ANZCTR search results

Patients who sustain a minimal trauma fracture benefit from co-ordinated secondary fracture prevention clinics - Osteoporosis Re-fracture Prevention (ORP) services. There is cumulative evidence that these services increase rates of identification, investigation and initiation of appropriate treatment as well as reduce the rate of re-fracture and mortality. Multiple models of ORPs exist, with increasing numbers being implemented worldwide. However, existing ORPs may vary considerably in quality and the contribution of these services in truly reducing the care gap and treatment burden must be critically evaluated. Successful implementation of ORPs into practice needs to be informed by implementation research, with trials of sustainable implementation strategies to support more rapid and effective translation of effective models of care into practice. The Implementing the Osteoporosis Re-fracture Prevention Model of Care effectiveness-implementation hybrid trial (IORP trial) will assess the effect of a facilitated implementation strategy using existing local implementation resources and supports on multiple implementation, effectiveness outcomes. This project is designed to improve the implementation of ideal ORP services into three different hospital settings across three local health districts in New South Wales, Australia. The IORP trial will use available implementation training and resources as well as improvement cycles and implementation stages. It is a type 3 hybrid study, with emphasis on testing the implementation strategy, whilst also gathering information on effectiveness. Each site will have pre-implementation formative assessments, two implementation cycles (initial implementation, full implementation) and post implementation summative assessments. The study will use a stepped wedge design, commencing at the three sites in a sequential fashion. The trial will report implementation and effectiveness outcomes including reporting of 3 monthly key performance indicators, capture the fracture assessments, linked re-fracture and mortality data and qualitative analysis, and will compare effectiveness outcomes to those of a fourth comparator site, currently operating as a model site.

This trial is designed to evaluate safety, tolerability, PK and PD of BI 730357 in male and female patients with psoriatic arthritis using multiple escalation schemes and doses, and will support dose selection for phase 3 clinical development of BI 730357. Although effective treatments for psoriatic arthritis are approved, the unmet medical need remains for safer oral therapy that works well, improves joint and skin inflammation, prevents structural damage and maintains the efficacy over time. This trial is a randomised, double-blind, placebo-controlled trial in which three dose regiments of BI 730357 will be compared to placebo over a 12-week treatment period. Only approximately 40 patients out of total 160 patients will be randomized to receive placebo treatment. A placebo-control design is required for evaluation of evaluation of BI 730357 efficacy and safety. In addition, a placebo arm is needed in order to avoid potential confounding factors, such as placebo effect, potential investigator bias in safety and efficacy assessment or regression to the mean in endpoint scoring. In addition, as a risk mitigation strategy, if the patient experiences an intolerable increase in diseases activity of psoriatic arthritis during the course of the trial treatment, the patient will be discontinued from the trial treatment and will receive a standard of care treatment as deemed appropriate by the investigator.

This research study will conduct a pilot evaluation of the Salvio digital platform to ascertain a preliminary understanding of the potential benefits to participants and their experiences of use. The research team has developed a platform that brings together various behaviour change programs into a common portal for self-management of heart disease. The platform enables users to customise their experience using a suite programs and tools. Participants will be able to choose from the technology and type of support that suits them to best self-manage their condition. Participation in this research study will require adults (>18 years) living with cardiovascular disease to trial the Salvio digital platform for a 6-week period and actively provide feedback to inform future development. During this time, participants can remotely access the platform alongside their usual care. They will create a profile and use an online decision support tool to guide them to the digital intervention that is best suited to their particular needs and preferences. Participants can choose to enrol in one or more of the interventions presented and will be able to view their progress on a personalised Salvio dashboard.

The proportion of elderly patients presenting to intensive care units following complex surgery or life threatening medical illness requiring mechanical ventilation, cardiovascular and other organ support is rising. More than 180,000 patients are admitted to intensive care units in Australia every year. More than 50% are over the age of 65. The SPICE III study, evaluated the use of early dexmedetomidine (DEX) as primary sedative agent in ventilated critically ill patients compared with usual care. In a pre-specified subgroup analysis, SPICE III found a significant interaction between age and DEX treatment on 90-day mortality with a significant reduction of mortality in mechanically ventilated adults older than the cohort median age of 63.7 yrs. These compelling findings, need to be urgently confirmed because their confirmation will change the practice of sedation in older adults worldwide. Accordingly, we will conduct a complementary multicentre randomised controlled trial in ventilated patients, who are older than 65 years, and expected to remain ventilated for longer than 24 hours. Patients will be randomised to receive DEX infusion started at 1 µg/kg/h or Usual-Care and titrated to target Richmond Agitation Sedation Score of -1 to +1. The primary outcome will be 90-day mortality. A sample size of 3500 will be recruited to detect a 5% reduction in mortality (baseline 37%). Such a cohort will then be merged into a harmonised individual patient based meta-analysis with the 1834 patients of > 63 years of age randomized in the recently completed SPICE III study to provide the most efficient and robust (90% power to detect 4.4% difference) assessment of the effect of dexmedetomidine on mortality in older ventilated adults to date, transform sedation practice, and save thousands of lives in Australia and worldwide.

