ANZCTR search results

This study is testing whether using HEPA filter air purifiers at home overnight can improve the quality of life for adults with asthma, particularly during high pollution days. Adults with asthma will be randomly assigned to receive either a real HEPA air purifier or a look-alike placebo purifier that does not filter the air. The study will measure changes in asthma symptoms, sleep quality, nasal health, and lung function before and after intervention.

Atrial fibrillation (AF) is the most common chronic heart rhythm problem and controlling risk factors are pivotal in management. Obstructive Sleep Apnoea (OSA) has emerged as an independent risk factor for AF and is defined by repetitive airway obstruction during sleep which overtime gives rise to AF. Nightly autonomic dysfunction as a result of sleep apnoea is important in understanding AF. The study hopes to better understand about nightly autonomic dysfunction on daily AF burden overtime and assess whether treatment including CPAP or MAS has a direct, positive impact.

BUILDS is a multicentre non-randomised cluster crossover trial with Type 1 hybrid effectiveness-implementation design to be conducted across seven Australian rural and regional health networks. It will systematically evaluate the effectiveness and adoption of a national stroke physician-led Tele-Stroke Unit inpatient service using a purpose-built digital platform to improve the quality of care and outcome of stroke patients in rural and remote communities.

Co-morbid insomnia and obstructive sleep apnea (COMISA) is common. When these disorders co-occur, they result in additive impairments to patients’ sleep, daytime functioning, and quality of life. Compared to OSA-only patients, patients with COMISA are likely to have mild upper airway collapsibility and a low respiratory arousal threshold. Targeting these two physiological traits serves as the scientific rationale for this investigation. Interestingly, trazodone is the only hypnotic that has been shown to significantly increase the arousal threshold in patients with obstructive sleep apnea (OSA). Trazodone is also effective in treating insomnia. Sulthiame has been shown to target airway collapsibility and high loop gain. As such, the combination of these two agents is postulated as a synergistic approach to the treatment of OSA and insomnia in patients with COMISA. Study Aims: The primary goal of the current study is to determine the effect of the combination of sulthiame and trazodone on OSA and insomnia severity in patients with COMISA. Specifically, we will assess the effect of combination pharmacological therapy on OSA severity as measured by the apnea-hypopnea index [AHI 3a% criteria, primary outcome] and insomnia as measured by the insomnia severity index [ISI, secondary outcome]. Hypothesis: We will test the primary hypothesis that combining therapies to lower loop gain (sulthiame) and increase the arousal threshold (trazodone) will improve OSA severity (AHI3a) and insomnia severity (ISI) compared to placebo in patients with COMISA.

Post total knee replacement surgery, approximately 34% of people have a poor clinical outcome with approximately 15% developing chronic post-surgical pain (long-lasting severe-extreme pain) after surgery. Post total knee replacement pain outcomes can be improved via early graded resumption of activity and early targeted medical attention if not improving. However, current total knee replacement care does not always facilitate this. Physiotherapist led pain science education to update inaccurate beliefs about pain, paired with activity goals has demonstrated reductions in pain and improved self-rated activity for people with knee osteoarthritis. Thus, we have now co-designed a total knee replacement-specific pain science-education intervention with osteoarthritis consumers and clinicians that is ready to pilot test. This parallel-group randomised controlled trial aims to determine whether pain science education informed optimised care for total knee replacement surgery is feasible, acceptable and demonstrates the potential for efficacy when embedded into Australian hospitals relative to usual care.

Suicide remains a leading cause of death for Australian adolescents, and suicide and self-harm related Emergency Department presentations are rising. Brief contact interventions are an important component of comprehensive treatment approaches for adolescent suicide risk. Research has found that families feel excluded from their adolescent’s care in the ED and don’t receive sufficient information about how to support them, despite evidence suggesting involving families in adolescent suicide prevention interventions leads to better outcomes. Additionally, there is a need to provide continuity of care after discharge from the ED. The EDBridge Pilot Feasibility & Acceptability trial involves a multi-component brief-contact intervention for adolescents aged 12-18 who are discharged from an Emergency Department with suicidal thoughts or behaviours, and their parents/carers. It involves a suicide safety planning intervention for adolescents, a parent factsheet resource to support parents to manage adolescent suicide risk outside the ED, and an automated follow-up text message support program for both adolescents and their parents/carers. The aims of this trial are to determine whether EDBridge is feasible (that is, how easy or practical EDBridge is to provide), and acceptable to adolescents, parents, and clinicians. We also aim to collect early information about whether EDBridge can help improve the mental health and suicide-related symptoms of parents and adolescents, and increase their engagement with community mental health support. We hypothesise that EDBridge will be feasible and acceptable to clinicians, adolescents, and parents. We also hypothesise that the pilot trial will give early indication that EDBridge can support adolescents and parents to improve suicide-related and mental health outcomes and increase engagement with community mental health support.

