ANZCTR search results

The aim of this research is to evaluate the potential role of Body Surface Gastric Mapping (Alimetry Ltd., New Zealand) in a multidisciplinary integrated care pathway for functional gastroduodenal disorders, to determine whether Body Surface Gastric Mapping test biomarkers are predictive of therapeutic response to a 12 week structured program of care. Hypotheses: Patients with neuromuscular disorders identified by BSGM will demonstrate reduced clinical response to an integrated care program incorporating psychological and behavioural interventions. Conversely, patients with normal BSGM tests will be more likely to respond to the integrated care program. They will also be more likely to also register reduced anxiety and depression scores.

Many babies and infants admitted to hospital need fluids or medicines delivered directly into their veins using an intravenous (IV) catheter. Over time, IV's can dislodge from the veins and some cases, the medicine or fluid can leak into the child's tissue around the vein, causing damage to the skin, tissue and the vein itself. This is called an extravasation injury. An early sign of extravasation injury is pain, however babies and infants cannot always communicate that the IV site is painful making early detection painful. The IV biosensor is a new device that may help detect extravasation injury sooner. A biosensor is a special light similar to an oxygen saturation probe that is placed on the child's skin above the IV site. It uses near infra-red light to scan the tissues to detect extravasation injury and alerts clinicians so the infusion can be stopped to limit damage caused to the surrounding tissue. This trial will examine whether the IV biosensor helps to detect extravasation injury in babies and infants earlier than compared to standard care. It will also assess whether it is safe and easy to use, and whether it decreases the severity of extravasation injuries.

New home spirometer devices (the SpiroHome device) have not yet been tested for accuracy compared to hospital-standard devices. We are assessing the accuracy of new home spirometers, and whether they are easy to use in the community. Participants also have the option to trial new technology called "EIT" which looks at ventilation across the lung using sensors placed on the skin.

The SWAP IT program is integrated within an app-based communication platform used by schools to communicate with parents and consists of text-messages sent to parents targeting barriers to packing healthier lunchboxes. SWAP IT has proven to be effective in improving child nutrition and weight outcomes, is acceptable to parents and principals, and is cost effective. Although SWAP IT has the potential to improve child health at a population-level, little evidence exists to guide efforts to encourage school adoption of these programs at scale. This research aims to maximise the impact of the SWAP IT program through a scale-up involving 1341 primary schools across 10 NSW local health districts. A modified platform trial design will be used to test the effectiveness of a series of scale-up strategies that have been tailored to context to maximise the adoption of an effective healthy lunchbox program within NSW primary schools located within 10 Local Health Districts of NSW. Adoption of the SWAP IT program will be the primary outcome of the trial. This research will result in new knowledge to inform how school-based nutrition programs can be successfully tailored to the local context and scaled-up at a population level.

The primary aim of this pilot study is to assess the feasibility and acceptability of conducting an RCT to evaluate the CREATE intervention in Queensland health services, and to inform the primary outcome measures and sample size for the full RCT. Our proposed intervention CREATE (Co-designed Retail Tools for healthier food Environments) directly addresses these factors through the provision of a Retailer Toolkit and Practitioner Training which have been co-designed with end-users to support the implementation of ‘A Better Choice’ healthy food retail targets. ‘A Better Choice’ Strategy aims to increase the provision of healthy food and drinks for staff, visitors, and patients within Queensland hospital and health services (HHS). The trial will determine the feasibility and acceptability of the implementation support tools, and that of the RCT study design, and will inform future full size RCTs.

Cognitive decline is the primary symptom of dementia and is preceded by reduced brain blood vessel (i.e. cerebrovascular) function. Cognitive decline and cerebrovascular dysfunction are made worse by obesity, which results from a poor diet and low physical activity levels. These are increasingly prevalent in regional Australia and contribute to the increase in dementia rates, reducing quality of life of older Australians. Current preventive treatments for dementia focus on reducing risk factors, including exercise and diet, but these are associated with low compliance. Capsaicin, the spicey molecule in chilli, reduces fat mass and blood pressure in humans. It also improves markers of cardiovascular disease and cognitive decline in animal models of disease by reducing inflammation and improving blood vessel function. However, capsaicin can cause oral and gastrointestinal irritation, limiting its potential for human use. Capsimax is a unique beadlet encapsulation of capsaicin that prolongs capsaicin release in the gut, and prevents irritation associated with capsaicin ingestion. Hence, Capsimax is a safe and tolerable supplement that can be used to examine the effects of capsaicin in humans. We will conduct a randomised control trial that will investigate the effects of Capsimax supplementation for 12 weeks on cognition and cerebrovascular function in middle-aged to older, overweight and obese adults who are at risk of cognitive decline and dementia. This pilot study will be the first human study to explore the use of a capsaicin supplement in improving cognition and cerebrovascular function, thus providing a foundation for future use as a preventive treatment for dementia.

