ANZCTR search results

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

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30950 results sorted by trial registration date.
  • Why does Good Living with Arthritis Denmark ( GLA:D®) work? A pilot study investigating the link between biomechanical factors and a successful outcome following a movement retraining program for knee osteoarthritis.

  • A Randomised Controlled Trial of Self-Management Support for Primary Care Patients with Chronic Obstructive Pulmonary Disease (COPD) and other Chronic Health Conditions

    Chronic Obstructive Pulmonary Disease (COPD) is a common chronic condition that can progress to disability and death. COPD frequently occurs in the context of other long-term conditions (multimorbidity). There is a lack of effective self-management programs for COPD in primary care. This cluster randomised controlled trial will test a self-management support intervention, based on the Health Belief Model (HBM), delivered primarily by Practice Nurses (PN) that is tailored to patient needs and recognises the context of multimorbidity. In a pilot study, this innovative intervention was associated with improvements in patient activation, COPD-related quality of life and COPD knowledge. The APCOM trial will rigorously test, using a cluster randomised controlled design, whether this intervention is effective in improving quality of life, decreasing COPD exacerbations and increasing patient knowledge of COPD and can be effectively implemented in primary care.

  • WiserAD: The effect of a structured online intervention on antidepressant deprescribing in primary care.

    The use of antidepressants (ADs) is increasing globally, including within Australia, which has one of the highest rates of AD prescribing. Despite clear benefits for many people, there is reason to believe that the ongoing use of these medications is often not properly monitored or stopped (deprescribed) when a person returns to better mental health. This trial sets out to test how well an online support tool (WiserAD) can help patients and their general practitioner to manage the careful and appropriate reducing and stopping of antidepressants, in primary care patients. It is anticipated that WiserAD (a novel, structured approach to deprescribing ADs) is more effective than usual practice in enabling GPs to help primary care patients to cease (or decrease) their AD medication whilst maintaining their mental health and wellbeing.

  • Feedback for reducing overuse of pathology test requesting by Australian general practitioners

    The aim of this study is to estimate the effectiveness of feedback for reducing pathology test requesting in general practice compared with control. A secondary aim is to evaluate which forms of feedback are most effective in reducing pathology test requesting.

  • Effect of Immersive Virtual Reality on Touch Perception in People with Discomplete Paraplegia

    Complete spinal cord injury (SCI) is associated with total loss of sensorimotor function below the level of injury. However, in a recent breakthrough finding we revealed that 50% of individuals with a complete SCI still have preserved spinal somatosensory nerve fibres. In our study, we stimulated the big toe of individuals with complete paraplegia while they were undergoing functional neuroimaging. Although our participants did not feel the touch, a significant signal was mediated within brain areas associated with perception of touch, including the somatosensory cortices. This became the first objective evidence of discomplete SCI – the idea that many spinal cord injured people who cannot feel still have touch information forwarded from the periphery (parts of their body, e.g. big toe) to the brain. The recognition of surviving nerve fibres in complete injuries has tremendous implications for physical and psychological adjustment. However, currently there are no effective interventions to promote or restore touch perception following SCI. We propose to draw on our recent discovery and on biological and technological innovations in SCI to develop and test a novel intervention to restore touch perception among individuals previously classified as having complete perceptual loss. The proposed intervention (Virtual Reality Haptic Walking/VRHapticWalk) will capitalize on the haptic, volitional, and embodiment capabilities of the existing technological interface to simultaneously enhance surviving somatosensory spinal nerve fibres and somatosensory (touch) signals in the brain in an effort to restore touch perception among individuals with discomplete SCI. In other words, subjects will receive touch simulation in the real world (e.g., the sole of their foot) while at the same time receiving corresponding multisensory touch stimuli in the virtual world. In people with discomplete SCI, the resultant superadditive effects of simultaneously enhanced peripheral/spinal and cortical somatosensory system activity is expected to lead to recovery of the disrupted sensorimotor system and further promote touch restoration. A growing body of evidence supports the role of superadditive effects in sensorimotor restoration in SCI. This project brings together front-line innovation in basic scientific understanding of neurological changes in SCI and cutting-edge clinical applications of virtual reality to provide a tangible outcome for SCI people in Australia. The outcomes to be achieved from this project were not deemed possible a year ago and will represent a cultural and scientific paradigmatic shift in terms of what can be expected from life with a spinal cord injury.

  • Does the position of the surgical bed affect paediatric patients in terms of perioperative respiratory adverse events?

