ANZCTR search results

Mild traumatic brain injury (mTBI) results in a range of debilitating symptoms including cognitive, sensory, and emotional deficits, sleep disturbances, and headaches. Despite increased awareness of the socioeconomic costs and risks of poor outcome, the clinical management of mTBI remains notoriously difficult because there are still no evidence-based interventions for individuals across the lifespan. Current treatment options for mTBI are sparse and not evidence-based, with the standard treatment for mTBI still being rest until asymptomatic. Initial studies led by members of our team have identified subthreshold aerobic exercise as a promising intervention for mTBI in adolescents. Findings from these studies show that this intervention may result in faster recovery and reduced incidence of persisting post-concussion symptoms; thereby allowing individuals to return to per-injury activities sooner. This intervention protocol is also straight forward and applicable in a vast range of clinical setting. However, studies are now required to extend and validate this subthreshold exercise intervention protocol as an effective mTBI intervention in adults. To address this knowledge gap, our complementary and interdisciplinary research team now propose a clinical trial to examine subthreshold aerobic exercise intervention in mTBI patients. We hypothesise that exercise intervention will improve recovery in mTBI patients. Based on these findings we will develop and distribute protocols/guidelines for both adolescent and adult mTBI patients that can be accessed and applied in clinical settings across Australia.

Mycophenolate is an immunosuppressant that is widely used as a treatment for systemic lupus erythematosus (SLE). Its biological effects involve a reduction in immune cell functions, which in turn reduce systemic or organ related inflammation and damage. The benefits of using mycophenolate in SLE need to be carefully balanced against unintended side effects such as increased risk of infection or blunting of vaccine responses. One strategy to counteract these effects is the temporary withdrawal of the immunosuppressant, which allows for the immune system to recover and effectively respond to a vaccine or infection. Our study will examine the effects of withdrawing mycophenolate for a short period in SLE patients. Our hypothesis is that this temporary withdrawal will result in an improvement in the immune responses to the influenza vaccination while maintaining disease control.

We aim to examine the feasibility of a new guided parent-delivered CBT-P (GPD-CBT-P) whose child is aged between 7 and 12 years of age in terms of recruitment through educational settings and retention rates. In addition, we will gather data how GPD-CBT-P performs against waitlist control for change over 18-weeks post-randomisation on self-report (parent and child) measures of perfectionism, stress, depressive symptoms, and body image disturbance. In addition, this will be the first occasion that academic outcomes (satisfaction and self-efficacy) will be examined in a randomised controlled trial design. This is a feasibility trial that will provide a plausible range of point estimates of the efficacy of GPD-CBT-P on standardised continuous symptom measures for our secondary aim. In this way, we can refine the treatment manual and contribute to the design. As a feasibility study we do not pose hypotheses but will examine our primary outcomes (number of enquiries, number recruited into the trial, number completing first assessment, number randomised, number retained in treatment, number of completed assessments at each timepoint, percentage of homework tasks completed between sessions, total hours of guidance used by each family), as well as the perceived treatment credibility, acceptability and effectiveness, and the between group effect sizes (95% confidence intervals) for our measures.

The main purpose of this research is to evaluate the feasibility of a two-week education module designed to inform individuals living with type 1 diabetes how to assess device generated data. This education module has been created by endocrinologists, diabetes educators, industry, dieticians, psychologists, community engagement and education specialists. The researchers will also evaluate participant’s satisfaction with the module and satisfaction in the management of their diabetes, as well as looking at their blood glucose control after the education module. Involvement will last around 26-28 weeks and will involve 7 visits, and at least 4 of these visits will occur at the clinical trial site. Participants will be asked to wear a continuous glucose monitor, and a keep a study diary at specified times over the course of the trial.

During general anaesthesia muscle relaxant drugs are administered to make airway management and surgery easier. Muscle relaxants are usually reversed with neostigmine at the end of the operation. A newer drug, sugammadex, reverses muscle relaxants more rapidly than neostigmine, but is not clear whether sugammadex results in fewer postoperative complications than neostigmine. We are conducting a large multi-centre randomised controlled trial to investigate whether sugammadex is associated with fewer postoperative lung complications than neostigmine.

