ANZCTR search results

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.

This study is testing whether a two-step, online support program can help adults reduce binge eating. Everyone will begin with a brief, self-guided online session about binge eating. Two weeks later, those who still need support will be randomly offered one of three options: a digital program based on cognitive behaviour therapy (CBT), a program based on dialectical behaviour therapy (DBT), or no additional support for now. We want to find out if these follow-up programs help reduce binge eating more than doing nothing further, and whether CBT or DBT works better. The study also aims to identify who benefits most from each step. Hypothesis: non early responders randomized to online CBT or DBT will experience greater reduction in primary outcome symptom measures than non-early responders randomized to waitlist and will not differ significantly to early strong responders.

Muscle-strengthening activities (MSA) are associated with a range of physical and psychosocial health benefits for youth. However, most school-based MSA interventions have been delivered by external providers or research staff, limiting scalability. This study aimed to assess the feasibility and preliminary efficacy of Muscle Movers, a teacher-delivered MSA intervention for primary school children.

Using a randomised controlled trial study design, 270 pregnant and 90 non-pregnant women will complete cycling trials in a climate chamber with increasing humidity at three fixed ambient temperatures (30°C, 35°C, and 40°C). Core temperature, local sweat rate, cardiovascular responses, and fetal heart rate (for pregnant participants) will be continuously monitored to determine the thresholds for heat strain. We will hence seek to quantify critical environmental limits (of temperature and humidity) in pregnant women compared to non-pregnant women during light physical activity. Lay hypothesis: Our study hypothesis is that the critical humidity before core temperature rises, will be lower for women in later stages of pregnancy regardless of ambient temperature.

We aim to determine feasibility of a single insertion prototype combined glucose-ketone continuous glucose sensor. Twenty participants (10 without diabetes and 10 with diabetes) will continuously wear the device over 72 hours with standardized meal and ketone drink tests performed on Day 1 (the day of sensor insertion) and Day 4 (the final day of study). Finger-prick blood glucose measurements will be performed a minimum of 8 times per day, for the duration of the study, while finger-prick blood ketone measurements will be recorded a minimum of 3 times per day in addition to those performed as clinically indicated. Blood ketone measurements will be performed on a capillary sample obtained by finger-prick using a hand-held Abbot meter using ketone strips during the at-home phase of the study. During the in-hospital meal and ketone drink tests blood will be collected for laboratory ketone level measurements. Comparison of investigational sensor outputs will be compared with the study blood glucose meter (Day 1 to Day 4), and glucose and ketone values collected for meal tests on Day 1 and Day 4.

In this study we will look at how the MCT supplement can be used in older adults to support brain function, mild cognitive impairment and Alzheimer’s disease. MCT oil is a supplement used to support nutritional ketosis, which is an alternative nutrient to glucose for providing energy to the brain and body. The primary aim of this research study is to assess the safe and optimal dosing of MCT oil to identify any change in participant cognition. This research will provide valuable information for aged care residents currently experiencing, or at risk of cognitive decline, to understand the most appropriate dose relative to weight to provide optimal cognitive support.