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Safety of a new variety of barley for participants with coeliac disease
The objective of this study is to determine if the ULG hull-less barley developed by CSIRO is safe for consumption by participants with coeliac disease (CD). The secondary objective is to determine if the fibre-containing characteristics of the ULG barley improves the bowel health of participants. In addition there is limited published information about the effects of barley gluten on coeliac participants as most relates to wheat. This study will add to the barley-related literature.
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How health labels affect behavioural intentions and perceptions of illnesses.
How clinicians describe a health problem influences the health decisions of patients. A recent systematic review (Nickel, et al., 2017) identified seven studies that provided participants with hypothetical scenarios that described health conditions. Each condition was described using two or more differing terminologies (medicalised or descriptive). For example, when a participant read a hypothetical scenario about polycystic ovary syndrome (PCOS), when the participant was given the name of the health condition (PCOS) compared with the description of a ‘hormonal imbalance’, they were more likely to have an ultrasound (Copp et al., 2017), or when told in the scenario their child had Gastro-oesophageal reflux compared with only a description of symptoms, participants had greater intention to treat the condition with medication (Scherer et al., 2013). These studies share several characteristics: subjects were young women, scenarios were hypothetical, and both investigated a single illness potentially prone to overdiagnosis. But they can only speculate on possible cognitive processes driving subjects’ decisions because they lack mechanisms to formally test possible psychological factors driving the changes in intentions. Using four hypothetical health conditions (each with a diagnostic labelled version and a description only version) we will analyse between group differences of participants intentions to undertake further tests. We will also report differences in satisfaction and confidence in decision making and explore the effects of participant characteristics (personality, health locus of control, regulatory focus, medical minimiser/maximiser), risk orientation, risk perceptions and stigma on intention to undertake further tests. Drawing from the extensive body of research on ‘perceptions of risk’ (Slovic 2000) and stigma (Brakel 2006), we will also explore differences in perceptions of risk between labelled and description only scenarios for each of four illnesses. Finally, we will conduct exploratory analysis of whether intentions to pursue follow on tests (as well as satisfaction and confidence in decision) differ by illness condition as well as by label versus description only. References: Nickel B, Barratt A, Copp T, Mynihan R, McCaffery K. Words do matter: a systematic review on how different terminologies for the same condition influences management preferences. BMJ Open 2017 Copp T, McCaffery K, Azizi L, Doust J, Mol BWJ, Jansen J. Influence of the disease label ‘polycystic ovary syndrome’ on intention to have an ultrasound and psychosocial outcomes: a randomised online study in young women. Human Reproduction 2017 Scherer LD, Zikmund-Fisher BJ, Fagerlin A, Tarini BA. Influence of “GERD” label on parents’ decision to medicate infants. Pediatrics 2013 Slovic P. (2000) The Perception of Risk. Brakel WH. Measuring health-related stigma – A review of the literature.
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Four-way crossover study to determine the safety, tolerability, and pharmacokinetics of ECs315 administered as a single or multiple sublingual wafer and oil to healthy volunteers
To determine the pharmacokinetics and safety of ECs315 wafer in healthy volunteers.
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Evaluating an enhanced care program (for You For Life Tapestry) for Australian residential aged care.
