ANZCTR search results

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.

The aim of the proposed study is to examine the efficacy of cold-water showers as a potential therapeutic intervention for the reduction of symptoms associated with depression amongst a non-clinical sample. The proposed study will address the question; “Can a cold-water shower intervention, decrease symptoms associated with depression and help to boost well-being”? It is hypothesized that a cold-water shower intervention will reduce symptoms associated with depression. It is additionally hypothesized that a cold-water shower intervention will increase levels of well-being.

Purpose of study: In Australia, up to 1 in 20 women will have a pregnancy impacted by pre-eclampsia, however recent changes to the definition of high blood pressure may assist in finding women most at risk earlier in their pregnancy. This study will explore a new approach to diagnosing pre-eclampsia that could benefit women in the future. Similarly, a third of women are affected by cardio-metabolic conditions during pregnancy such as gestational diabetes (GDM), pregnancy induced hypertension, pre-eclampsia, fetal growth restriction and spontaneous preterm birth. These conditions not only cause significant morbidity during pregnancy but are also associated with increased risk of maternal Type 2 Diabetes and Cardiovascular Disease (CVD) after pregnancy. However, CVD risk prediction tools do not capture these pregnancy-related cardio-metabolic conditions. Younger women and their health professionals have a limited understanding of the risks and screening and prevention are generally lacking. We know that these risks can be reduced by preventative screening (such as early screening for diabetes, abnormal lipid levels or elevated blood pressure) and optimising lifestyle strategies. This study offers an important opportunity to identify and target these women at risk for early intervention and screening. Hypothesis: Biological markers of endothelial, placental, inflammatory and cardiac dysfunction can be used to create an algorithm that can better predict the risk of developing pre-eclampsia, as well as risk of long-term cardiovascular sequelae in patients affected by pregnancy complications. Evidenced by derangement in cardio-metabolic markers following development of these conditions which persists post-delivery. Study design: Prospective observational trial involving two blood collection during pregnancy as well as after delivery. Where possible these blood test would be performed at time of routine pathology collection. Blood test result of patient who develops complication and those who does not is compared to develop an algorithm for prediction and diagnosis of pregnancy complications, as well as evaluate risk of long term cardiovascular complications. This study is observational only and does not interfere with routine antenatal care.

This study is a First in Human, randomized, double-blind, placebo-controlled study of subcutaneous EQ102 administered as single (SAD) or multiple (MAD) doses. In Part A (SAD), up to approximately 48 healthy adult men and women will be enrolled and randomized to 6 cohorts (n=8 per cohort) to receive single ascending doses of EQ102 at doses of 50, 100, 200, 500, and up to 1000 mg or placebo. Dosing in each cohort for Part A will commence with two sentinel participants with one of the two sentinels randomized to receive EQ102 and the other randomized to receive placebo. EQ102 will be given in sequential, escalating doses contingent on a review of safety, tolerability, and available PK data of the previous dose level by a Safety Review Committee (SRC). In Part B (MAD), healthy adult volunteers will be enrolled and randomized to 3 cohorts (n=8 per cohort) to receive multiple ascending doses of EQ102 or placebo. In Part B, up to three dose levels will be evaluated in healthy volunteers. The starting dose for Part B will be based on review of safety and PK data from Part A. The decision to escalate between dose levels will be based upon review of all safety and PK data.

Early childhood is a joyful but often stressful time for parents--mealtimes can be battlefields, leaving the house can be an ordeal, and reasonable requests can result in meltdowns. Parents who regularly feel stressed are more likely to experience poor mental health, including feelings of failure and isolation. In turn, children raised in a stressful environment can have poorer emotional and behavioural development outcomes. Our research aims to investigate a distinctive style of early parenting known as the Respectful Approach and how it may improve stress and other health outcomes in parents and their young children. Originally designed for institutional care in Eastern Europe and introduced to the USA by Madga Gerber, it focuses on developing a cooperative relationship with the child. Parents are guided to treat their infants as capable and independent, with emphasis on sensitive observation and attention to cues. Our preliminary research on the Respectful Approach showed that our parent-child education workshops significantly lowered parents stress levels and increased their parenting confidence. Parents also better understood their children’s capabilities. Going forward, we want to discover whether the Respectful Approach also has benefits for children’s health - particularly stress, behaviour, growth, and development. We want to provide a preventative, evidence-based education program to empower parents to develop cooperative relationships with their young children. We hypothesise this will reduce stress in families and improve child health outcomes.