ANZCTR search results

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

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32707 results sorted by trial registration date.
  • Developing a fracture risk application (app) to support care planning in aged care residents in Australia.

    This is an implementation study that involves adapting the Canadian Fracture Risk Scale (FRS) into an electronic webtool, and amending the fracture risk Clinical Assessment Protocol (CAP), for use in Australian Residential Aged Care Facilities (RACF) with the aim of increasing awareness and guiding practice on fracture risk identification and fracture prevention. It is expected that incorporation of the BreakFree application into the RACF admission process will reduce the risk of hip fracture, increase life expectancy, preserve or improve residents’ quality of life, and reduce health care costs by helping RACF health care workers to better understand fracture risk and guide them in using treatment strategies that have been demonstrated to prevent fractures in the RACF setting.

  • Creating ‘Partnership in iSupport program’ to optimise carers’ impact on dementia care

    Informal carers are the cornerstone of helping people with dementia remain at home for as long as possible. However, they have received less education preparation and limited support than professional carers to manage dementia. Caregiver stress and distress are widely reported and contribute to poor health and wellbeing of both carers and care recipients. We propose an innovative patient-centred approach, ‘Partnership in iSupport program’, in hospitals and community aged care settings to enhance support for carers. The intervention comprises support from an iSupport program facilitator, an online or hardcopy psychoeducation program for carers using Australian iSupport for Dementia and carer support groups. We will conduct a trial to determine the effectiveness (aim 1) and cost-effectiveness (aim 2) of the intervention. Carers in the intervention group will participate in the ‘Partnership in iSupport program’ for 12 months. The ‘Partnership in iSupport program’ includes (1) a program facilitator who acts as a link worker to assist informal carers to navigate, access and utilise dementia care services; (2) psychoeducation for informal carers to improve their dementia care capabilities; and (3) carer support groups to strengthen social support for informal carers. We will measure quality of life and health outcomes for carers and care recipients, the use of health and aged care services and the incremental cost per quality adjusted life years gained by the intervention compared to usual care. This study is important because the intervention will improve health and quality of life for both carers and care recipients, reduce preventable hospitalisations of people with dementia and improve dementia care services through reciprocal partnerships between carers and dementia care service providers.

  • Detecting serious infections early in the Emergency Department using data analytics

    Triage in the Emergency Department (ED) is an opportunity for a time critical point of identification of evolving severe sepsis. Current identification rates at triage are reported in the realm of 50-60% in the literature. Tromp et al undertook an education programme to improve identification of sepsis at triage, and their detection rates were 65%. Techniques to identify sepsis earlier may reduce the time to administration of antibiotics, source control and other resuscitative measures to improve patient outcomes. However, often the triage nurse is working under time pressures, and has limited information available to them to assist with their decision making. Hypothesis: Data analytic techniques may reveal early prompts to identify and place patients on sepsis pathways. Combining the demographic data and triage free text information inputted by the triage nurse could create prompts for the triage nurse to consider “is it sepsis?" earlier. AIMS: To create a predictive likelihood of sepsis from key words in inserted text. In future, develop as decision aid within EDIS (Emergency Department Information System) or separate triage tool. Methods: We will combine two large datasets - an Emergency Department dataset as well as the hospital admission dataset to create a way of determining whether information at the point of Emergency Department triage, may help predict the likelihood of subsequent diagnosis of a serious infection in a patient. "Big data" analytics tools will be used, and the datasets will be split into train, validate and tes components.

  • Feasibility of automated ultrasound imaging using the Vexev Imaging System

    The purpose of this study is to evaluate the functionality of the Vexev Robot Imaging System (VRIS) for arteriovenous fistula ultrasound scanning. Duplex ultrasound examinations are labour intensive and require highly skilled staff to perform, these staff are limited in the number of scans they are able to perform per day, and hence there are often issues of timely access to quality duplex ultrasound services. The VRIS is designed to autonomously perform high quality duplex ultrasound scans in a fraction of the time of a normal duplex sonography procedure. The VRIS is designed with the goal of outputting highly reproducible and accurate duplex ultrasound, which we hope will improve the ability for clinicians to map, monitor and intervene and hence increase AVF longevity. Normal duplex ultrasound scans involve a medical professional placing an ultrasound probe on the patient’s limb then moving the probe to image the regions of interest. In contrast the VRIS scan involves the patient placing their limb onto a scan bed and the ultrasound probe moving automatically, underneath the scan bed, to scan all regions of interest. It is expected that the VRIS scan will require significantly less time to complete (10mins for VRIS vs ~45mins for normal duplex scan). The primary objective of this feasibility study is to evaluate the feasibility (as defined by the primary endpoints) of the VRIS for AVF ultrasound (US) scanning, performed in a specialist vascular imaging practice. This study does not involve evaluation(s) of the clinical efficacy of the VRIS. Study participants will be enrolled for scanning with the VRIS in the same visit as their scheduled clinically, standard of care, indicated AVF US mapping or surveillance exam. Secondary objectives are to measure the practicality and feasibility of VRIS for routine clinical use and to collect paired outcome data to assist with the development of the VRIS system .

