ANZCTR search results

Evidence suggests that poor cardiorespiratory (CR) fitness is associated with increased risk of morbidity and mortality, and is therefore used as a measure of health. Submaximal exercise testing is commonly used in practice to assess CR fitness due to time constraints, lack of equipment and safety. Submaximal step tests have been shown to be valid method of assessing CR fitness (Bennett et al 2016), although the majority of these tests require a step and are externally paced. The 2-minute step test (2MST) requires minimal equipment (no step) and is self-paced. It has been shown to be reliable and valid in an older population (60+ years old) (Rikli and Jones 1999). If the 2MST is found to be valid in a wider age range, it may be a simpler method of assessing CR fitness that can be used in a variety of settings, potentially preventing a decline in health and physical fitness in the population. Here we will compare the number of steps completed in the 2MST in middle-aged adults to a direct measure of peak oxygen consumption (cardiorespiratory fitness) using an incremental cycle test.

Catheter-associated urinary tract infection (CAUTI) is possibly the most preventable healthcare associated infection. This study will implement a care bundle to reduce urinary catheter use and CAUTI in four acute care facilities in NSW, Australia. The care bundle includes evidence-based recommendations of: appropriate indications for catheter insertion, patient consent, clinician competency, asepsis, unobstructed flow, timely catheter removal, daily periurethral hygiene, and collecting urine specimen only when indicated. Implementation strategies used will include education, audit and feedback, and champions. Point prevalence will be used to evaluate changes to rates of catheterisation and CAUTI. A phased non-randomised pre-post design will be used, providing a contemporaneous control.

Introduction: Peripheral Venous Catheters (PVCs) are frequently used to provide treatment for hospitalised patients. However, the failure rate of these devices is extremely high. Recent evidence suggests that integrated PVC systems may improve patient outcomes compared to the traditional non-integrated PVC systems. However, more evidence is needed to inform clinical practice and guidelines. Objectives: 1. To compare the clinical and cost-effectiveness of two PIVC systems: (i) integrated, and (ii) non-integrated (current practice) to prevent PIVC failure, insertion pain, microbial colonisation, functional dwell time, and adverse events. 2. To assess the acceptability and implementation challenges of integrated systems via quantitative and qualitative feedback from inserters, patients, clinicians and policy-makers. Methods: Two-arm randomised controlled trial including 2200 adult (greater than or equal to 18yrs) patients. · Integrated system: BD Nexiva integrated intravenous catheter system with two SmartSite connectors to close the Y-connector completely (n=1100). · Non-integrated system: B Braun Introcan Safety 3 or BD Insyte Autoguard catheter, Connecta extension set 15cm, with SmartSite connector/s (n=1100). The primary outcome is PIVC failure: Composite endpoint of occlusion, infiltration, phlebitis/pain, dislodgement, haematoma, localised or bloodstream catheter-related infections. Results: Results could improve millions of patients' health outcomes by reducing PIVC complications and failure as well as clinicians' workloads and health-care costs. Conclusion: Results of this study could assist policy-maker decision-making about the best PIVC system choice, and inform clinical guidelines, which could benefit patients and health care systems worldwide.

In the absence of effective alternatives, residential aged care (RAC) still resort to using pharmacological interventions, such as antipsychotic and sedating medications, to manage behaviours of dementia despite there being strong evidence that these are ineffective and are associated with severe adverse outcomes for the person with dementia. Non-pharmacological interventions are recommended as best practice to mitigate adverse outcomes associated with behaviours of dementia. There is considerable evidence that listening to preferred music reduces agitation in dementia. However, there is also robust evidence that dementia-related wandering and agitation are distinct phenomenon. Therefore we cannot assume that an intervention effective in reducing agitation will also reduce aspects of wandering that incur risk or result in negative outcomes for the person with dementia. There have been no known trials of music based interventions for people with dementia who wander, despite the pressing need for non-pharmacological interventions in this area. The goal of this applied research is to test the feasibility of using an intervention protocol, previously found to be effective in reducing agitation for people with dementia, to determine if it can be used with people who wander. Therefore the aims of this feasibility study are: 1) For people with dementia who wander and exhibit boundary transgression (BT) (entry into out of bounds and hazardous areas) in residential aged care (RAC): a. Is listening to music for a period of 20 minutes five times per week for 3 weeks tolerated? b. Is listening to the music via ear bud head phones tolerated? c. Do participants enjoy listening to the music? 2) Does listening to preferred music daily for 20 minutes under two conditions: a) Reduce risky aspects of wandering including frequent ambulation and boundary transgression (BT)? b) Reduce participant agitation? c) Provide immediate pleasure to the participant? 3) Are facility care staff able to reliably identify residents with dementia who wander and exhibit BT at an intensity that is observable? 4) Do care staff and family members perceive the music intervention to be beneficial for resident with dementia who wander? This feasibility study will use cluster randomisation (Facility 1 and Facility 2) to trial two intervention conditions: Condition 1: Daily (Mon-Fri) session of listening to preferred music for 20 minutes, 30 minutes before unique peak activity period Condition 2: Daily (Mon-Fri) session of listening to preferred music for 20 minutes at a randomly selected time between 10 am-7pm not including 30 mins prior to individual peak activity periods. Pre, during and post intervention measures of wandering characterisitics (frequency, boundary transgression, pattern), mood and agitation will be collected.

