ANZCTR search results

By age 10, 1 in 5 children (~51,000 Australian children) will sustain a concussion and present with post-concussive symptoms (PCS) requiring medical treatment. Many children and youth recover rapidly from these symptoms and are symptom free and returned to pre-injury activities within 4 weeks. In contrast, ~40% of children suffer ‘persisting PCS’ (PPCS), defined as 2 or more PCS lasting more than 4 weeks. This group of children have limited tolerance for routine academic, sport/leisure and social activities and are unable to return safely to these activities. Despite their debilitating impact, intervention trials addressing PPCS in children are lacking. We propose a randomised trial of a novel multimodal intervention to reduce the burden of debilitating PPCS for the ~40% of children who experience delayed recovery after concussion. Participants with PPCS at 2-3 weeks post-injury will be recruited and randomised to either active (CE) or usual care (UC) interventions, which will be delivered over up to 8 sessions between 4 – 12 weeks post-injury. The primary aim of the CE is to reduce the number and severity of PPCS. We propose the following hypotheses: Hypothesis 1: Compared to the UC, children in the CE will have a clinically significant reduction in number and severity of PPCS by treatment completion Hypothesis 2: Compared to the UC, children in the CE intervention will have a significantly higher proportion of children who, at treatment completion, have: 2.1 Demonstrated reduction in PPCS across all clusters: generic, physical, psychological 2.2 Returned to normal activity (school, sports, leisure activities) 2.3 Improved physical and psychosocial quality of life 2.4 Lower rate of utilisation of health services

Title: A Mother’s heart beats for two: to explore the current provision of evidence based practice, outcomes and ‘lived experience’ for women with cardiovascular disease during pregnancy. Background: Although cardiac disease complicates approximately 1% to 3% of pregnancies it is responsible for 10% to 15% of maternal mortality. This rate is expected to increase in the current environment of elderly primigravida and increased obesity and diabetes in pregnancy. This study will evaluate the current care and outcomes for women with pre-existent or newly acquired cardiac disease during pregnancy. Methods: The proposed research will include phase 1 :-an analysis of the documented care and outcomes from a retrospective medical record review (MRR) for women with congenital and / or newly acquired heart disease during pregnancy and postnatal follow-up. Aims: 1. Describe the current the clinical course, appropriateness of care, referral and outcomes for these women and babies in relation to evidence based clinical practice guidelines 2. Identify gaps in the clinical management across the course of pregnancy, delivery and on-going care. 3. Elucidate and describe the experience of women with cardiac disease during pregnancy, delivery and on-going care. a. Articulate the difficulties encountered by women with cardiac disease in pregnancy. b. Identify elements that will facilitate improved clinical course and positive outcomes for women with cardiac disease in pregnancy Conclusion: The outcomes of this project will provide baseline data for further research, recommendations for practice change and strategies to improvement the uptake of evidence based guidelines.

The aim of this study is to determine the effectiveness of a text message intervention on lifestyle risk factor modification and diabetes self-management for people with type 2 diabetes. A pragmatic randomised controlled trial will be conducted in New South Wales. The intervention group will receive mobile phone text messages for 6 months; the messages will provide information, motivation and support on physical activity, nutrition, weight, smoking cessation and diabetes self-management. The control group will receive usual care. The primary outcome measure will be HbA1c; secondary measures will include physical activity, nutrition, body mass index, blood lipids, and medication adherence. A sample of 340 will be needed in the trial. People will be recruited through various sources such as the Illawarra Shoalhaven Local Health District (Ambulatory and Primary Health Care, hospitals & the Diabetes Service), general practices, local newspapers, pharmacists, podiatrists, and Diabetes NSW. People will be eligible to participate if they: have type 2 diabetes (HbA1c 7.0% or above); have a mobile phone; are 18 years or older; able to read and speak English; and have medical clearance from their doctor. Exclusion criterion will be pregnancy.