RECALL-Pilot is a prospective, decentralised pilot trial to investigate the feasibility of using a blood pressure lowering ‘polypill’ including telmisartan 20mg, amlodipine 2.5mg, indapamide 1.25mg in a decentralised trial to prevent ‘significant cognitive impairment’ (MCI or dementia).

Telehealth is an emerging way of assessing and managing patients, particularly after the COVID-19 pandemic. The role of telehealth in concussion diagnosis and management is not fully researched yet, therefore in this trial, we are in the first instance testing the effectiveness of the diagnostic ability of a telehealth program. This trial is running for 2 years and is available to all players in VAFA and will enrol at least 500 head-injured patients with suspected concussion. If deemed eligible, participants will be randomly allocated to either one of the following two treatment options: a) attending an online virtual video-based telehealth consultation with a neuropsychologist/ neurologist or physiotherapist which will take about 45 minutes OR b) provided with the most current and available concussion/head injury advice. There will be no restrictions on participants in terms of lifestyle or regular medications or behaviours. Regardless of which option participants are randomised to, they will be contacted on day 7 and day 14 post head injury regarding their clinical symptoms. If they attend the telehealth consultation, they will also be contacted again on day 30 to assess their satisfaction and feedback regarding the telehealth program. The primary outcome for this study is the diagnosis rate, whilst secondary outcomes include symptom improvements, RTP adherence, access to clinical specialists, and user satisfaction with the telehealth program.

The purpose of this study is to investigate whether we can use co-mutation NGS profiling (looks for gene changes in your cancer tissue) and circulating tumour (ct) DNA (looks for fragments of the tumour moving through the blood stream. These fragments are known as circulating tumour DNA (ctDNA) and carry genetic information) to determine which patients with EGFR mutant non small-cell lung cancer can safely avoid chemotherapy. Who is it for? You may be eligible for this study if you are an adult with non small-cell lung cancer, with a mutation in epidermal growth factor receptor (referred to as EGFR mutation) that has had their tumour completely resected by surgery. Study details: During screening NGS profiling and ctDNA testing will be performed. The NGS and ctDNA results will be used to determine if your cancer is at higher or lower risk of returning. Participants with a higher risk of their cancer returning will have up to 4 cycles (over 12 weeks) of chemotherapy followed by up to 3 years of daily osimertinib. Participants with a lower risk of their cancer returning will have osimertinib daily for up to 3 years. The following assessments will be conducted throughout the trial: physical exam, CT scans, MRI, blood tests, pregnancy test, ECG and questionnaires. It is hoped that this study will help determine if osimertinib alone may provide similar benefits with less toxicity, improved quality of life and reduced health care costs, to chemotherapy and osimertinib.

LeapForward is a digitised 6-week clinician supported program harnessing psycho-education, technology and coaching to support people in a return to health, life and work after (compensable) injury or illness. LeapForward aims to address the psychosocial barriers that can most significantly impact recovery – by empowering individuals with the will-and-skill to move forward in their recovery with confidence-and-control. Whilst LeapForward has been developed based on leading evidence-based principles, a rigorous evaluation is required to determine the program’s ability to engage and retain users, to induce change in users’ health and wellbeing, and ultimately – to causatively impact on (personal injury) claim costs on a macro-scale within an MVA-scheme environment, through impacting weekly benefits and/ or total treatment costs. IAG and NRMA are evaluating whether providing their customers with a web-based health program called LeapForward can help claimants as part of their recovery after a motor vehicle accident. We aim to conduct an independent evaluation of this program.