ANZCTR search results

This study will evaluate the impact of a novel question prompt list (QPL) for parents of children with attention-deficit hyperactivity disorder (ADHD) on their communication with their child’s doctor, and health outcomes such as adherence. The QPL aims to increase parent question asking and information sharing between clinicians and parents; improve parents’ ADHD knowledge across the developmental lifespan of their child; and thus improve adherence to medication in children with ADHD. A cluster randomised controlled trial will be used to evaluate the impact of the QPL. Paediatricians (n=26) will be recruited nationally; and randomly allocated to either the attention control group (whose patients will receive a published information leaflet about ADHD) or the intervention group (whose patients will receive the QPL to use with the paediatrician during the consultation). Intervention group paediatricians will “endorse” use of the QPL during the consultation. Both consultations will be audio-taped. Data will be collected from all parents/carers at four time points: a) baseline (prior to their next consultation), b) up to/approximately 7 days after the consultation when the QPL is first used, c) up to/approximately 7 days after their next consultation when the QPL is again used (about 1-6 months later), and d) 12 months after baseline.

We propose to perform F-DOPA PET scans in 10 healthy volunteers and 20 participants with typical features of Parkinson’s disease (PD). Each will undergo an F-DOPA PET/CT scan. The healthy participants will also undergo an MRI scan to identify brain structures. Analysis of these scans will allow us to estimate how sensitive this PET scan is in discriminating between Parkinson’s disease and healthy people with no evidence of Parkinson’s disease. The collected data will assist in establishing Australian reference ranges which will assist in future analysis of these PET scans for patients with Parkinson’s disease.

This study aims to assess balance, function, falls and gait in people with cervical dystonia (CD), using standardized physical assessment scales. Improving understanding of where people with CD differ from normal in balance and walking will allow targeted physiotherapy interventions to be developed and tested in a subsequent clinical study. Furthermore, the findings will highlight if people with CD present a falls risk similar to other movement disorder populations and provide objective methods of screening. The study will be observational in design, employing a single group of people living with cervical dystonia and will be conducted at Westmead Hospital. This study will be conducted at Westmead Hospital, in the Physiotherapy department. Adults with CD of unknown cause who can walk unaided are invited to join. Interventions: Participants will be assessed by 2 physiotherapists on a series of physical assessments of balance, walking and upper arm function. Participants will also be asked to complete 3 questionnaires on fear of falling and usual physical activity. The assessment will be conducted in the same week as scheduled Botox injections, to reduce the effect of botox on the assessment results. Participants who are able will be asked to return for a second assessment of the same physical scales within the same week. Finally, participants will be asked to complete a falls diary for the next 6 months, noting any falls they have had and the circumstances surrounding the fall Data will be compared with data from healthy people and data from people with other neurological conditions. .

Low urinary tract fistulas is an uncommon complication of pelvic/gynaecological surgery. It presents with urinary incontinence. As it is uncommon, some clinicians may not include this condition in the differential diagnosis of urinary incontinence following surgery. Therefore, some women with this condition may have had a number of investigations with a lag time from symptoms to diagnosis and hence, a delay in treatment of the fistula. This study will review the women's history, antecedent procedure, time of onset of urinary incontinence after surgery, type and number of investigations for the urinary incontinence, time-lag between symptomatology to diagnosis and referral for management. The aim is to provide clinicians with a recommendations for more accurate diagnosis to allow expeditious referral and management of the urinary incontinence due to the fistula.

This is a study evaluating the safety, tolerability and efficacy of CS1003, an new antibody therepy, in participants with advanced, relapsed or refractory solid tumours. Who is it for? You may be eligible for this study if you are aged at least 18 years old and have a confirmed advanced or metastatic tumour, for which treatment is not available, not tolerated or refused. Study details All participants in the study will receive intravenous treatment with the study drug CS1003. The dose may vary depending on when the participant joins the study. A number of tests will be performed, including physical examinations, electrocardiograms, blood and urine tests, CT and/or MRI. It is hoped this study will contribute important safety and efficacy information for this new treatment.

Sleep problems are estimated to effect between 20-30% of children internationally, with immediate and longer-term impacts on physical health, learning, behavior and family functioning. Current evidence identifies early childhood as a critical period for intervention strategies to avert sleep problems and establish positive lifetime health trajectories. Childcare is an integral part of most children’s early life experience, and provides a point for promotion of sleep health and early interventions for sleep problems. The benefit of early intervention in childcare to improve sleep health and address specific sleep problems has not been tested. The aims of this study are to establishing the fidelity of conducting a gold standard RCT of an educator focused professional development sleep intervention program (Choosing Rest) in childcare settings and estimate the effects of an educator focused professional development program (Choosing Rest) in reducing the severity and/or incidence of sleep problems in young childhood. We hypothesis that children in the intervention group will demonstrate a larger mean reduction in the severity and/or incidence of objectively measured sleep problems from pre- to post- intervention when compared to those in the control (treatment as usual) group. This study will integrate objective measurement of sleep patterns and sleep problems via actigraphy to a concurrent randomized control pilot trial testing the fidelity of a of a professional development program aimed at improving sleep practices in childcare settings. Pre- and post- intervention actigraphy (N=150 children aged 1-5 years) will be used to measure 24-hr sleep-wake patterns continuously across a 1-week period. If successful, this trial will lead to the application of a gold standard RCT study to provide evidence to support implementation into Australian childcare practice.

