ANZCTR search results

The typical way of presenting information on labels of dispensed medicines can confuse some people. The project aims to evaluate the effectiveness of dispensing labels designed to be easier to read, these labels are called "patient-centred labels". It is expected that patient-centred labels will improve comprehension of medication dosing instructions.

Patients requiring cardiac surgery during COVID-19 are at greater risk of death and adverse events. Smartphone based support could help to improve outcomes during this pandemic. Health services have been drastically reduced; preadmission clinics are limited or closed, telehealth services are inadequate, elective cardiac surgery is restricted, hospitals are limiting visitors and almost 50% of cardiac rehabilitation services have ceased. Evidence for strategies that optimise post cardiac surgery recovery is sparse. In this study the effect of a GoShare mHealth (smartphone) intervention on recovery after adult cardiac surgery during COVID-19 will be evaluated. Interventions using smartphone technology have proven effectiveness for a range of cardiovascular conditions under normal conditions. COVID-19 has created extraordinary circumstances that will persist for some time. We hypothesise that the GoShare mHealth intervention will improve (intermediate and ongoing) patient recoveryafter cardiac surgery, reducing representation and readmission rates when compared to usual care during COVID-19. This study provides an opportunity to improve patient outcome and experience for adults undergoing cardiac surgery throughout and beyond the COVID-19 pandemic in Australia. This study aims to reduce representation and readmission, by empowering patients as end-users with strategies for self-help.

Do you have type 1 diabetes and want to know how the glycemic index affects your blood glucose levels? The ‘iBolus: GI’ Study is exploring at how the glycemic index in meals high in protein and fat influences blood glucose levels in adults with type 1 diabetes and using insulin pump or multiple daily injections. You will be asked to have a blood test and do the test sessions at home with remote training and support by researchers to eat two different type of toast (high and low GI) served with peanut butter, take an insulin bolus and monitor your BGL by CGM system for 5.5 hr.

This trial is designed to evaluate safety, tolerability, PK and PD of BI 456906 in male and female patients with non-alcoholic steatohepatitis (NASH) and liver fibrosis using multiple escalation schemes and doses, and will support dose selection for phase 3 clinical development of BI 456906 . Currently, no approved pharmacotherapy for NASH, the progressive form of NAFLD, is available, relying on treatment of the comorbidities of the metabolic syndrome. Obesity is associated with a variety of medical conditions, including all components of the metabolic syndrome, cardiovascular, pulmonary, gastrointestinal, endocrine, joint and psychosocial disorders. Currently, the available weight loss medications lack sufficient efficacy, safety, tolerability and convenience to reduce body weight and improve its associated co-morbidities/ conditions. This trial is a randomised, double-blind, placebo-controlled trial in which three dose regiments of BI 456906 will be compared to placebo over 48-week treatment period. Only approximately 60 patients out of total 240 patients will be randomised to receive placebo treatment. A placebo-control design is required for evaluation of evaluation of BI 456906 tolerability 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.

This project aims to provide a scientific evaluation of a mental health program delivered in a "real world" clinical setting. The Tern Program was developed in response to a gap in local mental health services in regional Queensland, and was designed to provide a modern psychological treatment based on the latest knowledge in the field of trauma research. This program is being operated at two community youth mental health services in Townsville and Mackay, and is offered to young people aged 12-25 with a history of childhood trauma. The Tern Program is a multi-component intervention designed to address the broad needs of young people with a history of trauma. This program includes one-to-one counselling, a psychoeducational group program, Limited Case Management, and components designed specifically to support the therapists providing the intervention. Young people may access support through this program for for up to 24 months, or less as needed. As the Tern program is a new intervention model, it is necessary to conduct a formal evaluation to determine the tolerance and effectiveness of the program for the young people receiving it. This project will gather data on the participants in the program, on a number of clinical and functional outcomes, over an 18 month timeframe between 2021 and 2022. It is hypothesised that young people receiving the program will experience a reduction in their posttraumatic stress symptoms, and improvements in their overall quality of life and degree of occupational activity.

This study is a randomised controlled open labelled pilot trial. The research study aims to explore the effect of fibre and antioxidant supplementation on values of inflammation found in blood and the microbiome on older adults living in the community aged 60-70 years old. This pilot trial is significant because the researchers hope the results of this trial will provide initial evidence of the effect of nutritional supplements on the health status of older Australians especially in relation to nutrition, inflammation and frailty.

