ANZCTR search results

The aim of the study is to assess the feasibility, acceptability, and efficacy of the MY Self AdvocacY (MYSAY) self-advocacy for system navigation program, a 9-session individualised program delivered over 6 months during the hospital-to-home transition period after acquired brain injury (ABI). The study is for people with newly acquired brain injury and their family member, carer, or a relevant clinician and participants will be recruited through from the Princess Alexandra Hospital (PAH) Brain Injury Rehabilitation Unit and Jasmine Unit. The hypotheses are: 1) The MYSAY program will be feasible and acceptable to people with ABI and 2) Individuals receiving MYSAY will show greater improvements in self-advocacy, self-awareness, self-management skills, fewer service obstacles, and lower mood symptoms, relative to those receiving their usual care and rehabilitation. The design of the study is: 1) a randomised controlled trial involving the MYSAY program intervention group and a usual rehabilitation / care group. 2) Assessments will be conducted at baseline (pre-intervention), mid-intervention (3 months post-baseline), and post-intervention assessments (6 months post-baseline). The expected benefits of the research will be development of a novel program that supports individuals’ self-advocacy and system self-navigation skill development early in the brain injury rehabilitation process, to promote greater self-determination in decision-making about their journey through the complex health and disability service systems.

In this RCT study we are investigating if colchicine, an old but safe medication, can help speed up recovery from wet cough flare-ups in children with bronchiectasis. Colchicine is an anti-inflammatory medication which is used in children in Australia for other conditions and has been shown to be safe. Colchicine could likely work through its effects on the neutrophil cells that can cause inflammation. This inflammation in the airways is an important part of the lung disease in bronchiectasis. In adults, inhibition of neutrophils (via other new drugs) has reduced exacerbations and increased time between flare-ups. This study is the first to look at the role of colchicine in the treatment of bronchiectasis flare-ups in either adults or children.

Heart failure is a serious condition, and for some people with advanced disease, heart transplantation offers the best chance of survival. During transplant assessment, body mass index (BMI) is commonly used to assess risk, but BMI does not distinguish between muscle, fat, or fluid, meaning some patients with low muscle mass may not be identified. Low muscle mass is associated with malnutrition, frailty, and poorer recovery after heart transplantation, yet it is not routinely measured in clinical practice. This study will compare simple bedside muscle assessment methods, including ultrasound, anthropometry, and physical assessment, with computed tomography (CT) imaging. CT imaging is routinely performed as part of clinical care and can be used to measure skeletal muscle accurately. The study will also assess whether artificial intelligence–based software can accurately and reliably measure muscle mass from CT scans. In addition, the prevalence of malnutrition, frailty, cachexia, and sarcopenia among patients undergoing heart transplant assessment will be described. A subset of participants will be invited to take part in interviews to explore their experiences of nutrition care and the acceptability of bedside muscle assessment methods.

We will be using a web-based STI testing service as the intervention with traditional in-person STI testing conducted at MSHC acting as the control. The web-based service will allow users to create an account with Test it (also creating a client record at MSHC), complete an automated questionnaire and obtain an electronic pathology form for STI testing. This trial will give us important information about diagnosis and testing rates among MSHC MSM clients with the introduction of Test it. This service will bring improved testing access to all Victoria, including those who participate in the project. Additionally, this research will improve advancement of knowledge around digital sexual health and online STI testing.

The study aims to extend understanding and use of multilevel interventions in managing aphasia, focusing on identifying the critical ingredients of multilevel aphasia interventions and the role of discourse (connected speech) in bringing about change. Through comparison between Verb Network Strengthening Treatment (VNeST) which targets improved word finding and sentence production by emphasising verbs and the roles of other words in a sentence, and Narrative and Discourse Intervention in Aphasia (NADIIA) which also targets words and sentences through work on verbs and their roles, but embeds practice within connected speech and introduces discourse frameworks that organise ideas in daily, functional speaking contexts. Twenty adults with aphasia will participate, with 10 in each therapy group. Language improvements and their impact on daily communication will be measured. It is predicted that both interventions will improve word retrieval and sentence structure, but NADIIA will lead to greater gains in connected speech and discourse structure than VNeST.

