ANZCTR search results

The INFORM-AF Pilot Study is a quasi-experimental pre-post test, pilot-feasibility study of a novel digital education intervention delivered through mobile-based health (mHealth) technology targeted at patients living with atrial fibrillation, in Western and South Sydney. The study will evaluate the feasibility of this education program, in improving the Atrial Fibrillation (AF) patient’s knowledge and quality of life. The study will also assess the usability of the digital education intervention. The mHealth application is a smartphone-based spaced learning intervention and consists of six case scenario-based Atrial Fibrillation questions, based on a spaced timing algorithm, delivered over a 6-week period. The mHealth-based intervention is delivered by the QStream digital platform and is co-designed in consultation with stakeholders including patients living with AF, healthcare providers of AF patients and key opinion leaders from Stroke Foundation, Heart Foundation, NGOs and cardiovascular peak bodies. This is pilot feasibility study of this educational intervention is informed through our foundational qualitative research that has just concluded and is yet to be published. The study team interviewed a total of 45 participants including clinicians, expert key stakeholder and patients to identify the educational and self-management needs of patients living with AF. Data collection for this study will be conducted via pre and post implementation electronic surveys, and four follow up phone calls (a technical support check-in during the intervention at 3 weeks, and post-intervention outcome assessment at four time points - 6 weeks, 3 months, 6 months and 12 months).

Ageing is associated with a progressive deterioration of the immune system function, described as immunosenescence, which contributes to an increased risk of morbidity, poor responses to vaccination, and increased mortality in older persons. The COVID-19 pandemic has disproportionately impacted older people; particularly those living at residential aged care facilities (RACFs). In Australia, the death toll in RACFs has been devastating with two thirds of the current deaths in Victoria happening in residents of RACFs. Considering that calcium ß-Hydroxy-ß-Methylbutyrate (CaHMB), vitamin D, and protein supplementation have demonstrated a beneficial effect not only on the immune system but also on muscle mass and strength and respiratory function in frail older persons, we propose a cluster, randomised, placebo controlled trial administering residents in Victorian RACFs (n= 160) a multinutrient supplement versus usual care for 3 months. Overall, their immune response and improvement in muscle mass and strength, and respiratory function will be documented. Our results will fulfil an unmet need in this very high-risk population by testing whether a specialised nutritional supplement administered within a short period of time could prepare RACFs against this and potential future pandemics while preventing complications and adverse outcomes, and enhancing their immune response to current vaccines.

This study aims to compare the effectiveness of two online interventions for individuals with subclinical and mild OC symptoms. Through a randomised controlled design, we will compare the acceptability and effectiveness of the interventions in improving obsessions and compulsions, depression, anxiety, psychological flexibility and quality of life. We hypothesise that improvement in psychological flexibility will predict greater reduction in obsessions and compulsions and comorbid symptoms at post-treatment.

The MRI Linac is one of the newest and most technologically advanced radiotherapy machines used to treat cancer. Magnetic resonance imaging (MRI) is one of the best imaging tools available to guide radiotherapy. Linear accelerators (Linacs) are treatment machines used to deliver radiotherapy to treat cancers. By combining the MRI and Linac into an MRI-Linac, it allows the use of better images than standard X-rays to guide radiotherapy. The purpose of this study is to determine if it is feasible to use the bespoke MRI-Linac at Liverpool Hospital to treat patients. The data collected will be used in developing and improving the MRI-Linac for future cancer patients. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with cancer and will be receiving palliative radiotherapy. Study details All participants will need to attend at least two 1-hour sessions where the MRI-Linac machine will be used to guide radiotherapy treatments. If the MRI-Linac is being used effectively, as determined by your treating doctor, further radiotherapy treatments will also be guided using the MRI-Linac machine. This study will examine the patient experience, workflow, treatment accuracy, image quality, integration MRI-Linac clinical performance, radiotherapy quality and the treatment process. The data collected will be used in developing and improving the MRI-Linac for future cancer patients.

