ANZCTR search results

This project is the implementation and evaluation of a newly proposed model of service in the emergency department. The service comprises consultation with older patients (80 years and over) suffering from advanced frailty or chronic illness to make choices about their preferences and values so these can be incorporated in the treatment decisions. The evaluation will use a randomised trial design to compare the effectiveness of the new Goals of Care service with 'usual care' provided at Liverpool hospital before/during the intervention and with a control group in another teaching hospital (Westmead) where another model of service has been in place for several years. Mixed methods will include a qualitative investigation of the patient's and the implementers' satisfaction with the service. The aim of the study is to examine the feasibility, acceptability and effectiveness of the Goals of Care initiative in terms of type of care choices and place of death (institutional vs. community-based), as well as establishing concordance of wishes with actual care provided. It is hoped that the identification of the older people at high risk can be embedded in routine practice and the Goals of Care service will improve the uptake of advance care planning and reduce unnecessary hospitalisations.

Mild cognitive impairment (MCI) affects at least 10% of older adults globally, and in this cohort the risk of incident dementia is greatly increased from 1-2% per annum to 10-15%. Exercise has been shown to be beneficial for some cognitive outcomes in MCI, although results are heterogeneous, and the optimum exercise dose and modality for preservation or improvement of cognition is not fully defined. Progressive resistance training (PRT) has been shown to have larger effects on cognition than aerobic training in meta-analyses. The limited benefit of some aerobic training studies may be due to insufficient intensities of the intervention, which have produced suboptimal changes in aerobic capacity or other physiological adaptations potentially mechanistic for improved brain function. High intensity interval training (HIIT) results in more beneficial cardiovascular adaptations compared to standard moderate intensity aerobic training. The wealth of data linking aerobic fitness to cognition suggests that HIIT, which approximately doubles the average improvement in aerobic fitness compared to standard training, is of potentially great interest in MCI therefore. However, HIIT has never been tested alone or directly compared to PRT for cognitive benefits in any cohort. We hypothesize that PRT and HIIT will be robust, alternative exercise interventions to improve cognition in MCI. We will conduct a multi-national, randomised controlled trial over 4 years in which we randomise 210 older adults with MCI in Australia and Canada to PRT, HIIT or a sham exercise control group for 12 months. Executive function is the primary cognitive outcome. Secondary outcomes include other cognitive domains, biomarkers for cognitive decline and distinct mediators of benefit for PRT (e.g., anabolic hormones, lean mass) vs. HIIT (e.g., arterial stiffness, aerobic fitness), functional status, brain structure and connectivity, and psychological wellbeing. The study is powered for our primary hypothesis that both PRT and HIIT will improve Executive Function Domain relative to the control. We will recruit 70 participants per group for a total sample size of 210 across the three sites. This sample size will allow to demonstrate a relative ES of 0.48 (PRT vs. Control or HIIT vs. Control) assuming alpha less than 0.05 and beta of 0.2. Sample size has not been inflated for loss to follow-up, as we will utilise linear repeated measures mixed models and/or General Linear Models in intention-to-treat analyses including all randomised participants irrespective of dropout or adherence. We do not intend to compare PRT to HIIT as we hypothesise both to be effective, therefore the comparisons are for intervention vs. control only. BRAIN will be the first trial of HIIT for cognition in any cohort, and the largest and only multi-national study of exercise for Mild Cognitive Impairment ever conducted.

This study is looking at whether the use of robotic technology can assist youth with acquired brain injury function better in their lives. This is important because we know from previous studies that functional improvements in brain injury, such as better walking, can come from more intensity of therapy (doing lots of therapy). Robotic technology may be a fun way to provide this therapy to young people. Based on studies in people with neurological conditions it is felt that the technology could assist, but further studies are needed to determine whether this is true. This study is being conducted to assist in answering that question. This study will involve two robotic machines - the Lokomat and the Armeo. The Lokomat is a robotic device to assist with walking and endurance. You/your child will be fitted to the device and while using it have the opportunity to engage with the interactive software used for fun and motivation. The Armeo is an upper limb robotic device that allows for practice of upper limb (arm and hand) skills, movement and strengthening. This device is connected to computer graphics with games and activities to motivate you/your child to complete activities. They allow for repetitive functional movements with instant feedback and the user practices these movement skills in virtual reality games. They are both located in the Little Heroes Foundation Centre for Robotics and Innovation at the Women's and Children's Hospital. Initially you/your child will be randomly allocated to one of two treatment groups: robotic therapy or conventional physiotherapy (usual land-based physiotherapy). Then, after a 6 week break, will be crossed over into the other group for the second treatment block. All participants therefore get to experience both robotic and conventional physiotherapy. In each treatment group you/your child will receive 15 training (therapy) sessions in total over a 5 week period. Each training session should take approximately 1 hour to complete. There is a series of assessments (muscle length, walking speed, walking endurance etc) that will be conducted by an assessment physiotherapist before and after treatment blocks and at a 3 month follow up. We expect these to take about 1 hour each time.

