ANZCTR search results

Omnipod 5 is a wearable insulin pump that doesn't use any tubes and can automatically adjust insulin based on blood sugar levels, which it gets from a continuous glucose monitor (CGM). Because it is tubeless and can manage insulin on its own, it might be more comfortable and easier to use than current treatments for type 1 diabetes like multiple daily injections or traditional insulin pumps with tubes. Previous research studies looking at insulin pump systems have been primarily on glucose control. The purpose of this study is to gain insight into the experience of people with T1D using the Omnipod 5 compared to their usual treatment (either injections and CGM or a tubed pump and CGM), and impact on their quality of life (QoL). It is increasingly recognised that diabetes management extends beyond glucose control alone and an individual's wellbeing and quality of life are critical considerations in diabetes management. The aim of this study is to assess whether people using the Omnipod 5 report a better overall experience and improved QoL compared to those receiving their usual treatment. We will recruit 74 adults with T1D and randomly assign them into 2 groups; Group 1 participants will use Omnipod 5 or Group 2 where participants will continue using their current T1D care plan for a total of 6 months. Participants will be assessed for sleep quality, physical activity periods, quality of life, and clinical outcomes. We hypothesise that the Omnipod 5 will be associated with improved quality of life and management of T1D on a daily basis.

Post-exercise hypoglycaemia is a significant challenge for individuals diagnosed with type 1 diabetes' (TID).This study will look at the effect whey protein isolate has on post-exercise glycaemic outcomes in resistance and aerobic exercise sessions, in the afternoon. This multistage block-randomised crossover study, will be conducted in roughly 31 participants whom have been diagnosed with T1D. Participants will be using an AID (Medtronic 780G hybrid closed loop (HCL) systems) and their mainstay insulin management therapy. Metabolic parameters will be tracked from exercise commencement until 0600 the next day, and various different time-intervals contained within this time period.

To our knowledge, there are no known scientifically evaluated physical activity interventions designed for mothers and daughters from a Middle Eastern background and of an Islamic faith. While several physical activity interventions for mother–daughter dyads exist, none have been specifically tailored for Middle Eastern and Muslim families, an important gap given the distinct cultural and religious influences on women's and girls’ physical activity in these communities. The aim of this study is to assess the feasibility and acceptability of an 8-week culturally adapted physical activity program for mothers and their daughters from a Middle Eastern and Islamic background

The aim is to conduct an eight-week trauma and violence informed, non-contact cardio-boxing intervention designed using co-design principles, women victim-survivors of intimate partner violence. This intervention has been designed with input from a wide range of perspectives, with an attempt to develop a program that is both trauma and violence informed (i.e., increasing acceptability and feasibility) but is also something that could be implemented into the real-world sustainably, where it can have a direct impact on women’s lives. The results of this study will increase the limited evidence-base of moderate-vigorous forms of physical activity designed to support women victim-survivors of IPV. More broadly it will also help to inform trauma and violence informed considerations for both the design and delivery of physical activity interventions for victim-survivors.

This is a pilot pragmatic study to discover if starting Arginine Vasopressin (AVP) infusion at the same time as Norepinephrine (NE) infusion, and ceasing it after the NE is weaned reduces the number of hours on Vasopressors compared to starting the AVP after the NE dose reaches 0.2 mic/kg/min and stopping it when the NE is below that dose. Secondarily, are there less complications such as Continuous Renal Replacement Therapy (CRRT) requirement, less arrhythmias, less positive fluid balance, and less length of stay and death.

This study looks at patients with heart failure who have a special type of pacemaker called CRT, but sadly aren't feeling much better. Researchers want to test if upgrading this pacemaker using a newer technique, called Left Bundle Branch Area Pacing (LBBAP), is a practical option for these patients. The main goal isn't to prove the upgrade works yet, but simply to see if the procedure itself, recruiting patients, and follow-up appointments can be done smoothly at the Gold Coast University and Princess Alexandra Hospitals. About 25 patients will participate in this initial 'feasibility' study. The results will help doctors decide if it's worth doing a larger study in the future to properly check if this pacemaker upgrade helps improve patients' health and quality of life.

