ANZCTR search results

This study will focus on patients who are planned for surgical resection of the oesophagus or stomach as part of curative treatment for oesophageal, oesophagogastric junction (OGJ) or gastric (stomach) cancer. Oesophagogastric (OG) cancer surgery is associated with significant morbidity with specific challenges related to consuming enough food and fluids, poor nutrition status, reduced physical performance and impaired health related quality of life (QOL). Malnutrition and low muscularity (or low muscle mass) is common in patients with gastrointestinal cancer regardless of body weight or body mass index (BMI). Routine diagnostic computed tomography (CT) images can be used to assess body composition and have shown that low muscularity prior to surgery can lead to increased hospital length of stay, postoperative complications, mortality and reduced overall survival after gastrointestinal cancer surgery. Sarcopenia, commonly used to describe age related loss of skeletal muscle mass with low muscle strength and/or low physical performance, is also associated with poor health related outcomes but is yet to be explored in the context of the surgical oncology population. This prospective observational pilot study aims understand the clinical, nutritional and functional differences between sarcopenic and non-sarcopenic patients undergoing surgical treatment for oesophagogastric carcinoma, thereby defining two distinct syndromes. In addition, we aim to assess changes in the specific components of sarcopenia after OG cancer surgery and the influence on postoperative recovery. As a pilot study we aim to identify areas of potential difference between these sarcopenic and non-sarcopenic groups that may account for differences in treatment outcomes and lead to future larger scale research endeavours that consider specific interventions to prevent or reduce the development of sarcopenia.

A retrospective casenote review of three cohorts following changes to clinical practice, to determine the impact on breastmilk and breastfeeding outcomes. Group A is the historical baseline cohort and covers 6 months 1/1/18-30/6/18. Group B is a 6-month period following the introduction of PDHM into the Neonatal Unit for eligible infants and the employment of an IBCLC in a dedicated role within the Neonatal unit. Group C is a 6-month period following the introduction of an expressing box designed by the IBCLC, containing basic expressing equipment and information (syringes, medicine straws, expressing kit, information booklet), designed to encourage the earlier initiation of expression by making it easier for staff to provide equipment and information simultaneously. Across all cohorts, data assessed included: time of first breastmilk expression, any use of PDHM (where applicable), receipt of the expressing box (where applicable), the timing of the first infant exposure to breastmilk, the timing (corrected gestational age) at the first breastfeed attempt, and feeding outcomes at discharge (exclusive breastfeeding, exclusive breastmilk feeding, mixed feeding (breastmilk and formula), standard formula feeding or specialist formula feeding.

Women of reproductive age have been identified by the WHO as an important target group as they prepare for parenthood, as the time around conception and pregnancy often represents a significant turning point in a woman’s cardiovascular and health trajectory, inducing metabolic changes which contribute to weight gain and poor health. Australian data indicate that 3 in 4 pregnancies are planned, and for women planning pregnancy, ~86% will initiate changes in health behaviours before conception. More than 50% of women attending their general practitioner for pre-conception advice, including information about healthy lifestyle and nutrition. Accessing up-to-date, evidence-based health information in a contemporarily acceptable format during reproductive years presents an unmet opportunity in Australia, to improve the health and well-being of potential parents. Our aim is to conduct a randomised trial of a dietary & lifestyle intervention prior to conception • To improve maternal nutrition, physical activity and healthy behaviours and • To evaluate the impact on maternal, newborn and child health outcomes. Our hypotheses are that this innovative public health approach will • Improve health outcomes for women, and their babies and children, • Reduce health care costs and • Provide an evidence-based tool that can be readily scaled up for implementation in the community.

We seek to investigate the feasibility of integrating a therapy-homework smartphone app, “Cogito”, into an evidence-based psychological intervention for people with a diagnosis of psychosis. The intervention, individualized metacognitive training (MCT+), is an effective psychological treatment for reducing delusional symptoms in people with psychosis. The app, "Cogito", provides participants with brief once daily reminders of the lessons they learned in therapy sessions. Therapy homework is a core component of psychological therapies, allowing participants to keep practicing the lessons learnt and exercises/experiments covered in sessions outside of therapy session. Compliance with homework has been shown to improve treatment outcomes from therapy. MCT/MCT+ has traditionally used conventional homework sheets. While MCT/MCT+ has been shown to be effective, it has been noted that many patients with psychosis do not complete the homework exercises due to several factors, including forgetfulness and lack of motivation. Delivering therapy ‘homework’ via a smartphone app has the potential to increase engagement and compliance, and ultimately, may further improve the efficacy of interventions such as MCT. The “Cogito” smartphone app was developed to complement MCT/MCT+, with a goal of increasing homework adherence and thus maintaining and increasing the gains from therapy. We hypothesize that participants will find the app useful and will be more likely to complete homework activities using the Cogito app than they would using traditional paper worksheet style homework.

BACKGROUND:- Acute kidney injury (AKI) is a potentially life-threatening condition caused by unsafe levels of fluid and waste products accumulating in the body due to kidneys not working correctly. AKI can occur in when a person is already unwell with another health condition, and so is more common in people who are in hospital. AKI can increase the risk of heart events, further kidney disease and death. Dapagliflozin is a medication that is used to treat people with diabetes, heart disease and kideny disease. Recent studies have shown dapagliflozin to slow the progression of chronic kidney disease, but it has not been investigated in people who have recently recovered from AKI. AIM:- To determine if giving dapagliflozin (10mg in one capsule per day) compared to placebo (a capsule that looks and smells identical but has no active ingredients) reduces kidney injury in people who have sufficiently recovered from AKI. This is a feasibility trial to show whether this trial will be successful before expanding to a larger trial. DESIGN:- The trial will enrol 60 participants from 3 hospitals with in NSW. Participants will be randomised (randomly assigned; like tossing a coin) by a computer to receive either dapagliflozin or placebo for a maximum of 84 days (12 weeks) and followed up for a total of 112 days (16 weeks). This trial is 'double-blinded' which means the doctor and treating team, nor the participant will know which treatment that are receiving.

This was a (non-randomized) parallel cohort study with intervention and control arms looking at improvement of discharge processes. The study involved an intervention cohort and control cohort (approximately 1:3 ratio). The intervention cohort received a suite of educational, process change and culture change strategies that aimed at improving the discharge summary processes. Study Hypothesis Statement FOR General PUBLIC: Improved hospital processes will lead to tImely discharge summaries with better patient satisfaction.

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.