ANZCTR search results

The primary objective of this clinical research is to establish the effects of a standardised green-lipped mussel lipid extract (PCSO-524) in women and men with osteoarthritis (OA) of the knee. The study seeks to determine the effective dosage and will be conducted using an open-label design and is categorised as a Phase II clinical trial. Participants meeting the enrolment criteria will be randomised to either 200mg or 400mg daily for a 12 week period. The primary validated measurement will be the Comprehensive Osteoarthritis Test (COAT) which we developed in previous clinical trials on OA. The results will be used to inform a Phase III randomised controlled study.

As dietary patterns established in early childhood track into adulthood, interventions to improve children’s diets are a key focus of national chronic disease prevention strategies. The World Health Organization recommends the implementation of dietary guidelines in childcare settings to improve child health and prevent the development of non-communicable diseases. As such, most developed countries including Australia have sector specific regulations requiring that foods served to children attending childcare is consistent with national dietary guidelines. Research conducted by the research team, however, shows that less than 5% of Australian childcare services adhere to such guidelines. An online menu planning intervention (integrated into mandatory service operating systems) may represent a potentially effective, low-cost, and acceptable means of providing population-level support to childcare services to improve the nutritional quality of food provided in services. This study will assess the effectiveness of a web-based intervention in increasing adherence of childcare service menus to sector specific nutrition guidelines. The study will employ a parallel group cluster randomised controlled trial design with 54 long day care services in New South Wales. Services will be randomised to receive either the web-based intervention integrated into current childcare management reporting software or the control group. The primary trial outcome is the adherence to the nutrition guidelines regarding provision of fruit; vegetable; grains; milk, yoghurt, cheese (and/or alternatives); meat (and/or meat alternatives) and discretionary foods (foods high in energy, fat and/or salt) as assessed via a comprehensive menu review undertaken by a blinded dietitian or nutritionist. In a nested sample of up to 35 services child dietary intake in care will also be assessed

Water birth occurs when a baby is born fully submerged in water. There is a lack of strong (Level 1) evidence to conclusively agree on the safety or risk of water birth. We aim to determine if it is possible to run a large study that examines the safety of water birth compared to land birth in women with low-risk pregnancies. In this study, we will test recruitment parameters, research processes, and outcome measures (for mother and baby) to assess the feasibility of a main study. If this study proves feasible and funding is obtained, then we will consider an international study across multiple sites (subject to ethical approval) with the primary purpose of testing safety for babies who are born under water.

An non-randomised (single group) trial to test the safety and efficacy of the ARIA Emphysema Treatment System (ETS) for patients with Severe Emphysema and Hyperinflation of the Lung. The ETS device will be implanted in the lung and will remain insitu for the duration of the clinical trial.

This study is a clinical audit of patients undergoing implantation of a commercially-available and TGA-approved high frequency stimulator (TGA certificate DV-2011-MC-00182-3) between 1st January 2013 and 1st February 2017 for the clinical management of pain. The study will be a two-year audit of pain scores, disability index, analgesic drug consumption and patient satisfaction after implantation of a high frequency electrical nerve stimulator. Each patient will provide their informed consent for their data to be included in the clinical audit.

Stroke and dementia are two of the most common and disabling conditions worldwide, responsible for an enormous and growing burden of disease. There is increasing awareness that the two conditions are linked, with cognitive impairment and dementia common after stroke, vascular dementia accounting for about one-fifth of all dementia cases and recent evidence on the contribution of vascular risk factors to Alzheimer’s disease. Yet we still know very little about whether brain volume loss – a hallmark of dementia – occurs after stroke, and whether such atrophy is related to cognitive decline. The aim of this research is to establish whether stroke patients have reductions in brain volume in the first three years post-stroke compared to control subjects, and whether regional and global brain volume change is associated with post-stroke dementia in order to elucidate potential causal mechanisms (including genetic markers, amyloid deposition and vascular risk factors). We hypothesise that stroke patients will exhibit greater brain volume loss than comparable cohorts of stroke-free controls, and further, that stroke patients who develop dementia will exhibit greater global and regional brain volume loss than those who do not dement. An understanding of whether stroke is neurodegenerative, and in which patients, may be used to help guide the early delivery of disease-modifying therapies.

