ANZCTR search results

This study was designed to conduct an equivalence experimental trial adopting a randomized control design. The participants will be individually randomized to three independent groups, email or postal or telephone. Number of respondents required in each group is 229 and total number required n=687. The study was designed with overall aim to conduct a effectiveness analysis of three different methods of data collection; email, postal and telephone. The primary outcome of interest will be effective successful follow up. Effective successful follow up is defined as providing a response to each of the 26 questions in the survey. A valid response might be that the patient declines to answer a question and secondary objectives are to: a. Estimate recurrent costs of data collection using telephone, postal services/mail and electronic mail (email) for PROMs data in PCOR-VIC b.Compare the cost-effectiveness of the three different methods of data collection. c. Develop a cost projection model to estimate the cost for nation-wide scale-up of administering the PROMs data collection tool in the most efficient setting for follow up of prostate cancer patients in Australia. To collect costing data ABC (Activity Based Costs) method will be adopted and data will be collected through structured questionnaire. Cost data will be collected from provider perspective. A model will be developed based on most cost-effectiveness approach to determine the cost for national scale up. The main outcome of interest will be effective successful follow up. Secondary outcome measures will also include time to complete an effective follow up and direct costing associated with an effective follow up. This study will provide an opportunity to identify the most cost-effective approach for completed follow up of prostate cancer patients by using EPIC-26 tool. This will be important for many registries which are currently collecting data from patients. Moreover, we expect that the findings of this study will help us to understand the cost for national scale up.

Deep brain stimulation (DBS) is an established treatment for people with Parkinson's disease and other movement disorders whose symptoms are resistant to drug therapy alone. DBS uses electrical pulses applied to target regions of the brain (e.g. the subthalamic nucleus) to reduce symptoms such as tremor, rigidity and reduced movement at will. Standard DBS treatment is performed in an ‘open-loop’ fashion, where stimulation is continuously applied regardless of presenting symptoms. This leads to periods of unnecessary or inappropriate stimulation that can cause side effects, for example slurring speech, and limit battery life of the generator of the stimulation (or "pacemaker") thus decreasing efficiency of the device and treatment. These issues may be overcome by using 'closed-loop' stimulation, in which stimulation is only applied when symptoms indicate it is necessary. This study aims to identify in the brain suitable markers or measurable characteristics that we can then use to optimise stimulation. In particular we wish to evaluate closed-loop stimulation in participants with temporarily 'externalised' electrode leads. Externalising electrode leads is an established clinical practice involving a delay (typically 5-6 days) between implantation of the deep brain electrodes and implantation of the pacemaker. During this time an external connection to the electrodes is available, which can be used for stimulation and recording using equipment that is more flexible than standard implantable pacemakers. An externalisation period is also possible during routine follow-up surgical procedures, such as implanted pacemaker battery replacement. It is intended that approximately 30 participants will be studied in Melbourne and Brisbane. Experimental sessions will be scheduled twice per day over the externalisation period, depending on each participant’s condition. Within each day, sessions will be conducted both off and on medications. During sessions, objective measures of participant symptoms will be recorded along with conventional clinical assessments (e.g. the Unified Parkinson's Disease Rating Scale). Additionally, brain electrical activity will be recorded for use in deriving suitable markers or measurable characteristics. Comparisons will be made between different pacemaker stimulation patterns within a participant. Experimental protocols standard for this type of study will be observed including blinding of assessments, randomizing the order of conditions, allowing ‘wash-out’/‘ wash-in’ periods and taking account of the possibility of an implantation ‘stun effect’ and variability in electrode positioning. Following the externalisation period, the participants prescribed DBS procedure (e.g. system implantation, battery replacement) will be completed and clinical management will proceed as usual..

Over the last several years we have been working hard to understand recovery from whiplash injuries to help develop more effective treatments. We now believe that recovery may be facilitated if we change how care is delivered soon after their whiplash injury. We now need to test this process. In this randomised trial, people with whiplash will be allocated to two different processes of care. In the first process, people with receive the treatment normally provided to individuals with a whiplash injury. In the second process, people will receive care based on a questionnaire that assesses their risk of recovery. Care will range from 1-3 sessions with their usual health care provider, to referral to a health care provider with specialist expertise in whiplash injury. This specialist provider will then undertake a more detailed assessment of physical and psychological measures. The specialist provider may either 1) continue providing people with treatment , 2) refer them back to their own health care provider with advice on their or 3) refer them to another practitioner for additional treatment. The outcomes will be assessed at the initial assessment and three follow-up assessments at: 3, 6 and 12 months after the first assessment. Health outcomes assessed will questionnaires relating to how neck pain affects daily activities and in what way neck pain affects people personally. This study will uncover the best process to help people with whiplash recover.