Chronic subdural hematoma (cSDH) is a common condition, especially in older adults, where blood slowly collects on the surface of the brain. This can cause headaches, confusion, weakness, or other neurological symptoms. Current treatments often involve surgery, such as drilling small holes in the skull to drain the blood. However, surgery carries risks and the hematoma can sometimes come back. This study will test a new minimally invasive treatment called the NVS-1 System. In this procedure, doctors use a very thin tube (NVS-Catheter1) inserted through an artery in the groin or wrist to reach a small vessel called the middle meningeal artery (MMA), which supplies blood to the membranes around the hematoma. A liquid material called NVS-Gel1 is injected through the NVS-Catheter1 and then solidified using a special light (NVS-Laser1) delivered inside the artery. This is designed to safely block the blood flow to the membranes that cause the hematoma, with the goal of reducing or eliminating the hematoma without the need for open surgery. This is the first time the NVS-1 System will be used in people. The study will include up to ten patients at Gold Coast University Hospital. The main goal is to evaluate safety and effectiveness of the NVS-1 System. Patients will be followed for 90 days with CT scans and clinical assessments to check for hematoma resolution and improvement in symptoms.

This is a Double-blinded, Placebo-controlled Split-scar Study in a Cohort of Adult Participants with Hypertrophic Sternotomy Scars to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics. Who is it for? You may be eligible for this study if you are aged 18 to 60 years with a hypertrophic scar. Study details: This is a split-scar study where participants apply SNT9465 to one treatment segment of their scar (either superior or inferior) and the other will be treated with placebo daily for 90 days. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. The data generated in this study will inform the design of future clinical studies and to select the dose(s) for future studies in patients with Hypertrophic Scars.

The project will examine the effectiveness of co-located multidisciplinary primary care for the management of chronic conditions. The project aims to (1) explore, compared to stand-alone practices, whether GP practices with co-located primary care disciplines are more effective at reducing potentially preventable hospitalisations (PPH) and/or emergency presentations among patients with selected chronic conditions; (2) compare quality of life, patient experiences of care and health care use between a subset of patients with chronic conditions from multidisciplinary practices and stand-alone practices; (3) describe each practice’s approach to integrated multidisciplinary care and explore how this affects PPH, quality of life, healthcare use, and patient experiences of care. The study will recruit 12 GP clinics, with patients completing surveys at 4 time points, and a small subset of patients completing interviews at 2 time points. Clinicians will complete a survey and interview. Primary care data will be linked with admitted patient data to gauge health service outcomes. This study will provide information to inform policy decisions about which multidisciplinary models have the greatest potential for impact.

To create scalable solutions for the growing number of people living with dementia, we developed MATCH. MATCH is an eHealth solution – Music Attuned Technology for Care via eHealth – developed to support care staff to use music intentionally to support care with people with dementia. The MATCH App has been developed for home and professional care (RAC/hospital) settings, and preliminary trials have been conducted in Victoria, South Australia, and Western Australia. MATCHplus integrates the MATCH App with a bespoke agitation detection system via wearable sensors and an AI-based music recommender system. In this study we will recruit across different professional care settings to: a) Assess the feasibility of implementing MATCH in dementia care in different professional aged care settings; b) Understand the impact of using MATCH Strategies during care on their job satisfaction and care outcomes using self-reported data from care staff; c) Collect data via clinical assessment tools to understand the impact of using MATCH Strategies during personal care and in moments of agitation on neuropsychiatric symptoms of dementia; d) Explore the feasibility, acceptability and utility of the MATCH agitation detection and prediction system; e) Explore the feasibility, acceptability and utility of the MATCH music recommender system for suggesting appropriate individualised music; f) Understand care staff experiences of using MATCH Strategies during care using post-trial interviews; and g) Understand nursing (registered nurse/nurse-in-charge) and management perspectives on the acceptability and utility of implementing MATCH in their professional care setting using post-trial interviews.