ANZCTR search results

The project will explore the efficacy of an occupational therapy intervention in common use clinically with young children with autism, provided in the home to address a problematic behaviour indentified by the family. Two different interventions will be provided to each child in random order, one a sensory based intervention and the other is a relationship based intervention, Being Responsive. Ten participants will be included in a single case experimental design study, undergoing intervention and baseline phases over a 14 week period with daily behaviour ratings and parent stress levels monitored on a visual analogue scale. Each participant acts as their own comparison across phases. This study will help to understand the responses to each intervention. A follow up data collection will occur for two weeks, 6 months after the completion of the intervention. Intervention sessions will be audio recorded to allow for checking of the application of the intervention.

This proposal aims to use new technology to aid the management of women after gestational diabetes (GDM), to improve lifestyle behaviours and adherence to recommendations in the postpartum period. If successful, this model would support diabetes prevention programs for women following GDM, particularly those in remote or regional settings. This randomised controlled trial will recruit women during a GDM pregnancy, with the intervention being conducted in the 6 months postpartum. The intervention will include the use of interactive mobile phone messaging, the use of an activity monitor, supported by individual consultations with a health counsellor. Control subjects will receive standard care. The main outcomes to be analysed are the proportion of women meeting dietary and physical activity guidelines.

The primary purpose of our study is to determine whether home exercise programs delivered via an App have greater adherence rates than usual methods of prescription used by physiotherapists. We will conduct an assessor- blinded, randomised controlled trial, with a sample size of 80. Subjects will be deemed eligible for inclusion if they meet the following criteria: * have sustained an upper or lower limb fracture, injury or other musculoskeletal condition * have been prescribed a set of exercises for the next 4 weeks (or longer) by their treating physiotherapist * have been advised to complete their exercises at least 3 times per week * have access to a smart phone, tablet device or computer * are over 18 years of age and are able to provide informed consent * are willing to participate in the trial * are not expected to require surgery or be readmitted to hospital during the trial Subjects will be excluded if they: * are unlikely or unwilling to co-operate (e.g. serious medical condition, cognitive impairment, drug dependency, psychiatric illness, behavioural problems) * are scheduled to receive face- to- face physiotherapy for their condition or injury within the next 4 weeks * have limited English This trial will be undertaken in patients who have been prescribed a home exercise program by physiotherapists based on the orthopaedic ward or short stay surgical unit of Royal North Shore Hospital (RNSH); or from the outpatient department or hand therapy clinic of Royal North Shore Hospital (RNSH). Participants will be randomised to receive their home exercise program delivered via either the current paper-based method alone, or via our App with supplementary follow-up phone calls. The primary outcome will be self-rated exercise adherence in the first 4 weeks following prescription of exercises by a physiotherapist. The secondary outcomes will include functional status, degree of disability, perceptions of treatment effectiveness, satisfaction with healthcare service delivery and assessor-rated exercise adherence. Baseline assessments will be conducted just prior to randomisation by treating physiotherapists. Follow up assessments will be conducted 4 weeks after randomisation by a blinded assessor via telephone interview and online survey.

The project aims to develop a customised falls prevention plan in hospital settings using local data by improving staff knowledge and perceptions of falls prevention strategies and embedding improved clinical practice in participating wards of two metropolitan hospitals. This will inform a model that can be used to reduce the rates of falls, recurrent falls and injurious falls. The project will involve comprehensive collection and detailed analysis of specific local (geographic and demographic) data to determine the most appropriate evidence based interventions to be implemented at each particular site. The content of the specific interventions will be informed by the local context. The wards to be will be those nominated by each hospital. The initial phase will include a patient survey, a staff survey and data collection of historical and current falls prevention programmes and falls data. We will also collect information about the demographics of each ward, details on falls prevention activities have been or are being undertaken by the ward and which ones have been successful. We will then collect falls data for a 10 week period including number of falls and number of injurious falls per occupied bed days, circumstances and risk factors associated with each fall, and an environmental audit following each fall and of the ward in general. The data will be analysed to determine local patterns in falls predictors, risk factors and causes of falls. Interventions will be developed based on the findings of the analyses.

The purpose of this study is to collect and monitor ongoing safety and performance data from commercial use of the ACURATE neo trademark Aortic Bioprosthesis, hereafter referred to as the ACURATE neo trademark, and ACURATE TF trademark Transfemoral Delivery System. The ACURATE neo trademark and its Transfemoral Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR) using transfemoral access in study participants presenting with severe aortic valve stenosis. Note, the ACURATE neo trademark and its Transfemoral Delivery System has been CE Marked and approved for sale in Europe. This study protocol is being implemented in Australia and is equivalent to the post market clinical follow-up plan study protocol developed by Symetis post European certification.