The primary purpose of this study is to develop and evaluate a new low literacy decision aid relating to fertility preservation for younger women with early stage breast cancer. Who is it for? You may be eligible to join this study if you are a pre-menopausal woman aged 18 to 40 years of age, who has been diagnosed with early stage breast cancer with no history of metastatic disease, and was interested in finding out more about fertility and/or fertility preservation at the time of diagnosis. Study details Participants in this study will be randomly selected (by chance) to receive either usual care or to access the decision aid website. The decision aid includes easy to understand information regarding the side effects of cancer treatments in terms of their effects on women's fertility, and options for preserving fertility to increase chances of having a baby at a later date. Participants will then be asked to fill out a questionnaire before seeing the decision aid website, and also a questionnaire regarding the choices made and the use of the decision aid after one month, 6 months and again after one year. It is hoped that the findings of this trial will provide information on how helpful fertility preservation information is to women with early stage breast cancer, and to improve access to this information by women as part of their medical care going forward.

This study will evaluate the efficacy of a psychological strength training program. The program will be designed to improve coping skills and resilience with a view to preventing Posttraumatic Stress Disorder (PTSD) in professions that are frequently exposed to trauma. The program will be delivered to fire and emergency recruits, who will then be tracked for up to 5 years to assess their exposure to potentially traumatic events, PTSD symptoms and other coping indicators.

Participants will do four weeks of 'usual' care involving daily breathing exercises (PEP) and walking, running or step ups. After 4 weeks, those who have adhered to these requirements will be randomly allocated to either continue this routine or to stop the PEP and to just continue with the walking, running or step ups for 3 months. Participants will be assessed before and after the four weeks of usual care and at the end of the three month intervention phase.

To evaluate whether the Keeping Active program is effective in achieving the key program outcomes of supporting people with intellectual disability to increase social contacts and independent participation in mainstream community activities and whether these outcomes can be achieved within available funding available through the NDIS.

Cardiac surgery is one of the most common complex operations conducted on millions of patients worldwide every year. Advances in bypass technology and surgical techniques improved mortality and outcomes after cardiac surgery. Patients presenting to cardiac surgery are older, suffer multiple comorbidity and likely to undergo more complex operations. Therefore, significant morbidity continues to be associated with cardiac surgery including acute kidney injury and failure, neurological injury such as stroke, delirium or cognitive dysfunction, cardiac failure and arrhythmias such as atrial fibrillation and respiratory failure. These complications, in combination or individually, leads to increased hospital stay and increased disability and functional dependence. Dexmedetomidine is a strong sympatholytic agent that has been used as a sedative and adjunct for procedural sedation. Animal models of global hypoxic brain injury, myocardial ischaemia reperfusion and contrast induced kidney injury showed potential protective effects, possibly due to reduced apoptosis and inflammatory response. A Cochrane systematic review concluded that the perioperative use of Alpha2 agonist reduced mortality and myocardial ischaemia with most pronounced effect seen in vascular and cardiac surgery. In the context of cardiac surgery, randomised trials of dexmedetomidine has been shown to reduce delirium, acute kidney injury and postoperative ventilation time. Retrospective propensity score analysis suggested that dexmedetomidine reduced hospital and 1 year mortality in patients undergoing cardiac surgery. In concert, these studies suggest that perioperative use of dexmedetomidine may reduce cardiac surgery associated complications, including mortality and likely to days home and disability free following high risk cardiac surgery. Aims: 1. Assess the safety and efficacy of perioperative dexmedetomidine in high risk cardiac surgery. 2. Inform the design and conduct of a phase III multicentre study on the clinical effectiveness of dexmedetomidine in cardiac surgery Design: Multicentre Single blind placebo controlled RCT Population and sample size: 80 patients in 4 sites Inclusion criteria: consenting adult patients undergoing on bypass cardiac surgery with 1. Combined surgery (CABG + valve) or (valve) or aortic arch surgery OR 2. Chronic Kidney disease class III and IV with estimated GFR 1559 mls/min/1.72m2. Intervention: Dexmedetomidine infusion at 0.7 mcg/kg/hr will commence at the induction of anaesthesia and be continued throughout the surgery. Dose will be reduced by 0.4 mcg/kg/hr at skin closure and continue until clinically not required. Concomitant intervention: Standard anaesthesia. Primary outcomes: A composite outcome of number of days home, alive and disability free at 28 days following surgery will be the primary study outcome.

There is currently a lack of high quality evidence to inform the management of prosthetic joint infections (PJI), an uncommon, but potentially devastating complication of joint replacement surgery. Prosthetic Joint Infection in Australia and New Zealand Observational Study (PIANO) is a multicentre, prospective observational study of prosthetic joint infections in Australia and New Zealand. The study aims to describe the clinical, laboratory, microbiological and radiological features of patients presenting with prosthetic joint infections and their management and subsequent outcomes.

This is a cross body trial to compare the safety and efficacy of topical tranilast in morphea. This agent is an established pharmaceutical with a good safety record which has been available in Japan and Korea for 20-30 yrs but has never been marketed in Australia. It has approval for the management of keloid and hypertrophic scars in these countries. There are publshed reports of efficacy in morphea. The trial involves the application of a corticosteroid cream to one involved site on the body with the application of a cream containing both corticosteroid and the trial agent at an alternate site for a period of 3 months. Monthly clinical and laboratory assessments will be performed over this time. All currently prescribed treatments will be continued during this period.