ANZCTR search results

This study aims to determine safety and gastrointestinal tolerance of a novel ingredient for internal use up to a period of 14 days. This project is testing the safety of a traditional Australian Indigenous ingredient in a modern context. The sap resin produced by several species of eucalypts (gum trees) has an extensive history of oral use, however, the safety aspects have never been investigated. The purpose of this study is to demonstrate safety of a selection of sap resins taken from a range of different Eucalypt species (both Eucalyptus and Corymbia), in a modern context, at a standardised dose. The dosage form (in capsules) is not in accordance with traditional use (dissolved in water) and the ingredient has not been tested in this form before. The evidence of therapeutic internal use of this ingredient details a primary use of sap resin for digestive complaints. The potent astringent properties and ability to stem the secretion of body fluids have been detailed as the primary action for its effectiveness as a remedy for upset stomachs, diarrhoea and dysentery. The duration of use in the historical literature is not described, and it is expected, due to the primary use of this ingredient, to have been limited to short-term use, perhaps a few days to a week. Given the potential modern-day use of a mucilaginous astringent may extend to conditions such as diarrhoea predominant irritable bowel syndrome, the safe use of the ingredient for a period up to two weeks was chosen to be evaluated. The potential benefit of this research is to demonstrate the safe use of this ingredient internally at a standardised dose over a two-week period.

A randomised control trial investigating the surgical management of carbuncles, with the goal to identify whether incision and drainage with conservative debridement of carbuncles is superior to the current standard of full-thickness excision (saucerisation). The hypotheses tested involves comparing the two surgeries in their wound healing time, likeliness to require skin graft, and overall length of hospital stay and patient travel episodes.

The overall aim of this project is to adapt an existing Hearing Wellbeing Program (HWP) to be an implementation-ready online intervention that addresses the psychosocial and emotional needs of adults with hearing loss. The HWP is the output of a human-centred co-design process conducted in 2020-21 with people living with hearing loss, researchers, audiologists, and psychologists, policy makers, philanthropic organisations, and consultants, initiated by Soundfair (a consumer-driven charity) to address a gap in offerings that address the psychosocial and emotional impacts of hearing loss. It comprises 10 self-guided wellbeing modules, currently available only in hard copy. It is, however, ideally suited to adaptation as an online resource, thus allowing flexibility in its delivery in response to consumers’ desire for accessible support options that are not tied to specific help-seeking pathways (i.e., seeing a hearing healthcare professional) nor location or geography. There are three phases of this project: 1. The first phase will adapt the existing HWP to be self-paced and online, using co-design methods with adults with lived experience of hearing loss, audiologists, psychologists, educationalists, and digital technology experts. Co-design participants attend the first online workshop to formulate a plan and structure for the online version of the HWP. Following this development, a prototype of the online HWP will be created. A second online workshop will follow to test the prototype of the online HWP and provide feedback for further changes. 2. The online HWP will be deemed ready to be piloted in the feasibility study when there are no more significant issues or changes required. The second phase of the project will ssess and determine the feasibility of the online HWP, and revise the program based on these results. 3. The final phase of the study (registered separately) will evaluate the efficacy and health costs of the online HWP for adults with hearing loss, compared to an active control, via a randomised clinical trial.

The overall aim of this project is to adapt an existing Hearing Wellbeing Program (HWP) to be an implementation-ready online intervention that addresses the psychosocial and emotional needs of adults with hearing loss. The HWP is the output of a human-centred co-design process conducted in 2020-21 with people living with hearing loss, researchers, audiologists, and psychologists, policy makers, philanthropic organisations, and consultants, initiated by Soundfair (a consumer-driven charity) to address a gap in offerings that address the psychosocial and emotional impacts of hearing loss. It comprises 10 self-guided wellbeing modules, currently available only in hard copy. It is, however, ideally suited to adaptation as an online resource, thus allowing flexibility in its delivery in response to consumers’ desire for accessible support options that are not tied to specific help-seeking pathways (i.e., seeing a hearing healthcare professional) nor location or geography. Specifically, this project will: 1. Adapt the existing HWP to be self-paced and online, using co-design methods with adults with lived experience of hearing loss, audiologists, psychologists, and digital technology experts. 2. Assess and determine the feasibility of the online HWP, and revise the program based on these results. 3. To evaluate the efficacy and health costs of the online HWP for adults with hearing loss, compared to an active control, in a clinical trial.

