ANZCTR search results

Serious injury is life changing yet trauma care and research has typically focused on survival rather than survivorship. Over 90% of people survive serious injury. Throughout their recovery, they will need to navigate a myriad of health and social services. Many of these services are underpinned by complex funding mechanisms and eligibility criteria that can differ by demographics, cause and geography. Survivors of serious injury have identified the absence of a single point of contact for navigating and coordinating post-discharge care as a consistent barrier to recovery. We will trial a Trauma Patient Navigator (TPN) model to enhance patient and carer experience and improve the quality of survival. The Advancing Care Through Injury Outcome Navigators (ACTION) study is a Type 2 hybrid effectiveness-implementation design using a balanced staircase stepped wedge cluster randomised control trial (RCT, n=1,344) to be conducted across Victoria, New South Wales, Queensland, Tasmania, South Australia, and Western Australia. We will systematically evaluate the effectiveness and adoption of TPNs to address the endemic complexity of health and social systems faced by survivors of serious injury to improve post-discharge care and support, health-related quality of life and trauma outcomes. This project will test the feasibility, effectiveness and cost-effectiveness of the TPN intervention which directly addresses a critical need defined by survivors of serious injury and their close others. The findings will transform post-discharge trauma care and deliver the necessary evidence and implementation toolkit to achieve widespread adoption within trauma clinical practice and policy in Australia.

This randomised control trial will compare the effects of topical non-steroidal anti inflammatory drug (NSAID) to a sham topical gel in people with painful foot osteoarthritis (OA). The primary objective is to determine whether daily use of a topical NSAID gel leads to significantly greater reductions in foot OA pain with walking, compared to a sham gel, at 6 weeks. The secondary objectives are to determine whether daily use of a topical NSAID gel leads to significantly greater benefits on other clinical outcomes (physical function, other measures of foot OA pain, global ratings of change, health-related quality of life, and physical activity levels), compared to a sham gel, at 6 weeks, and evaluate the extent of use and clinical outcomes in a subsequent 6 week follow up period when use was deemed as needed, at 12 weeks.

The AWASH study aims to investigate the feasibility of applying an antibiotic wash to the bowel during surgery, with a short course of post-operative irrigation in some patients, for adults having planned colorectal surgery where the bowel is rejoined. Who is it for? You may be eligible for this study if you are an adult undergoing elective colorectal resection with primary anastomosis. Study details Participants will be randomly allocated to receive either the study treatment or standard care. The study treatment involves washing the bowel during surgery with antibiotics, and for patients undergoing an anastomosis within 15cm of the anus, a trans-anal drainage tube will be placed intra-operatively to facilitate antibiotic washing on postoperative days 1 and 2. Outcomes on success of delivery of the treatment and patient complications will be collected. It is hoped that findings from this study will help clinicians and researchers determine whether the intervention and study processes can be delivered safely and successfully to inform a larger future trial.

This Phase 1 study is testing a new drug called NB-9402. The study drug NB-9402 is being developed by Nura Bio Inc, as a potential treatment for diseases of the nervous system. The study will evaluate the potential drug-drug interactions of NB-9402 with repaglinide and midazolam.

This Phase 1 study is testing a new drug called NB-9402. The study drug NB-9402 is being developed by Nura Bio Inc. as a potential treatment for diseases of the nervous system. This study will assess the safety and tolerability of NB-9402 when given as single and multiple oral doses in healthy adult volunteers.

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of atumelnant in participants with ADCS. This entire study consists of 3 parts: Part A (not described in this registration), Part B (not described in this registration), and Part C. In Part C is an open-label long-term portion of the study. All participants will receive atumelnant by mouth for up to 2 years, using a concomitant B&R treatment regimen. Up to 201 participants will be included (up to 186 from Parts A and B, and approximately 15 new participants).

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of atumelnant in participants with ADCS. This entire study consists of 3 parts: Part A (not described in this registration), Part B, and Part C (not described in this registration). In Part B of the study, participants will be randomized into 2 arms: - Atumelnant and steroid medication. The atumelnant dose will be determined based on data from Part A. - Placebo atumelnant and placebo steroid. Participants will be randomized in a 2 to 1 ratio (for every 2 participants who receive atumelnant, 1 participant will receive placebo) and will receive the study drug (atumelnant or placebo) by mouth for 12 weeks. Whether a participant receives atumelnant or placebo will be determined by chance (like drawing straws). This part of the study is double blind, the participant, their caregiver(s), and the study doctors will not know which treatment is being given (blinded to treatment). After participation in Part B of the study, participants might be able to stay in the study in Part C (open-label extension where all participants will receive atumelnant and steroid replacement therapy) if, in the Investigator’s opinion, they would benefit from it.

Failure to provide vocational support after stroke costs Australia $3.6 billion in lost productivity yearly. Vocational support in Australia is limited to return to work (RTW) support in some rehabilitation services. This results in significant service gaps, particularly in rural and remote communities. We have co-developed a telehealth post-stroke Work Support Program designed to ensure vocational support needs are met any time throughout the RTW and long term work participation journey. We will conduct a randomised controlled trial comparing the Work Support Program to usual care to determine if the program results in a significantly greater improvement in work ability. We will recruit 194 stroke survivors across Australia, collecting work ability and other vocational and wellbeing outcomes by telephone at baseline, 3, 6 and 12-months post baseline; evaluate cost efficacy, and conduct a process evaluation to examine factors that will impact on translation.

The current study aims to deliver and evaluate a new telehealth, psychologist-led cancer-related fatigue ) treatment program in women with ovarian cancer, called REFRESH-Ovarian. Who is it for? You may be eligible for this study if you are an adult female with ovarian cancer who lives in a rural and remote area of Australia, and are experiencing mild-to-severe levels of cancer-related fatigue. Study details The program will screen and offer treatment to people with ovarian cancer experiencing mild-to-severe levels of cancer-related fatigue, in the form of a (i) workbook based on cognitive behavioural therapy (CBT) principles and (ii) psychologist support (e.g., phone-coaching and/or group CBT). Data on the acceptability, feasibility and appropriateness of the study will be collected. It is hoped that findings from this study will help inform future interventions for cancer-related fatigue and also address the health disparities faced by people with ovarian cancer and people living in rural and remote areas.

This study investigated whether the belief a healthcare practitioner holds about the treatment they are delivering influences the pain relief their patient experiences. Forty-five adults with knee pain attended a single appointment at one of two clinics in Adelaide and were each treated by one of twelve qualified practitioners; all patients received the same sham (non-penetrating) dry needling treatment. Practitioners at one clinic were told they were delivering real dry needling; practitioners at the other clinic were told they were delivering sham dry needling, while patients in both arms were informed they had a 50/50 chance of receiving real or sham dry needling. We hypothesised that patients treated by practitioners who believed they were delivering real dry needling would experience greater reductions in pain at rest and movement-evoked pain than patients treated by practitioners who knew they were delivering sham dry needling. Pain at rest and movement-evoked pain were assessed before treatment, immediately after treatment, and at 24-hour follow-up, with pressure pain thresholds also measured before and after treatment.