ANZCTR search results

The aim of this project is to develop and evaluate whether a digital monitoring and support tool, called Workplace Wellbeing Assist (WWA), is effective in promoting a workplace climate that enhances the mental wellbeing of direct-care staff working at Residential Aged Care facilities in Victoria, Australia (Western Division). Direct-care workers and managers will be invited to participate in a 24-week evaluation of WWA. The study is a non-randomised, pre-mid-post study design, including validated questionnaires and interviews. Specifically, this project seeks to: 1. Determine whether WWA increases perceptions of psychosocial safety in the workplace among consenting residential aged care staff as measured by differences on the Psychosocial Safety Climate questionnaire from Baseline (week 0), to mid (week 12), to post-intervention (week 24). 2. Determine whether WWA can successfully promote staff mental wellbeing and quality of life, and reduce psychological distress and workplace psychosocial risk factors as measured by differences in a pre-mid-post trial. 3. Use quantitative and qualitative evaluation trial data, to further explore the acceptability, usability and usefulness of WWA and allow for future optimisation of WWA for the residential aged care sector. The results of this research will be used to determine whether a digital intervention can effectively promote a mentally healthy workplace that enhances staff mental wellbeing within Residential Aged Care facilities and how it could potentially be optimised for other workplaces.

The aim of the study is to assess nutrition provision and practice over the duration of hospitalisation in critically ill adults in Australia and New Zealand (ANZ) to inform nutrition practice and future reserach. SItes will also use this study as a quality procedure being able to review their individual data compare to other sites in Australia and New Zealand. All data collected is observational. Participating sites will enrol eligible patients into the study over a 1 week study period and collect observational nutrition and hospital care data during their ICU admission and ward stay up to day 28, discharge or death (whichever comes first). Data will be collected daily for the first 7 days while the patient remians in ICU and then weekly where on the ward or still in ICU.

Erectile Dysfunction (ED) affects the quality of life of more than 50% of men aged over 40 years. Diagnosis is complex and requires a multidisciplinary approach. Treatment begins with lowering cardiovascular risks followed by oral medication. Third line is treatment with invasive procedures for example, intracavernosal injections, surgical ligations and implants. Venogenic involvement is one of the causes of ED and is diagnosed by cavernosography. Venogenic ED (vED) may be treated surgically or by the endovascular technique Pelvic Vein Embolisation (PVE). A 2019 review (8 studies, 212 pts) found that PVE was safer than surgical management and the success rate was cited as 60%. However, well-designed trials are lacking in the literature. Published data is limited by small patient numbers, study design and short follow up. Based on the positive findings in the 2019 review and because of our increasing referral rate, we aim to conduct a Level 1, randomised, single blinded, sham controlled study to assess the safety, efficacy and durability of PVE for the treatment of vED. As per standard of care, patients with suspected vED will be referred to Interventional Radiology (IR) by urologists. They will be seen in the IR clinic, counselled and if suitable, booked for cavernosography +/- PVE. 80 patients will be randomised 1:1 to PVE or sham after the cavernosography. Safety will be assessed by determining the composite number of procedural and post procedural complications. Efficacy and durability will be assessed quantitatively with pelvic vein Doppler ultrasound (End Diastolic Velocity (EDV) <5 cm/s) and qualitatively with the validated Quality of Life - International Index of Erectile Function (IIEF) patient questionnaire. Assessments will be made prior to the procedure, at 6 months and annually to 5 years. At the 12 month time point, patients in the sham arm will be able to have the procedure.

In this study, we plan to investigate the effectiveness of mouthguards to prevent or minimise tongue injury among epilepsy patients who are undergoing VEEG or Stereotactic EEG (SEEG) monitoring.

Glaucoma is the most common cause of irreversible blindness in the world, affecting more than 70 million worldwide, of whom approximately 7 million are blind. The only proven treatment for glaucoma is to lower intraocular pressure (IOP). There are various treatment options for lowering IOP including medicine, laser, or surgery. More recently, new minimally invasive surgical devices and procedures have been introduced that aim to lower IOP and reduce dependence on medical therapy and/or avoid the need for invasive surgery. The International Glaucoma Surgery Registry (IGSR) is an observational, non-interventional, study of people who have undergone or are going to have a laser or surgical procedure for glaucoma. The inclusion criteria are a history of glaucoma or ocular hypertension requiring treatment with a laser or surgical procedure. The registry only collects information and does not influence the choice of treatment in any way. As part of routine clinical care, data will be collected on patients undergoing glaucoma procedures annually for 5 years or more with the goal of providing high-quality longitudinal data on outcomes, treatments patterns, quality of life, and cost-effectiveness. The IGSR aims to make a major contribution to understanding the clinical effectiveness of glaucoma procedures, as well as guiding evidence-based decision making and providing data to support future clinical trials.

