ANZCTR search results

The Global Initiative for Asthma (GINA) and various national guidelines have recently recommended the use of Symbicort (a combination inhaled corticosteroid or ICS and long acting beta2 agonist formoterol or FORM) as-needed as an alternative treatment strategy (track-1) for patients with mild asthma. The existing evidence comparing regular ICS plus a short acting beta2 agonist (SABA) as-needed with ICS/FORM as-needed in GINA Step 2 asthma patients, however this data is limited to only four clinical trials. These have consistently demonstrated benefits in favour of regular ICS plus SABA as-needed in terms of symptom control and lung function improvement compared to ICS/FORM as-needed. An open-label study demonstrated a significantly greater reduction in forced exhaled nitric oxide (FeNO) with regular ICS plus SABA as-needed compared to ICS/FORM as-needed despite suboptimal adherence of 56% to twice-daily ICS. This suggests that regular ICS plus SABA as-needed provides more effective attenuation of inflammation compared to ICS/FORM as-needed in patients with mild asthma. To date there is no evidence evaluating the effect of ICS/FORM as-needed on airway hyperresponsiveness (AHR) a key feature of asthma that identifies active asthma. Thus, based on the established understanding of the mechanisms of attenuation of indirect AHR to inhaled mannitol, the hypothesis of this study is that regular ICS plus SABA as-needed suppresses AHR more effectively than ICS/FORM as-needed.

PICNIC aims to influence parents feeding practices and infant/child quality. The PICNIC study is a peer education model with peer educators supported by a website and social media. New parents with an infant aged 0-2 living on the Mid North Coast of NSW who consent to the project will receive an intervention over 12 months including online workshops, discussion groups, participant forums, and social media messaging, in view of on-sharing feeding information within their social and family networks. This study will use a progressive recruitment strategy within health services, through previous participants and online. Parents feeding practices will be measured when they start the project then again at 6 and 12 months to measure any changes. Parents feeding practices at 12 months will be compared with population data. Participants will complete a diet survey at 24 months after they first participated in the study and this will be compared against population data. Participants will work together with the research team (participatory action research) to guide ongoing intervention characteristics, to ensure modification and adaptation of the project model in partnership, consideration of participant and group characteristics. Over the intervention period the research team will provide opportunities for networking, consultation and input into all aspects of the program. Data will be collected in a number of methods including focus groups, participant correspondence, including social media forum activity.

Individuals with MS and migraine can face difficulties with thinking skills (e.g. concentration and memory), mood, fatigue, work and social activities. However, to date, there has been no CBT program developed that is specifically tailored to these difficulties for individuals with MS and migraine. The project aims to assess how feasible and acceptable such a CBT program would be among people with MS and migraine. The brief cognitive behavioural therapy program will be conducted in five sessions across, with one-hour weekly sessions and a follow-up phone call 4-weeks later. The study will be conducted entirely on telehealth via internet, so participants can attend from home. Sessions will be on a one-on-one basis, with a neuropsychology registrar. The CBT program itself targets reducing the frequency and intensity of migraines, and in turn improve fatigue, low mood, anxiety, thinking skills, and work and social functioning. The techniques learnt in therapy aim to prevent migraines from occurring and when they do occur, lessen their impact on daily life. This CBT includes education about migraines, relaxation strategies, skills to adapt negative thoughts, and strategies to manage thinking skills difficulties (e.g. with concentration).

Insomnia and obstructive sleep apnoea (OSA) are the two most common sleep disorders in Australia. In fact, in up to 40% of people with either insomnia or OSA, the two disorders co-occur, known as COMISA (Comorbid Insomnia and obstructive Sleep Apnea). However, it is not fully understood why insomnia and OSA co-occur so often nor how sleep disturbance due to the combination of insomnia and OSA impacts an individual's cognitive functioning. The aim of this study is to better understand the connection between insomnia and OSA by examining how the gold-standard intervention for insomnia, cognitive behavioral therapy for insomnia (CBT-I) impacts 1) OSA severity as well as 2) the underlying factors which are known to cause OSA. This study will also investigate the impact of CBT-I on cognitive functioning suspected to be impacted due to sleep disruption and sleep disorders. It is hypothesized that 1) CBT-I will increase the arousal threshold to respiratory events and 2) this in turn will be associated with a reduction in OSA severity in patients with COMISA. Additionally, it is predicted that CBT-I will also be associated with an improvement in cognitive functioning. By undertaking this research, we may better understand how insomnia and OSA interact and how to treat these conditions more effectively.

Melioidosis, an infection caused by the bacterium Burkholderia pseudomallei, can affect any organ and be rapidly fatal. The management of melioidosis is complex; antibiotic therapy occurs in two phases – an intensive phase of intravenous antibiotics followed by an eradication phase of oral antibiotics. Even with effective antibiotics, melioidosis can recur. As adhering to prolonged oral antibiotics is challenging, melioidosis treatment guidelines have evolved to recommend a longer intensive phase. This has resulted in excellent cure rates and recurrence is now uncommon, even in people who take no oral antibiotics at all. This pilot randomised control trial will investigate if oral antibiotics are still needed in the treatment of melioidosis and aims to provide initial data to support a larger, randomised control trial. We will recruit 60 participants with melioidosis and allocate them to either standard therapy or short course therapy (intravenous antibiotics only). Participants will be contacted weekly for 90 days and at one and two years to assess for disease recurrence. We hypothesise that with prolonged intravenous antibiotics, further oral antibiotics are no longer required to cure melioidosis and prevent recurrence.

