ANZCTR search results

The THRIVE Pilot project will examine whether smokers living with HIV find nicotine replacement products acceptable to use as a quit aid or replacement for smoking. This project aims to measure how acceptable and tolerable the participants find the products to use, and which products are preferred. It will also measure whether participants reduce their smoking while using their products. It will also explore whether providing the participants with information about the use of long-term nicotine substitution as an option to reduce health risk increases or decreases their interest in abstaining from cigarettes and nicotine. We will also monitor adverse events while using the products. Tobacco smoking is a major cause of serious disease. Those who quit smoking reduce their risk of developing a tobacco related disease. The project will help us to better understand whether vaporised nicotine products are a more attractive option than existing NRT products for people living with HIV who smoke. We will also measure their interest in and reactions to harm reduction messages about using nicotine products as a long-term substitute for cigarettes if they cannot or are unwilling to quit smoking. People living with HIV who smoke are a population group that are likely to benefit from harm reduction approaches as smoking is particularly harmful for this population group and previous trials have found low long-term success rates with standard abstinence-based approaches. We hypothesise that more participants will find the VNPs acceptable and preferable to use compared to NRTs and that advice on harm reduction options will not decrease interest in quitting smoking, but may decrease interest in stopping nicotine use.

This study will compare the use of a mechanical hysteroscopic morcellator to monopolar electrosurgical hysteroscopic resection to remove submucosal fibroid in symptomatic women. We hypothesize the hysteroscopic morcellator may reduce intraoperative time and allow additional procedures to be performed in a single operating list. The primary outcome of this study is to determine the difference if there is a difference in cost between two devices used to to resect the leiomyomas. As the operating time will is the most likely to have an impact on this, the time to resect intrauterine pathology between these two different instruments, from insertion of the hysteroscope to removal of instrumentation will form part of this primary outcome. Secondary outcomes include: Fluid deficit, Completeness of resection, and adverse events This is a prospective, randomised, single blinded study, with a minimum of 162 patients to be enrolled over a 1year recruitment period. All cases must satisfy the inclusion/exclusion criteria and will be followed for 6 months after surgery. Following decision to list a woman for a hysteroscopy and resection of fibroid, women will be considered for the study and offered participation. Women who qualify will be randomised to one of two groups: Hysteroscopic morcellator (Myosure, Registered trademark) with normal saline distension medium or monopolar electrosurgical hysteroscopic resector with a glycine distension medium. To ensure concealment, randomisation of women into treatment groups will occur via phone to an automated randomisation service. At the time of surgery, a diagnostic hysteroscopy will first be performed to confirm requirement for resection of a fibroid. Those that do not require resection will continue to have outcome data collected during the operation and followup but will not be included in analysis. Data collection will occur at: recruitment, on the day of admission for surgery and intraoperatively, postoperative review at 6 weeks after index surgery, and postoperative review at 6 months after index surgery. An economic evaluation will be conducted to determine the relative costs and benefits of hysteroscopic morcellation versus electrosurgical resection.

This study is to compare the rates of extravasation injury and phlebitis between newborn infants who have an elective re-site of their peripheral intravenous cannula (PIVC) at 72 hours compared to those in whom the PIVC is changed due to clinical concerns only. We hypothesise that the incidence rates of extravasation injury and phlebitis will reduce by half in our study group with the intervention.

This primary aim of this study is to determine if preoperative hypercoagulability, identified by ROTEM analysis, can predict postoperative thrombotic complications in overweight and obese patients undergoing elective lower limb joint replacements. Secondary aims: 1. To develop clinical threshold with ROTEM parameters to identify high risk patients with increased body mass index and/or waist circumference. 2. To monitor coagulation changes with ROTEM assays and platelet function with Multiplate analyser, preoperatively and postoperatively, in this cohort of patients. 3. To assess the sensitivity of the ROTEM assay to predict high-risk patients stratified according to body mass index and waist circumference.

Total hip replacement (THR) is the gold standard for management of severe hip osteoarthritis. A rising trend has seen an increase of approximately 40% over the last decade with almost 40,000 THRs being performed in Australia in 2013. Systematic reviews have demonstrated the benefits of physiotherapy delivered physical rehabilitation programs following THR which are effective in increasing quadriceps, hip abductor, extensor and flexor strength, walking speed and cadence and function. Although rehabilitation has clear benefits, many people who have had a THR find it difficult to access health care. The elderly demographic coupled with the risk of THR dislocation post-operatively can make travel difficult. Few patients can afford to self fund domiciliary rehabilitation and the public health system has limited scope to provide services outside of it’s centres. For patients living outside metropolitan areas access issues become magnified. This study will aim to determine if a telerehabilitation program delivered remotely is as effective as face to face rehabilitation in the THR population. The effectiveness of the telerehabilitation program will be determined via a randomised controlled trial comparing a traditional face to face rehabilitation program to a telerehabilitation program delivered directly in to patient’s homes.

