ANZCTR search results

The proposed project addresses the need to improve clinical outcomes for the population at risk of uncontrolled asthma, by extending the role of pharmacists in the delivery of primary health care services through a community pharmacy. The proposed intervention involves a simple version of an evidence-based pharmacist-delivered service for patients with uncontrolled asthma, which can easily be integrated into pharmacists’ workflow. This intervention targets three key factors associated with uncontrolled asthma: (i) poor adherence, characterised by underuse of preventer medication and/or overuse of reliever medication, (ii) suboptimal inhaler technique and/or (iii) uncontrolled allergic rhinitis. To deliver the intervention, the pharmacist will undertake three private consultations with the patient over a period of 12 months (at baseline, one month and 12 months), with a six-month telephone check-up mid-program. The number of visits and the time taken for each visit has been streamlined from our previous evidence-based interventions to increase feasibility and sustainability. The trial will use a cluster randomised design to test the clinical and cost effectiveness of a pharmacy based service for asthma patients in the community. Research Question: To compare the efficacy (increase in proportion of patients with controlled asthma) and cost effectiveness of a pharmacist-delivered asthma service comprising consultations with the pharmacist over a 12-months period for people with uncontrolled asthma (group A) with a “low-level” pharmacy intervention comprising identification of uncontrolled asthma with referral to the GP (group B). Hypothesis: The pharmacist-delivered asthma service comprising four consultations with the pharmacist over a 12-months period for people with uncontrolled asthma will be more effective and cost effective than a “low level” pharmacy intervention comprising identification of uncontrolled asthma with referral to the GP.

Short bowel syndrome (SBS) is defined as having insufficient bowel to absorb the necessary nutrition and hydration to maintain weight / sustain growth. The aetiology of short bowel syndrome can be either congenital (in children) or as a result of massive surgical resections. The prevalence of SBS in Australia is not known however it is estimated there are 220 patients on home parenteral nutrition in Australia for which SBS is a major indication. Despite the low prevalence of the condition these patients are complex to manage due to chronic diarrhoea, dehydration, macro and micronutrient deficiencies and electrolyte disturbances. Many rely on home enteral or parenteral nutrition or intravenous fluid and thus have to manage the complications associated with these forms of nutrition support. Despite medical therapy, oral rehydration solutions and a modified diet, the diarrhoea and malabsorption experienced in people with SBS is difficult to manage. This is not only debilitating but may also mean people who suffer from this condition are reliant on intravenous nutrition or hydration, therapies which are associated with a poor quality of life. High Amylase Resistant Starch (HARS) is a form of starch that occurs naturally in food. It is available as a supplement and is frequently added to foods by the food industry to increase fibre content. HARS has no taste and is usually undetectable in food or drinks. HARS has been shown to decrease diarrhoea from a variety of causes including gastroenteritis and cholera. A pilot trial completed at Austin Health showed that adding 50g/d of HARS to the diet of people with SBS significantly reduced the total amount of diarrhoea per day and showed a trend towards a decreased number of bowel actions per day. Larger trials are needed to confirm this effect and determine if there are any improvements in the person’s ability to absorb nutrition / hydration as well as their quality of life. We aim to recruit 50 people with SBS across Australia and supplement their diet with 50g of HARS each day for 2 months. Stool frequency and weight, urine output, body weight, handgrip strength and quality of life will be measured. The end of trial results will be compared to the participant’s baseline results (before they started taking the starch). This study aims to determine if supplementation of HARS to the usual diet of people with short bowel syndrome will reduce the diarrhoea (frequency of bowel actions and improve stool consistency), nutrition/hydration status and quality of life. It is hypothesized that the addition of 50g per day of HARS to the usual diet of people with short bowel syndrome will decrease the amount of diarrhea they experience and in turn improve their nutritional and hydration status as well as quality of life. Any therapy which can improve the quality of life of an individual with a chronic potentially life threatening condition has huge implications for the individual.

Participants are invited to take part in a research study into ‘difficulties with thinking and memory’ in people with COPD. The objective is to investigate the incidence of cognitive impairment (difficulties with thinking and memory) in people with COPD who attend a pulmonary rehabilitation program compared to an age-matched normal population. Participants (those with COPD and the age matched normal population) will be asked to complete a questionnaire designed to assess cognitive function. the questionnaire is the MoCa (described earlier in the application)

