ANZCTR search results

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

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31035 results sorted by trial registration date.
  • The effect of screening for Atrial Fibrillation with ECG on the incidence of stroke - a randomised controlled trial

    There are 445,000 stroke survivors in Australia and every year there are ~28,000 new strokes. Almost a third of ischemic strokes (the major stroke type), are related to Atrial Fibrillation (AF), an abnormal heart rhythm leading to blood clots in the heart which travel to the brain. 10% of these strokes are due to unknown AF only detected at the time of stroke. Ischemic strokes are potentially preventable by systematic population screening for AF in a setting where preventive treatment can be given. This could significantly reduce stroke burden and cost to society. One in four adults aged over 40 will develop AF in their lifetime. Prevalence and incidence of AF rise sharply with age (over 10% aged greater than and equal to 70 have AF). AF numbers are predicted to double in Australia between 2014 and 2034, even after adjustment for population ageing. It is an important health problem associated with a 5-fold increase in stroke, which is often disabling or fatal. AF is also associated with an increased risk of death, with growing evidence of an association with cognitive decline/dementia which may be reduced by oral anticoagulation, now standard therapy for AF. While AF may give rise to palpitations or other symptoms, often there are no symptoms in older people who are at the highest risk of stroke. Approximately 10% of ischemic strokes occur in people with newly diagnosed asymptomatic AF, which is unlikely to be identified without screening, thus a major opportunity for stroke prevention. The rationale underpinning a strategy of screening is to make an early diagnosis of asymptomatic and under-treated AF, so oral anticoagulants (showing a 64% stroke reduction by preventing cardio-embolism) can be started to prevent AF-related stroke. It is not known whether the screening strategy will be better than usual practice, This is the rational underpinning the the SAFER-AUS study which is a randomised controlled trial with stroke endpoint, where participants randomised to intervention (AF screening) or control (usual practice). We aim to recruit a total of 780 participants from a mixture of urban and rural settings across 3 states, with each practice having a minimum of 500 active registered patients aged greater than or equal to 70 years. The SAFER-AUS trial to screen for unknown AF is a research partnership between Australia and the University of Cambridge.

  • Self Management and Remote Monitoring of Heart Failure and Chronic Obstructive Airways Disease using a Smart Phone Application

    Use of a Smart phone application to encourage self-management with remote monitoring in patients admitted or referred to an East Metropolitan Heath Service hospital in Western Australia [Armadale Health Service (AHS), Royal Perth Hospital (RPH) or SJOG Midland Public and Private Hospital (SJOGMPPH)] with heart failure of chronic obstructive pulmonary disease: 1. The primary aim is to determine impact on quality of life. 2. Secondary aims include a. impact on symptom assessment scores b. change in average hospital length of stay in the 1 month, 3 months and 6 months following the intervention c. patient satisfaction with using the application Hypothesis The use of a Smart phone application to improve self-management with remote monitoring will significantly improve the domains of physical and emotional health, and positively impact symptom assessment and reduce average length of stay.

  • Safety and Tolerability of Hydroxychloroquine in Participants with Multiple Myeloma and Partial Response or Less to Carfilzomib

    This study aims to investigate the safety and tolerability of Hydroxychloroquine in combination with Carfilzomib and Dexamethasone for multiple myeloma. Who is it for? You may be eligible for this study if you are a patient aged over 18 years who has a diagnosis of relapsed or refractory multiple myeloma patients with a partial response or less after 2 cycles of Carfilzomib treatment. Study details Participants will undergo 2 cycles of once-weekly Carfilzomib and Dexamethasone as per the standard of care. If participants are deemed to have a partial response or less by clinician assessment, Hydroxycholoroquine treatment will be initiated for the next 10 cycles alongside continuing Carfilzomib and Dexamethasone. Data on adverse events, toxicities and dose limiting toxicities as well as disease response will be collected. It is hoped that data from this study will help to inform the role of Hydroxychloroquine in treating multiple myeloma.