Background: Royal Freemasons has developed an enhanced care program that emphasises the ‘transitions’ that residents experience in their journey in residential aged care. This program is called ‘For You For Life Tapestry’ (or just ‘Tapestry’). Elements of this program were evaluated in a pilot case-control study (Melb Health Negligible Risk Research Approved Project QA2014215), with positive outcomes. Royal Freemasons is now expanding this project by integrating the Tapestry program into existing routine care at multiple Royal Freemasons aged care facilities in Victoria, as part of a quality improvement service. Royal Freemasons has partnered with the National Ageing Research Institute (NARI) to assist with the quality assurance and research evaluation of this Tapestry program. Rationale for the study: Elements of the Tapestry program have been successfully piloted and evaluated. However a number of limitations warrant a larger more comprehensive evaluation. The pilot was short in length and small in sample size. Residents in the pilot were not systematically followed at regular time points over a sufficiently long time frame. The pilot also did not evaluate how the program impacted the families of residents. This two year project (ending June 2019) will address the limitations of the pilot by implementing and evaluating the Tapestry program in seven urban and regional Victorian residential aged care facilities. The implementation of the program includes the Transition Map scale (developed for the Tapestry program), Cumulative Illness Rating Scale Geriatrics (CIRS-G, an existing scale), and a resident goal care plan (developed for the Tapestry program), as well as systems and policies to support the integration of the Tapestry program with existing care. NARI will evaluate outcome measures of the Tapestry program integration that is being implemented by Royal Freemasons. This research study will evaluate the Tapestry program at seven Royal Freemasons residential aged care facilities. This program aims to better equip RESIDENTS and RELATIVES to make informed choices and timely plans, realistic resident goals, and accept that some treatments may be non-beneficial and should be avoided. Participating RESIDENTS will be regularly evaluated on a number of outcome measures for one year. Outcomes include quality of life, functional status, health and medical outcomes (including number of hospital admissions and number of potentially non-beneficial treatments), resident goal plans, and RELATIVE satisfaction with care and communication. After the implementation of the program, the primary hypotheses are: (1) improved RESIDENT quality of life, and appropriate and achievable goals at 12 months, (2) decreased RESIDENT hospital admissions and reduced non-beneficial treatments at 12 months, (3) RELATIVES report improved satisfaction with care and better communication
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Intraperitoneal instillation of local anaesthetic (IPILA) in laparoscopic bariatric surgery
Effective postoperative pain management continues to be an issue in laparoscopic surgery including gastric bypass. The aim of this study is to evaluate the efficacy of intraperitoneal nebulisation of ropivacaine to reduce post-operative pain in patients undergoing gastric bypass surgery.
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Rolling it out: Intervention to improve driving cessation outcomes for people with dementia and their families across metropolitan and regional areas
This project investigates the effectiveness of the evidence-based driving cessation intervention for people with dementia and their family members who are retiring from driving, through a cluster randomised controlled trial. Stopping driving impacts health and quality of life for people with dementia and their care partners, and poses considerable challenges to health professionals who monitor driving issues. Although a diagnosis of dementia does not immediately disqualify someone from safe driving, eventually they will need to stop. Without intensive practical and emotional support to plan for, and eventually, cease driving, people with dementia are at high risk for depression, anxiety, grief, social isolation, unsafe and unlicensed driving and injury. We have developed a comprehensive support- and education-based intervention targeted at people with dementia and their care partners and family members to manage the transition from driving to non-driving status. The intervention is a translation of a proven driving cessation intervention for people without cognitive decline (CarFreeMe, formerly UQDrive) and is based on what people who have experienced driving cessation said that they needed to adjust, and stay active and engaged. The intervention is unique in that it is focused on both the practical and emotional issues that are experienced as a result of driving cessation. The intervention includes seven modules that cover education and practical support, delivered by an experienced health professional who is trained in CarFreeMe delivery. It is anticipated that trained health professionals will deliver the intervention to people with dementia and their families in their homes and/or community settings. The intervention is individualised according to geographic location and the particular needs and preferences of participants and is intended to be flexible. The individualised program involves a combination of one-to-one sessions, groups, practical outings and activities with a local experienced health professional, as well as home-based independent written and verbal activities.
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Asking the right questions about attention-deficit hyperactivity disorder in children: evaluating the impact of a novel question prompt list
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.
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Establishing an Australian reference range for patients with Parkinson’s disease and healthy controls with F-DOPA Positron Emission Tomography.
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.
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An observational study of functional screening tests in people with cervical dystonia.
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. .
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Female urinary tract fistula following pelvic surgery
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.