ANZCTR search results

Up to two thirds of patients after stroke have swallowing problems. Patients with swallowing problems typically have worse health outcomes, reduced nutrition and hydration and poorer quality of life. Swallowing rehabilitation includes swallowing exercises which can improve swallowing ability. However, there is limited evidence about what dosage, or amount of swallowing intervention is most beneficial for patients. This project will investigate the effect of increasing the dosage of swallowing intervention for patients with swallowing problems after stroke. The project will recruit 15-20 adults with swallowing difficulties after stroke from an inpatient rehabilitation hospital. Participants will receive daily swallowing intervention (five days per week) with a high dosage of swallowing exercise repetitions per session during their inpatient stay. Intervention will involve typically used rehabilitative swallowing exercises as identified by a medical record audit. Change in oral intake, functional and instrumental swallowing assessments, muscle strength and quality of life outcome measures will be taken. Results will be compared before and after intervention. Results will also be compared with a historical control group of adults with post-stroke swallowing difficulties who received the same swallowing intervention at a lower dosage (i.e. mean of two-three days per week). We will also investigate patient experiences of high-dosage swallowing intervention and perceived barriers and facilitators to achieving high-dosage swallowing intervention through semi-structured interviews.

The study is looking for participants that are required to have abdominal surgery, liver resection, or liver transplantation. Portal hypertension is an increase in blood pressure in the portal vein; the blood vessel that carries blood within the gastrointestinal tract to the liver. Portal hypertension is a condition that is present in individuals with cirrhosis of the liver and other liver diseases, and assessing the degree of this condition is important for prognosis, risk evaluating, and to guide appropriate treatment. This is done by calculating a portal pressure measurement. The current gold standard for measuring portal hypertension is the ‘Transvenous technique’; however, this is a technically limiting procedure with potential complications, and may only provide indirect measurements of portal pressure. We aim to assess the safety and efficacy of measuring portal pressure via an ‘endoscopic ultrasound technique’ (EUS). Compared to the Transvenous approach, this method is new but is deemed relatively safer and more accurate. We are particularly interested in comparing the clinical outcomes of the two techniques, and to determine that the EUS approach for measuring portal hypertension is much more useful in predicting surgical and survival outcomes for liver disease patients. The study will not only determine the usefulness and safety profile of the EUS portal pressure measurement, but could also open up a whole new diagnostic approach for the majority of patients with liver diseases. We hypothesise that: (i) EUS technique for portal pressure measurement can predict clinical outcomes and survival in cirrhotic patients who undergo abdominal surgery, liver resection or liver transplant; and (ii) EUS technique for portal pressure measurement is safe and feasible.

This project aims to see how well a multi-component intervention can increase influenza vaccination for children and adolescents who are medically at-risk from severe influenza disease. The Flutext-4U intervention components at the tertiary, primary care and parent levels e.g. SMS reminders for parents; reminders for WCH specialists to discuss and/or deliver vaccines; and communication from the tertiary provider to the child's GP about influenza vaccination. Study participants are WCH specialists, GPs and parents. This single-site trial will provide the tertiary-level intervention components to a group of parents (trial arm#1), while another group will additionally receive primary care level and parent level intervention components (trial arm #2). Parents (of children identified as medically at risk of serious influenza disease) will be randomly allocated to either group. The study will test the intervention by comparing both groups and will use immunisation records to assess vaccine uptake. At the end of the intervention period, the study will also use an SMS survey to assess vaccine uptake; acceptability of the SMS reminders to get their child vaccinated; whether they would want to receive SMS reminders in the future; their most convenient place to receive the vaccine and what prompted vaccine receipt.

The primary purpose is to evaluate how long a single hand disinfection lasts.

This is a Phase 1 Open Label Crossover study of ML-004-ER, an extended release drug product (intended for use in the management of patients with autism spectrum disorder), in adult healthy volunteers that characterise the bioavailability and pharmacokinetic profile of single dose under fasted and fed conditions. Each participants will receive a single oral dose of ML-004-ER prior to or following a designated meal, and the pharmacokinetic profile will be assessed for up to 24 hours to assess the impact food has on the rate and extent of absorption.

A randomized, placebo-controlled Phase 2a study to test the efficacy and safety of cilnidipine alone and in combination with tadalafil in participants at least 18 years of age diagnosed with severe secondary Raynaud’s disease (Raynaud’s Condition Score [RCS] greater than o r equal 40 and at least a 2-phase colour change in fingers of pallor, cyanosis, and/or reactive hypermedia in response to cold exposure or emotion) mostly resulting from SSc and exhibiting regular and frequent RP attacks (averaging at least one attack per day) during the Screening period. Double-blind, Placebo-controlled, Parallel-group, Dose Selection to assess the safety and efficacy of two doses of cilnidipine (10 mg and 20 mg), alone and in combination with tadalafil. Participants will be randomized to one of six prespecified treatment arms. During the study 36 participants will receive treatments in a blinded fashion. Placebo tablets (matching cilnidipine) and placebo capsules (matching tadalafil), for oral administration, will be provided to the site as well as the investigational treatments (cilnidipine and tadalafil). Medications will be dispensed during the preceding in-clinic study visit for self-administration by the participant. Each Dosing Period will last for 12 days (allowing for a variance window of -2 days [d10] or +2 days [d14] ) in which participants will take daily doses of assigned treatment in the morning. For each day of dosing, participants will take one capsule and one tablet to blind the active therapy being received. Dropouts will not be replaced. Primary Efficacy Endpoint: Percentage change from baseline in frequency of weekly RP attacks. Safety Endpoints: Incidence of adverse events (AEs) and serious adverse events (SAEs), including clinically significant vital signs from the time of randomization until 7 days following the last protocol dose.

