ANZCTR search results

Bronchiectasis is a commonly seen chronic lung disease in our inpatient and outpatient services. The unmet needs of people with bronchiectasis are huge, with relatively few randomised controlled trials (RCTs) and evidence-based interventions. This RCT aims to improve the outcomes of children and young adults with bronchiectasis. It will examine the benefits (or otherwise) of a novel medication, erdosteine. Erdosteine’s effects include (a) mucolytic action, modulation of mucus production and increasing muco-ciliary transport; with (b) antioxidant; (c) airway anti-inflammatory and; (d) bacterial anti-adhesion properties. This RCT will answer: In children and adults aged <49 years with bronchiectasis, does 12 months treatment with erdosteine, compared to placebo, (i) reduce acute respiratory exacerbations and/or (ii) improve quality of life (QoL). The RCT will also determine the cost-effectiveness of the treatment.

Haemorrhage is a significant cause of preventable death in combat settings. Clinical practice guidelines advocate for the rapid delivery of intravenous fluid bolus challenges for the hypovolemic trauma patient in the tactical environment. However, peripheral intravenous catheter (PIVC) insertion is challenging in the austere setting and failure is common. The aim of this study is to investigate dressing and securement methods that prevent catheter dislodgement and explore participants’ experiences with these devices within an Australian Defence Force tactical care of the casualty (TCCC) training course. A two phase mixed-method design will be used to compare the Ruggedised Field (Ranger) IV method to the S-Wrap technique to reduce PIVC dislodgement rates during TCCC simulations. The study will be undertaken at the Australian Army School of Health in Victoria, Australia. Observational data from this study will reveal securement techniques that optimise practice in high threat/disaster settings and enhance patient safety and quality.

People often spend time recovering in a rehabilitation hospital after an injury, illness or surgery. During their rehabilitation stay, most patients experience improvement in their ability to move and think. However, patients sometimes don’t get enough time with their occupational therapist (OT) or physiotherapist (PT) to practice their tasks and exercises, and maximise the benefits of rehabilitation. Although it would be good to hire more staff, this may not be an option due to financial pressures within the hospital. An alternative is to help patients become more independent with their rehabilitation so that they can continue to practice their occupational therapy tasks or physiotherapy exercises outside of supervised sessions. The ‘My Therapy’ program does this by motivating patients to be pro-active in their approach to rehabilitation through education and empowerment, so that the patient continues to safely and independently practice their tasks and exercises outside of supervised sessions. This is in addition to the usual supervised therapy sessions. In this project the ‘My Therapy’ program will be tested in four Victorian rehabilitation hospitals to see if patients can be more confident in managing their own health, and make even more gains in their ability to move and think. This project will also see if My Therapy can reduce the cost of a rehabilitation stay in hospital.

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of alectinib in a population of participants with newly diagnosed metastatic non-squamous small cell lung cancer (NSCLC) or patients with advanced cancers harbouring ALK gene alterations identified using comprehensive genomic profiling (CGP). Who is it for? You may be eligible to join the study if you are aged 18 years and older, with pathologically confirmed advanced and/or metastatic NSCLC or solid tumour of any histologic type or an earlier diagnosis of a poor prognosis cancer. Your tumour will need to harbour ALK gene alterations identified using CGP. Study details: Participants will receive alectinib treatment. The alectinib is to be taken orally, at 600mg twice daily (days 1 to 28 in a 28-day treatment cycle). Alectinib will be given to participants continuously as long as they and their doctor agree there is a benefit from treatment. Participants will undergo imaging assessments at 8 weekly intervals from first treatment until progression. Safety and tolerability of treatment will be assessed at 4 weekly intervals. Health related quality of life during treatment will be assessed at 4 weekly intervals and then every 8 weeks after end of treatment until progression. We cannot guarantee that participants will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that Alectinib will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

Major Depressive Disorder is a leading cause of death and disability worldwide. Although the uptake of treatment varies between nations and amongst socio-demographic groups, overall there is a considerable unmet need for treatment. Many reasons exist for this, including lack of education, social stigma, limited treatment options and unaffordability. There is increasing interest in repurposing and repositioning of extant compounds in the management of mental illnesses, partly due to the retreat of pharmaceutical companies in neurosciences potentially as a result of lengthy approval processes for new discoveries, poor or delayed returns on investment relative to the investment risks, and logistical barriers. The investigational agents, Naltrexone and Flumazenil, both have existing uses in medicine and psychiatry around the world, but both may offer unique mechanisms of action in the treatment of depression contingent upon the doses utilised. Both have short elimination half-lives in the human body and have either a low oral bioavailability and/or short duration of action. Subcutaneous infusions allow for pulsatile, sustained and predictable delivery of the investigational agents in an ambulatory setting. The investigational agents will be combined into a 4 day infusion, and each infusion will have a total volume of 30mls. In total, each participant will receive 4 infusions with a break between the 2nd and 3rd infusions. There is no proposal for ongoing treatment.

The study aims to assess whether a novel type of mandibular advancement device (MAD) design that does not require retention on the teeth is effective in the treatment of obstructive sleep apnoea (OSA). Specifically, the study will compare two settings (active vs sham) of the MAD. Participants that meet the selection criteria undergo a 4 week sham treatment and 4 week active treatment phase with the order being determined randomly. There is a washout period of 1 week after the initial 4 weeks of treatment. The participants will be informed of the nature of each phase at the study conclusion, i.e., the end of 9 weeks period.