Background: First Nations children hospitalised with acute lower respiratory infections (ALRIs) are at increased risk of future bronchiectasis (up to 15-19%) within 24-months post-hospitalisation. An identified predictive factor is persistent wet cough a month after hospitalisation and this is likely related to protracted bacterial bronchitis which can progress to bronchiectasis, if untreated. Thus, screening for, and optimally managing, persistent wet cough one-month post-hospitalisation potentially prevents bronchiectasis in First Nations’ children. Our study aims to improve the post-hospitalisation medical follow-up for First Nations children hospitalised with ALRIs and thus lead to improved respiratory health. We hypothesize that implementation of a strategy, conducted in a culturally secure manner, that is informed by barriers and facilitators identified by both families and health service providers, will improve medical follow-up and management of First Nations children hospitalized with ALRIs. Methods: Our trial is a multi-centre, pseudo-randomized stepped wedge design where the implementation of the strategy is tailored for each study site through a combined Participatory Action Research and implementation science approach informed by the Consolidated Framework of Implementation Research. Outcome measures will consist of three categories related to (i) health, (ii) economics and (iii) implementation. The primary outcome measure will be Cough-specific Quality of Life (PC-QoL). Outcomes will be measures at each study site/cluster in three different stages i.e., (i)Nil-intervention control group, (ii)Health information only control group and (iii)Post-intervention group. Discussion: If our hypothesis is correct, our study findings will translate to improved health outcomes (cough related quality of life) in children who have persistent wet cough a month after hospitalization for an ALRI.

Spinal cord injury involves damage to spinal cord that causes loss of movement, sensation and physical function. Spinal cord injury is common in Australia. People with spinal cord injury live with weakness, loss of dexterity, spasticity and contracture (loss of joint range of motion). The use of electrical stimulation as a treatment modality may improve function in people with a spinal cord injury by decreasing problematic spasticity. The Mollii electrodress suit was developed to improve function in people with neurological conditions. The Mollii suit consists of long-sleeved upper and lower body garments with implanted electrodes that deliver customised low-level electrical stimulation. At present, small studies suggest that wearing the Mollii suit improves function in some neurological conditions but not others. Receiving stimulation through wearing the suit for 60 minutes may improve function and spasticity temporarily for people with a spinal cord injury, but no studies have formally investigated this. This study aims to determine if receiving stimulation through wearing the Mollii suit for a single 60-minute session produces short-term improvements in function and spasticity in people with chronic spinal cord injury.

The proposed study will investigate a novel approach to delivering naturopathy to people with endometriosis using a group visit model based on the shared medical appointment model. The study aims to assess the feasibility of a program of group-delivered naturopathic consultations specific to the needs of people with endometriosis, and to examine health outcomes for people who participate in the intervention. The study will be a non-randomised quasi-experimental design with four cohorts of 5-10 participants who will participate in a 12 week program including six fortnightly group consultations lasting approximately 2 hours per fortnight. This study hypothesises that group-delivered naturopathy will be well-received and improve health outcomes for people with endometriosis.

This project uses an advanced ultrasound technique called Shear Wave Elastography to assess the stiffness of muscles in stroke survivors. Shear Wave Elastography can determine the stiffness of tissue by measuring the Shear Wave Velocity, with stiffer tissues returning a higher velocity. After a stroke, the muscles may develop an increased stiffness which is typically assessed clinically, however SWE will be able to detect small changes more accurately and reliably than the current clinical assessment. This prospective cohort project aims to measure stiffness during the first four weeks after a stroke as the stiffness develops. A qualified Sonographer will perform the scans bedside at Sunshine Coast University Hospital. Stroke survivors will have their biceps muscle and biceps tendon scanned twice a week, for the first four weeks after their stroke. Both the affected and non-affected side will be assessed, with the elbow in both full extension, and 30 degrees flexion. It is hypothesised that as the participants stiffness develops the recorded Shear Wave velocities will increase and will correlate with the clinical assessments.

This study aims to validate the newly-developed eDIS-ICU app for the screening of delirium in adult intensive care patients. This study will be completed at five sites in three different countries (Australia, Estonia and Japan), and will recruit 700 patients total. The app will be validated against the 'gold standard' of delirium screening (DSM-V assessment by a specialist clinician), and also compared to the current standard of practice ICU delirium screening tool (CAM-ICU). If validated, the eDIS-ICU app will be freely available and able to be easily implemented and used in clinical practice by bedside clinicians will no prior training. This will assist in improving delirium screening and diagnostic rates, and thereby assist in improving patients outcomes.