ANZCTR search results

The global impact of COVID-19 has been profound, and the public health threat it represents is the most serious seen in recent pandemic history. One of the major impacts of COVID-19 is the long-standing financial stress that it is imposing on millions of people worldwide. Unemployment, under-employment, and other forms of financial stress are causing marked increases in depression, anxiety, and suicide risk. There is an urgent demand for programs that can address the effects of financial stress experienced by people during the COVID-19 pandemic. There are major challenges in dealing with this issue because this mental health problem is affecting unprecedented numbers of people, it is affecting people all across Australia and beyond regions traditionally serviced by mental health services, and people are limited in accessing health services in the context of social distancing. A suitable and evidence-based program that helps to cope with stress in times of crisis is the Problem Management Plus (PM+), which was developed by the World Health Organization. As a low-intensity intervention for adults affected by adversity, this program teaches people well-documented strategies to manage stress. This project aims to conduct a rapid trial of a brief psychological intervention, termed Problem Management Plus (PM+) to reduce distress associated with concerns about COVID-19. There is an urgent need for publicly available strategies to reduce COVID-19 related distress. This project does not aim to treat a mental disorder but rather alleviate distress and improve coping in people with distress about COVID-19. This brief program will be offered via teleconferencing to allow for social distancing on a group basis. We hypothesise that PM+ will result in greater reductions in distress and worry relative to provision of currently available online resources to manage distress. Adults who screen positive for psychological distress will be randomized to PM+ or a control condition. PM+ will comprise 7 x 60-minute sessions delivered by a clinical psychologist via teleconferencing to groups of 4 people at a time. The control arm will direct people to a portal with stress coping strategies. All participants will be assessed at baseline, post-intervention, and 3 and 24 months follow-up.

Hypertrophic cardiomyopathy (HCM) is an inherited condition that results in an abnormally thickened heart muscle. It is the most common inherited heart muscle condition affecting up to 1 in 200 of the general population. The genetic mutation (or “spelling mistake” in the genes) leads to inefficient heart muscle contraction, and over time it leads to heart muscle thickening. The thickness of the heart muscle is one of the most important predictors of symptoms in patients with HCM. Treatment of HCM has focussed on relief of symptoms by medications which slow the heart rate and improve heart function. However, the symptom relief is incomplete and there is no evidence of medications to reverse abnormal heart muscle thickening. Perhexiline, a drug currently used safely as an anti-anginal agent, increases the energy efficiency of the heart. The principal driver of increased muscle thickness in HCM is energy depletion of cardiac muscle cells. As Perhexiline improves energy efficiency in the heart, there are plausible reasons (not yet tested) that it may reduce heart muscle thickness as well as improve patient symptoms. We aim to study the effects Perhexiline treatment on heart muscle thickness in symptomatic HCM patients. If our study is positive, it would lead to the design of a definitive clinical trial that would address the question whether Perhexiline use reduces heart failure and sudden death events in HCM patients.

Peripheral Vascular Disease (PVD) is a common condition often treated with angioplasty, a minimally invasive endovascular procedure to widen narrow or obstructed arteries or veins, typically used to treat atherosclerosis. Removal of the femoral sheath requires adequate compression which can be achieved by manual compression (MC) or with the use of vascular closure devices (VCD). The aim of this study is to evaluate the safety of the FemoStop™ II Gold compression system post-peripheral angioplasty in patients with PVD. The study will also aim to analyse rates of groin complication between the FemoStop™ II Gold compression system and VCD, allowing physicians to better decide which method has least post-operative complications and better patient satisfaction.

The Queensland Children’s Hospital and Perth Children’s Hospital have identified a need to determine if SASS is superior to SSD for PICC and tunnelled CVC securement for; a) patients requiring PICC that have compromised skin integrity and b) all patients requiring insertion of tunnelled CVC. The results of this study will inform paediatric healthcare practice, provide reliable estimates of the comparative effect of SASS, and inform the feasibility of conducting a larger, definitive trial. We have completed an inbuilt feasibility study (n=60) and are continuing on to a powered RCT.

This is a Phase 1b, randomised, double-blind, placebo-controlled, parallel study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of multiple SC doses of OLP-1002 in patients who have pain due to moderate to severe osteoarthritis (OA) in a hip and/or knee joint. The study consists of: • Screening period: up to 14 days (defined as Day -23 to -9) • Washout period: 5 days (± 1 day) (defined as Day -8 to -4) • Baseline period: 3 days (± 1 day) (defined as Day -3 to -1, where Day -1 is the day before dosing) • Treatment period: 15 days (± 1 day) (defined as Day 1 to 15, where Day 1 is the day of first dosing) • Follow-up period: 30 days (± 5 days) (defined as Day 16 to 45, assuming Day 15 is the day of the last dose) Up to 30 patients will be enrolled in the study and will be randomised in the ratio 1:1:1 to the following arms: • Arm A: 10 patients will receive 5 µg twice-weekly (BIW) OLP-1002 • Arm B: 10 patients will receive 10 µg BIW OLP-1002 • Arm C: 10 patients will receive Placebo BIW

This study will examine the impact of the National Bowel Cancer Screening Program (NBCSP) on colorectal cancer outcomes for people over the age of 50 with severe mental illness. Who is it for? This retrospective study will be looking at data on people aged 50-74 and who have participated in the NBCSP, with or without severe mental illness. We will also be consulting with people with severe mental illness and their carers on barriers to screening and optimal care. Study details This is a data linkage study of multiple Commonwealth datasets: NBCSP, Medicare Benefits Schedule, Pharmaceutical Benefits Scheme, Australian Cancer Database and the National Death Index. Data linkage with NSW Cancer registry and hospital data will also be used. This research project is directly focused on identifying where access and/or treatment disparities exist along the colorectal cancer care pathway for people with severe mental illness in order to improve access and service utilisation, and ultimately to improve cancer survival for this very disadvantaged group.

