ANZCTR search results

The aim of the study is to develop and pilot a mindfulness and compassion based group intervention for youth with psychotic experiences. The program has been designed as an conjunct to treatment as usual. It specifically focuses on developing mindfulness and compassion skills in relation to attenuated psychotic symptoms, depression, anxiety, stress, self-criticism, social and daily functioning.

The proof of concept pilot explores the effectiveness of Remote Patient Monitoring (RPM) to support patients with COPD and Diabetes. The IT system used in this pilot project is a web based platform that can be accessed from any internet connected device. The patient, when accessing the platform, will be directed to their personalised care plan that has a questionnaire designed to educate and guide the client to monitor and support their own health. The peripheral devices that link to the system, enable the monitoring of clinical signs and symptoms such as SaO2, blood pressure and blood glucose measures. For the health service clinicians accessing the platform, the RPM system identifies in real time which clients have recorded results at that point in time and which have not, it provides an indication of which results are at variance to the result parameters set for each individual;, thus enabling a rapid and timely response. The RPM system generates individualized reporting that allows the clinicians to monitor trends within a client’s health care over time, enabling treatment to be appropriately adapted as and if required. The pilot was supported by a Data Safety Monitoring Board and is aim at evaluating the effectiveness of the tele-health intervention

People with Chronic Obstructive Pulmonary Disease (COPD) or asthma usually experience swelling (inflammation) in their airways (breathing tubes), that makes is difficult to breathe. This inflammation can worsen their condition and lead to further medical problems. An inflammatory cell called the neutrophil is often present in the airways of people with COPD or asthma, and when activated these cells release molecules that lead to swelling and damage of the lungs. Neutrophils also release ‘extracellular traps’ called NETs, which look like a spider web and are made up of the cell’s DNA (the genetic code which carries all the information about how we look and function) and other inflammatory molecules. These traps can kill bacteria, however if they are not cleared they are toxic to the lungs. We have shown a build-up of NETs in sputum from patients with COPD and asthma. In another lung disease called cystic fibrosis, NETs are broken down and cleared by a treatment called Pulmozyme, which improves lung function and decreases lung attacks. This study will investigate NETs in COPD and asthma, their effects on the lungs, and whether treatment with Pulmozyme can improve symptoms.

The primary aim of this study is to characterise the effects of prolonged sitting on femoral artery endothelial function in patients with type 2 diabetes and to investigate the potentially beneficial effects of (i) 3 min every 30 min; and (ii) 6 min every 60 min of simple resistance activity (SRA) breaks on endothelial function, and postprandial glucose, insulin and lipid profiles in comparison to prolonged sitting. Secondary outcome measures will also provide information on the potential signalling pathways (insulin and SNS-mediated vasoconstriction pathways) that are contributing to the decline in vascular function with prolonged sitting. For this, we propose to undertake a randomised crossover trial in twenty four inactive and injury-free overweight/obese adults aged between 35-70 years diagnosed with type 2 diabetes. This study will involve three acute experimental conditions (each of 8 hours duration), separated by a minimum 6-day washout period to account for any residual physiological effects of the intervention. Each participant will complete three conditions, involving (i) Uninterrupted Sitting - 8 hours of prolonged sitting; (ii) Simple Resistance Exercises (30) + Interrupted Sitting: 8 hours of sitting with 3 minutes of simple resistance activity breaks every 30 minutes; and (iii) Simple Resistance Exercises (60) + Interrupted Sitting: 8 hours of sitting with 6 minutes of simple resistance activity breaks every 60 minutes. Standardised breakfast and lunch will be provided for the test. Dinner will also be provided prior to each condition, and dinner and breakfast will be provided following each condition. Vascular function will be directly measured using Flow Mediated Dilation (FMD). FMD is a widely-used non-invasive method to describe endothelial function and vasodilation of an artery following ischaemia. Participants will be fitted with a flash glucose monitoring system (Libre) to wear from the first visit to the day after the final study visit. During the experimental conditions, venous blood samples will be collected every 30 minutes and blood markers of endothelial function will also be measured, including endothelin-1 production. Changes in Sympathetic Nervous System (SNS) activity may help to explain any differences in FMD over the day and between conditions. SNS activity will be indirectly measured via catecholamine levels in the blood. Plasma markers of cardiovascular health and inflammation will also be measured, as well as blood pressure (during experimental sessions). At the conclusion of each condition, participants will be fitted with a 24 hour ambulatory blood pressure monitor (ABPM).

The purpose is to investigate the role of tranexamic acid (TA) in the setting of intra-capsular neck of femur fractures which is the type of broken hip. (TA) is a medicine (synthetic type of amino acid lysine) which is used to prevent excessive blood loss during surgery. (TA) is commonly used in elective joint replacement (Total hip and total knee replacement) and is recognized to reduce blood loss during surgery and the need of blood transfusion afterward. However we do not have as much evidence on its effect in the setting of broken bone in hip. We intend to explore the relationship between its use and blood loss after surgery and the need for blood transfusion. If the patient agrees to participate in this study, they will be asked to sign the Person Responsible Consent Form. This study will be conducted over 1 to 2 years. The treatment being investigated in this study is three doses of (TA) given intravenously at the time of surgery and 8 and 16 hours after surgery. Study participants are put into two groups and given different treatments, and the results are compared to see whether one treatment is better. To ensure the groups are similar to start with, a computer allocates each study participant into a group randomly, Neither the doctor nor the study participant can decide which treatment the participant receives. Once the patient agrees to participate in this trial, they will then be randomly allocated a number which decides whether they receive either 3 doses of (TA) (intervention group) or not. The first dose is given at the time of surgery and next two 8 and 16 hours post surgery. Study hypothesis 1. Administration of intravenous TA in patients presenting with intra-capsular neck of femur fractures undergoing hemiarthroplasty or total hip arthroplasty reduces the rate of post-operative blood loss and blood transfusion. 2. The intravenous administration of TA is safe and is not associated with an increase in the rates of post-operative venous thromboembolic, cardiovascular or cerebrovascular events in this population. Aims This study aims to provide high quality evidence of the relative benefits and risks of the use of TA in the setting of emergency hemiarthroplasty or THA for the management of NOF fractures. The results of this study will support and influence the future treatment of this common injury. Primary outcome 1. To determine the effect of administration of a three dose protocol of intravenous TA on the incidence of acute postoperative blood transfusion in patients presenting with intra capsular neck of femur fractures undergoing hemi or THA Secondary outcomes 1.To assess the incidence of acute post-operative venous thromboembolic (deep vein thrombosis, pulmonary embolism), cardiovascular (acute myocardial infarction) and cerebrovascular events (stroke) in this study population 2.To assess whether the administration of TA in a three-dose intravenous protocol leads to a reduction in post-operative drop in Haemoglobin.