This study aims to evaluate the validity of a pain psychology therapy delivered by virtual reality to volunteers, by measuring metrics of presence and factual information recall. Who is it for? You may be eligible for this study if you are 18 years or older, healthy without acute or chronic pain Study details: Participants will be randomly allocated (50/50 chance) to either the intervention group or control group. The intervention group will receive 2 x 30 min modules of VR-delivered pain therapy. This will be done in one session totaling 70 minutes - 30 minutes for one module, 10 minutes rest break and 30 minutes for the other module. The pain therapy program is self-contained and consists of 2 modules: (1) Progressive muscle relaxation (2) Guided pain visualisation Participants will be required to answer questionnaires about their presence whilst using the VR hardware immediately after the session is complete. They will also be asked to complete a set of multiple choice questions designed to test information recall immediately after the session and also 2 weeks after the session. It is hoped that this validation study will strengthen the evidence base for clinical use of the VR-delivered therapy.

Non-invasive, continuous positive airway pressure (CPAP) immediately after birth of a very preterm infant (“VPTI,” <32 weeks’ gestational age at birth) is currently recommended as the standard of care during the stabilisation of preterm infants following birth. After birth, the infant must rapidly transition from a fluid filled lung, and dependence on the placenta for oxygenation and the elimination of carbon dioxide, to an aerated lung that successfully exchanges gases. CPAP supports the transition from fetal to newborn physiology by providing a distending pressure to the lung, thus maintaining a functional residual capacity (FRC) and enabling oxygenation and ventilation. Preterm infants who are successfully managed with CPAP versus mechanical ventilation via an endotracheal tube have increased survival without chronic lung disease, which improves long-term neurodevelopmental outcomes. Caffeine, and minimally invasive surfactant therapy (MIST) are other key treatments after admission to the NICU to avoid intubation and mechanical ventilation. Following stabilisation on CPAP, caffeine and MIST may be administered to further optimise respiratory support and reduce the risk of requiring intubation and mechanical ventilation, ultimately reducing the incidence of death and chronic lung disease in our patients. 97% of VPTIs at Monash require respiratory support to facilitate stabilisation. Current neonatal resuscitation training programs advocate a trial of CPAP via a facemask that covers the infant’s nose and mouth. An adequate seal is difficult to achieve and the use of a facemask has the additional adverse effect of high compressive forces being applied to the infant’s face and head during resuscitation regardless of which brand of facemask is used, and even with the use of adjunct respiratory monitoring. Ninety percent of VPTIs will initiate spontaneous breathing by 1 minute after birth. Despite VPTIs commonly having a good respiratory drive, respiratory support is nearly always indicated because of respiratory distress syndrome caused by the immature lungs. In this situation, facemask CPAP has a high failure rate due to stimulation of the trigeminal nerves which cause apnea, bradycardia, and hypoxia. Our multidisciplinary team has over a year of experience with nasal CPAP at birth and we have equipoise between providing initial respiratory support in the delivery room with nasal CPAP versus facemask CPAP. We believe that nasal CPAP may be a more effective method of supporting the VPTI than facemask CPAP, specifically maintaining adequate spontaneous breathing and reducing the need for PPV, supplemental oxygen, and intubation in the delivery room. We believe a randomised controlled trial is warranted to test this hypothesis, in order to improve outcomes for high-risk, preterm infants, inform local practice, and provide critically important evidence to the global neonatal community.