  • Effect of workplace mental health screening on help-seeking behaviour in first responders

    First responders, corrective service, and other frontline workers perform some of the most important roles in our society. As a result, first responders are at disparate risk of exposure to traumatic and/or stressful events, demanding workloads, and irregular hours – all known risk factors for mental ill health. Indeed, previous studies report high rates of post-traumatic stress disorder (PTSD), depression, and distress amongst first responders. Widespread reluctance to seek treatment for such mental health issues is especially prevalent in first responders. Mental health screening attempts to detect individuals at risk of, or suffering, a mental health condition to direct them to resources/treatment. Early detection of mental ill health is associated with less intensive treatments and improved recovery. This, in tandem with the fact that mental illness is currently a leading cause of sickness absence and work incapacity in many developed countries, has meant that screening of employee mental health is increasingly applied in workplaces. While increasingly common, workplace mental health screening has received criticisms including the cost and resources required, and employee concerns regarding confidentiality and consequences of disclosure leading to biased reporting. Nonetheless, workplace mental health screening is occurring in real-world first responder workplaces.

  • The impact of the HIRAID emergency nursing program on patient and hospital outcomes

    Australia’s 287 emergency departments (EDs) see more than 8 million patients a year. Failure to assess, treat comprehensively and escalate appropriately can be catastrophic. Emergency nurses are the first clinicians with whom patients have contact, so patient safety is contingent on their accurate assessment, interpretation of clinical data, intervention and escalation. Particularly as across Australia in 2017-18, only 64% of urgent patients were seen by medical officers within 30mins of ED arrival and were solely in the care of emergency nurses during this time. Patient assessment and management by Australia’s 29,000+ emergency nurses is hospital dependent and inconsistent resulting in avoidable patient deterioration, poor pain management, poor nursing documentation, human suffering and patient dissatisfaction with emergency care. We propose a solution - HIRAID (History, Identify Red flags, Assessment, Interventions, Diagnostics, communication and reassessment). HIRAID is the only validated framework designed to teach emergency nurses how to systematically assess and manage emergency patients. We have successfully piloted HIRAID across rural, regional EDs for usability. In the simulated environment HIRAID improved nurse assessment and communication. We now need a multi-centre RCT to generate the ultimate evidence for embedding of HIRAID into policy and practice. Over 5 years, our team of Australia’s leading emergency clinician, nurse and health economic researchers will use an effectiveness-implementation hybrid design including a step–wedge cluster RCT across 31 NSW and Qld hospitals. We hypothesise that when HIRAID is implemented there will be a 20% reduction in inpatient deterioration events related to emergency nursing care and an increase in patient/carers who report their ED experience as very good. Our partners have been engaged with this proposal since inception and represent several of the key agencies that deliver or support emergency care in Australia.

  • Effect of REVTx-99 on alleviating or preventing allergy symptoms

    This is a study to evaluate the safety, tolerability, and effectiveness of intranasal REVTx-99 in adult volunteers with a history of allergic rhinitis to rye grass pollen. The study has 2 parts (Part A and Part B), in which each participant will be enrolled in only 1 part, and within each part there are 2 treatment periods (Period 1 and Period 2) that each participant will complete in a crossover manner. Part A will assess the effectiveness of REVTx-99 as a preventative for allergy symptoms and Part B will assess the effectiveness of REVTx-99 for treatment of allergy symptoms. Participants will receive both REVTx-99 and Placebo in both parts.

  • The effect of practice nurse coordinated home care package administration model for cancer patients: a pilot randomised controlled trial

    Cancer patients/survivors have complex care needs beyond daily living assistance. They need a range of medical and allied health services as well as support for their daily living. The purpose of the study is to implement a pilot intervention of a practice nurse-led home care package administration aiming to improve your functional status, health-related quality of life, experiences of care and health service utilization. Who is it for? You may be eligible for this study if you have have cancer have previously had cancer and are receiving home care services. Study details All participants have equal chances to be allocated to Group One or Two. Group One will receive additional support and ongoing monitoring from a practice nurse. Group Two will continue to receive home care services as usual. Both groups will continue with usual medical and nursing care. It is hoped that this study will help determine whether additional support is beneficial to those who have cancer or have survived cancer.

