ANZCTR search results

This project will investigate the effectiveness and feasibility of implementing an exercise physiologist (EP) led, 12 week therapy program to individuals living independently and in residential care at MercyCare. Our hypothesis is that through a prescribed exercise program, levels of activity and the capacity to engage in daily tasks will be enhanced thus providing an increased quality of life for participants. A mixed-methods design will provide evidence to support future decision making by management as to the feasibility of employing an EP, and will identify barriers and facilitators to the effective delivery of EP services within this environment and organisation.

The aim of this study is to determine the feasibility of running a randomised controlled trial in which participants with dementia and sleep disturbance are randomised to either participation in a behavioural intervention (sleep hygiene program), taking melatonin or usual care.

Interstitial lung disease (ILD) is a group of chronic lung diseases of different causes which lead to symptoms of breathlessness, fatigue, reduced exercise tolerance and poor quality of life. There are limited medical treatments available to date for the majority of patients with ILD. Although ambulatory oxygen is commonly prescribed for patients with ILD suffering significant breathlessness or low oxygen levels during exercise, its clinical benefits are uncertain. Potential adverse effects include increased systemic oxidative stress and the negative impact on patients’ mental well-being from such a burdensome treatment. In addition, the use of oxygen therapy has significant costs for both patients and the health care system. Ambulatory oxygen is usually delivered using oxygen cylinders. Portability and comfort of oxygen cylinders are important factors which prevent patients from using ambulatory oxygen as prescribed. The new lightweight portable oxygen concentrator (POC) may be an attractive alternative to oxygen cylinders. This study aims to compare the effects of ambulatory oxygen with room air delivered via portable concentrator on health outcomes, including exercise capacity, symptoms, activity levels, systemic oxidative stress and inflammation, in patients with chronic ILD and low oxygen levels during exercise.

Chronic pelvic pain (CPP) is pain in the pelvis of greater than 6 months duration, and is severe enough to cause functional disability or require medical intervention. Endometriosis, the presence of endometrial tissue outside the uterus, is a common cause of CPP. Worldwide, endometriosis is as common as lower back pain. Endometriosis related CPP includes a variety of pain symptoms including dysmenorrhea (period pain), dyspareunia (pain during sexual intercourse), dyschezia (pain on bowel motions) and dysuria (pain on urination). Current treatments tend to be expensive, invasive or have significant side effects. Acupuncture shows promise in treating endometriosis related chronic pelvic pain however no studies have examined the feasibility of undertaking a fully powered trial in Australia or the effect of acupuncture on a number of objective biomarkers that are altered in women with endometriosis, such as IL-6, an inflammatory marker, or changes in functional connectivity in the brain. The aim of this study is to assess the feasibility and acceptability of acupuncture and to investigate any changes in neurological or biomarkers when using acupuncture to treat endometriosis-related chronic pelvic pain.We are partnering with Endometriosis Australia, a leading not-for-profit in Australia, to recruit women for this study. We will recruit 30 women to either acupuncture plus usual care or usual care alone. We will measure daily pain ratings as well as pain measured during the period and will take blood samples before and at the end of treatment to determine any changes in levels of IL-6. Women will also have an EEG taken to determine if there is any change in the way their brains are processing pain. This data will help provide the important information necessary to help design a larger trial to test if acupuncture is an effective adjunct to current treatments.

The aim of this study is to determine the total cost of administration of a unit of red blood cells for a patient with thalassaemia major treated at Monash Medical Centre, Melbourne, Australia. This study involves determination of the processes and costs associated with administering a unit of RBCs to adult patients with thalassaemia at Monash Medical Centre, Clayton, Victoria, Australia. The unit of observation is the process involved in preparation or administration of a unit of RBCs and as such, patients are not enrolled into this study. Transfusions can be life-saving, but they also carry risks and substantial costs. Alternatives to transfusions exist for some patients, but evaluations and decisions about treatment options are often complex, and may be more difficult when the benefits, risks and costs are not well characterised. Australian governments through the National Blood Authority (NBA) spend in the order of $AUD 1 billion annually in provision of blood products for the community. However, visibility of transfusion-­-related costs is generally low. The “manufacturing cost” is now carried on the blood product label, and for red blood cells (RBCs) at October 2015 this is $AUD 374.72(1). In some Australian states the costs of the product is devolved to the hospital level, but most hospitals have little or no idea of the true costs of transfusion therapy, over and above the costs of providing components, including laboratory and clinical costs. Thalassaemia is associated with significant complications and often requires lifelong therapy, involving red blood cell transfusion every three to four weeks which require the individual to attend hospital for the day. Estimates of the total healthcare costs for a beta thalassaemia major patient experiencing minimal complications are $150K per year, however there are currently no Australian transfusion costing data in the thalassaemia context. Understanding the full cost of transfusion will inform policy development and facilitate safe and cost effective treatments and transfusion support for patients with beta thalassaemia; resulting in improved outcomes for patients and better utilization of limited health resources.

