ANZCTR search results

Most older people with disabilities live in the community with support from informal carers. Whilst carers are generally willing to take on the caring role, it often has an adverse impact on their physical and emotional health, particularly depression. There is evidence that the lower the care recipient’s function, the more their carer experiences these problems. Whilst the effectiveness of exercise interventions for older individuals has been demonstrated, to our knowledge this is the first RCT that targets both the care recipient and the carer. This study will address the question of whether an individualised physical activity program for care recipient/carer dyads (that they can do together) can improve both the physical and psychological wellbeing of the care recipient and their carer. It will also examine whether the intervention is cost effective.

Term PROM is a common problem. Women have traditionally been offered oxytocin infusion. This requires intravenous fluids, continuous FHR monitoring and the woman is restricted to bed. PG gel has been shown in a large RCT to be safe and effective but has not become widely used in the public sector. This study will address safety and efficacy as well as womens satisfaction of the two methods of induction.

The primary purpose of the study is to assess the efficacy and safety of 12 Weeks supplementation of a novel extract of saffron stigma, Satiereal (Registered Trademark) on food cravings and preferences, body composition, satiety and appetite regulatory hormones, and clinical safety markers in overweight/obese individuals. We hypothesize that oral supplementation with Satiereal may reduce snacking and enhance satiety through its suggested mood-improving effect, and thus contribute to weight loss and/or maintenance.

This project will evaluate a client-centred motor-training intervention to improve functional outcome after botulinum toxin injection (BoNT-A) for people with a neurological injury (stroke or brain injury). Spasticity is common following stroke and those with greater spasticity typically experience less recovery. Current treatment for spasticity is to provide BoNT-A, an antispasticity drug. Some evidence exists to support the use of BoNT-A, but all studies recommend that BoNT-A be provided in conjunction with physical therapy. However, little direct evidence exists for optimum type, dosage and timing of therapy. Participants will be recruited on a consecutive admission basis from hospital outpatient spasticity clinic and receive an 8-week intervention which will include intensive one-on-one physiotherapy, behavioural strategies to increase patient motivation, and a task-specific home exercise program. A distinguishing feature of the program is that it is tailored to the specific needs of each participant, patients are extended to receive intensive physiotherapy practice, and the content is driven by the Clinical Guidelines for Stroke Management (National Stroke Foundation, 2010). Outcomes will be assessed at baseline, post-intervention, and at 3 months following the conclusion of intervention and will include assessment of functional movement, quality of life, and cost.

In the last decade, catheter ablation procedures for atrial fibrillation (AF) have increased dramatically and this therapy is now a well entrenched treatment option for drug-refractory AF. The technology associated with mapping the atrial anatomy and localization of catheters within the heart has concurrently evolved to meet the demands of pulmonary vein isolation procedures for paroxysmal AF and a variety of adjunctive substrate ablation approaches for non-paroxysmal AF. Navigation technologies aim to improve clinical outcome, increase safety, reduce procedure times and reduce X-ray exposure for AF ablation procedures. Compared to fluoroscopy led ablation, early randomized trials reported shorter procedure times and reduced X-ray for adjunctive virtual 3D mapping. Non-randomized trials/registries have suggested that adding CT/MRI merge capabilities to 3D mapping provides incremental benefit over 3D mapping alone; however, randomized trials have proven that the addition of CT/MRI merge capabilities to 3D mapping systems may be associated with negligible impact on clinical results and/or X-ray use. Furthermore, randomized evidence for new radiographic mapping technologies (3D rotational angiography) and early data on robotic sheath navigation also result in equivalence compared to standard 3D guided procedures. Prior studies have demonstrated the efficacy of intracardiac echocardiography (ICE) for guiding ablation at the pulmonary vein ostia, within the cavotricuspid isthmus and for detection of left atrial thrombus and assessment of left atrial appendage mechanical function. In addition, one recent case series has reported ‘flouro-less’ AF ablation procedures with ICE as an adjunct to 3D mapping. CARTOSOUND integrates ICE into a 3D mapping system, such that the CARTO system can visualize the location and orientation of a specialized ICE catheter to enable the construction of a 3D geometry from a series of 2D ultrasound slices. CARTOSOUND has been validated in an animal model, tested in several clinical patient series and its unique utility is described in case reports. However, there have been no studies that have assessed the impact of CARTOSOUND mapping/navigation on AF ablation outcomes as compared to conventional EAM. We sought to compare clinical parameters and mapping accuracy between CARTOSOUND and EAM mapping/navigation for AF ablation procedures via a randomized controlled trial.

The purpose of this study is to determine how safe and tolerable the Oxette (Registered Trademark) Nicotine Inhaler Pack is. This includes the device and how the nicotine is absorbed into your body and the levels of nicotine in your blood. The study is also looking to compare the Oxette (Registered Trademark) Nicotine Inhaler Pack against the Nicorette (Registered Trademark) Inhaler (this product is approved and readily available as a stop smoking aid), to see how the levels of nicotine in your blood from each product compare. This study consists of 4 different parts. PART A: A total of 18 participants. Will receive 2 different doses of nicotine on one single day. PART B: A total of 24 participants. Will receive 2 different dose levels of nicotine over three separate days. PART C: A total of 18 participants. Will all receive the same single dose level of nicotine every hour for 12 hours. Part D: A total of 24 participants. Will attend the clinical trial unit on two consecutive days and will be randomised to receive one complete refill of Oxette (Registered Trademark) Nicotine Inhaler device at the medium dose level of nicotine (0.056%w/w) on one day, and one treatment of Nicorette (Registered Trademark) Inhaler (10mg) on another day in random order.

