ANZCTR search results

Sophisticated wearable sensors now exist that can collect an almost continuous stream of physiological data. These sensors have evolved from simple fitness tracking devices to multifunctional, compact, and versatile sensors, which can be integrated into clothing or attached to the body to monitor our physiology & interact and communicate. While the sensors have rapidly evolved & become highly sophisticated in recent years, there remains many issues with the algorithms used to analyse the sensor data. They are imprecise, often inaccurate & frequently misinterpret data, incorrectly labelling movements as ‘steps’ or reading a book as ‘sleep’. This incongruity creates a reluctance to use & rely on these wearable sensors, even though their potential to provide increased awareness about physiological and mental state is tremendous. The standard software also frequently relies on averaged and aggregated data for any predictions about state, rather than tailored to the individual. If wearables are to be used in a variety of complex, austere environments (those where access to resources is significantly limited or unavailable) personnel must be able to trust not only the sensors to measure signals accurately but also the algorithms & software to analyse & interpret the data correctly. There is a need for more accurate, sophisticated algorithms to take advantage of the next generation sensors on the market and a more personalised, individual approach is needed to build trust and increase acceptance. Using deep expertise in understanding individual performance dynamics over time, under different environments and conditions to refine novel algorithms.

This study aims to evaluate the effectiveness of the ‘Primary Breathe Australia self-management intervention’ for chronic breathlessness. Who is it for? You may be eligible for this study if you are a male or female, aged 18 or over, and expected survival of 3 months at time of recruitment. You must have a clinician-confirmed diagnosis of at least one of the following CRDs: chronic obstructive Chronic obstructive pulmonary disease (COPD), Interstitial lung disease (ILD), Chronic asthma, Bronchiectasis, and lung cancer. Study details Participants will be randomly assigned to either intervention arm (Primary Breathe Australia self-management intervention) or treatment as usual. The Primary Breathe Australia self-management intervention consists of at least 2, but up to 3, one-on-one clinical consultations delivered over an 8-week period (or shorter period according to patient preference) by the Primary Breathe Australia nurse who is embedded within the primary care or residential aged care site. Each consultation is expected to last 20-60 minutes. The content of the interventions will involve patient assessment, general chronic breathlessness education, non-pharmacological self-management education, and provision of digital resources developed for the intervention. During and after the intervention, participants will be assessed using questionnaires for breathlessness, qualify of life, distress, anxiety, depression and fatigue. It is hoped that this research will demonstrate a scalable approach to improving the management of chronic breathlessness, leading to better symptom control and quality of life for people living with chronic respiratory conditions and other diseases.

The FAST Walk study is a multicentre prospective cohort study that aims to enrol 1672 participants in Canada and Australia. The FAST Walk study will evaluate the association of 6MWT distance and 3 tests completed before surgery with outcomes assessed at 30 days and 90 days after major non-cardiac surgery. The primary aim of the study is to determine whether preoperative 6MWT distance adds prognostic value to usual clinical factors for predicting 30-day major postoperative complications. We hypothesise that a 6MWT will improve prediction of complications are elective non-cardiac surgery.

Comorbid insomnia and sleep apnoea (COMISA) is a prevalent and debilitating disorder in Australian sleep clinic settings. The recommended treatment for insomnia is Cognitive Behavioural Therapy for insomnia (CBTi). CBTi is effective in patients with comorbid sleep apnoea. However, very few patients with COMISA access CBTi. Digital CBTi programs are an effective and potentially scalable intervention to manage insomnia. There are currently no publicly-available self-guided digital CBTi programsin Australia that provide personalised weekly behavioural therapy recommendations, and no programs tailored for COMISA. This randomised controlled implementation trial will recruit two sub-groups of patients with COMISA; 1. At least 140 patients that have been recommended Positive Airway Pressure (PAP) therapy by a treating clinician, and 2. Up to 140 patients that have not been recommended PAP therapy. This trial aims to investigate the feasibility and effectiveness of a digital CBTi referral pathway for people with COMISA in Australian sleep clinic settings. Patients that are referred, eligible and consent to participate will be randomised 1:1 (stratified by sub-group) to a digital brief CBTi program, versus waitlist education control. The RE-AIM framework will be used to investigate the effectiveness and implementation of the intervention. Reach o Sleep and Respiratory Physicians in all States/Territories of Australia will participate. o At least 50 Sleep and Respiratory Physicians will be recruited. Effectiveness o The CBTi group will report a greater improvement in symptoms of insomnia, depression, and fatigue from baseline to 8-weeks, and baseline to 24-week follow-up (primary time point), compared to the education control group. o Among a sub-group of 140 patients recommended PAP therapy, the CBTi group will report greater nightly average use of PAP therapy at 24-week follow-up (primary time point) compared to the education control group. Adoption o There will be an increasing number of patients referred to the study per month of the study. o At least 400 patients with suspected COMISA will be referred. o At least 80% of patients allocated to the intervention group will commence the digital CBTi program. Implementation o Qualitative interviews with Physicians and patients will indicate that the pathway and CBTi program is acceptable and feasible. o At least 60% of patients allocated to the intervention group will complete the full 5-session program. Maintenance o There will be an increasing number of patients referred to the study by participating sleep physicians per month of the study. o Improvements in insomnia, depression, and fatigue following digital CBTi will be sustained by 24-weeks. o Qualitative interviews with Physicians and patients will indicate interest in sustained access to the pathway after conclusion of the study.

