ANZCTR search results

Patients admitted to the Intensive Care Unit (ICU) are the most acutely unwell in hospital, and those that survive experience significant muscle wasting and poor functional outcomes. Nutrition therapy, usually delivered to ICU patients as liquid formula via a tube into the stomach, has the potential to improve at least part of the significant muscle atrophy that occurs, and hence enhance functional recovery from critical illness. Current international guidelines recommend delivery of protein doses of 1.2 - 2.0 g/kg bodyweight/day or higher, but this is based on very low quality of evidence. It has been reported in observational studies that a large proportion of ICU patients do not meet these prescribed protein targets. The TARGET Protein study is a large randomised controlled trial comparing augmented protein doses recommended in international guidelines to current standard care (ACTRN12621001484831). Augmenting dietary protein has the capability to achieve these recommended protein targets, yet it is unknown whether meeting protein targets improves muscle mass or functional outcomes following critical illness. We propose undertaking a prospective sub-study within a large randomised controlled trial to measure muscle mass, strength and physical function in critically ill patients receiving high protein protein doses compared to standard care.

Functional Neurological Disorders (FND) are neurological problems that are thought to have a psychiatric cause. Though they are very common - the commonest reason for a referral to a neurologist – and very disabling, we know very little about how to treat them. This study would try out a new treatment – or rather, try out a very old treatment that has never been tested for FND before. Sigmund Freud proposed, 120 years ago, that FND (then known as hysteria) were a post-traumatic disorder - an abnormal reaction to stressful life events - and that the way to treat them was by getting patients to fully experience their traumatic memories, rather than avoiding them. This proved to be the best way to treat post-traumatic stress disorder (PTSD), in what is known as ‘prolonged exposure therapy’. However, it has never really been tested for FND, probably because deciding what the traumas are is difficult. In PTSD it is easy, because the traumas are life-threatening events, such as those that occur in warfare; in FND it is hard, because the traumas are less dramatic, such as a fight with a spouse or being bullied by your boss. We have developed a method for identifying these traumas in FND, and have confirmed that FND is a post-traumatic disorder – symptoms began following a traumatic life event in over 90% of cases. The next step is to see if the treatment that works so well for PTSD will work in FND. We propose to adapt the standard therapy by incorporating our method of identifying the traumas in FND, and then performing exposure therapy on those traumas. We will recruit patients from FND services at Austin Health, and then randomly allocate them to 16 sessions of exposure therapy, or a waiting list control. We will then compare the symptoms and quality of life in our patients at the beginning and end of the therapy to see if it has made a difference, when compared to the controls. We will then offer the same therapy to those on the waiting list. If successful, it will form the pilot for a larger grant for a full-scale trial of the therapy, and would represent an historic breakthrough in the management of this ancient condition.

Insomnia is a prevalent and debilitating disorder in Australia. The recommended treatment for insomnia is Cognitive Behavioural Therapy for insomnia (CBTi). However, there are very few clinicians in Australia with training in CBTi. Consequently, most patients with insomnia never access CBTi. Digital CBTi programs are an effective and potentially scalable intervention to manage insomnia. There are very few evidence-based digital CBTi programs available in Australia, and currently no publicly-available digital CBTi programs that provide personalised weekly behavioural therapy recommendations. This randomised controlled implementation trial aims to investigate the feasibility and effectiveness of a digital CBTi referral pathway in Australian general practice. Patients that are referred, eligible and consent to participate will be randomised 1:1 to a digital brief cognitive behavioural therpay for insomnia program, versus waitlist education control. It is hyopthesised that the group who receive the brief CBTi program will report a greater reduction in insomnia symptoms, compared to the group that receive education (waitlist control). • It is hypothesised that the digital CBTi program will be adopted by general practitioners throughout each state and territory of Australia. • It is hypothesised that there will be an increasing number of patient referrals to the study during each month of the study. • It is hypothesised that the intervention group will report a greater improvement in insomnia, and depression symptoms from baseline to 8-week follow-up, compared to the education control group. • It is hypothesised that insomnia and depression symptom improvements will be sustained by 16-week and 24-week follow-up.

The study aims to establish and evaluate Australia’s ‘Birthing on Country’ very remote, demonstration site in Galiwin’ku, Elcho Island, Arnhem Land. We will redesign the health service to increase continuity and quality of maternity care as Yolngu women move through services in Galiwin’ku, Nhulunbuy and Darwin. We will facilitate early medical and allied health referral for women with complex needs and chronic conditions and enable Yolngu to use Indigenous knowledges across the first 1,000 days by providing djäkamirr (Indigenous doula) support to women during pregnancy, childbirth and until baby turns 2-years old. Improving midwifery care and support through clinical and cultural supervision and greater integration of care and services across the jurisdiction is a key strategy. We will increase Yolngu engagement, governance, and control as we develop community reproductive health data reports to facilitate reproductive health literacy. The clinical efficacy, acceptability, cost-effectiveness, and cost-benefit of the very remote ‘Birthing on Country’ will be systematically evaluated.