The purpose of this study is to describe the safety and tolerability of the study drug compared to the vehicle solution with twice daily dosing in subjects with Atopic Dermatitis. Patients with Atopic Dermatitis aged between 18 and 65 years, inclusive, will participate. BTX 1204 4% Solution or Vehicle Solution will be applied twice daily for 28 days. The study consists of a screening visit (up to 14 days before receiving study treatment) and an enrolment visit initially. There is a visit on Day 8 and Day 15 during the 28 day dosing period. Participants will return to the clinic on Day 29 for safety assessments. The maximum study duration for any participant will be a total of up to 43 days; screening period (up to 14 days), 28 days of treatment and a visit on Day 29.

A private hospital in Western Australia introduced a pilot Enhanced Recovery Program (ERP) for THR in 2012 based on an orthopaedic recovery program established in United Kingdom (Wainwright & Middleton, 2010). The ERP for THR included a range of strategies to support the pre-admission, peri-operative, post-operative and post-discharge patient care. After an extensive evaluation of the pilot program the ERP was introduced as part of standard care in 2013 and has continued as standard care. The education components of the ERP include information book, hospital based pre-operative education session and post-operative phone follow-up. Patient feedback of the ERP was positive but for patients living in rural locations it was difficult to attend the pre-operative education session. The private hospital recognised a virtual platform as a solution to provide information for all patients undergoing a THR and also provide a patient clinician interface in the post-discharge period. The private hospital commissioned the development of a virtual program for THR and plan to implement a pilot study to compare the effects of the virtual program versus the standard program for patients undergoing primary THR replacement on patient outcomes. The aim of this study is to compare a virtual program versus standard program as part of care for primary total hip replacement (THR) on patient outcomes.

Retinoblastoma is the most commonly occurring paediatric eye cancer. The earliest signs of disease include leukocoria (white pupil) and strabismus (crossed eye). Untreated, retinoblastoma results in loss of sight, eye or life. Common strabismus occurs in up to 2-4% of children resulting in poor vision when diagnosed and treated late. Unfortunately, white pupil or strabismus are often ignored as there is a lack of information and misinformation regarding the importance of these signs. Currently, no systematic information is provided to parents in Victoria regarding leukocoria or strabismus. Raising parental awareness of these signs could reduce delays in diagnosis and result in earlier treatment with the potential for improved outcomes. This randomized controlled trial aims to evaluate an evidence-based, theory-informed information pamphlet that has been developed for parents. It is hypothesized that parents who receive the pamphlet would be more alert to these early signs and have heightened help-seeking intentions.

Heart disease is the number one killer worldwide, with over one million cardiac operations performed each year. Patients undergoing cardiac surgery are typically elderly with multiple health conditions. Whilst cerebral (brain) complications such as stroke are infrequent (3%), a decline in cognitive (brain) function is more prevalent following surgery with reports that concentration, focus, cognitive processing speed and short-term memory is impaired in 15–40% of patients at 3 months or longer after surgery (Ahlgren et al., 1998; Roach et al., 1996; Newman et al., 2001; Royse A et al., 2000). This permanent loss of cognitive function is even higher in elderly patients (Moller et al., 1998; Benvenuti et al., 2014; Royse C et al., 2011), and results in disability and loss of independence. It may also accelerate the incidence of dementia, as high as 30% in patients 7.5 years after cardiac surgery (Evered et al., 2016). Dementia occurs in approximately 9% of the general population over the age of 65 years, causing substantial personal and family suffering, and a high cost to the health care system. Within the next 20 years, 100 million people are predicted to have dementia, which will pose a serious challenge for the health care system (Andrieu et al., 2009). Furthermore evidence of mild cognitive impairment (MCI), considered a precursor to dementia, is evident in 30-50% of patients prior to undergoing cardiac surgery (Royse C et al., 2017). Preventing further deterioration of cognitive function after surgery is therefore critical in reducing dementia in this vulnerable cohort. Previous studies have shown that exercise preserves or even improves cognitive function (Vaynman et al., 2004), as well as reducing long term cognitive decline (Liu-Ambrose et al., 2010; Hamer et al., 2009). This study will look at the effect of early weight training exercise, requiring an increased effort and heart rate, following open heart surgery. We aim to determine if there is an optimal dose (type, intensity and duration of exercise) to maximize cognitive and physical health benefits. Participants will be randomly assigned (like tossing a coin) to either a 12-week moderate intensity weight training program or to a 6-week low-intensity exercise program (usual care). Participants in both groups will attend twice weekly exercise rehabilitation, lasting for approximately 60 minutes per session (12-24 sessions). All exercise sessions will be supervised by an accredited exercise physiologist or physiotherapist to ensure patient safety. We predict that the weight training intervention will prevent further cognitive decline, and result in significantly greater improvements in patient-reported recovery, exercise ability and muscular strength up to 6 months after surgery. We anticipate that the participants will return to pre-disease levels of health and function or better.

