ANZCTR search results

Work4Dementia is a novel evidence-based intervention that aims to improve the capacity and resilience of the aged and dementia care workforce. The intervention will include an organisational component addressing change readiness with workplace leaders. This will be followed by a shared practice group for employees involved in direct care. The employee component of the intervention will cover topics including capacity and resilience in care work, understanding dementia and communication, the power of social connections and strengths to cope with emotionally demanding jobs. This study will use a waitlist controlled trial design to pilot test the intervention in two aged care organisations in Australia focusing on the acceptability and feasibility of implementing the intervention. Qualitative interviews and focus groups, and quantitative audits of participation data will be undertaken to assess this and explore perceived enablers and barriers to the intervention. This study will also include a preliminary assessment of the efficacy of this intervention to reduce job stress, enhance work engagement, reduce turnover and improve quality care. Study participants will include managers and direct care workers of the participating organisations, care recipients and those who support them. Pre- and post-intervention questionnaires will be used to assess the impact of the intervention and interviews and focus groups will explore perceptions of whether any care changes occurred.

Cardiac Implantable Electronic Device (CIED) therapy is a safe and effective therapy, but is not without complications. Bleeding complications, which can potentially be preventable, are of concern as they significantly increase the risk of infection with subsequently increased morbidity and mortality. Arista™AH Absorbable Hemostat (Arista) is a novel powder, that has been shown in surgical settings to be safe, effective and result in significantly reduced haemostasis time and requirement for blood transfusion. The aim of this study is to investigate the potential benefits of routine use of Arista in CIED implantation procedures. Participants will receive either standard of care, or standard of care in addition to the administration of Arista to the CIED pocket prior to skin closure. It is expected that participants who receive Arista will have a lower incidence of device haematomas post-implant. Participants will be followed up for 6 months post device implant.

This study, PRIME005, aims to investigate if treatment with oral Azacitidine and Carboplatin enhances the immune response to immunotherapy rechallenge with Ipilimumab and Nivolumab in patients previously unresponsive to treatment. Who is it for? You may be eligible for this study if you are aged 18 years or over and have unresectable or metastatic melanoma, with failed previous CPI immunotherapy with a combination of anti-PD1 and anti CTLA4 antibodies. Study details Participants will receive injection of Azacitidine and injection of Carboplatin for 2 cycles of treatment and addition of injection of Ipilimumab and Nivolumab over cycles 3 and 4 of treatment. Ipilimumab and Nivolumab will continue for 24 months or until disease progression, unless the treating clinician believes there is benefit with continuing treatment. Tissue samples, disease progression rates and adverse events will be collected from participants. It is hoped that data from this trial will help investigators understand the tumour microenvironment of treatment-resistant metastatic melanoma

Currently about 50% of patients living with diabetic retinopathy remain unaware they have the disease. Similarly, large amount of glaucoma and age-related macular degeneration cases remain undetected. To improve the detection rate. a novel system of automated fundus photography coupled with artificial intelligence (AI) will be evaluated in real world clinics to provide opportunistic screening for diabetic retinopathy, glaucoma, and age-related macular degeneration. The device is fully automated for image acquisition, analysis and report, which negates the need for clinical staffs. No prior training is required of the users. Within 2 to 3 minutes, participants can complete their own retinal photography and obtain a grading report based on the retinal photos for the risk of the above diseases. Referral recommendations are also included. This may benefit the patients in clinical settings where eye clinicians are in short supply. This study aims to test the performance of the AI screening kiosk in real world clinical settings. The AI screening results will be compared with the gold standard assessment by three eye clinicians. We hypothesize that this AI screening system is accurate, user friendly and can help improve the detection rate of some common eye diseases.

This pilot study will trial a personalised 12-week home-based physical activity intervention, using ICT, to help middle aged and older people who experience memory concerns and troubles with low mood, anxiety or stress to meet Australian physical activity guidelines.