Chronic obstructive pulmonary disease (COPD) is a systemic disease linked with a multitude of extrapulmonary manifestations, including low bone mineral density (BMD). The prevalence of low BMD in people with COPD is significantly higher when compared with the general population. Studies have also demonstrated that people with COPD have impaired balance, an increased risk of falls and higher mortality rates following falls-related fractures. These factors highlight the need to prevent and manage the loss of BMD in this population. Optimal management of treatable-traits (i.e. extrapulmonary manifestations) is now widely recognised as a priority for people with COPD. To date, there are no guidelines for the maintenance and management of BMD in this population. Thus, there is an urgent need to explore strategies that can optimise BMD in people with COPD. In addition, interventions to address impairments in balance and falls risk must also be considered. Impact loading training has been identified as an intervention that improves or maintains BMD in both post-menopausal women and men with prostate cancer undergoing androgen deprivation therapy. Exercise prescription in people with COPD has largely been focused on aerobic and resistance exercise, offered within the framework of a pulmonary rehabilitation program (PRP). Currently, impact loading training is not part of PRP and there are no clinical guidelines for this type of exercise in this population. This study aims to i) investigate the feasibility and tolerance of adding impact loading training to a standard PRP and (ii) estimate the effects of adding impact loading training to a standard PRP on bone health, balance and falls risk.

Recurrent Vulvovaginal Candidiasis (RVVC) is a dermatological and sexual health disorder impacting 5-10% of the female population. The management of RVVC often requires ongoing drug management called maintenance therapy. Even with maintenance regimes, up to 57% of women may experience a relapse of symptoms within 3-6 months of therapy completion. The ongoing and recurrent symptom presentations associated with RVVC have significant impacts on health status and quality of life, as well as pose an economic burden. The proposed trial will assess whether "Intravaginal Combination Therapy of Acetic and Lactic Acid" (ICTALA) is effective and well-tolerated for the prevention of RVVC. ICTALA will be utilised to ultimately provide an intervention that can reduce antimicrobial drug usage and decrease relapse.

The purpose of this study is to test the feasibility and acceptability of a shared-care model involving specialists and GPs for post-radiotherapy treatment cancer follow-up. Who is it for? You may be eligible for this study if you are aged 18 or older, and have completed radiotherapy treatment for breast, prostate or colorectal cancer at least two and a half years ago. Study details Participants in this study will attend a series of post-treatment follow-up appointments with their regular GP who will assess their health and reviews for signs of cancer recurrence. The GP will complete a follow-up review with the patient using a system that is directly linked to the hospital so the radiation oncologist can oversee the results and assess if further medical intervention or support is required. The patient maintains their standard care with their radiation oncologist, with one appointment of 15 minutes. Over the six months, the patient is being offered an additional two review appointments with their general practitioner, 20 to 30 minutes each. As part of the study all participants will be asked to attend two interviews, before and after the study period to discuss how they felt about the shared-care model of cancer follow-up care. It is hoped this research will demonstrate the feasibility and usefulness of the new model of care which could influence future post-treatment cancer care.

This research project is to investigate the feasibility and efficacy of a multi-component exercise program in patients with borderline removable or locally advanced (irremovable) pancreatic cancer receiving preoperative therapy. Who is it for? You may be eligible to join this study if you are aged 18 years or over, have a diagnosis of borderline removable or locally advanced pancreatic cancer, and are scheduled to receive or within four weeks after starting the neoadjuvant chemotherapy. Study details: Eligible participants will be randomly allocated 1:1 to either an intervention group or a usual care control group. The intervention group will undertake supervised exercise training for a maximum period of 6 months along with their neoadjuvant therapy, while participants in the control group will receive usual care and be offered advice on physical activity through a printed exercise booklet. The intervention group will be required to attend two sessions per week for 45-60 minutes/session. In each session, participants will perform 20-30 minutes of resistance training, with the addition of either a maximum of 20 minutes of aerobic exercise or adapted sport-related activities/drills, which will be alternated from session to session. All participants will be closely monitored by the investigator, study clinicians and themselves throughout the intervention period for adverse events and other feasibility variables. In addition, they will undergo assessments at baseline (prior to intervention) and post-intervention (prior to elective surgical resection or at completion/permanent discontinuation of prescribed neoadjuvant therapy) for physiological and psychosocial outcomes as well as for a range of clinical-relevant outcomes. For patients with more than four months of neoadjuvant therapy and potentially distinct treatment modalities (i.e., chemotherapy and chemoradiation), an additional assessment will be scheduled before the alteration of treatment modality (~4 months post-intervention commencement). All participants will be followed-up for 6 months after completion of the post-intervention tests. This study will provide information on the feasibility of the exercise program and its preliminary efficacy in patients with borderline resectable or locally advanced pancreatic cancer receiving preoperative therapy.