Skin-to-skin contact (SSC) between a parent and their baby is a commonly used intervention in Neonatal Intensive Special Care Units (NISC). It can help parents to feel more connected to their baby, and feel attached and bonded, as well as help them to feel like they are interacting with their newborn baby, and helping them to feel a little more like a "normal" parent. It also offers multiple benefits to the baby and is the closest for them to being back inside their mother's stomach, as they were before being born. They can hear their mother's heart beat and know their smell, so it can offer the baby comfort and warmth and feel love from their parent. Over recent years, there has been an increased focus on the use of family centred-care interventions, such as SSC, being utilised in NISCs. However, there is an overall lack of studies conducted in Australia on the effect that the duration of the SSC between a parent and baby in a NISC setting has on physiological benefits to the baby, as well as physiological benefits to the parents (both mothers and fathers). The physiological measurements examined in the current study are the baby's heart rate, respiratory rate, temperature and oxygen saturation. The parent's physiological measurements examined in the current study are the parent's heart rate and blood pressure. For the current study, it is hypothesized that the effects from the SSC for the baby will be increased when they have longer SSC with their parent. For the parents, it is hypothesized that there will be physiological benefits from the SSC with their baby, reflected as lower heart rate and blood pressure, and that these benefits will increase with a longer duration of SSC.

This project is a pilot study of an intervention program called Body Brain Life-Fit (BBL-Fit). BBL-Fit aims to determine the effect of a multi-domain dementia risk reduction intervention on cognitive function in community dwelling middle-aged adults with multiple risk factors for dementia. The sample will be healthy but have several risk factors for dementia. The intervention is tailored to individuals based on their level of risk in particular domains. There will be two groups; a control group who receives a pre and post assessment without interventions, and an intervention group who receive online intervention as well as physical activity and dietary (where indicated) interventions.

The primary objective of the project is to determine the effectiveness of a treatment program combining serial casting with Botulinum Toxin for the management of contractures in adults with acquired brain injury. An assessor blinded, randomised controlled study with a cross-over design will be conducted. Ankle joint is selected as a model to assess the effectiveness of the intervention. Participants will be adults with acquired brain injury admitted to the Brain Injury Rehabilitation Unit of Royal Rehab for sub-acute rehabilitation. Between-group comparisons will be made to determine the effectiveness of the intervention program. The participants in the control group will be placed on a wait list for the same treatment program. Pre-and post-intervention comparisons will also be made within the control group. Follow-up assessments for both the experimental group and control group will be conducted 8 weeks post interventions, at discharge and if possible 1 year after discharge to assess the long-term effects of the interventions.

A randomised controlled trial will be used to investigate the effectiveness of the iMindTime eHealth program. The iMindTime program will be placed within the Federation eHealth Platform. People visiting the website, in response to advertisements or through self interest, will be informed of the availability of the iMindTime program and invited to participate in the study. People who consent to take part in the study will be randomly allocated to either an immediate access to the program, or delayed access (7 week delay). The iMindTime eHealth program consists of six brief sessions, over 3 weeks, designed to make an individual more mindful or increase awareness of moment-to-moment experiences (e.g., thoughts, feelings, sensations) and simply accepting what is there without wanting it to change in any way. Participants will spend three days on each session before moving onto the next session. Each session will require 5-10 minutes to read and its user friendly and interactive components are designed to keep the user engaged. To consolidate learning, participants will be given activities (10-20 minutes per day) to complete offline to practise the principles of specific mindfulness exercises (i.e., mindfulness of the breath, mindfulness of body sensations, mindfulness of emotions, mindfulness of sounds, mindfulness of thoughts and loving kindness meditation) and asked to provide simple feedback on this practise at the next session. Participants will also receive automated emails (e.g., to remind them to log on, when to complete post/follow-up questionnaires) and will be asked several questions during the study period to monitor their progress. Participants randomised to the iMindTime eHealth (immediate access) group will complete a pre-intervention assessment (Week 0), during intervention (Week 2) assessment, post-intervention assessment (Week 4) and a 1 month follow-up assessment (Week 8). Participants randomised to the delayed access group will complete the same assessment phases and will be given access to iMindTime eHealth program following the 1 month follow-up assessment (Week 8). However the delayed access group will be asked to complete the post intervention assessment after they have completed the iMindeHealth program (Week 11). It is expected that people who undertake iMindTime will show increases in mental wellbeing and optimism and reductions in negative affect at post and follow-up time points

Delirium is common in patients recovering from surgical procedures, particularly those involving major cardiac surgery. It is associated with numerous adverse consequences, including increased patient suffering, longer hospital stays, increased postoperative complications, increased mortality and poorer cognitive outcomes. Current strategies are only modestly effective in treating delirium and the cornerstone of management is prevention, however even best practice multifactorial interventions only result in a modest reduction in delirium incidence. Melatonin is a naturally occurring compound that is important in the regulation of sleep. Melatonin metabolism dysregulation has been implicated in the development of delirium, although only sparse evidence about its possible role in delirium prevention exists. The main aim of this randomised, placebo-controlled, double blind clinical trial is to determine if 3mg melatonin can reduce the incidence, severity and complications of delirium following cardiac surgery. We plan to enrol 210 participants due to undergo elective cardiac surgery. Participants will be randomly allocated to melatonin 3mg or matching placebo for 7 days beginning two nights prior to the scheduled surgery. We are primarily interested in whether those given melatonin have a lower rate of new-onset delirium but will also be interested to see if they experience less delirious symptoms, less depression and anxiety, less cognitive impairment, require less medications during their admission (especially sedative medications) and have shorter stays in hospital and ICU. Melatonin is safe, inexpensive and readily available and thus offers a potentially simple, cost effective intervention suitable for use in routine clinical practice.