their families. In remote communities, rates of ESKD are 15 or more times higher than amongst non-Indigenous Australians of the same age and sex, and people need to relocate to distant urban centres to take up dialysis. Community-based dialysis or a kidney transplant allows a patient to return to live in their community. However, Indigenous Australians have very low rates of such community-based treatment. This multicentre prospective interventional study will investigate why this is, and test if interventions to address these identified barriers can get more people home for treatment.

  • Identifying and addressing barriers and enablers to implementing best-practice cardiac rehabilitation: the Quality Improvement in Cardiac Rehabilitation (QUICR) Cluster-Randomised Controlled Trial

    Our primary aim is to determine whether implementation of a data-driven collective approach to best practice cardiac rehabilitation, which addresses shared gaps in quality and access improves CR uptake and completion in CHD patients. The collective approach will be supported by an electronic data platform. Clinical, service and patient-reported outcomes and cost-effectiveness will be assessed. In partnership with CR programs, we will evaluate barriers and enablers to best practice care, develop a framework for scale-up and establish sustainable collaborations. We hypothesise that a collaborative quality improvement approach is feasible, improves outcomes and offers a novel approach that can be replicated in other outpatient health areas.

  • Feasibility and preliminary efficacy of a Hospital Fall Prevention Moments of Care intervention: a pilot trial

    St John of God Health Care (SJGHC) want to develop an innovative solution to prevent falls at Midland hospital as a model for other hospital sites. The incidence of falls is influenced by the complexity of the ward environment and patient characteristics such as age and cognitive status. A common theme of falls that occur in hospital is that many patients do not accurately identify their risk of falling. Studies have identified unwillingness of patients to ask for assistance when mobilizing in hospital, often because they don’t want to be a burden to caregivers. As such, communication between patients and caregivers is a potentially modifiable factor that influences the ‘risk-taking’ behavior of inpatients. Another factor that may be contributing to the risk of falls during the hospital admission, as well as after discharge is that the prevention of falls may have created a disincentive to mobilize patients. Immobility, imposed to prevent falls, may, itself, be an important contributor to falls and subsequent disability. Individualized patient education is an important strategy for falls prevention and will be implemented during the trial to understand what works best for patients and caregivers at Midland hospital. We will use the admission moment of care to engage with the patient and their family and demonstrate how to safely mobilize around their room and take action to prevent their own falls. An additional intervention will address the daily mobilization of inpatients. The first phase will co-design interdisciplinary caregiver training for effective delivery of patient focused falls education during the trial. This project is motivated by the need to impact hospital falls prevention and to understand if the caregiver training and patient education is feasible for consideration in a larger trial.

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