This study is assessing whether a mobile phone SMS prompt will affect how many people choose to complete the National Bowel Cancer Screening Program (NBCSP) test among 50 to 60-year-old patients in Victoria. Who is it for? You may be eligible for this study if you are aged between 50 to 60 years, you are eligible to receive the free National Bowel Cancer Screening Program test kit, your GP has agreed to participate in the study and you have access to a smartphone. Study details Participants in this study will be randomly assigned to one of two groups. The first group will receive a single SMS message sent by their GP's practice one month prior to receiving their NBCSP test kit in the mail. The SMS message will include web links to a number of resources, including a message from their GP endorsing the free home test kit; a link to a narrative video of someone describing their positive experience of doing the test; a link to information about bowel cancer; and an animation showing how to do the test. The second group will not receive a SMS message but will still receive the NBCSP test kit in the mail. Participants in the second group will be able to discuss the test with their GP as part of their usual care. It is hoped this research will determine whether an SMS prompt about completing the NBCSP test kit impacts on the number of people choosing to take up the screening test at home, which could increase early detection of bowel cancer.

A Phase 1 Study to Evaluate the Pharmacokinetics and Pharmacodynamics of GS-9688 upon Co-administration with a Representative Proton Pump Inhibitor or H2-Receptor Antagonist in healthy adults

This project aims to generate experimental evidence from one online randomised controlled trial to determine the relative effect of simultaneously displaying multiple added sugar labels to facilitate healthier choices by consumers. We hypothesise that displaying multiple added sugar labelling on food and beverage items will reduce the proportion of intended purchases of products that are high sugar, compared to no added sugar labels or only one added sugar label. Further we hypothesise participant characteristics including age, gender, education, income, and usual levels of sugar consumption alter the effect of added sugar labelling on intended purchasing. This new evidence will be critical to the development of effective labelling policies to reduce added sugar consumption for all Australians and New Zealanders.

The purpose of this study is to investigate the use of the medication combination Bazedoxifene and conjugated estrogen, a hormone replacement therapy, in the treatment of depression with a first onset or relapse during the peri-menopausal phase that is still persisting. The study will employ a 12-week, double-blind, randomised, two-arm parallel-group design. Participants will be randomised to one of two groups: (1) Daily oral Bazedoxifene and conjugated estrogen (20mg/0.30mg), (2) Placebo (sugar pill). The aim is to compare, in a twelve-week double-blind randomised controlled trial, the psychological and physical outcomes of women experiencing a first-onset, relapse or persistent depressive symptoms that commenced during the peri-menopause in four groups: i) women taking Bazedoxifene and conjugated estrogen (20mg/0.30mg oral/day) in adjunct to standard antidepressant treatment, ii) women taking placebo in adjunct to standard antidepressant treatment, iii) women taking Bazedoxifene and conjugated estrogen (20mg/0.30mg oral/day), iv) women taking placebo alone (i.e. women not using any psychotropic / hormone treatment). It is hypothesized that women receiving Bazedoxifene plus conjugated estrogen alone, and Bazedoxifene plus conjugated estrogen in adjunct to standard antidepressant medication will have the same as or significantly greater improvement in depressive symptoms compared with women receiving placebo in adjunct to standard SSRI and women not using any psychotropic/hormone treatment.

The aim of the proposed study is to determine the proportion of patients who are administered oxygen therapy in accordance with the current World Health Organisation (WHO) guidelines by anaesthetists in Australia and New Zealand. The primary outcome of this study will be to determine the proportion of cases where time-weighted average intra and postoperative inspired oxygen concentration (FiO2) was at least 0.8 in accordance with WHO guidelines. We hypothesise that among the population group studied, fewer than 5% of patients will be administer intraoperative oxygen therapy as recommended in the WHO guidelines.