Dystonia is a neurological disorder causing involuntary muscle contractions, and is thought to be caused by abnormal firing of specific brain networks. There are a number of types of dystonia, each defined by the body region/s that are affected. For example, and relevant to the present application, cervical dystonia (CD) affects the muscles of the neck. The current ‘gold standard’ treatments for CD are the injection of botulinum toxin type A (botox) into the affected muscles, or deep brain stimulation via brain surgery in more severe cases. However, injections only treat patients’ symptoms, rather than the underlying substrate of the disorder, and include side effects such as muscle wasting, while surgery is invasive and can be risky. As such, new treatments for CD are needed. Repetitive transcranial magnetic stimulation (rTMS) has shown some promise in patients with CD, however, overall results have not yet been compelling enough to carry rTMS forward as an approved treatment method. rTMS in CD has been hindered by the fact that the particular brain region that should be stimulated is still unknown. This is because previous neuroimaging findings have identified many different brain regions as abnormal in CD. This research will build upon findings by Corp et al. (2019), who demonstrated that the somatosensory cortex is abnormal in CD patients. Thus, this will be the first study to investigate whether a form of rTMS (called continuous theta-burst stimulation, or cTBS) to this brain region can effectively relieve CD symptoms. Aim 1 of the project is to investigate whether cTBS is an effective treatment for CD symptoms. It is hypothesised that there will be a significant overall reduction in CD symptoms post-intervention, as measured by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). CD symptoms will also be measured through kinematic testing using a custom-made device to measure head and neck angle, tilt, and position. Aim 2 of this study is to investigate neurophysiological changes within the somatosensory cortex, due to the application of cTBS. It is hypothesised that there will be significant changes in the excitability of the somatosensory cortex (as measured by IHI) after the application of real cTBS in comparison to sham stimulation. Further, it is hypothesised that there will be a correlation between these changes in excitability, and reductions in CD symptom scores (as measured by the TWSTRS).

Dysphagia is the term used to describe difficulty with swallowing. It is common condition and increases the risk of choking, pneumonia, malnutrition and dehydration which, in turn, can result in hospitalisation or even death. Dysphagia can have a major adverse impact on quality of life. A relatively new computer-based training program, called Biofeedback in Strength and Skill Training (BiSSkiT), was developed in New Zealand. BiSSkiT comprises a training protocol and accompanying software program, with surface electrodes as the underlying hardware, for the rehabilitation and outcome measurement of swallowing impairments. The effectiveness of the BiSSkiT program in clinical settings apart from Parkinson’s Disease has not been investigated to date. The overall purpose of this preliminary study is to evaluate whether the BiSSkiT computer-based program improves the swallowing ability of patients with chronic dysphagia.

The primary objective of this 3- arm randomised controlled trial, is to evaluate the effects of gait retraining interventions on proxy measures of medial knee load (early- and late-stance peak KAM, KAM impulse, and varus thrust) in people with medial knee osteoarthritis. This will be assessed at baseline, six weeks after the initial assessment and three months following this.

Burn wound infections continue to cause significant health problems for patients following a range of burn injuries. Current therapeutic options are sub-optimal and are often associated with delayed wound healing. We therefore plan to study the antibiotic, RECCE®327 to assess the clinical effectiveness and safety of this agent for the treatment on infected chronic burn ulcers. The study is exploratory and will deliver the new RECCE®327 antimicrobial via an innovative spray-on formulation, specially developed for this study. We plan to study two dosing schedules with ten participants receiving daily and a further twenty receiving three times a week application of the spray-on RECCE®327 antibiotic, over a 14 day study period. If this exploratory study suggests clinical effectiveness and no toxicity signal, we then plan to undertake a much larger study of the novel RECCE®327 antibiotic comparing it to standard care.

This trial aims to evaluate the feasibility of using 89Zr-TLX250 PET/CT in the detection of localized and metastatic urothelial carcinoma or bladder cancer. Who is it for? You may be eligible for this trial if you are aged 18, able to provide informed consent, and histologically diagnosed with bladder cancer or urothelial carcinoma or known metastatic urothelial carcinoma or bladder cancer. Study details Participants will be screened through FDG PET/CT scan and baseline procedures (physical examination, general blood test, vital signs, medical and surgical history, and previous medications), within 28 days of selection to day 0). At day 0, participants will receive an injection of 89Zr-TLX250, followed by a diagnostic PET/CT scan on day 5 ± 2 days after 89Zr-TLX250 administration. Participants will be followed up at day 14 post-scan for a telephone consult regarding safety evaluation. It is hoped that information from this trial will help evaluate the effectiveness of 89Zr-TLX250 PET/CT in detecting primary bladder cancer and upper tract urothelial carcinoma.

This study aims to improve mental health outcomes for those with anxiety and depression by using an innovative text messaging intervention to supplement therapy. We hope to develop a scalable intervention via psychological flexibility-based text messages, which does not require personal contact, and can be delivered remotely. This study will involve a randomised controlled trial to determine the efficacy of the text messaging intervention. Clients of a psychology clinic will be allocated to a control (treatment as usual) or intervention group (treatment as usual plus text messaging intervention). Text messages will be based on Acceptance and Commitment Therapy and will be delivered daily for 8 weeks. We hypothesise that the intervention group will have improved wellbeing compared to the control group after 8 weeks.