The purpose of this research is to compare 2 different formulations of a study drug called asengeprast. The study will compare the safety, side effects, pharmacokinetics (the amount of study drug or any of its breakdown products in your body), of these two different formulations of a single oral dose (taken up to 3 times). This study will allow Certa to determine the doses and the type of formulation to take into future clinical trials in patients with Systemic Sclerosis. You may be eligible for this study if you are a healthy male or female volunteer aged 18 to 65 years of age who has met all inclusion criteria and do not meet any exclusion criteria. Part B involves participants receiving a single dose of the original form of asengeprast and then a single dose of asengeprast new formulation before and after a high fat meal. Therefore, participants in Part B will receive a total of 3 single doses of the study drug. Participants will be screened and if eligible (i.e. they meet all of the inclusion criteria and none of the exclusion criteria) participants will be enrolled into the study. Being enrolled means being admitted into the study centre on three occasions for a 3-night inpatient stay. You will also be required to attend the study centre on three occasions, following your discharge. All participants will have their vital signs (heart rate, blood pressure, oxygen saturation, temperature and respiratory rate) and ECGs checked, and will provide blood and urine samples for testing to ensure asengeprast is safe and well tolerated.

Shortness of breath, known as dyspnoea, is a common and distressing symptom experienced by lung cancer patients that can severely impact physical functioning and quality of life. Yoga is an ancient mind-body practice that may provide relief from dyspnoea in this cohort, however few quality studies have been conducted to test effectiveness. The purpose of this study is to determine if an 8 week yoga therapy is a feasibly treatment in lung cancer patients. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with non-small cell lung cancer and are experiencing shortness of breath. Study details Participants in this study will receive one of the two below treatments: Group 1: Participants in this group will receive an information booklet focussed on optimal care and receive video recordings of all yoga sessions 9 weeks after enrolment. Group 2: Participants in this group will take part in an 8-week yoga exercise intervention, requiring participants to attend one face-to-face session per week and up to two online sessions per week. The group that participants take part in will be determined randomly (by chance). Throughout the study, participants will be asked to complete questionnaires and complete physical exercise testing. It is hoped that this study will help determine whether an 8-week yoga intervention is a feasible treatment to address shortness of breath in lung cancer patients and provide information that will help inform a larger trial.

Japanese Encephalitis (JE) vaccine and Yellow Fever (YF) vaccine we are using in this study are both “attenuated” vaccines. This means the virus they contain is live but has been weakened and doesn’t cause sickness in healthy people. After JE or YF vaccination, the weakened virus can reproduce itself a little bit for around 1-2 weeks, this makes your immune system start fighting the weakened virus and gives you lasting protection against the disease. The JE vaccine virus has part of the YF virus inside it. If someone is having both vaccines, isn’t known if the order you receive the vaccines changes the immune response to the vaccine viruses. The primary study objective is to assess how the adaptive immune response (responses to antigen) to a live-attenuated JE vaccine impacts the replication of YF virus vaccine following YF vaccination. We will randomise participants to the order in which they receive a YF vaccine and a JE vaccine (JE-YF or YF-JE vaccination arms), given 4 months apart. Participants will have blood samples collected to follow their immune responses to the vaccines.

This study aims to determine the efficacy of 1) topical (applied to the nasal mucosa) lidocaine and usual care, 2) intranasal midazolam plus topical lidocaine and usual care and 3) intranasal fentanyl plus topical lidocaine and usual care compared to 4) usual care for reducing the occurrence of severe distress experienced by children aged 6 months to less than 5 years (i.e. 4 years and 364 days) associated with NG tube insertion.

This project aims to assess the feasibility of a student-led, semi-individualised Falls Prevention and Education Program (FALLS-EDU) for community-dwelling older adults in a university health clinic setting. Participants aged 55 years and older will complete a structured assessment, falls risk stratification and receive tailored falls prevention education and exercise strategies delivered by supervised student osteopaths. The study will evaluate recruitment, attendance, acceptability, logistical considerations, and resource needs over an 18-week total study period. Mixed-methods will be used, including pre-post outcome measures and focus groups with participants, students, and staff to explore experiences and perceptions. Findings will inform future integration of student-led falls prevention models into broader community and aged care settings.

The SMART-AF trial is a single-centre, randomized controlled study evaluating an AI-powered educational platform for patients newly diagnosed with atrial fibrillation. Participants are randomized 1:1 to receive either standard care or access to a structured online curriculum and chatbot designed to improve AF-related knowledge. The primary outcome is the improvement in patients’ AF knowledge, assessed through validated questionnaires before and after the intervention. Secondary outcomes include changes in quality of life, symptoms, lifestyle measures, and anxiety and depression. The study aims to recruit 158 participants over 9 months, with follow-up assessments completed within 12 weeks.