This experiment is designed to assess cortical and neuromuscular mechanisms involved in control of leg muscles and how these are modulated by standing on a vibration platform. The study will help us to understand the effect of whole body vibration on the contribution of cortical function and reflex pathways to maintaining balance during quiet standing. This may have implications with regard to prescription of whole body vibration for enhancing exercise prescription that leads to improved function of lower leg muscles for young and older individuals. This may have important implications for optimisation of exercise for strength, endurance and balance. Volunteers will attend the lab on two occasions. During one visit they will undergo transcranial magnetic stimulation in a standing position with feedback about their muscle activation level, and without the feedback. They will then stand on the vibration platform for 5 minutes with breaks after each minute and repeat the brain stimulation tests. On the second occasion they will lay on a massage table while the tibial nerve is stimulated with an electrical pulse to measure H reflex. They will again stand on the vibration platform for 5 minutes with breaks after each minute and repeat the H reflex test.

The aim of our study is to examine the efficacy and safety of auto-titrating continuous positive airway pressure devices (CPAP) when compared to standard of care fixed-pressure CPAP in patients with obesity hypoventilation syndrome with concurrent severe obstructive sleep apnoea who are suitable for CPAP therapy. We hypothesis that auto-titrating CPAP is not inferior to CPAP with respect to improvements in ventilatory failure (measured by arterial CO2 tension), sleep quality, quality of life as well as a number of cardiovascular biomarkers.

While invasive coronary angiography (ICA) remains one of the most commonly performed procedures in Australia, currently exceeding >100,000 admissions per annum, we have demonstrated >7-fold geographic variation in its use, and only ~27% of these procedures are performed in the context of its core indication of type 1 myocardial infarction (T1MI). Compared with other similar OECD countries, ICA use in Australia is high despite comparable rates of ACS, suggesting that the “appropriateness” of ICA use is sub-optimal in Australian clinical practice. Appropriateness of care depends on three “sufficient” conditions: 1. The patient needs to be at sufficient risk of specific clinical events to warrant the treatment; 2. The treatment must be of sufficient efficacy in reducing relevant events; and 3. The treatment strategy must be of sufficient value to the patient (i.e. absolute benefits versus side-effects, complications and economic costs) Anatomical investigation of the coronary arteries is of proven benefit in directing care and improving outcome in T1MI, but the appropriateness of such investigations in type 2 myocardial infarction (T2MI) and myocardial injury, where there is high risk of cardiac mortality and high competing risk of death from other causes, is unknown. As such, clinical equipoise remains. To date, few studies formally integrating risk assessment into the strategy of coronary investigation and management have been undertaken. A randomised trial of routine early angiography versus conservative management that carefully evaluates baseline patient risks and competing risks, is critical to the development of robust recommendations for these common high morbidity and mortality patients. This study will comprehensively evaluate the clinical impact, and economic value of early anatomic coronary investigation in T2MI and myocardial injury within a pragmatic multi-centre randomised clinical trial.

Healthy eating can assist people with Type 2 Diabetes Mellitus (T2DM) to achieve and maintain glycaemic control, thereby lowering their risk of developing diabetes-related complications. A dietary pattern rich in whole-grains, fruits, vegetables, legumes, and nuts; moderate in alcohol; and low in refined grains, red or processed meats, and sugar-sweetened beverages has been shown to improve glycaemic control in people with T2DM. Consequently, a key feature of international T2DM management recommendations is to eat healthy foods that provide a high-quality diet. People with T2DM have been identified to have low-quality diets, despite recommendations to eat healthy foods. However, it is currently unclear whether people newly diagnosed with T2DM change their diet quality after diagnosis, nor if they maintain positive changes over time. No research has quantitatively explored changes in diet quality after diagnosis, and the factors (demographic, physical and psychosocial) that predict sustained improvements. Therefore, there is no evidence as to whether diet quality remains fixed once an individual is diagnosed with T2DM, or whether there are periods of marked dietary change. There is a clear need to investigate how diet changes over time so targeted strategies can be developed to facilitate improved glycaemic control. Therefore, the aims of the proposed study are to; (i) Describe diet quality changes in the 12 months following T2DM diagnosis. (ii) Identify the demographic, physical and psychosocial predictors of sustained improvements in diet quality defined as an increase in Dietary Approaches to Stop Hypertension (DASH) score of 3 points.