The drug sugammadex (Bridion) has recently been introduced into clinical practice at the Royal Perth Hospital (RPH). This drug provides the anaesthetist with a new and very efficient way of reversing the effects of amino-steroidal neuromuscular blocking agents. If not completely reversed, the residual effects of muscle relaxants are known to significantly impair postoperative patient outcome (Murphy et al. , Anesthesia and Analgesia 2010; 111: 120-8). Unfortunately, when muscle relaxants are either not reversed or neostigmine is used, the incidence of such residual paralysis is extremely high (50-60% at RPH 2011, own pilot data)! This is at least partially due to a lack of appropriate monitors (already highlighted this matter to hospital and monitors are being bought) but also the lack of a reliable muscle relaxant antagonist. The latter may have changed since introduction of sugammadex in Australia in 2010. In a just completed audit we found strong evidence for a potential of sugammadex to result in better postoperative outcomes (lower incidence of residual neuromuscular blockade and lower incidence of postoperative pneumonia/atelectasis). However, the numbers investigated were too low to draw final conclusions. Based on this pilot data we will need to investigate at least 721 cases with the use of sugammadex and compare them with at least 721 control cases in whom no or a different reversal drug (neostigmine) has been used. This equals the investigation of data from patients intubated at RPH over approx. 12 months. The goal of this retrospective study is to build on our previous audit and investigate whether the use of sugammadex indeed resulted in beneficial patient outcomes over the last 12 months. For this purpose, the data review will identify all eligible patients who received neuromuscular blocking agents and the mode of its reversal at the end of surgery. Main outcome data are adverse events in the recovery room, within 30 days after surgery (lung associated complications) and length of stay (recovery/hospital).

This randomised controlled trial will explore whether remote access to clinical care, supported by telehealth technologies over high speed broadband, leads to improved diabetes control in a way that benefits patients, carers and clinicians, and improves the overall health system. People with poorly controlled type 2 diabetes mellitus who reside in the suburbs connected to the national broadband network will be recruited from general practices (GP). People in the intervention arm of the trial will receive additional diabetes care from a diabetes educator nurse via an in-home broadband communication device that can capture clinical measures, provide regular health assessments and videoconference with other health professionals when required. The GPs will continue to manage their patients’ care in partnership with the diabetes educator nurse (DEN). The intervention period is 12 months. Each care plan will include frequency for remote monitoring of clinical measures and patient health assessments, and protocols for managing changes in the clinical status of the patient. The DEN will be in close communication with the GPs throughout the trial. Patients in the control arm of the trial will receive usual care from their GP and participate in the clinical measurement and quality of life components of the evaluation. On completion of the trial, the control patients will be offered remote DEN care for a three month period. The trial evaluation will include biomedical, psychological, self management and quality of life measures. Data on utilisation rates and satisfaction with the technology will be collected, and cost -effectiveness analyses undertaken. The role of this technology on health care reform will be explored. The trial aims to answer the following specific questions about remote telehealth monitoring: Does it improve health outcomes? Does it improve the experience of care for patients , their carers and clinicians? Does it improve primary care capacity and integration of care? Does it improve service utilisation and efficiency of the healthcare workforce? How well does it utilize the high speed broadband network?

This study aims to determine the if telephone support and print materials can increase physical activity participation in lung cancer survivors . Who is it for? You may be eligible to join this study if you have been diagnosed with lung cancer, have no metastatic disease, and are no longer on treatment. Trial details. Participants in this trial will be randomly (by chance) allocated to one of two groups. One group will receive print-based materials and telephone follow-up designed to increase physical activity participation for 12-weeks. The other group will receive print-based materials and telephone follow-up for 12-weeks to ask about their general health and well being. After this time participants in this group will be given print-materials designed to increase physical activity levels. Participants will complete questionnaires about physical activity levels, fatigue and quality of life as well as wear a physical activity monitor at baseline,3 months and six months. It is thought that the intervention will increase physical activity participation when compared to the control.

This study will assess the effect of hyperbaric oxygen therapy on quality of life and saliva in patients with dry mouth (xerostomia) following radiotherapy for head and neck cancer. Who is it for? You may be eligible to join this study if you are aged 18-90 years and have been diagnosed with xerostomia of at least 6 months duration following radiotherapy for head and neck cancer. Trial details Participants in this trial will be randomly (by chance ) allocated to one of two groups. Participants in one group will undergo 30 daily hyperbaric oxygen treatments of 90 minutes duration each. Participants in the other group will receive 30 placebo (control) treatments initially but will be offered the hyperbaric oxygen treatment after 3 months. Participants will not know which group they are in until the trial is completed. Participants will be regularly assessed over a 12 month period to determine their quality of life, saliva components and treatment costs.