  • Metformin for low back pain: A clinical trial to examine the effectiveness of metformin for chronic low back pain.

    Low back is the leading cause of disability globally. Despite this, effective treatments are limited and narcotic use is alarmingly high. Metformin is a widely prescribed, safe and low-cost medication been used clinically for over 50 years as first-line therapy for type 2 diabetes. Recent evidence has shown that metformin can inhibit the mTOR pathway which is a major contributor to pain hypersensitivity, while human clinical studies show preliminary evidence that metformin may reduce pain in individuals with chronic low back pain. A randomised clinical trial is urgently needed to determine if metformin is effective in the management of individuals with chronic low back pain. AIMS: To examine the efficacy of metformin compared to placebo on pain intensity over 4 months in individuals with chronic LBP. HYPOTHESIS: We hypothesize that metformin will be more effective in reducing pain in individuals with chronic low back pain compared with a placebo. PARTICIPANTS: 124 participants with chronic low back pain. INTERVENTION: Metformin (2000 mg) once daily COMPARATOR: Identical placebo once daily OUTCOME: Change in back pain intensity at 4 months SIGNIFICANCE: Given the large and growing burden of low back pain and it associated costs, this trial has the potential to deliver enormous health, economic, and social benefits. The repositioning of metformin, a cheap, safe, old drug for this new indication, offers an unprecedented opportunity to significantly and immediately impact the management of low back pain globally.

  • e-DiVA (empowering Dementia Carers with an iSupport Virtual Assistant)

    This proposal will address these gaps in two ways, by: (1) developing and evaluating an iSupport Virtual Assistant (VA) to support dementia carers through a partnership of four APR countries: Australia, Indonesia, New Zealand, and Vietnam; and (2) building capacity of researchers and Non-Government Organisation (NGO) partners to support this development and evaluation. Seven versions of iSupport VA will be evaluated in Australia, Indonesia, New Zealand and Vietnam using a pilot RCT. Feasibility, acceptability, intention to use, and preliminary impact on carer perceived stress of the iSupport VA intervention will be assessed.

  • Opioid PrEscRiptions and Usage After Surgery (OPERAS): a prospective multicentre observational cohort study of opioid use after common surgical procedures

    Pain relief is considered a fundamental right in medicine. With over 80% of patients reporting pain after surgical procedures, adequate postoperative analgesia is essential to patient care. However, pain management is complex and requires the consideration of many factors including the specific surgical procedure, patients’ needs, and their perceived analgesic control. Opioid prescriptions for non-cancer-related indications, including postoperative reasons, have been increasing in recent years. While often effective for acute pain, opioids are addictive and have numerous side effects, the most serious being respiratory depression. In the United States, there are 530 opioid-related deaths every week and the opioid epidemic has been recognized as a public health emergency. The many nonfatal health consequences of opioid abuse and addiction in Australia contribute to an annual cost of $15.7 billion. In Australia, opioid-related deaths in adults between 15-64 years of age have increased by 3.8% per year since 2007. In New Zealand, the figures are similar, with the rate of opioid-related deaths increasing by one-third in total from 2001 to 2012. Globally, the overprescription of opioids after common surgical procedures is a well-recognized contributor to the opioid epidemic, including in Australia. Opioid initiation post-surgical hospital visit leads to chronic use in a small but significant proportion of patients. Similarly, there are a wide variety of reasons for overprescribing. Awareness of opioid prescription practices locoregionally can advise targeted interventions to change prescribing patterns and reduce the overprescribing of postoperative discharge opioids. The aim of this prospective multi-centre cohort study is to describe the correlation between discharge opioid prescriptions to consumption by patients after common surgical procedures and the impact on patient-reported outcomes.

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