Depression in older adulthood is a risk factor for social isolation, poor health behaviours, and cognitive decline. Despite recognition as a debilitating risk factor for poor wellbeing outcomes, there remains a significant treatment gap for older adults seeking treatment for depressive symptoms. Hence, there is an opportunity to bridge this gap by addressing barriers of cost, effectiveness and accessibility. MCT-Silver is a novel, low-threshold, educational intervention that combines components of Cognitive Behavioural Therapy for depression with Metacognitive Training, targeting the problematic thinking styles that underlie depression. Content of MCT-Silver has been redesigned to specifically suit older adults. For example, modules emphasise the importance of constructive lifestyle changes, (re)defining values later in life, and at the same time, recognising the value of acceptance in response to age-related loss. MCT-Silver will be piloted amongst older adults in the Australian community who self-identify with depressive symptoms. The primary aim of this project is to determine the effectiveness of MCT-Silver for reducing depressive symptoms and improving unhelpful thinking styles. The secondary aim of this project is to assess feasibility of the MCT-Silver program in an online, videoconference format. Feasibility will also be assessed by offering both group-based and one-on-one settings, as well as measuring adherence and attrition. It is also expected MCT-Silver will be positively evaluated by older adults as a measure of effectiveness. Primary hypothesis: It is expected that older adults who complete MCT-Silver will show reduction in self-reported depression, depression-associated dysfunctional thinking styles, as well as improvements in quality of life and mood improvement.

The social determinants of health are the everyday things in life that all families need to thrive including childcare and schooling; government benefits and vouchers; housing; food; money to pay bills; and transport. Research from Australia has shown that many parents/caregivers of children with cerebral palsy (CP) want help with these everyday things in life and have trouble finding the right supports and services for their family. Studies from the United States of America with parents/caregivers of children (children who do not have a diagnosis of CP) have tested different programs to help families with social determinant of health concerns/ unmet social needs. These studies have found that providing families with a resource pack containing information about local supports and services can help them address problems they are having with their unmet social needs. These studies have also found that providing families with a resource pack and connecting parents/caregivers with a person called a “Community Linker” can help. The Community Linker provides 1:1 support to help families access supports and services for their unmet social needs. These programs have not been done before with parents/caregivers of children with CP in Australia. Together with parents/caregivers of children with CP and their health care professionals, we have designed a resource pack and Community Linker program that aims to be suitable for the unique needs of families of children with CP. We are now testing these two programs (resource pack; resource pack plus Community Linker) in a pilot research study to see if parents/caregivers find them helpful and easy to use. Finding this out is important so we can provide programs to help parents/caregivers get the support they need for their unmet social needs.

Inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, is an incurable, chronic illness. Patients with IBD often require long term immune suppressing medications. Infliximab is a biologic medication that achieves and maintains remission in the majority of IBD patients. However, between 30 and 50% of patients require higher doses of infliximab than that which is registered in Australia. Infliximab is traditionally administered intravenously (IV). However, a new infliximab formulation administered directly beneath the skin (subcutaneous tissue), appears to be equally effective to IV infliximab. Subcutaneous medications are preferred by the majority of patients given greater flexibility and convenience. Emerging evidence demonstrates that, in patients receiving dose-intensified IV infliximab, switching to subcutaneous infliximab maintains remission in the vast majority of patients. This study aims to confirm that patients with Crohn’s disease and ulcerative colitis receiving dose-intensified IV infliximab can switch to subcutaneous infliximab and maintain clinical and biochemical (blood and stool test) remission and adequate drug levels. We will perform a multicentre, randomised non-inferiority trial. We will recruit 120 adults with IBD in remission receiving stable dose-intensified IV infliximab. Participants will be randomly allocated to continue their current regimen or to switch to subcutaneous infliximab. Clinical and biochemical activity as well as drug levels will be measured every 12 weeks until study conclusion at week 48. The primary outcome is rate of relapse between the two groups at week 48. Relapse is defined as composite clinical and objective activity OR need for corticosteroids, immunomodulator or switch in therapy OR need for IBD-related hospitalisation/surgery. Patients meeting the first clinical and biochemical relapse criterion are permitted one dose-escalation in their subcutaneous or IV infliximab. They will be recorded as meeting the primary endpoint whilst still remaining in the study to 48 weeks to measure response to further dose-intensification. Secondary endpoints will include changes in infliximab drug levels, anti-infliximab antibodies, economic impact, patient satisfaction and the change in clinical and biochemical markers of disease activity throughout the study.