Fractures of the distal radius are the most common fractures presenting to emergency departments and orthopaedic surgeons. These fractures are more common in the elderly (due to osteoporosis and increased risk of falls) and the incidence in this age group is increasing. Considerable practice variation exists in the management of distal radius fractures in the elderly in Australia, ranging from closed reduction (manipulation of the arm to realign the fracture) with cast immobilisation, to open reduction (surgical exposure and realignment of the fracture) with plate fixation. Open reduction and (volar locking) plate fixation is currently the most common treatment provided. While there is evidence showing no significant advantage for some forms of surgical fixation over closed treatment, and no difference between different surgical techniques, there is a lack of evidence comparing the two most common treatments used in Australia: volar locked plate fixation versus cast immobilisation. Surgical management of these fractures involves significant costs (implant costs, medical costs, hospital costs) and risks (infection, implant failure, general surgical risks) compared to non-operative management (closed reduction and cast immobilisation in the emergency department). Therefore, high level evidence comparing the current treatment alternatives (plate fixation versus casting) is required in order to address practice variation, justify or avoid costs, and to provide the best clinical outcome for patients with these common fractures. This pragmatic, multicentre randomised comparative effectiveness trial aims to determine whether (volar locking) plate fixation leads to better pain and function and is more cost-effective than closed reduction with cast immobilisation in displaced distal radius fractures in adults aged 60 years and older. The trial will compare the two techniques, but will also follow patients that are unwilling to be randomised (but consent to follow up) in a separate, observational arm. Inclusion of non-randomised patients provides a more complete spectrum of fracture presentation, provides practice and outcome insights about standard care, and improves the generalisation of the results from the randomised arms. Given that plate fixation requires hospital admission and surgery, and that closed reduction with cast immobilisation is usually performed in the emergency department without admission, the findings have important implications for use of resources (theatre time, bed days, staff and implant costs) and may also reduce harms associated with plate fixation (infection, implant mal-positioning, tendon rupture and reoperation for implant removal). This trial will have significance in Australia, New Zealand and internationally, as it will address an important need for evidence supporting surgical practice.

The focus of this program of research is on carers of young people (aged 15-27 years) diagnosed with a first episode of psychosis. The proposed research program is a randomised controlled trial (RCT) which will examine the effectiveness of a novel online intervention for improving carer stress. The key research question is: can an innovative web-based intervention entitled “Altitudes”, which utilises moderated online social networking therapy (MOST), lead to improvements in stress at 6 month follow up in carers with a relative receiving treatment for a first episode psychosis, when added to specialist first-episode family work? The primary hypothesis is that carers randomised to the Altitudes online application+STAU will report significantly less stress at 6 months follow up compared with carers randomised to specialist family treatment as usual (STAU). The secondary hypothesis is that carers randomised to Altitudes will experience reduced objective stress, improved positive coping, self-efficacy, depression and perceived social support compared with carers randomised to STAU at 6-months follow up.

The glycocalyx is a particle that is important in maintaining blood vessel health. Patients with kidney disease have impaired blood vessel function, and previous studies have indicated that the glycocalyx is affected in those who have kidney disease. Laboratory studies indicate that the use of spironolactone, a common medication used for blood pressure, heart failure and to reduce protein in the urine, can have beneficial effects on the glycocalyx. The purpose of this study is to assess if the glycocalyx is affected in people who have kidney transplants, and whether spironolactone has any additional protective benefits on the glycocalyx.

Chronic obstructive pulmonary disease (COPD) is characterised by chronic inflammation of the airways and obstruction to airflow in the lungs, resulting in dyspnoea, chronic cough, and sputum production. The GOLD guidelines define mild COPD as a post-bronchodilator forced expiratory volume in 1 second (FEV1) to forced vital capacity ratio less than 0.7 and an FEV1 greater than of equal to 80% predicted. With COPD being a progressive and irreversible disease, disease management in the earlier stages is of great importance in order to optimise long term outcomes. People with mild COPD already have dynamic hyperinflation, impaired gas exchange and increased dead space ventilation which are associated with exercise limitation and fatigue. Also, a reduction in physical activity levels develops early in COPD, even before patients are diagnosed with the disease. According to a study exploring physical inactivity in patients with COPD, people with mild COPD were found to have 13% reduction in step counts and 47% reduction in time spent in moderate physical activity compared to healthy subjects. This is significant because lower physical activity levels are associated with increased mortality and increased hospitalisation in people with COPD. Pulmonary rehabilitation (PR) is an eight-week program involving exercise training, education and support. In our previous research, we developed a home-based model of PR for people with moderate to severe COPD. Our findings suggested promising results in improving physical activity levels and enhancing health related quality of life. People with even the mildest forms of COPD have been shown to have markedly reduced levels of physical activity. We believe that the benefits attained in our home based program for patients with more severe disease may also be achieved in people in the early-stages of COPD. As most individuals with early-stage COPD are managed in primary care (and many are still working), a home-based PR program may be more acceptable for this patient group. We hypothesise that a. pulmonary rehabilitation will result in clinically important improvement in six minute walk distance in people with GOLD stage I COPD; b. PR will improve dyspnoea, quality of life, and physical activity in GOLD stage I COPD. In this RCT we will recruit 58 people diagnosed with early stage, mild COPD according to the Global Initiative for Chronic Obstructive Lung Disease guidelines. Participants will be randomised to receive either usual care or home-based pulmonary rehabilitation program. Clinical measures will be recorded at baseline, 8 weeks-time point and 6 months. Outcome measures will include exercise capacity using change in 6 minutes walk distance, physical activity levels objectively measured by the sense wear armband (SWA), health related quality of life measured by change in the Chronic Respiratory Questionnaire and change in dyspnoea measured by the Modified Research Council Scale.