Aims: The objective of this project is to advance knowledge on the aerobic exercise options that are available for persons with advanced MS. Currently persons with advanced MS have severely reduced exercise options and little is known about the benefits of those exercises. Much of the information available is anecdotal and persons with MS and practitioners are in need of clearer guidelines and information. The specific aim of this research project is to explore the potential of electrical stimulation exercise to expand the aerobic exercise options available for persons with advanced MS. In this project we will investigate the relative benefits and drawbacks of arm cranking, FES cycling, and hybrid FES exercise in persons with advanced MS. We will measure the cardiorespiratory and cardiovascular responses, the fatigue levels induced, and the effort required. Intervention: Ten persons with advanced multiple sclerosis will participate in three exercise trials using different modes of aerobic exercise. The trials will be performed at the Faculty of Health Sciences, University of Sydney. Prior to the exercise trials participants will complete 1-6 practice sessions to become familiarized with FES cycling and a maximum arm crank test. The three trials are an arm cranking trial, an FES cycling trial and a Hybrid FES cycling trial (which involves simultaneous voluntary arms and FES leg cycling exercise). Each trial will be separated by between 2 days to a week. During each trial routine non-invasive measures of cardiorespiratory metabolism will be performed. Oxygen consumption and other cardiorespiratory metabolism will be measured by a metabolic cart. Heart rate will be monitored with a standard chest strap heart rate monitor. At the end of each exercise trial participants will be asked how hard the exercise felt and how fatigued they feel on a visual analogue scale. Hypothesis: It is predicted that hybrid FES exercise will result in the greatest aerobic exercise response of the three exercise modes. Therefore, the primary hypothesis tested during this project is that: “Hybrid FES exercise elicits greater oxygen consumption than either arm cranking exercise or FES cycling exercise.” We will also examine if there is a difference in the heart rate, tolerance, perceived exertion, and the fatigue response between the three different exercise modes.

Peripheral nerve repair still remains a challenging problem for surgeons. Despite improvements in microsurgical techniques, the sensory recovery remains suboptimal. With the advancement in molecular biology and tissue engineering techniques there has been further development in the realm of nerve repair using various synthetic and biological materials to develop nerve wraps and conduits. It is now vital to be able to compare these newer repair techniques with conventional methods to determine whether they provide an improvement in outcome in the form of sensory recovery. The aim of this study is to compare outcomes between 3 types of digital nerve repair techniques following digital nerve laceration where primary neurorrhaphy is possible. These 3 arms are direct end to end repair of severed nerve ends, direct end to end repair with protection of site using a collagen nerve wrap and short gap neurorrhaphy using a collagen conduit.

Many carers of people with dementia develop affective symptoms of depression and anxiety as a result of their carer role. The START program has been shown to be effective in the UK context in improving these symptom in carers. This study seeks to: 1. Examine the acceptability of the START program in an Australian context as reported by therapists and carers of people with dementia including examination of: a) Adherence of therapists to the treatment manual and their perceptions about the value of the program and potential generalisability in the Australian context; b) Carers perceived acceptability of the program as reflected by their self-report and completion of all 8 sessions; c) Benefit to carers as measured by a decrease in depression, anxiety and carer burden, relative to the control (CBT) group. 2. Examine the feasibility of the START program in an Australian context by examining the practicality and viability of intervention delivered by provisionally registered psychologists from within an Australian university psychology clinic.

The aim of this research is to investigate the functional impact of compression therapy (to manage chronic oedema) for adults who have chronic oedema and a history of recurrent cellulitis in a lower limb or limbs who access health services within the ACT. Reducing cellulitis recurrence could decrease the burden on the healthcare system and may positively influence the quality of life (QOL) of individuals experiencing recurrent episodes of cellulitis. Whilst this study will be performed in adults receiving healthcare services in the ACT, it is hoped the results may provide insight for cellulitis management within Australia. Research Objectives For adults with a history of chronic oedema and recurrent cellulitis who are accessing healthcare services within the ACT, we plan to investigate if use of compression therapy: (1) prevents recurrence of leg cellulitis (2) prevents cellulitis-related hospital admissions; (3) reduces affected leg volume; and (4) improves quality of life (QOL). Research Hypothesis: Addition of compression therapy to manage chronic oedema will prevent recurrence of cellulitis