We will conduct a 12-week feasibility and pilot randomised controlled trial of a personalised exercise and dietary intervention delivered via VIPAs in adults aged 50 to 75 years with oral hypoglycaemic agent-controlled type 2 diabetes mellitus (T2DM). Primary Aim: Our primary aim is to assess study processes including recruitment and retention rates, adherence to the exercise and nutrition intervention, acceptability and adverse events. Secondary Aim: Secondary aims are to compare changes in scores for the Diabetes Self-Management Questionnaire (DSMQ), objectively-assessed physical activity, self-reported fruit and vegetable intakes, health-related quality of life (EQ-5D-5L) and productivity, compared to a control group receiving general advice on physical activity and healthy eating via email. Hypotheses: Our primary hypothesis is that a 12-week home-based personalised exercise and dietary intervention delivered by VIPA will be feasible and acceptable, as evidenced by greater than or equal to 70% retention in the study, completion of greater than or equal to 66% of prescribed exercise and dietary advice, recruitment greater than or equal to 20% of eligible participants and overall themes of acceptability expressed. We also hypothesise that the VIPA group will demonstrate improvements in diabetes self-management, objectively-determined physical activity, health-related quality of life, self-reported fruit and vegetable intakes and direct and indirect productivity. We anticipate that these preliminary data will support the need for future studies to explore cost-effectiveness of this telehealth approach in Type 1 or 2 insulin dependent diabetes mellitus and gestational diabetes. This innovative model of service delivery has the potential to markedly reduce health care practitioner workloads and telehealth costs in type 2 diabetes management, while increasing empowerment and accessibility to evidence-based programs for patients most at need

Asthma is the most common chronic condition affecting children. Education is an important part of asthma management; however, multiple studies have shown it is poorly done by health professionals and 90% of people with asthma are still not using their medication or devices correctly. It is clear there is a need for innovative ways for education to be delivered. Augmented reality (AR) may provide a generation appropriate, engaging modality for this. This research is part of a larger study, which aims to investigate if AR is an effective educational tool for children with asthma. The aim of this phase of the study is to design an optimal, functional and suitable AR tool for educational use. An AR tool will be created for use via a smartphone or tablet to deliver education in an innovative way. Participants in this study will be asked to trial the tool, and interviews will be undertaken with participants to determine the usability and appropriateness, as well as any barriers of its use. Participants will include children and teenagers with asthma, their parents, and the health professionals involved in their care.

This is a prospective, open-labelled study in patients with pigment epithelial detachment (PED) secondary to neovascular macular degeneration. All subjects will receive 6.0mg of intravitreal brolucizumab every 4 weeks between baseline and week 8 (3 loading doses), and subsequently receive 6.0mg of intravitreal brolucizumab every 8 or 12 weeks for the remainder of the study period (weeks 52). Fifty five subjects who meet the inclusion/exclusion criteria will be recruited from Sydney Retina Clinic and followed up for 52 weeks. All assessments and treatments will be performed at Sydney Retina Clinic. All eligible subjects will initially receive 3 monthly loading doses of 6.0mg of intravitreal brolucizumab injection. Following these loading doses, a disease activity assessment will be performed at week 16. Disease Activity Criteria at Week 16: • Decrease in BCVA of greater than or equal to 5 letters compared with Baseline • Decrease in BCVA of greater than or equal to 3 letters and CSFT increase greater than 75µm compared with Week 12 • Decrease in BCVA of greater than or equal 5 letters due to neovascular AMD disease activity compared with Week 12 • New or worse intraretinal cysts (IRC) /intraretinal fluid (IRF) compared with Week 12 If a subject meet any of the above disease criteria at week 16, the subject will be assigned to receive injections every 8 weeks (q8w) thereafter, up to study exit (Week 16, 24, 32, 40 and 48). If a subject does not meet any of the above disease activity criteria, the subject will be injected every 12 weeks (q12w) up to study exit (week 20, 32 and 44).

Rib fractures account for a significant proportion of trauma presentations. Chest trauma alone is associated with significant morbidity and mortality; the mortality rate increases from 15% for 3-5 fractured ribs to 34% for 6 or more fractured ribs. The accepted approach involves multi-modal pharmacological therapies incorporating simple analgesics, non-steroidal anti-inflammatory drugs (NSAIDs) and opioids. But drug therapy has multiple side effects and is often insufficient. As such, there is growing interest in regional techniques in the management of these patients, such as chest wall catheter infusions of local anaesthesia. At Liverpool Hospital, referral to the Acute Pain Service to insert chest wall catheters was incorporated in the Rib Fracture Pathway for patient care in 2019. The implementation of chest wall catheter infusion techniques aims to reduce patient discomfort, reduce opioid requirement, reduce pulmonary complications and facilitate earlier discharge from ICU and hospital. This is a before-and-after quality improvement/assurance audit of a cohort of patients treated with traditional oral and intravenous analgesics, and comparing to the cohort of patients treated with traditional analgesics as well as the catheter infusion techniques. This is a retrospective study for both the control and interventional arms. We will collect pre-collected data on pain scores, analgesia requirements, ICU stay, length of stay, from Jan 2019 to March 2020.