In this project, we will use a new therapeutic lighting technology developed by our team at Queensland University of Technology, that can provide preferentially directed light spectrums to increase melanopsin activity thus may improve non-motor circadian/sleep behavior and motor symptoms in people with PD. Participants will be exposed to the light therapy at home every day for 30 minutes over 4 weeks and sleep and motor function will be assessed before, after 4 and 6 weeks of light intervention. We hypothesize that using light to preferentially activate melanopsin cells in the eye will help people with Parkinson’s disease sleep better. A better sleep will also positively impact on their movements such as balance, gait and tremor during the day.

This is a parallel, single-blinded, randomised clinical trial evaluating the effectiveness, cost-effectiveness and safety of 8 weeks of treatment with a vaporised nicotine product (VNP) and nicotine liquid/pods compared to traditional oral nicotine replacement therapy (NRT; gum or lozenge) for smoking cessation among low-socioeconomic smokers. We hypothesize a higher 6-month cessation rate among the VNP, compared with the NRT group.

Low dose atropine eye drops of various concentrations are used to slow the rate of myopic refractive error (short-sightedness) progression in children and adolescents. Atropine is an anticholinergic agent (inhibits the parasympathetic nervous system) which when used as an eye drop, leads to pupil dilation and cycloplegia (reduction or temporary elimination of focusing ability). While these side effects are desirable when treating certain ocular conditions like uveitis or amblyopia, when atropine is used in treating myopia progression, only very low concentrations are used to minimise these side effects. While the effect of low dose atropine on pupil dilation and cycloplegia are widely documented, the implications for single and clear binocular vision when taking this medication have not specifically been studied. The objective of this research project is to examine the effect of nightly dosing of 0.05% atropine sulfate eye drops for 10 days with respect to the binocular vision characteristics of young adult myopes. Outcome measures will include: distance and near heterophoria (measures the coordination of the aiming between the two eyes at distance and near), positive and negative relative accommodation (measures the range of the focusing system over which clear focus is maintained when performing near tasks), accommodative posture (accuracy of focusing when reading), positive and negative fusional vergence (measures the range of the focusing system over which single vision is maintained when performing near tasks), binocular accommodative facility (a measure of the flexibility of the focusing system), and near point of convergence (a measure of the degree to which the two eyes can focus inwards while still maintaining single vision). The outcomes of this research would be expected to inform the development of clinical protocols for assessing patient suitability for low dose atropine treatment, through determination of effects on binocular vision, and identification of patients who would be most impacted by these side effects. This will help to identify potentially unsuitable candidates for treatment and any contraindications to treatment.

Brief statement: Two types of general anaesthesia are given to patients to keep them asleep during the removal of clots causing large vessel strokes, most commonly either an anaesthetic gas (sevoflurane) delivered via inhalation, or medication (propofol) administered continuously through a drip. This study is a preliminary study looking to determine whether the choice of which of these methods used during the procedure makes a difference to how well a patient recovers. PROSPER will assess the feasibility of conducting a multi-site randomised control trial comparing two general anaesthetic techniques- volatile anaesthesia and total intravenous anaesthesia (TIVA) during endovascular thrombectomy for acute ischaemic stroke. PROSPER will primarily assess the hypothesis that the trial protocol is feasible. Secondary outcome measures will include functional recovery at 90 days primarily using modified Rankin scale (mRS). We will assess the data for potential relationships between mRS scores and intra and post-operative blood pressures, near infrared spectrometry (NIRS) calculated optimal blood pressure, pre- and post-operative risk factors and thrombolysis. PROSPER will be a pilot study prospective randomised controlled trial. Prospective data will be collected by the anaesthetic and stroke teams at the PA hospital. This data will include: • Baseline patient characteristics • Details of anaesthetic drugs administered • Physiological parameters measured during the clot retrieval procedure • Radiological outcome of procedure (TICI (thrombolysis in cerebral infarction) score) • Clinical outcome measures • Procedural complications, death rate and cause of death Data will be analysed in 2 groups – Volatile anaesthetic only after induction versus TIVA only after induction. Patients who change groups during the procedure (becoming a mixed group) will be treated with intention to treat analysis. We will report both feasibility for RCT and secondary outcomes.