Tuning in to Kids is an evidence based program teaching parents skills in emotion coaching where they assist their child to learn about and manage their emotions. Parents also learn to develop their own skills with regulating their emotions. This trial will test out different forms of the program for parents of children with challenging behaviours relative to control participants. A) Aims and Objectives This study will evaluate the effectiveness of three delivery methods (one-to-one, group, online) of an emotion-focused parenting program, Tuning in to Kids (TIK) compared to control with parents of 3-10 year-old children with behaviour problems. There three aims include: • Examine whether the different interventions (relative to control) improve parenting and children’s emotional, social and behavioural functioning. • To examine for whom the program works (moderators) of program outcomes in order to establish which families do best with which intervention delivery method. • To establish the evidence for three different methods of TIK delivery and making this knowledge available to professionals working with families of children with behaviour problems. B) Key Question(s) Key questions are whether the three different versions of TIK are effective in comparison to control and whether any one program is more effective. Specific hypotheses are that at 6-month follow-up, participants in the three intervention conditions (but not the control) will have: • Improved parenting (emotion socialisation, parental sensitivity, warmth, hostility/criticism), via parent self-report and direct observation of parent-child interaction; • Improved parent functioning (emotion regulation and mental health) on parent self-report; • Improved child emotional knowledge and reduced behaviour problems, measured via direct assessment and parent- and teacher-report. C) Research Design The study will use a randomised controlled design with 400 parents of 3-10 year-old children with behaviour problems, randomised into four conditions (one-to-one, group, online delivery, and waitlist control). Measurement will be taken before, immediately after and 6 months after parents participate in a parenting program. Measures include parent and teacher report plus assessment of the child and observation of the parent and child. The Tuning in to Kids program will teach parents how to emotion coach their children in order to improve children's emotional understanding and regulation. D) Analyses and Outcomes Analyses will be conducted with the data to see for whom the program works and on which factors there are changes. Findings will be reported in peer review journals and at conferences. A summary of findings will also be given to all participants.

The primary purpose of this study is to investigate the safety and tolerability of multiple doses of 67Cu-SARTATE administered to participants with meningioma. Who is it for? You may be eligible to join this study if you are aged 50 years or over. Study details: All participants in this study will be injected with a single dose of 64Cu-SARTATE (a drug molecule) to demonstrate how it is absorbed in the body. Then participants will receive individualised doses of 67Cu-MeCOSar-Octreotate ("67Cu-SARTATE")for up to 4 cycles. It is hoped that this research will develop a product, which may help patients with meningioma.

The primary purpose of this pilot RCT is to investigate whether parents of infants at risk of CP with feeding difficulties deem standard care and a new feeding therapy for infants, called “I-EAT” feasible and acceptable interventions. The secondary outcomes are to: • document the range of practices used in the standard care arm. • estimate: o volume of oral consumption, o oral feeding efficiency, o oral feeding and swallowing skills, o measures of health, and o family stress, in infants who are at risk of or have been diagnosed with cerebral palsy and have feeding difficulties, under both the I-EAT program and standard care. • perform exploratory comparisons of feeding and other outcomes between the two study arms with a view to design of a confirmatory study. Hypotheses: • We hypothesise that parents will find both the I-EAT program and standard care feasible and acceptable interventions • We hypothesise that by the end of the intervention infants receiving the I-EAT program will: o consume at least 20% more of their recommended nutrition orally, o consume at least 20% more of their recommended meal during 30 minute mealtime o require a reduction of at least one compensatory strategies required, and o be no worse on growth trajectory, incidence of aspiration pneumonia or feeding related hospitalisations. • We hypothesise that parents receiving the I-EAT program will report an improvement of at least 20% on the Feeding Swallowing Impact Survey

The main purpose of this study is to explore the levels of stress and anxiety perceived by physiotherapy students during the course of their clinical placements. Clinical placements are designed to challenge students’ learning and expose them to situations which they would not otherwise experience. The transition between university-based learning and clinical practice is challenging for many students. Developing competency in safe patient management in the clinical setting is demanding, with a noticeable gap between what is learnt in the classroom and implementing this in a clinical setting. Supervised clinical placements provide experiential learning where students gain concrete experience, and have opportunities for observation and reflection, formation of abstract concepts and practise of new skills. In our anecdotal experience, a high number of physiotherapy students report that clinical placements are a source of stress and anxiety. It is the amount of stress and an individual student’s capacity to manage it that can result in stress being either beneficial or detrimental to learning. It is currently unknown whether the perceived levels of stress and anxiety that physiotherapy students experience during clinical placement impacts on their learning, either positively or negatively, and what factors may contribute to this. The primary aim of this study is to measure the levels of stress and anxiety perceived by physiotherapy students at a number of time points across their clinical placements (acute care, rehabilitation and primary and ambulatory care) to determine if the students’ perceived levels of stress and anxiety change over the clinical placement. Secondary aims include whether any patterns emerge in the levels of stress and anxiety perceived by students and whether baseline measures of anxiety traits influence anxiety levels during clinical placements. It is anticipated that the study will provide insight into the levels of stress and anxiety perceived by physiotherapy students during their clinical placements. It is possible that patterns of perceived stress and anxiety may emerge during particular time points in the clinical placement which could be used to help inform future research and to guide time specific changes to the clinical placement framework (e.g. strategies for stress reduction, education around resilience) which in turn may enhance clinical placement experiences and optimise student learning