Dysplasia is an important precursor to bowel cancer in IBD, which can be very challenging to detect. Previous studies suggest that dysplasia is detected in approximately 9% of colonoscopies performed for IBD surveillance. Dye-based chromoendoscopy (DBC) which involves spraying the entire colon with contrast materia such as indigo carmine or methylene blue is thought of as the current gold standard for dysplasia detection. However, dye-based chromoendoscopy is expensive, time consuming and difficult to perform, which limits its use as a surveillance test. A routine survey of Australian Gastroenetrologists suggests that more than half did not use the dye-spray technique. Virtual chromoendoscopy with Pentax i-scan Optical Enhancement(OE) uses in-built technology in the endoscope processor with the same principles as dye-based chromoendoscopy to enhance colonic mucosal pit and vessel pattern. We therefore hypothesise that virtual chromoendoscopy is non-inferior to dye spray chromoendoscopy in detecting dysplasia. It will also consume less resources and time. The aim of our study is to compare virtual and dye-based chromoendoscopy in a prospective tandem colonoscopy study. Research design & methods: We plan to conduct a prospective study, enrolling patients with known IBD who are due to have their standard surveillance colonoscopy to look for dysplasia. A tandem colonoscopy model will be used. Enrolled participants will have a colonoscopy using virtual chromoendoscopy with i-scan OE first during insertion and withdrawal. All lesions detected will be removed or biopsied, as appropriate. On completion of withdrawal, a second look will be performed with dye-spraying as is the current clinical practice. This will allow any additional pathology detected to be treated.

Two hundred primary hip replacements with Delta-Motion heads and cups were performed between December 2008 and December 2009 and were followed-up for a minimum of five years. The two hundred patients have been reviewed at regular intervals, and data has been obtained from the patients pre-operatively, and post-operatively at 6 weeks, 6 months or 1 year, and at a minimum of 5 years. Patient outcome were assessed using The Harris Hip Score and X-rays were taken for radiographic evaluation. The aim of the study is to measure clinical and radiographic outcomes such as ceramic breakage and squeaking to verify the clinical effectiveness of the product that is new to the market. The primary objective of the study is to investigate the clinical outcome of the Delta-Motion hip system and to demonstrate improved range of motion, head engagement and stability of the replaced hip. The null hypothesis is that the large diameter ceramic on ceramic bearing will not improve patient outcomes compared with published data. Complications will also be assessed and x-rays will be used to validate component positioning and quality of bone in-growth.

The 123-Magic parenting program provides strategies for parents with children aged 2-12 to reduce children's undesirable behaviours, such as temper tantrums. The program is taught to parents by a number of social services and practitioners but has not yet been formally evaluated in Australia for use with children diagnosed with ADHD. Aim: Evaluation of the original 1-2-3 Magic DVD-based program for use with children diagnosed with ADHD, in comparison to a control group. Significance: The 1-2-3 Magic program has been taught to parents throughout Australia; however, the effectiveness of the program for use with children diagnosed with ADHD has not been evlauated in Australia. Expected reaserch outcome: It is expected that the techniques shown in the 1-2-3 Magic DVD will be of benefit to parents in reducing children's undesirable behaviours (i.e., children diagnosed with ADHD).

The study will compare the intervention of driving instructor lessons with the use of a driving simulator to undertake driving tasks in order to identify the most effective rehabilitation approach for returning to driving post stroke or traumatic brain injury. This study will identify the most effective rehabilitation approach for returning to driving in order to inform clinical practice.

Patellofemoral osteoarthritis (PF OA) is a leading cause of pain, disability and health expenditure in Australia, has no cure, and there is little evidence for effective treatments. Pilot data shows that simple contoured shoe inserts (foot orthoses) worn in everyday footwear can reduce pain in older adults with PF OA immediately and after 2 months of wear. This clinical trial will investigate whether contoured shoe inserts are an efficacious longer-term intervention for PF OA. The primary aim is to compare the 3-month efficacy of prefabricated, contoured shoe inserts to flat shoe inserts for reducing the severity of knee pain in people with PF OA. The FOOTPATH trial is a multicentre, randomised, controlled, assessor-blinded superiority trial with two parallel groups and 12-month follow-up. 160 participants aged 50 years and older will be randomly allocated to receive either contoured shoe inserts or flat shoe inserts. Outcomes will be evaluated at 3 and 12 months. Secondary aims will compare the 3- and 12-month effects of contoured inserts and flat inserts on pain, global improvement, function, quality of life, self-efficacy, kinesiophobia, adverse events and use of co-interventions, while cost-effectiveness will be evaluated at 12 months.