ANZCTR search results

Inclusion Body Myositis (IBM) is increasingly being associated with respiratory muscle weakness. The purpose of this study is to implement an at-home 12 week long inspiratory muscle training (IMT) program and compare measures of respiratory muscle strength, functionality, sleep quality and quality of life before and after the intervention in 15 IBM patients. IMT protocols have been effective in many medical conditions including other neurological disorders so we hypothesise that it will improve IBM patients' inspiratory muscle strength while secondarily improving functionality, sleep quality and quality of life.

We hypothesise a dose-dependent relationship between aerobic exercise duration and serum-derived BDNF concentration in stroke survivors. We also hypothesise that upper-limb outcomes and functional recovery will improve following combined aerobic and task-oriented interventions in stroke survivors. This study aims to explore the relationship between the ordering of aerobic exercise and upper-limb rehabilitation to promote motor learning and retention post-stroke. Participants will complete a six-week individualised exercise program under the supervision of an Accredited Exercise Physiologist (AEP). Participants will then be randomised to one of two groups for the two-week combined intensive intervention. Modified-Constraint Induced Movement Therapy (mCIMT) will be completed on 10 consecutive weekdays and a High-Intensity Interval Training (HIIT) program will be completed on three days per week.

MICArdiac study is a 6-month multi-centre randomised controlled trial to determine whether an adaptive mobile health program optimised with artificial intelligence can improve cardiovascular risk factors in a primary prevention cohort, compared to a standard text-message program. The study population will be participants who have high blood pressure, with no prior history of cardiovascular disease. Participants must be over 35 years of age and own a compatible smartphone. Potential participants will be identified through cardiometabolic clinics, primary care and the community. Patients will be randomised to MICArdiac intervention or standard-text care in a 1:1 allocation ratio. The intervention group will receive MICArdiac mobile health program comprised of the MICArdiac smartphone app, messages delivered via in-app notifications, and two wireless monitoring devices (blood pressure monitor and physical activity tracker). The primary outcome is the mean change in systolic blood pressure between intervention and control at 6 months. The MICArdiac mobile health program was co-designed with researchers, clinicians (GP and Cardiologists) and consumers, and developed in collaboration with the Sydney Informatic Hub (SIH), being downloadable via the Apple and Google app stores. This study was funded through the Tides foundation and Australian Stroke and Heart Research Accelerator (ASHRA) and aims to recruit a total of 500 patients.

The purpose of the study The purpose of this study is to discover better ways to care for the psychological wellbeing of mothers, particularly in supporting mothers to cope with difficult thoughts and feelings about their childbirth and early feeding experiences. This study is a micro-RCT of a brief online information package. All participants will initially complete an online survey asking about their own coping, childbirth, and feeding experiences (both breastfeeding and bottle feeding). Participants will then be randomly assigned to either have immediate access to the online package (intervention group) or to an 8-week waiting period (wait-list control group). All participants will complete a second online survey 8 weeks later. Those participants who do not receive the information package straight away will still be offered access to the resources once they have completed the second survey – that is, they will have an 8-week wait before receiving access to the resources. It is hypothesised that, compared to the waitlist-control group, the intervention group will demonstrate improved mental health outcomes at post-intervention. This study is being conducted by Laynee Brophy as part of the requirements for the Masters of Clinical Psychology at the University of Queensland, under the supervision of Dr Amy Mitchell (Registered Nurse & Lecturer/Research Fellow, Griffith University) and Dr Koa Whittingham (Clinical/Developmental Psychologist & Senior Research Fellow, UQ).

Intrauterine devices (IUDs) are medical products placed inside the uterus to provide patients with reliable contraception but their use is often limited by pain at the time of insertion. Virtual reality (VR) is a technology that uses a headset to create a 3-dimensional interactive environment for the user and has been shown to be helpful for improving pain in other settings. This research project aims to find whether VR can help reduce the discomfort of having an IUD inserted. The study hypothesis is that VR will help to manage the pain of having an IUD inserted.