Irritable bowel syndrome (IBS) affects at least 10% of the world's population. Our current go-to symptom management strategy, the low FODMAP diet, is an extremely restrictive diet. 1/4 of people with IBS having disordered eating behaviours making them inappropriate for dietary restriction. Therefore the aim of this study is to evaluate the efficacy of a FODMAP enzyme in a pill form to help break down these foods that contribute to IBS symptoms without the need for a restrictive diet. This study will be a randomised cross-over controlled feeding trial which will require 34 participants to eat provided study meals for a week while taking either the FODMAP enzyme or a placebo. They will then have a minimum 3 week washout before another week of study meals on the pill they did not have the first time allowing each participant to be their own control. Across the study duration will will assess IBS symptoms, breath hydrogen, fatigue, quality of life and psychological indices. We will also be take blood and urine samples to assess intestinal barrier function ('leaky gut'). The primary endpoint will be IBS symptoms as measured by IBS-SSS at completion. We hypothesis that IBS symptoms will be significantly less in the FODMAP enzyme group.

Cognitive Behavioural Therapy for insomnia (CBTi) is the recommended 'first line' treatment for insomnia in Australia, but is accessed by only 1% of people with insomnia. To improve access and use of CBTi in Australia, we have developed a software-assisted insomnia screening, traiging, education, and management system named Sleep Drive. Sleep Drive includes an evidence-based self-guided digital CBTi program "Bedtime Window" that will be made freely available to suitable patients in this study via an embedded clinical trail. We aim to investigate the feasibility, and acceptability of Sleep Drive in Australian primary care, and the effectiveness of Bedtime Window in a sub-sample of participants eligible for the clinical trial. It is hypothesised that Sleep Drive will be a feasible and acceptable intervention in Australian primary care that will improve access to CBTi. It is hypothesised that patients recruited to the clinical trial of Bedtime Window will experience large post-treatment improvements in symptoms of insomnia and depression, and reduced use of sleeping pills that are sustained by 24-week follow-up. Feasibility; • It is hypothesised that GPs, psychologists, pharmacists, and nurses in all Australian states/territories, and from rural, remote, and metropolitan locations will engage with Sleep Drive and refer patients, and that there will be an increasing number of clinicians that register for the trial per month of the study. • It is hypothesised that there will be an increasing number of patient referrals to Sleep Drive per quarter of the study. • Qualitative feedback from patients and clinicians will indicate that Sleep Drive is feasible in the Australian primary care system (free-text qualitative feedback opportunities at key points in the Sleep Drive ecosystem). Acceptability; • At least 70% of patients that complete screening forms will be eligible for Bedtime Window. • At least 60% of patients provided access to Bedtime Window will complete the 5-session program. • At least 95% of patients completing Bedtime Window will indicate high-very high levels of satisfaction and acceptability. • Qualitative feedback from patients and clinicians will indicate high levels of acceptability of Sleep Drive in Australian primary care. Effectiveness will be defined as; • In participants provided access to Bedtime Window and recruited to the clinical trial: Change from baseline to 8-weeks, 16-weeks, and 24-weeks in measures of insomnia (Insomnia Severity Index), depression (PHQ9), current overall health, and reduced sleeping pill use (self-reported use of medicines for sleep at each follow-up).

KITE-363 is an exploratory treatment for chronic, moderate to severe autoimmune diseases such as systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and idiopathic inflammatory myopathies (IIM). KITE-363 utilizes a patient's own T-cells, which are genetically modified to target and eliminate pathogenic B-cells. By depleting these harmful cells, KITE-363 aims to reduce the effects of autoimmune diseases

Delirium is a sudden and serious change in thinking and awareness that can affect older people in hospital. Delirium is the most common hospital acquired complication in older adults, it is preventable and comes at a significant health and social care cost. Carers are key to recognising cognitive deterioration associated with delirium in their family members. The Prevention & Early Delirium Identification Carer Toolkit (PREDICT) model of care is designed to inform carers about delirium risk factors and preventive strategies and empower and assist them to be actively involved in the care of their family member. PREDICT was developed through an extensive scoping literature review and a pilot study that was codesigned and validated with carers using the eDelphi technique. The pilot demonstrated both the acceptability of PREDICT and its potential for impact on outcomes at a larger scale. This study evaluates the implementation of PREDICT. It provides carers with information, tools, and support so they can: • Understand delirium and how to prevent it, • Complete a simple 7-question checklist each day to detect early signs, • Access educational videos and printed resources, • Receive support during the hospital stay, and • Help plan for a safe and personalised discharge. We believe that involving carers in this way will improve care for older patients, reduce delirium, and support carer wellbeing. The study is being tested in four hospitals across NSW using a phased approach.