ANZCTR search results

Osteoarthritis (OA) is a common and debilitating condition affecting millions worldwide, with no known cure. Physical activity is beneficial for managing OA, but most patients fail to meet recommended activity levels. Walking is a safe, low-cost, accessible form of exercise suitable for OA patients. The Walk with Ease program, initially from the US, is a 12-week walking program designed to help OA patients manage pain and symptoms while staying active. It has proven to reduce pain, stiffness, and improve function in people with moderate to severe pain (greater than 4/10), also boosting physical activity levels in individuals with arthritis. This study will test whether Walk with Ease Australia has an effect on physical activity levels in Australians with OA through a two-arm, parallel, randomised controlled trial using a hybrid type 1 effectiveness-implementation design. The primary endpoint is assessed at 12 weeks. After screening and consenting, participants are randomized into either the Walk with Ease Australia plus Fitbit group or the Fitbit-only group. Surveys are completed at baseline (T0), six weeks (T1), 12-weeks (T2), and follow-ups at six and 12 months (T3 and T4). We expect that people assigned to the Walk with Ease Australia will have higher physical activity levels, compared to control at 12 weeks.

Active-Prem is a novel intervention aiming to improve physical activity participation for preschool age children born very preterm. Active-Prem is a 6 part intervention developed through previous research, pilot studies and co-design. It includes goal setting, parent support, coach training, and facilitating the inclusion of children born preterm into physical activities in their local community. The aim of this study is to evaluate the effectiveness of Active-Prem compared with goal setting at improving physical activity participation, as well as evaluating the acceptability, fidelity, feasibility and cost-effectiveness of the Active-Prem intervention.

This study aims to evaluate the safety and functionality of the ProtonPetal Alpha One device, focusing on generating early feasibility data regarding its performance. The device will measure participants' interstitial potassium levels, and these measurements will be retrospectively compared to standard clinical blood potassium measurements, both during baseline conditions and after introducing a potassium challenge.

The purpose of this study is to test a new version of mental health and wellbeing program, the Be Well Plan, in university students. This program aims to build the mental health and wellbeing of participants through 5 weekly, online or in-person, group-based sessions which are designed to assist participants in in developing their own wellbeing plan to better cope with the challenges of university life. In addition, the project aims to understand if the program is beneficial for students with body image or eating concerns and whether any adaptions need to be considered.

This clinical trial will evaluate the effectiveness, safety and cost-effectiveness of NVPs compared to the pharmacotherapy, varenicline, for smoking cessation among people experiencing social disadvantage. The trial is a two-group superiority randomised controlled trial (RCT) that compares smoking rates between two groups of 436 low-socioeconomic status smokers (N = 872), randomly allocated to either: 1) standard varenicline treatment; or 2) NVPs treatment. Both groups will be provided text message behavioural support. This work is of national and international significance as it will provide much-needed data on the effectiveness, safety and cost-effectiveness of latest generation vaping products at achieving smoking cessation amongst a priority population. This will directly address peak health bodies’ calls for high quality large-scale RCT evidence and contribute significantly to existing knowledge in this research area. Furthermore, the outcomes of this study will help guide government and policy decision-making in the future.

The goal of COSMOS is to conduct an open label feasibility study of hypertonic sodium ascorbate for the management of intracranial hypertension in traumatic brain injury

Rates of single-occasion heavy drinking are higher among young university students (17-25 years old; 50%), particularly residential college students (67%), compared to their same-age, non-student peers. There have been calls for more effective alcohol and other drug (AOD) interventions in colleges, particularly during the first week of semester one (Orientation-week or O’week) when risky drinking and related-harm is highest. We developed the QuikFix Good Night Out (GNO) College harm reduction program with college students and staff to address this need. The program is comprised of two parts: (i) an AOD trivia harm workshop delivered by student peer leaders during O’week; and (ii) the delivery of a brief telehealth intervention to socially influential heavy drinking students in the college network. We have demonstrated the feasibility of the QuikFix GNO College Program for reducing alcohol use and related problems in young university students in two pilot trials. Our 2021 feasibility trial (497 students from four colleges) found that students in co-educational colleges which received the QuikFix GNO College Program (AOD trivia workshop + QuikFix brief telehealth intervention) reported significantly less alcohol use than those in colleges which received only the AOD trivia Workshop. Our 2022 cluster RCT (716 students from six colleges) replicated these findings with students who received the full QuikFix GNO College Program reporting less alcohol use and related problems at 24 and 52 weeks compared to those in the AOD trivia workshop-only group. While the results of these pilot studies are promising, both of these trials were conducted at one university. We are now seeking to evaluate the scalability, efficacy, and cost effectiveness of the QuikFix GNO College Program for reducing AOD use and related harms in first-year college students across three Australian states. A two-arm randomised controlled design will be conducted comparing the impact of the QuikFix GNO College Program to an AOD-education only control on alcohol use and related problems. The inclusion of a control group (usual AOD-education) will evaluate the effects of the QuikFix GNO College Program compared to the typical college AOD messaging that first-year students receive within the residential college environment.

This is a Phase 2 study to evaluate the safety and tolerability, PK/PD, and antiviral activity/efficacy of cavrotolimod and cavrotolimod-containing combinations in CHB infected subjects who are on nucleos(t)ide therapy. Cavrotolimod +Nivolumab+ BJT-778 is being developed to address the high unmet medical need with possible benefits for participants with Chronic Hepatis B virus infection (CHB). This study will enroll non-cirrhotic, chronic hepatitis B (CHB) infected adults aged 18-65 years of age, inclusive, on nucleos(t)ide therapy. The study consists of four parts (Part A, Part B, Part C and Part D). Part D will enroll up to 90 participants. 15 to 30 participants per cohort across 3 possible cohorts.

The aim of this project is to demonstrate that for patients with a UTI in whom intravenous antibiotic therapy is clinically indicated, there is a subset of these patients who can be safely managed at home by Hospital in the Home (HITH). The hypothesis is that HITH treatment for appropriately chosen patients with UTI has comparable (or even better) clinical outcomes when compared to available data on UTI treatment in a hospital ward setting in terms of length of stay, morbidity and mortality. It also aims to determine what patient factors may be associated with prolonged length of stay and poorer clinical outcomes. How well antibiotic prescription concurs with recommended antibiotic prescribing practices will also be assessed

Study Title: The NIKI-PT Study - A study of plasma pharmacokinetics of nebulized ketamine in post-operative and trauma patients in intensive care unit: A phase 2, single site, prospective, interventional, open-label pharmacokinetic study. A minimum of 20 patients will be consented and enrolled to receive a single dose of nebulized ketamine 0.75mg/kg (ideal body weight). Over a 2 hour sampling period 8 blood and 2 urine samples will be collected. Assessments will be conducted to report on feasibility, pain, tolerance, concomitant sedatives and analgesia as well as monitoring for study specific adverse events. The hypothesis of the study are that 1. Plasma blood levels of nebulized ketamine in ICU post-operative or trauma patients is adequate to provide analgesia 2. Nebulized ketamine is not associated with any serious adverse events in ICU post-operative or trauma patients