The aim of this study is to examine whether new chemotherapy regimen, BrECADD is non-inferior to BEACOPP as first line treatment in advanced stage classical Hodgkin lymphoma. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have first histologically proven classical Hodgkin lymphoma at stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV. Study details Patients will be randomised in a 1:1 ratio to either 6 cycles of the escalated BEACOPP regimen (standard of care) or 6 cycles of the BrECADD regimen (experimental) . Treatment in both arms will involve intravenous infusions and oral tablets to be administered on specific days during the treatment cycle to deliver specific drugs in each treatment arm. Patients will receive treatment in 21 day cycles until disease progression, unacceptable toxicity, or withdrawal or consent. Patients will be followed up for a period of at least 5 years after chemotherapy completion to assess progression free survival. It is hoped that this trial will determine if BrECADD is non-inferior to escalated BEACOPP as first line treatment in advanced stage classical Hodgkin lymphoma.

Psychosis is a debilitating neuropsychiatric syndrome characterized by delusions, hallucinations, disorganized thinking and cognitive and emotional disturbances. It is a defining characteristic of schizophrenia, and occurs frequently in other major mental illnesses such as depression and bipolar disorder. All current treatments for psychosis modulate levels of the neurotransmitter dopamine (DA), and it is thought that DA dysregulation within circuits linking frontal brain regions with a set of subcortical nuclei called the striatum (the so called frontostriatal circuits) is a final common pathway for the emergence of psychotic symptoms. Precisely how this dysregulation arises however, remains a mystery. This study will be the first to combine Positron Emission Technology (PET) measures of striatal DA function with functional Magnetic Resonance Imaging (fMRI) measures of frontostriatal connectivity to investigate the way in which altered subcortical dopamine may give rise to, or arise from, aberrant frontostriatal connectivity. The project has three specific aims: 1. characterise the direct relationship between PET markers of striatal DA function and fMRI measures of frontostriatal functional dysconnectivity; 2. determine whether striatal DA abnormalities are a cause or consequence of frontostriatal dysconnectivity; and 3. investigate the potential of these two phenotypes as clinical biomarkers by determining whether they can predict patients’ 12month clinical outcome. We will recruit 50 First Episode Psychosis (FEP) patients and 50 healthy controls to take part in the study. All participants will complete a clinical and brain imaging assessment at baseline. The brain imaging assessment will involve MRI and PET. FEP patients will additionally complete a clinical assessment after a 12 month followup period. No brain imaging will be conducted at this time. No followup of controls will be performed. During the followup period, the research staff will maintain regular contact with the patients' clinical team. Information on treatments will be acquired, enabling us to account for variations in treatment protocols in our analyses.