  • Music Attuned Technology for Care via eHealth – MATCH - Study 2

    An eHealth solution – Music Attuned Technology for Care via eHealth (MATCH) – was developed to support family carers of people living with dementia to use music intentionally to support care. The mobile application was developed as an extension of an in-person music intervention training program (HOMESIDE) which involved a qualified music therapist offering one on one training to carers in the intentional use of music. To create scalable solutions for the growing number of people living with dementia in the community, we developed a minimal viable product, the MATCH-MVP. A minimal viable product (MVP) is a version for the new product that allows a team to collect the maximum amount of validated learning about customers and is a concept used in entrepreneurship that stresses the impact of learning in new product development. Our Proof-of-concept study aims to test the initial MATCH-MVP prototype in people’s homes to: a) examine the user experience and evaluate the design features of the prototype, and b) test and evaluate whether the MATCH-MVP content is feasible, acceptable, understandable, useful, and the content is learned by carers of people living with dementia.

  • Is there a synergistic effect of adding social cognition remediation to cognitive remediation therapy versus cognitive remediation alone in young people? A randomised controlled trial

    We have known for some time that serious mental illnesses such as schizophrenia, bipolar disorder or severe depression cause significant problems in thinking skills such as attention, concentration, memory or planning. Recently we have become aware that they also cause problems in social cognitive skills such as recognising a person’s emotional state from the expression on their face or being able to think in another person’s shoes. Both of these sets of skills- neurocognition and social cognition – have serious flow on effects upon a person’s ability to function at school, in work or in the community. Unfortunately medications does not help with these problems, but psychological treatments – cognitive remediation and social cognitive remediation therapy does. This study will trial different combinations of these treatments to see if they have separate effects upon treatment outcome. The study will be run in frontline mental health services which will mean that the skills and knowledge will be communicated to the clinical teams maximising benefit.

  • Group cognitive rehabilitation via telehealth for brain cancer

    This study aims to investigate the feasibility, applicability and reach of an online group program targeting management of everyday memory and thinking problems of brain cancer survivors. Who is it for? You may be eligible for this study if you are an adult survivor of brain cancer over the age of 18 years old at least three months post-diagnosis and have not undergone radiation therapy in the past month. Study details Participants will attend six weekly 2-hour memory-focused group sessions via Zoom, with a booster session scheduled 6 weeks thereafter. Data will be collected on participants' perception of their memory and cognitive abilities, as well as emotional wellbeing and quality of life. It is hoped that this study will help inform future programs aiding brain cancer survivors manage their cognitive function.

  • Prospective cross-sectional study of 68Ga-PSMA PET/CT in addition to mpMRI in men undergoing 12-month confirmatory biopsy during Active Surveillance for low- or intermediate-risk prostate cancer

    A multicentre clinical trial evaluating the additive value of a novel diagnostic test (Prostate Specific Membrane Antigen Positron Emission Tomography (PSMA PET)) in addition to and in combination with the current gold-standard reference in men undergoing 12-month confirmatory biopsy during Active Surveillance for low- or intermediate-risk prostate cancer Who is it for? You may be eligible to join this study if you are aged 18 and above, have been newly diagnosed prostate cancer deemed suitable for active surveillance by treating urologist and not yet had a 12-month confirmatory biopsy on active surveillance Study details All participants in this study will undergo a limited (pelvic only) 68Ga-PSMA PET/CT in addition to their standard-of-care surveillance mpMRI within 3 months prior to their 12-month (range 6-18-months) confirmatory biopsy. The diagnostic accuracy of PSMA PET will be compared to the current gold-standard reference test of mpMRI and saturation transperineal confirmatory biopsy. Although recent studies have demonstrated the value of mpMRI as a surveillance tool, it has a propensity to miss a small proportion of clinically significant PCa which has limited its ability to safely replace surveillance biopsies. To date, the additive value of PSMA PET in AS has not been evaluated. Given its promising performance in the detection of both metastatic PCa in a BCR setting and the primary diagnosis of intraprostatic PCa, we propose the evaluation of its use in AS.

  • A manualised group program targeted towards internalised stigma.

    This study aims to determine the efficacy of the Narrative Enhancement Cognitive Therapy (NECT) program in reducing SS in Australian youth (16 to 24 years) treated for mental illness and moderate to severe SS. This quantitative project will involve a randomised controlled trial (RCT) assessing the effectiveness of the manualised group program, which has been designed to reduce SS in youth with a mental illness and will be further adapted to the Australian context. A total of 110 youth will be required at baseline of the RCT. It is hypothesised that the NECT program will improve SS, overall mental and physical health, and wellbeing in this vulnerable population.

  • Beyond Now: Evaluating the effectiveness of a self-guided suicide safety planning app for people at risk of suicide

    This study will examine whether app-based suicide safety planning is effective over a 3-month period in increasing suicide-related coping, reducing suicidal ideation, and supporting the basic psychological needs of self-determination (autonomy, competence, relatedness). It is hypothesised that (i) overall, participants will experience significant increases in suicide-related coping and self-determination, and significant decreases in suicidal ideation, and (ii) these outcomes will be superior for participants who made a safety plan in collaboration with a clinician, made plans of higher quality, had higher distress tolerance, and had higher autonomous causality orientations.

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