In anaesthesia, traditional agents used for the reversal of paralytic agents are designed around the use of an anticholinesterase inhibitor (commonly neostigmine) to increase motor end plate acetylcholine. This is usually combined with an anti-muscarinic agent (atropine or glycopyrullate) to offset the autonomic effects of excess acetylcholine. Sugammadex is a newer agent that works via encapsulation of aminosteroid neuromuscular blocking agents. Whether or not sugammadex is superior to neostigmine based techniques in terms of prevention of the morbidity associated with residual paralysis have never been shown in a prospective randomised trial. P-PERSoN is a prospective multi-centre, double blinded, randomised controlled trial to compare neostigmine/glycopyrullate and sugammadex reversal. The primary outcome is all in-hospital respiratory events. Secondary outcomes will be, recovery room airway and desaturation events, hospital stay, quality of recovery scores, all-cause 30-day mortality and respiratory morbidity.

The communication difficulties associated with aphasia can create a significant barrier to the involvement of people with stroke in healthcare decisions. Our research team has previously demonstrated that people with aphasia can train health professionals to effectively communicate with individuals with aphasia. The current project will extend this research by investigating the effectiveness of delivering the training over the internet to cater for rural clinicians. The project will be a pre-post intervention study with random allocation of health professionals to groups (internet vs. face-to-face). During the study, 60 health professionals will attend a training session where they learn and implement strategies for communicating with people with aphasia (via a 1 hour lecture on communication techniques and then a 15 minute conversation with a person with aphasia). The health professionals will be randomly allocated to either training using the traditional face-to-face format, or training over the internet. The proposed project will provide valuable evidence about whether communication partner training programs for health professionals involving people with aphasia can be delivered over the internet, and will be used as pilot data for a multisite RCT. It is anticipated that the program has the potential to increase the participation of people with aphasia in healthcare decisions.

The purpose of the study is to compare two different chemotherapy regimens for the treatment of inoperable, locally recurrent, or metastatic anal cancer to demonstrate which is more effective and less toxic for patients with this disease. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with inoperable, locally recurrent or metastatic anal cancer. Study details: Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive chemotherapy treatment with cisplatin and 5-FU for 8 x 3 week cycles (about 24 weeks in total) – this is the most frequently prescribed chemotherapy for this condition. Participants in the other group will receive chemotherapy with carboplatin and paclitaxel in 6 x 4 week cycles (24 weeks in total). Both groups will receive their chemotherapy intravenously, i.e. given into a vein through a drip. All participants will be followed for up to 3 years post treatment in order to evaluate treatment response, toxicity and quality of life. This is the first time that a formal comparison of these chemotherapies has been performed.

The research team aims to investigate the use of venous phase coronary angiography to visualise the coronary sinus and tributary vessels in patients who are having a standard coronary angiogram and that are not having CRT implantation. We hypothesise that this imaging will enhance knowledge of CS anatomy and pathology; and that this knowledge will assist both this specific patient population (if needing CRT in the future), and other general populations from a greater understanding and better planning of CRT lead placements. We seek to prove that venous phase coronary angiography CS imaging is able to successfully provide satisfactory imaging of the coronary sinus and its tributaries for cardiac interventions such as left ventricular lead placement in cardiac resynchronisation therapy/biventricular pacing. We also seek to determine relationships between factors (ie. age, gender etc.) and the anatomy/visualisation of coronary sinus and its tributaries.

Dementia is the leading cause of mental and physical disability in the elderly. Vascular dementia (VaD) that accounts for 15-20% of all dementia cases is a syndrome of acquired cognitive functional impairment with a complex pathophysiological basis. Viable pharmaceutical options are currently lacking. Herbal medicine has been used for the treatment of ageing-related disorders for more than 2000 years ago in ancient China. Combination therapies are complex mixtures are believed to be able to enhance therapeutic efficacy through synergistic and multi-target mechanisms and are ideal and may be relevant for disorders such as VaD that has multifactorial / multisystem pathophysiology components. Conventional pharmaceutical techniques have been used to develop a novel, standardised herbal formulation, Sailuotong (SLT) targeting VaD. Data from pre-clinical studies have shown significant improvements in memory functions and in pathogenic biochemical parameters in various animal models. Appropriate safety of SLT has also been shown in acute and chronic toxicity and herb-drug interactions studies. We propose to undertake a rigorous phase III clinical trial of SLT in 250 patients with mild to moderate probable VaD or Alzheimer’s disease with cerebrovascular disease (AD+CVD). The aim of this 52-week randomised, multicentre, double-blind, placebo controlled trial is to: 1. Determine the efficacy of SLT on cognitive function and activities of daily living, and 2. Monitor the safety of SLT as a treatment for VaD or AD+CVD during a 52-week treatment period. The primary outcome measures include Vascular Dementia Assessment Scale cognitive subscale (VaDAS-cog) and Alzheimer’s Disease Co-operative Study Activities of Daily Living Inventory (ADCS-ADL). In addition, there are six secondary outcome measures including: The Clinician’s Interview Based Impression of Change-plus (CIBIC-plus), CLOX, EXIT-25, Quality of life, Neuropsychiatric Inventory-Clinician rating scale (NPI-C), and Functional MRI Assessment in a subset group. Liver and renal function and routine haematological tests will be conducted regularly during the trial. All adverse events will be recorded at each visit, including those suspected to be related to the treatment and any worsening of symptoms will be closely monitored.