In children, acquired brain injury (ABI), and in particular traumatic brain injury (TBI), represents a common interruption to the course of normal development, with both international and local statistics citing an annual rate of 250–300 per 100,000 children (Kraus, 1995). Working memory refers to the capacity to temporarily store information for use in everyday activities (Alloway et al., 2006). Decision-Making is conceived as a complex interplay of high-level cold cognitive processes such as working memory, information processing, problem-solving, and hot emotional processes (Cassotti et al., 2011; Reimann and Bechara, 2010). Efficient working memory and decision-making abilities are essential as they underpin one’s performance in functional skill areas such as academic, adaptive, behavioural and social domains (Catroppa & Anderson, 2006; Ganesalingam et al, 2011; Gathercole et al., 2006; Mandalis et al, 2007; Muscara et al., 2008). Using a prospective, longitudinal design, adaptive abilities, behaviour, educational progress and everyday memory skills were investigated acutely post-injury and again at 12 and 30 months post-injury. Results suggested a strong association between injury severity and outcomes across all domains.With regard to social outcomes following childhood brain injury, deficits have been reported in many areas of social functioning and communication style, often resulting in low self-esteem, isolation, high rates of psychiatric disorder, criminal behaviour, and unemployment, and therefore poor integration into society (Anderson et al., 2009) The overall aim of the proposed study is to enhance working memory and decision-making abilities and therefore potentially strengthen academic, social, behavioural and improving quality of life for children and adolescents post traumatic brain injury (TBI). To achieve this aim, the objectives of the proposed study are: (i) To evaluate the effectiveness of Cogmed using a randomized controlled trial (RCT) to investigate improvements in working memory and decision-making, in children post-TBI, compared to children in an active control group. (ii) To determine whether these improvements in working memory and decision-making generalise into other areas of function and so also improve academic,social, behavioural, and quality of life outcomes. It is hypothesized that (i) Compared to children in the active control group, those children receiving Cogmed will display better working memory and decision-making skills immediately post-intervention and at 6 months post-intervention. (ii) Improvements in working memory and decision-making will result in improvements in functional areas such as academic, social, behavioural and quality of life outcomes.

The primary purpose of this trial is to evaluate the safety and efficacy of a Blinatumomab, Cytarabine (AraC) and Methotrexate therapy protocol for the treatment of acute lymphoblastic leukaemia. Who is it for? You may be eligible to enroll in this trial if you are aged 40 to 65 years, and have been newly diagnosed with B-precursor acute lymphoblastic leukaemia without Ph positive disease. Study details All participants enrolled in this trial will receive the same therapy protocol. This involves a 15-day debulking treatment with oral and/or intravenous vincristine followed by eight 28-day cycles alternating between intravenous blinatumomab therapy and intravenous methotrexate, methylprednisolone and cytarabine. After completing these alternating cycles, maintenance treatment will continue in 28-day cycles for 24 months with a combination of intravenous vincristine and oral prednisolone, mercaptopurine and methotrexate. Participants will be asked to complete questionnaires regarding their quality of life and will undergo assessments for disease progression, side effects and survival for 5 years.

In a novel approach we propose a randomised controlled trial to investigate the cognitive benefits of reducing prolonged sitting in adults aged 60 years and older with two risk factors for cognitive decline: being frail and not meeting physical activity guidelines. The 16-week theory-informed sitting reduction program will include one face-to-face session and five telephone calls. Participants will receive normative feedback on their objectively measured sitting time, work through a series of activities in a workbook and set goals which they will integrate incrementally. 144 older adults will be randomised to receive either the sitting reduction program or a control condition. Participants will be assessed at baseline, at end of intervention at 16 weeks and at 32 weeks to assess maintenance. Primary outcome is cognitive function assessed with the California Verbal Learning Test with secondary outcomes of objectively measured sitting time, executive function, mental wellbeing (anxiety and depressive symptoms, and quality of life), and body composition (waist circumference, weight, and % body fat) and sleep (duration and quality).

This study will explore the feasibility of delivering an online 6-week mindfulness-based intervention (MBI) to patients with increased risk of melanoma recurrence. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have a melanoma diagnosis of stage 2c, 3a, 3b, or 3c, for which you have completed your last treatment within the past five years. You will also require access to the internet. Study details Participants in this study will be randomly allocated (by chance) to the 6-week online mindfulness based intervention (MBI) or usual care group. The MBI is designed to: (1) help patients understand the potential benefits of using mindfulness in their day to day life; and (2) support the establishment of daily meditation practice. Each week of the program explores a different topic, which builds on the topic explored the week before. The program includes three main components: (1) educational component – weekly themes related to the application of mindfulness; (2) informal practice; and (3) formal meditation practice. Participants allocated to the usual care group will continue to receive their usual care for the first 6 weeks of the study, after which they will be offered the MBI. All participants will be asked to complete questionnaires assessing fear of cancer recurrence, worry, rumination, stress and mindfulness before and after the 6-week study period. Intervention adherence, meditation quality and home tasks will also be assessed weekly. If this intervention proves to be feasible, and trends for changes in outcome measures are observed, a larger randomised-controlled study will be planned to assess intervention efficacy and cost-effectiveness.