The primary purpose of this study is to provide long-term patient follow-up and review of clinical and correlative data outside of clinical trials. Who is it for? The registry will collect information on patients with a diagnosis of sickle cell disease, alpha-thalassemia, beta-thalassemia and other haemoglobinopathies. Study Details Treating clinicians at sites will identify patients and enrol them to the study. The following categories of data items will be collected to the Haemoglobinopathy database using a web portal: Demographic details Clinical presentation Laboratory results Therapy Complications (of therapy or condition) Outcomes It is hoped that the findings from this study will identify patterns of treatment and variation in outcomes, for survival and quality of life. Findings will be valuable in informing optimal treatment strategies.

The primary purpose of this study is to provide long-term patient follow-up, and review of clinical and correlative data outside of clinical trials. Who is it for? The registry will collect information on patients age 18 years or older, with a new diagnosis of non-Hodgkin lymphoma, Hodgkin lymphoma, chronic lymphocytic leukaemia and related diseases. Study details Treating clinicians at sites will identify patients at the time of referral and enrol them to the study. The following categories of data items will be collected to the LaRDR database using a web portal: Demographic details Health at diagnosis Laboratory and imaging results at diagnosis Therapy decisions, including pre-therapy benchmarking, chemotherapy, autologous and allogeneic stem cell transplantation, and maintenance and supportive therapies Outcomes including (survival and QoL measures. It is hoped that the findings from this study will identify patterns of treatment and variation in outcomes, for survival and quality of life. Findings will be valuable in informing optimal treatment strategies for lymphoid cancers and assist with evaluation of the translation of advances in therapies outside the setting of clinical trials.

The study aims to assess the effectiveness of structured, mindfulness-based practice on improving stress, empathy and workplace engagement in junior medical officers (“JMOs”) and final-year medical students who will imminently become JMOs. Based on current available evidence, we hypothesize that mindfulness-based program participation will: 1. Reduce levels of stress, anxiety, and burnout, and improve mood 2. Improve employee work-related outcomes including empathy and engagement We also aim to evaluate the acceptability, feasibility and implementation barriers to this approach in routine practice.

This pilot clinical trial will characterize the wild type Plasmodium malariae isolate HMPBS-Pm as an agent for use in CHMI for the future assessment of antimalarial treatments. The study has been designed based on previous experience with similar Plasmodium spp. master cell banks. Inoculum preparation, administration and clinical score criteria are unchanged. Participant follow up intervals have been adjusted to account for differences in Plasmodium spp. lifecycles. The study population will consist of healthy participants who meet the inclusion and exclusion criteria for similar trials, including appropriate ABO and Rh (female participants) blood group matching. It is hypothesized that the inoculum HMPBS-Pm will demonstrate infectivity in healthy participants. Parasite growth rates are expected to be slower compared to P. falciparum and P. vivax cell banks.

This study aims to build the evidence base for an effective public education campaign for young people. It involves the development and testing of content which will culminate in the production of four Community Service Announcements (CSAs) with different key messages, designed for television or cinema. 240 young people will be recruited from the general population and headspace, and randomly allocated to view one of the 3 suicide prevention intervention CSAs or a control CSA on accessing emergency contraception. Participants will answer questions pre-viewing, post-viewing and four weeks later to permit an examination of several positive and negative outcomes. In addition to understanding the impact of three suicide CSAs this project provides a unique opportunity to collect information about how well a CSA about emergency contraception may work at improving knowledge among young adults.