ANZCTR search results

This study aims to compare the efficacy of two types of Self-Expandable Metallic Stents (SEMS) in the treatment of gastric malignancies. Who is it for? The study is looking for participants that are required to have stents inserted for treatment of malignant gastric outlet obstruction (or “GOO”). Purpose of the study Self-Expandable Metallic Stent (or SEMS) are placed to open a stricture or tightening within the small bowel that is causing your symptoms, as food cannot pass through from the stomach into the small bowel. Uncovered stents (U-SEMS) are often placed to open this but there is the risk of tumour growing into the stent. When the stent is covered (C-SEMS), the tumour cannot grow into the stent. However, there is the risk of the stent moving (migrating). Though there have been multiple studies assessing the difference between C-SEMS and U-SEMS, and there are both advantages and disadvantages to using either, newer comparison studies are needed, as the introduction of recent technological developments have allowed for better SEMS fixation it is not clear which type of technique is preferred. Study Details We aim to compare the differences of two types of Self-Expandable Metallic Stents (SEMS) for GOO relief: • “Covered” SEMS (C-SEMS), and • “Uncovered” SEMS (U-SEMS). These two types will be assessed in terms of stent patency, technical success, clinical success, and safety. These will be assessed at the day of the procedure, and three follow-up visits. We are particularly interested in comparing the stent patency rate between groups; the percentage of participants with stents that do not require re-intervention at 3- and 6-months post placement.

The aim of this study is to conduct a 12-week feasibility and pilot randomised controlled trial of a co-designed home-based personalised reablement strategy program delivered via Voice-Controlled Intelligent Personal Assistants (VIPAs) in older adults aged 60-89 years with mild cognitive impairment (MCI) and/or dementia. The primary aims are to assess study processes including acceptability, retention rates and adherence to the personalised reablement strategy program. The secondary aims are to compare changes in scores on the Short Form Geriatric Depression Scale, the Illness Cognition Questionnaire, the Multifactorial Meta Cognition Questionnaire, Bayar Activities of Daily Living Scale, Everyday Cognition Scale and Zarit Burden Scale. The primary hypothesis is that a 12-week VIPA-delivered home-based personalised reablement strategy program will be feasible and acceptable, as evidenced by greater than 70% retention in the study, completion of greater than 66% of the personalised reablement strategy program, and by overall themes of acceptability expressed through participant interviews. The proposed study is significant as it has the potential to transform healthcare delivery for people with MCI and dementia. The novel VIPA lifestyle delivery method can reduce the need for regular face-to face care and increase implementation and adherence to evidence-based recommended care. This will ultimately lead to improved healthcare outcomes and reduced costs on a massive scale, especially given this telehealth method removes some of the barriers to implementation related to traditional telehealth and face-to-face methods and therefore is more easily scalable. It is anticipated that this research has the potential to support the need for future studies to explore cost-effectiveness of this telehealth approach in MCI and dementia. Future projects will explore the delivery of this project to reduce healthcare inequalities by providing high quality and cost-effective services to low-income individuals and people in remote and rural areas.

Anorexia nervosa (AN) is a serious psychiatric condition with high morbidity and mortality, for which existing treatment paradigms demonstrate suboptimal therapeutic efficacy and duration of treatment effect. Convergent lines of evidence point to the use of estradiol as a pharmacological treatment option for AN. Through restoring hormonal imbalances, estradiol can address many domains of AN including mood and cognition, bone density, and appetite regulation. The proposed study aims to investigate whether estradiol is more effective in reducing symptoms of AN than placebo. Previous studies in bone health have found significant bone mineral density improvements at 100mcg/day and 40mcg/day, however, no study to date has investigated the use of estradiol to address mood and cognition. Based on our clinical work, we propose to use 50mcg transdermal estradiol patch.

The application of pressure bandage, combined with immobilisation of the bitten limb, has been the standard of care for Australian snake bite since the studies by Straun Sutherland. The technique was shown to slow the systemic absorption of an analogue of the venom of the elapid family of snakes native to Australia by cessation of lymphatic flow carrying the venom from the affected limb. A recent systematic review by Bert Avau and others has recommended against the use of the pressure bandage for 2 main reasons: First that the venom of the crotalid family of snakes (found in many countries) has a different mechanism of action resulting in increased necrosis at the bite site and second because studies have demonstrated that lay application of pressure bandages exerts too little pressure to stop lymphatic flow. Avau et al cite multiple papers disputing the efficacy of the technique or the ability of first aiders to apply sufficient pressure.. The current study aimed to determine if experienced first aiders are able to apply sufficient pressure to stop lymphatic flow (estimated to be 40 - 70 mmHg for the upper limb and 55 – 70 mmHg for the lower limb)

The study aims to establish and evaluate Australia’s ‘Birthing on Country’ remote, demonstration site in Mparntwe, Alice Springs, Northern Territory. We will redesign the health service to increase continuity and quality of maternity care, and positively impact the health and wellbeing of First Nations women and babies in Central Australia. The clinical, cultural and cost effectiveness, and acceptability, of the new service will be systematically evaluated.