Aim: This randomised controlled trial will assess the feasibility and acceptability of EndoOptions, a new co-designed online resource which aims to support people with endometriosis to make decisions about their symptom management. The mixed-methods trial will also assess whether EndoOptions (i) reduces decisional conflict, and (ii) improves emotional wellbeing, and will also explore whether decisional self-efficacy mediates these effects. Participants: N=150 (aged 18 or over, living in Australia, with a diagnosis of endometriosis or suspected of having endometriosis) will be recruited via the offices of obstetrician-gynaecologists and specialist Endometriosis and Pelvic Pain Clinics, then randomly assigned to the Intervention group or the Control group. Design: The Intervention group will receive access to EndoOptions immediately, while the Control group will receive access after three months. Individual links will enable researchers to examine back-end user statistics on site access and navigation, and participants will also be asked to fill out online questionnaires at baseline, 1 month, 3 months and 6 months. Participants who have completed the six-month survey will also be offered the chance to take part in a 30-minute interview to give more detailed feedback on EndoOptions. In recognition of their time, we will be offering all participants who complete the six-month trial a $50 honorarium. Outcome: It is hoped that participants report EndoOptions to be acceptable and feasible, and that EndoOptions reduces psychological conflict in relation to making decisions about endometriosis symptom management.

The BREATHE FAST study (Breathlessness Rapid Evaluation And THErapy – Fast Assessment Spirometry Testing) aims to improve the early and accurate diagnosis of chronic obstructive pulmonary disease (COPD) in rural and regional general practice. It will use a self-administered digital screening questionnaire for breathlessness and a point-of-care micro-spirometry test (FAST) performed within the practice to support general practitioners (GPs) in identifying and managing patients with chronic breathlessness. Each practice will participate for 3-6 months. The study will assess the benefits for patients and GPs in terms of case detection of COPD. The BREATHE FAST system will • Identify patients with chronic breathlessness through a short digital questionnaire completed on their phone or tablet and provide results directly into the GP software ahead of the consultation. • Enable practice nurses or GPs to perform a Fast Assessment Spirometry Test (FAST) using a simple handheld device to detect a lung condition called chronic obstructive lung disease (COPD). We hypothesise that this approach will provide clinicians with timely, objective information prior to and during the consultation, improving the case detection of COPD.

This is a double-blind, placebo-controlled, dose-escalating study conducted in healthy adult volunteers. The study will be conducted in 2 parts, with each part having a double-blind period and an open-label period. Phase 1a will evaluate the safety and immunogenicity of Centi-Flu 01 in healthy adults aged 18 to 64 (Cohorts 1 and 2), and healthy adults aged equal to or greater than 65 (Cohorts 3 and 4). In this part of the study, 6 different dosing regimens of Centi-Flu 01 will be evaluated in a double-blind manner. Sentinel dosing will also be utilised in each cohort. Dose and age escalation will be based on the principle that to proceed with the lowest doses in older adults and to proceed with higher doses in the younger adults, preliminary safety of the lowest doses in younger adults will first be established. This phase also incorporates an open-label evaluation of the safety and immunogenicity of Centi-Flu 01 against an age-appropriate seasonal influenza vaccination. Adaptive design elements will be used to determine whether a booster vaccination dose will be given 1 year after the initial immunisation.

Our study aim is to determine the promise of a Communication Enhanced environment for improving aphasia recovery and patient goal attainment. Our Communication Enhanced Environment intervention incorporates individual activities and resources, staff and volunteers training, and enhancing the ward's physical environment. It is hypothesised that i) the Communication Enhanced Environment will be successfully implemented defined by 75% of the intervention implemented during our fidelity monitoring checks and, ii) the Communication Enhanced Environment will have sufficient promise for one or both participant strata (mild-moderate aphasia; severe aphasia) to progress the intervention to a Phase IIb-III clinical trial.

The primary aim of this study is to determine the feasibility of undertaking a large randomised clinical trial investigating the effect of MHT on pain and function in postmenopausal women with SAPS. This aim will be addressed by an evaluation of key parameters including i) ease of recruitment (rate and number as well as suitability of the assessment algorithm), ii) adherence to the hormone and exercise interventions with a standardised diary, iii) drop-out number and rate, and iv) adverse events (nature and number) will be undertaken and used to inform the implementation of a large-scale RCT. The study is a triple blinded pilot randomised clinical trial and will be known as the EMPOWER (Exercise and MenoPausal hOrmones for postmenopausal WomEn with shouldeR pain) Trial. Participants will be randomised into one of two intervention groups: menopausal hormone therapy (MHT) plus exercise and education or placebo plus exercise and education. This pilot study aims to screen 150 participants over a 12-month period with a recruitment rate of greater than or equal to 30%, resulting in 50 participants (25 each group) entering the pilot trial, with an additional five per group to allow for attrition. We therefore aim to recruit a total of 60 participants over a 12-month period