This research study aims to evaluate the level of implementation support required to achieve adherence to the Clinical Pathway for the Screening, Assessment and Management of Anxiety and Depression in Adult Cancer Patients. Who is it for? Cancer services in New South Wales may be eligible to participate in this study. Study details Cancer services enrolled in this study will be randomised (allocated by chance) to one of two sets of strategies and resources which they must use to implement a Clinical Pathway. The Clinical Pathway describes how cancer patients with anxiety and depression should be identified, supported, referred to appropriate care, and monitored over time. Strategies and resources 1. The Portal: an online management system for registering cancer patients for screening, assessment, referral and monitoring. The Portal alerts staff when screening and re-screening is due, and to the appropriate level of stepped care for the patient. The Portal has patient pages where patients may log-in and complete screening as well as access information and online therapy for depression and anxiety. The Portal links to online cancer-related anxiety and depression screening education and training modules for staff. All sites will receive full access to the ADAPT Portal and training to use the Portal resources and systems. The study arms will differ as to the extent to which they receive the following implementation strategies (interventions): 2. Academic Detailing and Support: Initial staff training and support about the Clinical Pathway and use of the ADAPT Portal. Tailoring of the ADAPT Portal set up to fit individual service requirements, service and staff profile. 3. Awareness Campaigns: Roadshow and poster campaigns to inform cancer service staff about the Clinical Pathway and the Portal. 4. Champions: ADAPT program staff will work with sites to identify and support local Clinical Pathway and Portal Champions. 5. Education: Staff will be trained to use the Portal, in face-to-face training and also by engaging with User Guides and by seeking the support of the Local Champion. 6. Reporting: Reports will be provided to site Leads and Champions regarding use of the Portal and the Clinical Pathway issues and concerns. This study will enable us to determine the level and type of support required by cancer services to introduce the Clinical Pathway, the costs associated with the resources required and the levels of identified anxiety and depression in patients with cancer.

The Fetal Kicks is a novel device developed by Monash MIME to monitor fetal movement. For the following study, the current phase entails a proof of concept in women antenatally to assess the quality of signals obtained on Fetal Kicks. For this, Fetal Kicks will be utilised together with the conventional cardiotocography (CTG) to ascertain the equivalence of Fetal Kicks with conventional fetal movement counting Aims 1. Accurately corroborating maternal perceptions of movements on the CTG (via sensor imprints) to device captures of fetal movements 2. Accurately corroborating maternal perceptions of movements on the ultrasound (via sensor imprints) to device captures of fetal movements Research design The following study is a cross sectional survey with a cohort design. The following design has been chosen as it is considered to be the design of choice in evaluating a diagnostic test- in this case, Fetal Kicks. Utilising the following design, measurements of test accuracy and precision will be carried out on Fetal Kicks in comparison to CTG and conventional fetal movement countings. Primary Outcomes 1. Correlation between the signals obtained from Fetal Kicks and routine cardiotocography over a similar time period. This will be done electronically utilising cross correlation. 2. Correlation between the information obtained from Fetal Kicks and CTG as interpreted by clinicians. This will be measured on a CTG reporting tool designed specifically for the study. Secondary Outcomes: 1. Patient view on Fetal Kicks (i.e pros, cons, will they recommend it, areas for improvement etc.). This will be measured through a questionnaire designed specifically for the study

Elevated blood glucose levels are common in many acute diseases, resulting in worse clinical outcomes for patients. Hyperglycaemia in acute ischaemic stroke (post-stroke hyperglycaemia [PSH]) occurs in up to 50% patients, reduces the efficacy of stroke thrombolysis with increased risk of haemorrhage, increases infarct size, and results in worse clinical outcomes and death. Insulin-based therapies have not proved beneficial in treating PSH: they are difficult to implement and maintain, cause frequent hypoglycaemia, may cause increased infarct size, and have not shown to reduce mortality or improve clinical outcomes. An alternative, simple to use treatment for PSH may therefore have a significant impact not only for acute stroke care, but in other acute diseases. Exenatide is a commonly used diabetes drug (a synthetic glucagon-like peptide-1 receptor agonist) that amongst its effects increases insulin secretion. Importantly, this action is glucose dependent - as blood glucose levels decrease, its stimulatory effect on insulin secretion subsides, with a very low risk of hypoglycaemia. A previous pilot study of 17 consecutive, unselected patients (i.e. regardless of their admission glucose level) with acute ischaemic stroke compared subcutaneous Exenatide 5 micrograms for 5 days versus routine standard care. Blood glucose levels remained consistently lower (and less variable) in the treatment group, most noticeably in those stroke patients with known diabetes. Exenatide was safe and well tolerated by all patients, with no symptomatic hypoglycaemia. TEXAIS is a 3 year Phase 2, multi-centre, prospective, randomised, open label, blinded end-point trial comparing subcutaneous Exenatide (5 micrograms) to Standard of Care. The number of patients to be recruited is 528 patients (264 in each arm) with a primary end point of early neurological improvement at 7 days, and secondary end points of recovery at 90 days. Continuous glucose monitors will track the intra-day dynamic variability of glucose in acute stroke in all trial patients (treatment and standard care).