ANZCTR search results

Restorative care to date has focused on physical and daily function but not considered social engagement and quality of life. This highlights the need to develop a restorative care program focusing on quality of life which specifically includes those with cognitive impairment. The significance of this research is that if we show that Lifeful is feasible we will apply for funding to conduct a well-powered randomized controlled trial. This larger trial will add to a growing body of literature on restorative residential aged care, and is timely given the increasing focus of the Australian Aged Care Quality Agency and Department of Health on quality of life. The pilot study aims are to examine: 1. To investigate the feasibility of a delivering and evaluating restorative care program (Lifeful), 2. To investigate staff behavior change and obstacles experienced in adhering to the program 3. To investigate the suitability of the outcome measures. The hypotheses are: 1. It will be feasible to deliver the Lifeful training program to at least 80% of staff working on study units and it will be feasible to recruit at least 80% of residents to participate in the evaluation of the program 2. Care staff will improve engagement with residents as demonstrated by the person-centred assessment tool, as reported in focus groups and through an audit of resident care plans and progress notes. 3. The outcome measures chosen will be suitable i.e. residents can answer the questions, there are no floor or ceiling effects, they capture the changes on outcomes reported by staff in focus groups

This study aims to investigate whether palm oil and cocoa butter that are high in saturated fat, but contains primarily monounsaturated fat in the sn-2 position of triglycerides, have similar effects on blood lipid profiles than monounsaturated fat olive oil in normal healthy Australian participants.

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.