The National Hand Hygiene Initiative (NHHI) was implemented in Australia aiming to improve healthcare worker hand hygiene and thus reduce the risk of healthcare-associated infections. However, health care associated infections are still ongoing issues in hospitals nationally. It is therefore important to monitor healthcare worker hand hygiene compliance and also its effectiveness. The use of remote video auditing has been described in the operating theatre to improve patient quality care because it influences healthcare worker’s behaviour, encourages best practice and also helps objectively analyse any adverse events. At the Royal Melbourne Hospital, we are installing remote video cameras in the operating theatre complex. The aim of this study is to assess healthcare worker hand hygiene compliance after contacting post-surgical patients in recovery rooms. We will compare the compliance rate before and after feedback with the use of remote video auditing. Methods This study will be conducted over an 8-week period – 4 weeks without feedback of results to healthcare workers (HCW), followed by 4 weeks of weekly feedback of performance reports to HCW. We hypothesise that the compliance rate will improve after weekly feedback.

In these unprecedented times of global concern associated with the effects of COVID-19, the aim of the study is to produce and disseminate a low-intensity, self-help CBT guide to coping with anxiety and depression during the COVID-19 pandemic. This will include information for use with regards to children (use of parts relating to children will be facilitated by adult participants only), adolescents (use of parts relating to adolescents will be facilitated by adult participants only), and adults (including older adults) and include simplified CBT coping strategies as well as a comprehensive resource list of the many internet-based CBT programs, websites, and self-help books available as e-books to help people recognize and address different types of unhelpful thought patterns and behaviours which may contribute to heightened anxiety and depression during the pandemic. The recommendations for coping strategies and resources will be compiled by an international panel of experts in CBT. The guide will be disseminated through GP practices, WA hospitals, public mental health services, private mental health services and WA government websites, and the research will involve feedback from consumers on the relevance and usefulness of the information in relation to their stress, worry and low mood related to the pandemic. The information will be evaluated for the effectiveness of the treatment on symptoms of anxiety and depression. Research Questions and Hypotheses: 1. Do adult consumers find the CBT strategies to improving mental health guide for COVID-19 useful as indicated by their qualitative feedback in interviews? Due to the exploratory nature of this question no specific hypotheses are outlined. 2. Is there evidence through a pilot investigation of the efficacy of the guide in decreasing anxiety and depression in adults? It is hypothesised that participants randomised to the intervention will show significantly lower symptoms of anxiety on the GAD-7 and depression on the PHQ-9 after 1 week compared to control participants. 3. Can a CBT guide to improving mental health during COVID-19 be produced which covers strategies for both and adults and children (including those with specific needs, for example children with special needs such as Autism; use of parts relating to children will be facilitated by adult participants only)?

COVID-19 is associated with a high rate of lung infection (pneumonia), and it is uncertain for how long the inflammatory changes of pneumonia remain in the lungs once people have recovered from their symptoms and whether this is associated with adverse long-term outcomes. This study aims to determine if there are persistent areas of inflammation in the lungs in people who have recovered clinically from COVID-19 pneumonia, and also to assess whether there is evidence of increased blood vessel inflammatory activity in these people. As inflammation has an important role in the development and progression of cardiovascular disease, the persistence of inflammation may be a predictor of increased risk for future heart disease. 18FDG-PET/CT is an imaging test which is very sensitive to detection of inflammation.

The purpose of this study is to determine what dose of ReoCure, a virus that targets and kills cancer cells, is safe to use in humans. Who is it for? You may be eligible for this study if you are an adult who has a confirmed advanced/late stage solid tumour. Study details: Dose Escalation: Part A will test ReoCure at 3 different dose levels, Participants will receive 1 injection every 3 weeks in 3 Cohorts. Part B will test 2 dose levels of ReoCure in combination with a fixed dose of Pembrolizumab (200mg every 3 weeks) in 2 cohorts. Dose Expansion: ReoCure in combination with a fixed dose of pembrolizumab (200 mg once in every 3 weeks) treated with the recommended dose selected from Dose Escalation part. Blood, sputum, urine and faeces samples will be obtained for PK assessment before and after administration of study drug. Blood and urine will also be collected for clinical laboratory tests (haematology, clinical chemistry, blood coagulation and urinalysis), tumour marker evaluation and immunological response evaluation. It is hoped that this study will determine the safest and most effective dose of ReoCure for those with advanced or late stage cancer, and help provide more insight in the effect of ReoCure.