ANZCTR search results

The Point of Care Peritoneal Dialysis System Early Evaluation Study (POC-PDEE) will utilise different methodologies to establish the safety, efficacy and usability of the Ellen Medical - Point of Care (EM-POC) peritoneal dialysis system with Australian dialysis patients as a key step in the system evaluation. This study comprises three inter-linked components: (1) a series of human factors usability assessments, (2) a shadow study testing the reliability of the chemical composition and sterility of PD fluid produced by the EM-POC system when used by dialysis patients or their carers independently at the point-of-care and (3) patient perspectives regarding the EM-POC system, it’s usability and the training provided prior to using the EM-POC system will be sought through semi-structured interviews.

Social anxiety is a prevalent mental health condition, with 4.2% of the population meeting the criteria for social anxiety disorder within a 12-month period (McEvoy et al., 2011). Current treatments for social anxiety tend to focus solely on individual psychological factors (e.g., a person’s negative thoughts) while ignoring the influence of social factors. Groups 4 Health (G4H) has strong potential to address social anxiety symptoms because it focuses on these social factors and how they influence health. G4H is a manualised group therapy program that seeks to increase social connectedness by building group-based connections over five sessions. Its effectiveness for depression and loneliness has already been demonstrated in three trials (i.e., Cruwys et al., 2021; Haslam et al., 2016; 2019), however, it has not yet been tested in people with elevated social anxiety symptoms. Our study is a pilot test of G4H for people with social anxiety. We aim to recruit 80 people with elevated social anxiety symptoms. The primary outcomes we will use to assess whether the intervention is effective are social anxiety and loneliness. Our secondary outcomes include participants’ social connection to their therapy group, depression, multiple group memberships, social isolation, self-focused attention (which has been linked to social anxiety), and wellbeing. We are also interested in what therapist behaviours help foster a sense of connectedness in the therapy group and thus other secondary outcomes include therapists’ identity leadership (a leadership style that aims to build group connectedness) and social support. We hypothesise there will be reductions in social anxiety, loneliness, depression, social isolation, and self-focused attention across the course of therapy, and increases in social connectedness to the therapy group, multiple group memberships, and wellbeing. We also expect that these outcomes will be better when therapists engage in more identity leadership and provide more social support.

Glaucoma and diabetic retinopathy are leading causes of irreversible blindness in Australia which pose considerable public health concerns. Early detection and appropriate management is required to prevent vision loss and blindness. A gap between best practice recommendations and actual care provided for people with glaucoma and diabetic retinopathy exists. This project aims to test the feasibility and potential effectiveness of a quality improvement program for optometrists to improve the quality of care provided by optometrists to people with diabetes and with or at risk of glaucoma. The quality improvement program for optometrists consists of self-assessment with benchmarking, peer support, educational activities and resources.

This study is looking to assess whether alternative treatment to prevent variceal bleeding (variceal banding involving multiple endoscopic procedures) is required if you are on a suboptimal dose of a beta-blocker (Propranolol or Carvedilol); a medication that reduces your heart rate and blood pressure, with the aim of reducing the pressure gradient in the liver. Suboptimal dose suggests this is not the highest dose possible reaching the target of a heart rate less than 60. Reasons for being unable to increase the dose may include side effects such as low blood pressure. The aim of the medication is to reduce portal hypertension (portal vein pressure gradient in the liver, causing higher risk of varices and bleeding). If your portal pressure gradient measurement is adequate (<12mmHg) then you would not require alternative prophylaxis with variceal banding. The aim of this study is to assess the effectiveness of suboptimal doses of beta-blockers in patients unable to tolerate higher doses. Liver inflammation and pressure can be assessed through blood tests, ultrasound and liver elastography (fibroscan) as well as splenic elastography, all of which are non-invasive however these investigations do not measure portal pressure gradient. We are doing this study in the hope that we can optimise treatment management of patients with cirrhosis. Our overall hypothesis is that directly measuring portal pressure gradient via endoscopic ultrasound (EUS-PPG) can identify patients on suboptimal doses of beta-blockers who do or do not require variceal band ligation for primary prophylaxis.

1 in 5 patients after total knee arthroplasty (TKA) are left feeling unsatisfied. Therefore, patient selection prior to TKA is critical. We have developed a prognostic tool that can predict outcomes after TKA before the patient undergoes surgery. Our tool (PROTO-KNEE) uses machine learning algorithms to predict TKA outcome before patients undergo surgery. Patients can use the tool by inputting their age, gender, and pre-operative quality of life (using a validated questionnaire) and the tool will predict their likelihood for improvement or no improvement after TKA. The study will evaluate this tool on patients decision making. In particular, we are interested to understand how this predictive tool influences a patient's willingness for surgery. Our hypothesis is that use of this tool will better inform patient decision making through individualised outcome prediction early in the TKA journey.

This study aims to conduct a first in human, single arm, multicenter trial of the BD(TM) Sirolimus Drug Coated Balloon Catheter for the treatment of femoropopliteal arterial disease to assess the need for future clinical research to evaluate performance and safety.

This pilot trial seeks to evaluate the outcomes of CBT-I delivered via videoconferencing with young adult university students. Self reported sleep quality is the primary outcome in this study. Outcomes will be compared pre to post treatment. This pilot will identify any aspects of the program that need to be adjusted before a larger scale RCT is conducted.

Currently, there are no published trials examining the effect of non-surgical weight loss interventions on CKD progression in those with obesity and CKD. Clinical trials, utilising an effective non-surgical method of low energy meal replacements or prep-prepared meals plus specialised support over the longer term, are needed to determine whether weight loss can reduce cardiovascular risk factors, improve quality of life and delay progression of kidney disease. Before undertaking a definitive trial, the safety, feasibility and acceptability of low energy diets should be tested in patients with kidney disease. Our study has the potential to benefit patients if we can offer an acceptable and effective non-surgical weight loss intervention to potentially modify the course of CKD associated with obesity.

This RCT seeks to evaluate the outcomes of CBT-I delivered via videoconferencing with young adult university students. Self reported sleep quality is the primary outcome in this study.. Outcomes will be compared pre to post treatment with a one month follow up.

This is a pivotal Phase 3, multicenter, randomized, double-blind, placebo controlled study to investigate the efficacy and safety of DMX-200 120 mg twice daily (BID) compared with placebo over a treatment period of 104 weeks in adult patients with FSGS who are being treated with an ARB. With a potential 2-year extension study, after completion of double-blind period.