Dental plaque has been defined as a community of microorganisms found on oral structures are embedded in a matrix of polymers of host and bacterial origin (Marsh, 2006). The nature and complexity of oral biofilms have led to the development of various intra-oral devices and models to study the oral microbiome. In vitro biofilm models with conventional culture methods have contributed to significant advances in understanding the oral microbiota, however, the in vitro model cannot mimic the exact in vivo environment which leads to incomparable biofilm to the one found in situ (Robinson et al., 1997; Yu et al., 2017). Several techniques have been identified in the literature to harvest the dental plaque by using paper points, cotton rolls, and scalers (Abdullah et al., 2019; Prada-López et al., 2016). However, these methods mentioned above are impossible to collect all bacteria from in situ and doubtlessly disrupt the three-dimensional architecture of the biofilm (Wood et al., 1999). A rapidly developing technique for studying an undisturbed biofilm is using an intra-oral dental appliance as a biofilm collection device (Abdullah et al., 2019). However, the main shortcomings of these devices are that they are removed during mealtimes with the biofilm not being exposed to the patient’s diet, as well as no exposure to gingival crevicular fluid. The aim of the project is to develop an implant-supported device that can grow a biofilm that has a similar composition to that collected subgingivally at a natural tooth.

Accessing effective contraception and abortion services for women living in rural and regional areas can be challenging. The study’s primary aim is to assess the effectiveness of a nurse-led model of care (involving task-sharing, and where appropriate implant insertion by nurses and use of telehealth) in general practice for improving women’s uptake of long-acting reversible contraception and access to medical abortion in rural and regional areas. We will utilise a stepped-wedge, cluster randomised controlled trial study design to trial this complex intervention in regional and rural general practices in Australia. The delivery of the nurse-led model will be supported by a set of implementation activities consisting of (a) online education and clinical upskilling for LARC and medical abortion care, (b) educational outreach to discuss practical strategies for model implementation, and (c) participation in a digital community of practice for access to clinical experts, peer support and resources to support provision of LARC and medical abortion services. It is anticipated that broadening the scope of practice nurses to provide LARC and EMA services in general practice and supporting them in providing this service will be effective in helping overcome issues of access to LARC and medical abortion services for women living in regional and rural Australia. This has the potential to improve reproductive health outcomes for this priority population in Australia.

This randomised controlled study will examine the impact of a 3D virtual reality (VR) intervention versus a two-dimensional (2D) video on pre-operative anxiety and induction compliance. .This study will provide evidence on the ongoing clinical use of 3D VR Goggles during the preoperative period at Perth Children's Hospital (PCH), to reduce anxiety and improve coping of children undergoing surgery. Given preoperative anxiety is so common amongst children, it is vital to find suitable strategies to control and reduce this anxiety in order to improve the overall patient experience. Children exposed to negative medical experiences may have a higher incidence of negative post-operative behavioural outcomes and often display increased fear and poor coping during subsequent medical procedures. By fostering a more positive and fun environment for children through the use of 3D VR goggles, there is potential to reduce negative post-operative outcomes and help children to recall their surgical journey as a more positive, exciting and non-threatening experience. Primary hypothesis: Children allocated to the 3D VR intervention group will display a significantly smaller increase in anxiety during anaesthetic induction from baseline, compared to the 2D video group Secondary hypotheses: 1. Children allocated to the 3D VR intervention group will display better induction compliance than children in the 2D video group 2. The 3D VR intervention will be more useful than the 2D intervention in helping the child cope with the induction process

This study aims to evaluate the safety and tolerability of an experimental new drug. This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The total maximum study duration for participants is 36-39 days. Cohorts 1, 2, 3, 5 and 6: Single dose of GSBR-1290 or placebo administered on Day 1 under fasted conditions. Cohorts 4 (food effect): Single dose of GSBR-1290 or placebo administered on Day 1 under fasted conditions and another dose administered on Day 4 under fed conditions (total of 2 doses). In this study, up to 48 healthy volunteers will be enrolled across various cohorts receiving single ascending doses of the study drug. All participants will have to remain confined in the study center as required (between Days 1 to 7) depending on the cohort assigned and undergo blood tests and answer questions regarding their health

This study is investigating the safety and efficacy of cannabis in relieving distressing symptoms of advanced cancer. Who is it for? You may be eligible for this study if you are an adult with advanced histologically proven cancer (metastatic or locally advanced) and have been evaluated by a physician for suitability to join this study. Study details Participants will be randomly allocated to either take a combination of the two main components of cannabis, delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) in standard doses as an oral solution, or a placebo. Participants will be asked to complete simple ratings to measure symptom burden and quality of life for up to 28 days of the trial. It is hoped that data from this trial will inform the efficacy of cannabis to manage patient distress caused by cancer-related symptoms.