"One Million Skin Checks: A Feasibility Study of Teledermatology and Artificial Intelligence in General Practice For Skin Checks in Adults” is a research study looking at using teledermatology and artificial intelligence to help diagnose skin cancers. The primary aim of the study is to assess the feasibility of using these technologies in general practice to support skin cancer diagnosis and management. The secondary aim is to evaluate GPs’ experience of using the teledermatology and artificial intelligence diagnosis tools and the online training modules for these tools. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have a skin lesion where the GP is concerned about possible skin cancer and the lesion is suitable for imaging and biopsy. Study details All participants who choose to enrol in this study will have their skin lesion assessed by the GP using both standard care methods, and the newly developed artificial intelligence (AI) diagnosis tools. All participants will have a biopsy of the lesion taken and sent for further cellular analysis to determine next treatment steps. Please note that the use of the AI tools will not impact upon the care you receive. The GP will continue to treat all participants as they would without the AI tools, but they will then assess their treatment decisions against those provided by the AI tools at a later time. In order to assess the lesion using the AI diagnosis tools, the GP will attach a specialised microscope fitting to their smartphone and use this to take photos of the lesion. These photos will then be uploaded to a new app (DermEngine) which will connect the GP to a consultant dermatologist for further review of the lesion. The app also has an AI algorithm built into it which will assess the lesion photos, make a diagnosis, and tells the clinician how likely it is to be cancer. The AI result and the teledermatology opinion from the consultant dermatologist will be made available to your GP a day or two after your consultation. As all of the images in the study are anonymised before leaving the GP practice, the AI and teledermatology results will not be communicated directly to patients, but may be available from your GP upon request. It is hoped this research will demonstrate that use of these AI diagnostic tools for skin cancer checks is practical and acceptable to GPs. If this study does find that using the AI diagnostic tools is beneficial, a larger study enrolling more participants may be undertaken to determine the efficacy of the diagnostic tools compared to standard care for skin cancer checks.

Reform of secondary prevention in rural and remote areas is required to improve reach and access for patients living in such areas, and consequently improve clinical and other health outcomes. The purpose of this project is to evaluate the feasibility of an innovative, tailored telehealth education and counselling program in patients with hypertension living in rural South Australia. This program aims to improve cardiovascular disease prevention, by providing tailored education and empowering patients to self-manage their condition and reduce their risk of heart disease. Tailored telehealth intervention optimises secondary prevention of cardiovascular disease.

This is a phase 2, randomized, double blind, placebo controlled trial to evaluate the efficacy and safety of twice daily APC201, for 4 weeks in adults with osteoarthritic pain of the knee. This will be done by analysing pain score and skin check, knee pain and rescue medication diary, and side effects. Safety will be monitored during treatment visits using standard measures, including physical exams, vital signs, clinical laboratory tests and side effect monitoring. Skin at the application sites will be checked to see if there is any irritation or reactions present after applications. The primary purpose of phase 2 study is to evaluate the clinical efficacy and safety of APC201 in reducing pain in patients with osteoarthritis of the knee compared with those on placebo.

This cluster randomised controlled trial will test the effectiveness of a co-designed online educational help-seeking program against a psychoeducation alone (active control condition) program on improving help-seeking intentions in workplaces.

Obstructive sleep apnoea (OSA) is a condition in which a patient’s airway repeatedly narrows or closes during sleep. This leads to low levels of oxygen and multiple awakenings throughout the night. Many factors contribute to the blockage of the upper airway during sleep, including the shape, length and strength of the upper airway itself. Oral appliances can improve airway size and can thus also improve OSA. Similarly, exercises that are focused on strengthening the orofacial muscles (Orofacial Myofunctional Therapy) can improve the airway and, therefore, reduce OSA severity. Orofacial Myofunctional Therapy involves exercises targeted to facial and oropharyngeal structures (lips, tongue, and the soft palate) and typically involve aspects of suction, breathing, and chewing. There is some evidence supporting the concept that orofacial myofunctional therapy improves OSA symptoms in adult patients, alongside other benefits including reduced snoring and improvements in sleep quality, oxygen saturation levels and daytime sleepiness. These therapeutic benefits are hypothesised to arise from muscle gain in the upper airway, from improvements in upper airway muscle responsiveness, and from improved coordination in the way that different compartments of tongue and other pharyngeal muscles are recruited together. This trial investigates potential benefits of using the combination of a passive myofunctional oral device along with an active myofunctional device designed to strengthen the oral and facial musculature on OSA severity. Aim: This study will investigate the efficacy of an oral appliance combined with tongue muscle exercises in improving OSA severity. Hypotheses: (1) Wearing the oral appliance for 2 weeks will improve objective measures of OSA severity compared to a baseline assessment conducted prior to commencing wearing the device. (2) Wearing the oral appliance in combination with exercise will be superior to wearing the appliance without exercise in improving objective measures of OSA severity.

The current study aims to evaluate a recently developed online, skills-based educational tool, SkillED. The proposed program has been specifically developed to provide psychoeducation and motivation for individuals with a clinical or subclinical diagnoses of an eating disorder. Overall, we aim to investigate: (1) Program Effectiveness and Safety: The changes in participants’ eating disorder symptomology, general mental health, quality of life, self-perceived skill-level, understanding, knowledge and confidence in eating disorders and the motivation to seek help/treatment, in addition to self-harm and suicidal risk assessment and self-reported weight changes. (2) Program Evaluation: The extent to which participants find the program content and delivery format acceptable and useful, with identification of areas of improvement and consideration to the broader feasibility of online skill-based programs for individuals with an ED across the diagnostic spectrum. We anticipate that engagement with SkillED will result in improvements in eating disorder symptoms, overall wellbeing, knowledge and confidence in understanding of eating disorders, and increase motivation to seek treatment and actual help-seeking behaviours.