The purpose of this study is to determine if using the PROMs and PREMs questionnaires and its language translations in real-time within selected outpatient clinics for those with cancer will help to identify patient concerns for immediate discussion and management with their treating teams. Translations of the questionnaires in 10 commonly spoken non-English languages will also be available for patients who speak these languages. Who is it for? You may be eligible for this study if you are aged 18 or over, have a diagnosis of cancer, and attend a selected Monash Health medical oncology outpatient clinic. Study details All participants in this study will complete a variety of questionnaires about their cancer and treatment experience. There will be study questions relating to cancer symptoms, services for support, and your overall quality of life. These questionnaires will be available to complete online up to 2 days prior to routine clinic visits. No additional visits are required for participation in this study. Participants will also be asked to complete a survey and/or contacted via email or post to evaluate the study at the end of the research period. It is hoped this research will improve patient oncology services and identify that these questionnaires and their translations are feasible, acceptable, and useful for patients and doctors in real-time.

This crossover study will examine the effect of body position (30 versus 60 degrees head of bed elevation) on moisture under the skin (subepidermal moisture), at the sacrum (the lower back) and at the heels, in healthy adults. When pressure is applied to the skin, there is a possibility of blood and lymphatic vessel being compressed resulting in inflammation and oedema (increased moisture). This increased moisture is not visible on the skin’s surface; however, technology is available to measure it. It is understood if the pressure is relieved then the increased moisture resolves quickly and is of little consequence to overall health; however, if pressure is maintained PI has the potential to ensue. PI commonly occur over skin that covers bony areas, like the sacrum or heels. By examining if body position influences oedema development in healthy adults we aim to contribute baseline information to inform future studies of populations at greater risk of PI and operational procedures in using the technology. To assess the amount of subepidermal moisture in the tissue at the sacrum and heel, the Bruin Biometrics Provizio Sub-Epidermal Moisture (SEM) scanner will be used. The Provisio SEM scanner is a non-invasive, hand-held device that is used in healthcare clinical practice in the United States of America. The Provizio scanner detects the capacity of tissue to hold electrical charge, known as capacitance by light contact between the disposable sensor (one per participant) and the skin. Tissue will have a larger capacitance with increased moisture levels, as in the case of oedema. The Provizio SEM scanner calculates the capacitance at specific points of contact and computes the delta reading, being the difference between the highest and lowest measurement at an anatomical location. Research to date is suggesting the Provizio delta reading of greater than 0.6 units at the sacrum or heels indicates an increased risk of PI. There is however a gap in knowledge on whether the position prior to utilising this medical device influences the readings. Because each participant is measured in both body positions, the crossover design allows the research team to compare measurements in different positions while limiting individual confounding factors. To attempt to remove any influence of the first position on the second the order of position will be randomly allocated and there will be a 60-minute ‘washout’ period between each position where the participant will be off the bed and be able to walk around. The study will take place over a two-hour period at Griffith University’s School of Nursing and Midwifery clinical laboratories on the Gold Coast.

Fasting is standard of care prior to catheter laboratory procedures. The purpose of this is to reduce the risk of aspiration events during procedural sedation. Generally, this involves 6 hours of solid food fasting with 2 hours of clear fluid fasting. Currently there are limited prospective data reviewing the utility of fasting versus no fasting prior to catheterisation procedures. Recently the CHOW NOW study based in America performed a randomised control trial assessing this question. They demonstrated non-inferiority of no-fasting with a pre-specified margin of 5.9%. We wish to assess the non-inferiority of no fasting for catheterisation laboratory procedures in a multicentre trial with a narrower non-inferiority margin of 3%. Fasting prior to procedures may be associated with patient discomfort and distress. In addition, there are some populations where oral intake is important to prevent adverse events. Examples include those with chronic kidney disease where dehydration, potentially precipitated by fasting, associates with increased risk of contrast induced nephropathy. Moreover, patients are frequently cancelled due to lack of fasting. Relinquishing prerequisites for fasting prior to procedures may assist in providing expedited patient care and reduce adverse events related to underlying disease. The main risk associated with no fasting is that of aspiration pneumonia. In the CHOW NOW study, only 0.7% of the non-fasting group experienced this adverse event. This is an uncommon and treatable complication. Risks of fasting (dehydration, hypotension, hypoglycaemia, contrast induced nephropathy, patient discomfort) may outweigh the benefits in preventing the uncommon event of aspiration pneumonia. Though a randomised trial has already been performed, the American Society of Anaesthesiologists has requested more data prior to the acceptance of no fasting before simple catheterisation laboratory procedures.