People with type 1 diabetes (T1D) need insulin for survival but hypoglycaemia (low blood glucose, also called ‘hypo’) is a common side effect. Untreated hypos can cause confusion, injury, coma, and sudden death. Living with the risk of hypo impairs mental health. For example 75% of people with T1D have mild fear of hypo and 25% have severe diabetes distress. Fear of hypo drives misguided coping strategies (e.g. skipping insulin or maintaining glucose above target), which increases risk for long-term health complications. HypoPAST (Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment), is the first Australian fully online self-guided psycho-education program. It aims to reduce fear of hypo through improved prevention and management of hypos. This study will evaluate the effectiveness, cost-effectiveness and acceptability of HypoPAST. We expect that HypoPAST will lead to lower fear of hypo and improvement in other psychosocial and clinical outcomes. We expect that HypoPAST will be acceptable to adults with T1D and cost effective.

This examiner-blinded, randomized controlled clinical trial will use a two-treatment, parallel design to assess the effects of the treatments on the severity of gingivitis, accumulation of supragingival plaque and changes in the microbial composition of supragingival plaque. Participants will be randomly assigned to one of two treatments with each treatment comprising 21 days. The two treatments will be as follows: A. Tooth brushing with GC MI Paste One Perio containing 10% CPP-ACP and stannous fluoride (1100 ppm F) three times a day (after breakfast, after dinner and before bed), with no other oral hygiene procedures over 21 days. B. Tooth brushing with Colgate Total SF containing stannous fluoride (1100 ppm F) three times a day (after breakfast, after dinner and before bed), with no other oral hygiene procedures over 21 days. During the treatment period, all participants will be requested not to brush with any other toothpaste and not to consume any antibiotics or antimicrobials including antimicrobial mints, lozenges, films and chewing gums.

This feasibility study will Virtual Reality (VR) delivered mindfulness as a treatment for chronic insomnia. The experimental treatment is VR-delivered mindfulness ("VRmind"). The investigators will demonstrate the feasibility of conducting a trial of at-home VRmind for people with chronic insomnia. Participants will be randomised to receiced 4 weeks of twice weekly mindfulness sessions delivered using a VR-headset (VRmind) or a or a computer-screen ("2Dmind"). At the end of treatment, participants will provide feedback by completing a satisfaction questionnaire. To complete the weekly at-home mindfulness sessions participants in the VRmind group will be provided with a VR-headset by the study and details to access the weekly mindfulness content. Participants in the 2Dmind group will be given online access to the same mindfulness content be using their own computer/phone. Participants randomized to 2Dmind will be the option to complete an additional 4 weeks of VRmind at the end of the study.

Sleep disturbances are common among people living with dementia, with consequences far reaching for the person, their carers and care systems. Sleep disturbances result in decreased quality of life for the person with dementia and cause significant stress for caregivers. Additionally, sleep disturbances are associated with increased admissions to care settings and healthcare costs. As such, sleep disturbances for people living with dementia are recognised as a major challenge that requires addressing. Nonpharmacological interventions are prioritised for the treatment of sleep disturbances; however, medication is frequently used, with a range of risks (including increased falls and confusion). Currently there is no gold standard sleep intervention for people with dementia. Use of weighted blankets is emerging as a safe sleep intervention option, although little is known about the effectiveness of use for people with dementia. A staged investigation will be conducted to 1) examine the effectiveness of weighted blankets as a sleep intervention for people with dementia; 2) understand the barriers and facilitators to use of weighted blankets; and 3) co-design a plan for future implementation across a range of settings. This trial reports on stage 1 of the project. During this stage we will recruit 14-18 participants living in a dementia-care unit to be randomly divided into either the intervention group or usual care group. The intervention group will use the weighted blanket overnight for two weeks, then the groups swap. A range of measurements, including sleep duration and quality, and medication use, to determine the blankets’ impact. We hypothesize that participants in the intervention group will have improved sleep outcomes and reduced behavioral and psychological symptoms of dementia. Research questions: 1. Are weighted blankets an effective and feasible sleep intervention for people with behavioural and psychological symptoms of dementia? 2. What are the implementation strategies for uptake of weighted blankets for people with behavioural and psychological symptoms of dementia in an inpatient setting? 3. What are the recommended implementation strategies for uptake of weighted blankets for people living with dementia across a range of settings?

Most chronic lung conditions cause variable changes in the movement of air within the lungs (known as regional lung ventilation), and therefore alter how the lungs function. These changes are difficult to detect early by conventional lung function tests, such as spirometry. The newly developed 'XVD lung scanner' intends to provide a quick, non-invasive and accurate assessment of regional lung ventilation, which may allow for earlier diagnosis and improved monitoring of patients with chronic lung conditions. This scanner is a medical imaging device which captures four images of the lungs during one breath, in the seated position. These are combined with recent lung CT scan images and using XV software, produce an XV scan report. We aim to scan the lungs of 60 adults with chronic respiratory conditions assess feasibility compared to other pulmonary function test measures used in standard clinical practice.