It is currently estimated that approximately 35% of all dementias can be attributed to risk factors that are highly modifiable, including low mood, poor sleep, poor heart health and low cognitive/social engagement. The BetterBrains trial will test whether remotely delivered (via online, telephone and smartphone application) person-centred education and lifestyle behaviour change strategies, targeted at modifying these four risk factor clusters, can prevent cognitive decline in middle-aged adults aged between 40 – 70 years. The trial will recruit 1510 people living in the community throughout Australia. Of these people, 755 participants will be randomised to the intervention group and will receive the personalised BetterBrains program, while the other 755 participants will receive health education materials about dementia risk reduction. We hypothesise that a higher proportion of participants randomised to the BetterBrains program will show a favourable cognitive outcome at 24-months than those randomised to the control group.

This study builds on pilot work testing 2- and 3-session perfectionism programmes with early adolescents which found improvements in emotional problems, self-imposed perfectionistic standards (sustained at 4-week follow-up), and well-being, sustained at 3-month follow-up (Fairweather-Schmidt and Wade, 2015; Vekas & Wade, 2017). The modified programme for the current research expands the pilot programme to a 5-lesson perfectionism intervention led by teachers which include an emphasis on the difference in pursuing excellence and pursuing perfection to Year 8 and Year 9 students universally. To date no research has examined whether perfectionism interventions can increase intrinsic motivation and there have been no perfectionism interventions led by teachers. Research objectives 1. To examine the impact of the LIFE curriculum on primary (perfectionism) and secondary (anxiety, depression, wellbeing, self-compassion, academic motivation) outcomes. 2. To test whether improvements in certain outcome factors (anxiety, depression, well-being, academic motivation, self-compassion) are moderated by the following outcome factors: level of perfectionism, self-compassion and sex. We hypothesize that the intervention group will experience significantly greater decreases in perfectionism, anxiety, and depression, and significantly greater increases in wellbeing, self-compassion and academic motivation at follow-up. We also hypothesize that decreases in perfectionism and increases in self-compassion between baseline and end of treatment will moderate the association between group and follow-up changes in anxiety, depression, well-being and academic motivation.

Antipsychotics are commonly prescribed for behavioural and psychological symptoms of dementia (BPSD) and delirium despite serious short and long term risks. Australian guidelines recommend limiting use in these situations to 12 weeks due to evidence of increase risk of stroke and sudden death with prolonged prescribing; however the prevalence of use beyond this time frame is high. A Macquarie University study cited at the 2020 Australian Royal Commission into Aged Care Quality and Safety, showed 65% (n=5825) of aged care facility residents prescribed antipsychotics for BPSD, remained on treatment for an average of 30 weeks. Pervasive and inappropriate use of antipsychotics (among other ‘restrictive practices’) was a key finding of the Royal Commission’s Interim Report, negatively impacting patient outcomes, quality and dignity of life. Reducing antipsychotic use requires multifactorial approaches including systems to support non-pharmacological interventions. Whilst not all of these are addressed in this study, increasing patient/carer understanding of evidence base and best practice use of antipsychotics addresses a key element, centered on patient/carer empowerment. This project aims to evaluate the impact of changes to hospital standard care, including increased GP and specific patient/carer engagement on the use of antipsychotics after hospital discharge. We predict it will have an impact of reducing antipsychotics prescribed (either dose or complete deprescribing) at 12 weeks after hospital discharge.

Chronic Low Back Pain (CLBP) is a major health issue worldwide. Pain-related fear and activity avoidance are the most recognised barriers to recovery. Virtual Reality-based Cognitive Behavioural Therapy (VR-CBT) is an emerging exercise and education approach designed to better target fear and activity avoidance through graded exposure to movement by simulating an engaging environment, and reinforcing positive pain beliefs through education and augmented video feedback on performance. This project aims to evaluate the outcomes of VR-CBT on 1: fear-avoidance beliefs, reported pain; and 2: trunk movement; and 3: physical activity, in individuals with CLBP. The participants will be a single cohort of 37 individuals (18-65 years) with CLBP and at least moderate fear avoidance beliefs, quality of life and pain severity. These participants will be recruited through the RBWH Physiotherapy Department. This will be a repeated measures single-arm study. The expected outcomes are: the addition of VR-CBT to standardized PNE alone will reduce reported pain and fear-avoidance beliefs, increase trunk movement and walking speed, and increase physical activity levels during daily life among individuals with CLBP and pain-related fear of movement.