Cardiac rehabilitation (CR) is a secondary prevention program for cardiovascular disease. Physical activity (PA) is considered a core component of cardiac rehabilitation programs. Despite this, studies have found that PA levels are low in CR participants and sitting time is high. The aim of this study is evaluate the feasibility of a behavioural smartphone application (ToDo-CR) to decrease sedentary behaviour (SB) in CR participants. A secondary objective will be to determine whether the smartphone application increases MVPA in CR. Studies have identified that CR patients are interested in support via the internet and mobile phones. Yet, few studies have investigated the efficacy of smartphone applications in CR. To our knowledge this will be the first study to investigate the use of a smartphone application in CR and its effect on SB.

A self-monitoring digital health program (MonitorMe), offered to adult clients from a large local regional healthcare service provider, will be evaluated using a quasi-experimental trial design. People taking part in the study will receive immediate access to the MonitorMe program following completion of the pre-program survey. MonitorMe is self-help digital health program designed to enable people to self-monitor their mood and daily lifestyle events with minimal effort, and provide them with decision supports to help them interpret their self-monitoring scores and stayed engaged. These decision support tools also provide the person with relevant feedback and timely ‘life skills’ strategy information and practice tools that either work at maintaining their current healthy behaviours or assist them to get back on track when things are not going so well (depending on what their actual scores indicate. Participants will be asked to complete the self-monitoring survey that should take approximately 1 minute each day. Then once every week, participants will be asked to use the ‘Monitoring Graph’ decision support tool that will walk them through their self-monitoring scores from the past 7 days. Using the decision support tool will require 2 to 20 minutes per week (depending on their individual scores). Participants will be asked to complete a pre-program survey assessment (Week 0), followed by 1 ‘during’ assessments (Week 5), and a post-program (Week 9) and 3-month follow-up (Week 21) survey assessment. Participants will also be asked questions relating to their program engagement levels at post-program assessment. Participant engagement with the program will be obtained through by passive analytic data (e.g., what pages / strategies they visited / used and when), as well as reviewing the completion of daily mood and lifestyle event survey data and the scheduled intervention assessments. Program access will continue for 4 weeks following the 3-month follow-up assessment. It is expected that people who undertake MonitorMe program will show reductions in their stress, anxiety and depressive symptoms at post-intervention and follow-up assessment time points, as well as increases in mental wellbeing.

PTG-200 is an experimental drug being developed by Protagonist Therapeutics as a treatment for moderate to severely active Crohn’s Disease (CD) which is an inflammatory bowel disease (IBD). CD causes gastrointestinal signs and symptoms such as diarrhoea, abdominal pain, weight loss and passing blood or mucous. Current treatments for this highly complex disease have unacceptable side effects or cannot be used long term as they suppress the immune system and may increase the risk of serious infection or cancer. PTG-200 is believed to reduce the swelling that contributes to CD by blocking a specific part of your immune response pathway. There are a number of new treatments for CD which have been approved for use in other countries . PTG-200 is thought to be a better treatment for CD compared to these other medications as PTG-200 is restricted to the gut and very unlikely to spread to other parts of the body, meaning it would have fewer side effects and remain in the gut. The primary purpose of the study is to evaluate the safety and tolerability of the study drug referred to as PTG-200 in healthy individuals using single or multiple dose over number of days. The study will also evaluate how the PTG-200 is absorbed, spread in the body, and the body’s response to the drug.