Stroke continues to be a major public health issue. It is the third most common cause of death. The financial cost in Australia is estimated to be $5 billion each year. Tasmania and South Australia are the worst affected States. Atrial fibrillation (AF), the most common sustained cardiac arrhythmia, is a major modifiable risk factor for stroke. AF is associated with a five times increased risk of stroke and is responsible for up to 25% of strokes in elderly adults. Recently, international guidelines and expert consensus statements have recommended more widespread screening for AF in those aged 65 years or older. The case is compelling - AF is common and a leading cause of stroke. Unfortunately, AF often has no symptoms and is commonly undiagnosed or untreated by the time stroke occurs. AF-related strokes are associated with significant morbidity, mortality, and healthcare costs, yet they are highly preventable with the use of warfarin or newer anticoagulant drugs. Given the availability of effective therapy, along with accurate and inexpensive screening technology, population-based AF screening has the potential to become an important public health program. In older age groups, identification and management of AF is the most significant way to prevent stroke. Internationally, there have been recent recommendations for more widespread screening for AF in those aged 65 years or older, as a cost-effective strategy for stroke prevention. This project will raise public awareness of AF and improve its detection, and hopefully lessen the burden of stroke in Tasmania. We intend to screen approximately 3,000 Tasmanians aged 65 years or older, and without previously diagnosed AF. Screening will take place throughout most of 2018 at a range of community venues across Tasmania. If the presence of AF is suspected, the project team will advise the participant and ensure they understand it is not a definitive diagnosis and that they should make an appointment to see their GP for review. They will be given specific information to take to their GP. The GPs of individuals with a suspected diagnosis of AF upon screening will also be directly contacted by telephone. The project team will contact each participant with suspected AF approximately one month after the screening, to ensure they have not been lost to follow-up and to determine the outcome of the initial screening. The project objectives are to: 1. Successfully develop and implement an AF public screening and education program across Tasmania. 2. Promote community awareness of AF through talks, screening events and marketing. 3. Ensure that individuals with a tentative diagnosis of AF are followed up by their GP. 4. Determine evaluation outcomes from the AF public screening program e.g. rates of detection of previously undiagnosed AF (with analyses by age and gender etc.), rates of false positives based on subsequent GP assessment, AF management initiated.

Conventional orthokeratology (OK) lenses are specialised rigid contact lenses that are worn overnight during sleep in order to reshape the front surface of the eye (the cornea) to temporarily correct mild to moderate degrees of refractive error, most commonly short-sightedness or myopia. OK lenses produce subtle changes in the curvature and power of the cornea, in the order of microns of change, when worn overnight. When the lens is removed on awakening, the reshaped cornea is now able to correct the vision of the patient during the day. The reshaping effect is temporary, and the cornea returns to its original shape and power if overnight lens wear is discontinued. Conventional OK lenses produce a single central zone of altered corneal power, and are usually used for refractive correction of simple myopia. Multifocal OK (MFOK) lenses differ from conventional OK lens designs in that the back surface design of the lens is modulated to produce a multifocal effect on corneal shape. In other words, the lens is designed to induce annular regions of alternating corneal flattening and steepening which result in concentric rings of varying corneal surface power. Contact lens designers claim that this produces a multifocal defocus effect on the neural layer of the back of the eye, or the retina, which is potentially useful for correcting presbyopia (poor reading vision), and for reducing myopic progression in children. There are no published data on the fitting performance of MFOK lenses of differing designs. For a MFOK lens to be effective for its optical purpose, in correcting or controlling refractive errors, the corneal reshaping effect must be centred over the pupil, and the corneal reshaping induced by overnight lens wear must produce the desired changes in corneal power. The research proposed here will investigate these aspects of MFOK lens performance, to determine the potential for various designs of MFOK lens to be useful for their refractive purpose in long term use.

5 Fluorouracil (5fu) is administered in combination with leucovorin (LV) to enhance clinical activity. However, simultaneous administration is not possible because 5FU and LV are chemically incompatible. Collectively, these adverse events lead to poor patient outcomes due to treatment interruption and discontinuation. Deflexifol, an all in one formulation of 5FU/LV with cyclodextrin (HP-ß-CD 100mg/ml, 5FU 15mg/ml & LV 1mg/ml) at physiological pH, was developed as an alternative. This trial is to test the safety and efficacy of Deflexifol when given as a bolus or infusion to patients that have failed standard of care. The main outcome of this trial is to establish the safety and efficacy of Deflexifol and determine a suitable dose for further study in a phase II trial