Obstructive sleep apnoea (OSA) affects 1 billion people worldwide. It is characterised by breathing pauses during sleep when the air passage in the throat narrows or blocks. The severity of OSA is based on the number of these breathing pauses per hour of sleep. Recent studies suggest that OSA may be an important cause of depression. OSA and depression have common symptoms such as disrupted sleep, poor concentration, fatigue and low mood. Also, the risk factors for each condition overlap. It is difficult to know whether OSA causes depression (or vice-versa), or if these two conditions simply have overlapping features, but it is clear that 1 in every 4 adults with OSA have significant symptoms of depression. The Depression in Sleep Apnoea study aims to determine if CPAP is more efficacious than placebo, and at least as efficacious as standard antidepressant medication (escitalopram), for the treatment of a major depressive episode in adults with OSA. CPAP is an approved intervention for the treatment of OSA, but its efficacy for the treatment of major depressive episodes has not been established. Escitalopram is a selective serotonin reuptake inhibitor (SSRI) approved for the treatment of depression and anxiety, but it has not been tested for the treatment of a major depressive episode among adults with OSA nor as a treatment for OSA. Our objective is to identify if CPAP is more efficacious than placebo, and at least as efficacious as standard antidepressant medication, to treat a major depressive episode in adults with OSA. We hypothesise that among adults with moderate-severe OSA and a major depressive episode will experience clinically significant improvement of depressive symptoms compared with participants randomly assigned to treatment that with placebo for 12 weeks.

Reducing repetition of deliberate self-poisoning is an important suicide prevention objective. The Way Back Support Service is a non-clinical care coordination service for people who have attempted suicide that is designed to link people with the services and supports they need after discharge from hospital. The aim of this study is to investigate the effectiveness of the Way Back Support Service as delivered in the Hunter region (Australia) for a population of hospital-treated deliberate self-poisoning patients. Primary outcomes include any, and number of, deliberate self-poisoning readmissions within 12 months of the index admission. Outcomes will be compared for the intervention cohort with two historical control cohorts using intention-to-treat analyses. Findings from this study are relevant to the design and dissemination of aftercare models and other Way Back Support Service sites.

This study is aiming to create an adverse event database to document any negative side effects that people with cancer who are taking specific immunotherapy drugs (immune checkpoint inhibitors) may experience. Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with any type of cancer that features solid tumours and you are about to start an immune checkpoint inhibitor therapy alone or in combination with chemotherapy. Study details All participants who choose to enrol in this study will be asked to provide a blood sample once before they start the immunotherapy and then before the second and third cycle of treatment. Participants will also be asked to provide stool and tissue samples before starting treatment and before the second cycle, for biomarker analysis. All participants will be asked to list any side effects/adverse events that they experience while taking the immunotherapy drugs to their usual treating oncologist. It is hoped this research will identify potential biomarkers and clinical features that may predict adverse events related to treatment with immune checkpoint inhibiting drugs that are increasingly being used to treat cancer patients. This information may then be used to improve health outcomes for future cancer patients.

People with cerebral palsy (CP) have significant health issues. We will access National Prescribing Service MedicineWise (NPS) data to provide baseline information about the use of primary care (general practitioner, GP) services by people with CP compared to an age and sex-matched control group without CP. NPS MedicineWise holds deidentified data from 8.6% of GPs in Australia and is considered to be representative of all GPs in this country. We will be able to determine the frequency and reasons for GP visits, medications prescribed and investigations ordered. From this data, we will gather information the health care for this vulnerable population and whether there are barriers that can be addressed.

Ultrasound-guided nerve blocks require integration of motor skills, visuo-spatial orientation, and cognitive processing. This complex medical procedure is usually taught through intensive one-on-one teaching with an expert tutor. VR is a computer-generated, artificial environment designed to replace real-world sensory inputs. Participants can interact within this world, using hand controllers to manipulate objects, while user head movements are replicated by shifting fields of view. Training using VR also engages muscle memory, allowing users to practice the same motor movements that they would have to reproduce in real-life situations. This trial seeks to investigate if a virtual reality teaching program be just as effective in teaching ultrasound-guided nerve blocks as a human tutor, with great potential for future medical education. It is a prospective, double-blinded, RCT, single-site study comparing the effectiveness of VR training against standard training (a face-to-face, didactic training). Participants will be medical students with no anaesthetic training at Liverpool Hospital. The VR software is a bespoke trainer programmed by the research group. Data collected will be the difference in the Global Rating Scale and composite error scores between VR and standard training groups, measured by two independent assessors. If shown to be useful, VR training has several advantages: 1. The opportunity to pre-train skills prior to attendance at hands-on workshops to reinforce teachings 2. Pre-training prior to clinical exposure, potentially reducing errors and improving safety 3. Enable remote learning, and not constrained by access to expert teaching faculty, particularly useful in COVID lockdowns 4. Computer-based learning calculates errors accurately, giving audible and visual cues which is more precise and consistent than a human teacher.