    Perioperative respiratory adverse events (PRAE) are one of the major causes of morbidity and mortality during paediatric anaesthesia. Three quarters of critical incidents and at least one third of peri-operative cardiac arrests are linked to adverse respiratory events. Fortunately most perioperative respiratory adverse events are easily managed with no postoperative sequelae but some can lead to life threatening hypoxemia. Various definitions of perioperative respiratory adverse events are in use, but they are commonly considered to be any adverse event impacting the respiratory system at the induction of anaesthesia, intraoperatively or early post operatively. This includes laryngospasm, bronchospasm, hypopnea or apnea, breath holding, hypoxemia or the prolonged need for supplemental oxygen, pulmonary aspiration, airway obstruction, severe cough, stridor or reintubation. These events can adversely affect perioperative outcomes, including increased resource utilization and costs. The induction of anaesthesia and the immediate post-operative periods are high risk times for PRAE. While multiple management strategies exist to prevent PRAE at these critical phases of patient care, there is a paucity of data on whether patient positioning on the surgical bed alters the incidence of PRAE. In this study we will investigate if positioning the patient’s head elevated at a 30- degree incline for induction and transfer to the operating room and again from the end of surgery through to fully awake in post anaesthesia care unit (PACU) results in a lower incidence of PRAE in children, as compared to flat positioning (0 degrees) throughout this period. Both patient positions are commonly used in routine clinical practice in our institution both in theatre and in PACU. There are no guidelines or evidence specifying the use of one over the other.

  • Impact of different unconditional monetary incentives on survey response rates in men with prostate cancer: a 2-arm SWAT

    The main study aimed to explore men's reasons for transitioning from active surveillance to further treatment in prostate cancer management, and the factors which may have contributed to this decision. In this study within a trial, we investigated whether response rates to the questionnaire would differ by incentive amount (provided as an unconditional monetary incentive in the form of a gift card). All participants were required to complete a one-time survey (sent via mail but may be completed on paper, online, or via telephone). This survey consists of questions relating to social-ecological factors (i.e., personal, social, community, organisation, policy) and your experience with active surveillance. Participants in the main study were randomised to receive either a $20AUD or $10AUD unconditional incentive with their study materials. We aimed to investigate whether (a) response rates to a 30-minute questionnaire completed via mail, online, or phone would vary with different unconditional incentive amounts, and (b) demographics would vary in those who responded within the different incentive groups.

  • Patient-reported and functional outcomes following ReActiv8 implantable neurostimulation

    Chronic low back pain (CLBP) is associated with functional instability of the lumbar spine that results from impaired motor control and atrophy of the multifidus muscle. In previous research, ReActiv8 has shown preliminary efficacy, however, the individual mechanisms that can restore the multifidus muscle at a functional and biological level require further exploration. Therefore, the aim of this observational study is to evaluate changes in a) multifidus morphology, b) patient function and physical activity and c) patient-reported outcomes (PROMs) in patients eligible for ReActiv8. The hypothesis of this study is that patients treated with ReActiv8 experience measurable changes in a) multifidus morphology, b) patient function and physical activity and c) patient-reported outcomes.

  • An Investigation of the effect of using a conformable and wearable ice pack on pain and discomfort following sacroiliac joint injection.

    The research project aims to investigate the effect of using a cold pack on any pain felt following an injection to the sacroiliac joint. We are also interested to see if the use of the cold pack changes any need for pain medications.

  • A mobile and reusable personalised ventilation hood: A phase 1 safety study of a new device in patients with suspected or confirmed COVID-19.

    Since December 2019, the coronavirus disease (COVID-19) pandemic has affected millions of people worldwide. Modern hospital negative pressure rooms have high flow rates and negative pressure to prevent the spread of TB, measles etc. Nevertheless, such negative pressure rooms do not prevent droplet spread of the infectious disease to personnel within the room. Western Health and The University of Melbourne conceived and developed a small personalised ventilation hood device (the Mini Isolation Hood) to provide a physical barrier to droplet and aerosol spread. The device is based upon the already extant McMonty personal ventilation hood; the Mini Isolation Hood is significantly smaller, is mobile, and is designed to attach directly to an Emergency Department trauma trolley. The hood will provide health care workers with protection from droplets and aerosols during routine care, during the administration of specialised oxygen therapies (including high flow oxygen and non-invasive ventilation), and during the conduct of aerosol generating procedures. The hood has a plastic barrier to prevent droplet spread from a COVID-19 or other infectious patient, and a ventilation system to reduce aerosol spread. The hood relies upon air being drawn from the front near the patient’s legs etc. up to the rear, i.e. away from the healthcare worker, who is principally at the front/sides of the patient. The air passes through the fan and then a High Efficiency Particulate Air (HEPA) filter, thereafter returning to the local Emergency Department environment (similar to that for a patient’s mechanical ventilator). The entire Mini Isolation Hood is designed to be reusable in order to ensure security of supply during the COVID-19 pandemic. The SARS CoV-2 virus is susceptible, amongst other disinfection treatments, to bleach (chlorine based, e.g. ‘Actichlor’ one part per thousand= one tablet per litre), quaternary ammonium chloride based wipes (e.g. ‘Clinell’), and soap/detergent (exposure to soap for 15 minutes). We aim to evaluate the safety of the Mini Isolation Hood in a clinical setting on use with 20 Emergency Department patients.

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