Chronic pain is one of the most common chronic conditions in Australia and the prevalence is on the rise. It is estimated that by 2050, the prevalence of chronic pain will rise to 5.23 million Australians. People with chronic pain suffer not only physically, but also financially and emotionally. One of the eight goals identified by Painaustralia in the National Strategic Action Plan for Pain Management (2021) is for “People living with pain have timely access to consumer-centered best practice pain management including self-management, early intervention strategies and interdisciplinary care and support”. Chronic pain can have a significant impact on mental health and they commonly occur together. Depression and anxiety are the most common comorbidities associated with chronic pain in Australia at 44.6%, followed by osteoarthritis and degenerative arthritis (29.3%) and hypertension(25.1%). Nearly half of the patients with chronic pain presenting for treatment suffer from major depression. Major depression in people with chronic pain often leads to reduced functioning, poorer treatment response, and increased healthcare costs. Breathing intervention is an effective self-management for a range of medical and mental health conditions. To date, there has not been a reported randomized control trial examining the effectiveness of a breathing intervention for adults with a range of chronic pain types. This research aims to examine the efficacy of telehealth-based group breathing intervention on patient-reported outcomes in patients with chronic pain as compared to usual care. The research question for this trial is “In people living with chronic pain, what is the effect of a telehealth-based group intervention on mood, pain intensity and interference, catastrophising, and self-efficacy compared with no breathing intervention within a 12-month period?”. The hypothesis of this randomised control trial is “telehealth-based group breathing intervention is beneficial for improving patient-reported outcomes in adults living with chronic pain”. Once consented to participate this research, participants will be randomized to either treatment (telehealth breathing intervention group) or usual care (control group). Patient reported outcomes will be collected at baseline, 4 weeks post-initiation of treatment, 8 weeks post-initiation of treatment, and 6 months post-initiation of treatment.

The proposed study will deliver an existing validated and empirically supported Cognitive Behaviour Therapy (CBT) program, Exploring Feelings - Anxiety, for anxious young autistic children. The program will be slightly extended based on the results for an earlier study, by way of the inclusion of two additional sessions specifically focused on social skills. A within-subjects design with repeated measures will be used to evaluate changes in levels of anxiety across the delivery of the program. Delivery of pre- and post-intervention assessments along with session-by-session measures will allow the researchers to explore (a) changes in anxiety levels from before to after intervention delivery, and (b) if any changes that do occur are more likely at certain timepoints of the intervention, pointing towards particular components of the intervention as being more helpful than others.

The purpose of this study is to evaluate the survivorship (revision rates) and patient reported outcomes (PROMs) following implantation of the Insignia hip stem in patients undergoing cementless total hip replacement surgery compared to currently available stems used for the same type of surgery. It is hypothesised the 2-year survivorship of the Insignia stem is noninferior to the benchmark survivorship of similar stems used in the same type of surgery.

It is anticipated that intra-uterine instillation using autologous platelet-rich plasma (A-PRP) injected into the uterus will improve successful pregnancy outcomes in current IVF cycles and frozen embryo transfer cycles for women either with RIF, an endometrium of <7mm, or an Asherman's Syndrome diagnosis. In the non-randomised prospective trial, around 10mLs of your own blood (autologous) will be collected to produce around 1mL of A-PRP. The A-PRP will be injected into the uterus transvaginally via an embryo transfer catheter either 48 hours prior to trigger for thin endometrium cases or 48 hours prior to ET for RIF cases.

By 2030, road crashes are predicted to be the fifth leading cause of death globally. Although Australia has made great strides in road injury prevention and safety, road fatality rates have plateaued over the last decade. Of concern is the fact that young drivers are overrepresented in road injury and fatality statistics in Australia - whilst young drivers comprise only 14% of all licence holders, they are involved in about one-fourth of all serious crashes (Australian Transport Council 2011). For young people aged 18-25, driving is a high-risk activity, with the risk of a crash greatest in the first six months of licensure (VicRoads 2005). In-vehicle telematics presents a promising technological means of reducing road trauma. Telematics technology generates real-time motor vehicle data, such as acceleration and braking information, providing drivers with direct feedback on driving performance. Moreover, linking safety-specific feedback with financial incentives may achieve safer driving behaviours. This study aims to assess whether personalised safety feedback linked to financial incentives will improve driving behaviour and reduce road crashes among novice drivers. This study will be the largest trial of personalised transport safety feedback delivered using telematics technology in Australia. Recent aforementioned research highlights that personalised driving feedback and financial incentives shape safer driving behaviours (Mortimer et al. 2006; Stevenson et al. 2018), and this study will extend this important finding by assessing the likely impact that personalised safety feedback and incentives have on reducing the likelihood of road crashes. This study will be a crucial step in advancing scientific knowledge around road safety and enabling large-scale implementation of interventions to reduce road trauma. A unique element of this trial is that it delivers across the entire state(s). Most technology trials have relied on participants and researchers in close proximity to ensure appropriate installation of the technology in-vehicle, and hence have been wholly delivered in urban environments. This trial, on the other hand, will overcome the underrepresentation of regional and rural young drivers in such studies. This is a significant strength as about two-thirds of serious injuries and fatal crashes occur in regional and rural areas. In the past decade, hospitalisations from road crashes in Australia have not declined. As such, the market penetration of technologies like telematics highlights the opportunity to reduce the burden of road traffic injury. Furthermore, this research will provide decision-makers with data in order to guide policymaking. Our research will generate new knowledge that can be directly translated into transport safety policies associated with all newly licensed drivers.