ANZCTR search results

This proposal is a type-1 hybrid randomised controlled trial, focussing on effectiveness and implementation. Our aim is to grow the capacity of parents of children with neurodevelopmental disabilities (NDD) to continue to effectively implement and manage ongoing interventions for their children, with an easily translatable online/telehealth intervention: E-PACT. Parent capacity is underpinned by multiple factors including physical and mental health and is associated with multiple child outcomes. Our primary outcome is parent capacity itself, specifically the core parenting competency: emotional availability measured on the Emotional Availability Scale (EAS). Secondary outcomes include parent and child physical and mental health. Tertiary outcomes will measure the cost and consequences, barriers and facilitators of E-PACT delivery compared to Care as usual to inform implementation. We will conduct a phase III RCT of an online/telehealth intervention E-PACT with 300 families of children with NDD. This is a two-arm RCT in which families of a child (0-10 years) with a diagnosis of any NDD or at identified increased likelihood of a NDD will be randomly assigned to E-PACT or Care As Usual (CAU) with follow-up until 6 months post baseline. All families will complete pre-intervention assessment at baseline (T1), post-intervention assessment (T2), and 6 months follow up (T3 6 months post baseline). Families in the CAU group will then be provided with E-PACT after completion of the six months follow up (wait-list control).

Depression is the top leading cause of disability, yet existing treatments leave many people with a shortfall in recovery. In addition, medical and particularly cardiovascular comorbidity dramatically shortens the lives of people with depression, and there are no routine strategies to reduce this burden. Current evidence suggests a possible aetiological role for inflammation in the genesis and pathophysiology of depression and comorbid medical disorders especially cardiovascular disorder. Statins and metformin reduce inflammation and have established benefits for medical comorbidity. Both agents show antidepressant effects in preclinical models. Multiple epidemiology studies and preliminary clinical trial data suggests an antidepressant effect of both agents. Hearts and Minds is a 3-arm multicentre, randomised, double-blind, trial of atorvastatin (40 mg daily) and metformin (2000 mg daily) for the treatment of depression in people who remain symptomatic after a trial of established therapy. This will be a 16-week placebo-controlled trial with a 6 month follow up period.

The aim of this study is to investigate the effectiveness of Compassionate Mind Training among university students experiencing self-criticism. University students are faced with multiple psychological and social stressors throughout their studies. This puts them at risk of experiencing poorer psychological wellbeing and self-criticism. Diminished psychological wellbeing is associated with poorer academic outcomes, university dropout and poorer social functioning. Compassionate Mind Training was developed to target self-criticism and promotes wellbeing by cultivating compassion. Research suggests CMT can significantly reduce psychological distress and self-criticism, and improve wellbeing. Details of the study include: Participants who wish to participate in the study will be required to attend an 8 consecutive-week group therapy session at the School of Psychology, the University of Queensland, St Lucia. Each session will run for 150 minutes, with groups consisting of approximately 20 people and 2 facilitators (a registered clinical psychologist and a provisional psychologist). Group programs will start between the end of February and beginning of March, 2022. We are aiming to run groups on a Monday. Spaces are limited for the program. In total we will be recruiting up to 80 participants. We will be recruiting from January 2022 until spaces are filled. Participants will be required to complete questionnaires at 3 time points, 1) upon recruitment, 2) at week 8 and 3) at a 3-month follow-up. Participants will be required to attend all sessions. There is no cost, outside of the time to complete the questionnaires. All sessions are free. We hypothesise that compassionate mind training will help students by reducing their levels of depressive symptoms, perfectionism and improve their self-compassion and wellbeing

This research is investigating a naturally occurring compound called N-acetyl-D-mannosamine monohydrate (ManNAc). ManNAc is a sugar (monosaccharide) which is found in humans. Once in the body, ManNAc is converted to another compound called N-acetylneuraminic acid (Neu5Ac) which plays a role in the synthesis and maintenance of muscle; specifically, it facilitates a process called ‘sialylation’. It is being studied as a supplement drug to treat a condition known as GNE myopathy, a rare genetic disease which is characterised by progressive skeletal muscle wasting (atrophy) caused by a lack of sialylation. In patients with GNE myopathy, this wasting and weakness of muscle affects movement and other bodily functions resulting in disability, wheelchair use and/or incapacitation. Previous studies have shown that the administration of ManNAc can replace the important compounds that patients with GNE myopathy are lacking, and therefore may be useful in treating the disease. While supplementation with ManNAc is a promising treatment for patients with GNE myopathy, additional information on how to best administer this sugar-like compound is needed. Two new formulations have been developed; a chewable tablet formulation and a gastroretentive tablet formulation. This study is therefore being conducted to investigate how ManNAc is absorbed into the body when administered as the chewable tablet formulation and the floating tablet formulation, compared to the current oral solution. This information will provide pivotal data to guide the further development of ManNAc treatment strategies for patients with GNE myopathy.

The trial will test the clinical benefit and cost effectiveness of an implementation package to increase clinician use of arm and stroke rehabilitation evidence in practice. We hypothesise that providing support (education, mentorship) alongside resources (such as equipment and processes) will increase clinician use of the evidence. We will recruit 14 hospitals across 3 Australian states to deliver arm rehabilitation to 238 patients after stroke. The primary outcome is clinician adherence to guidelines, with secondary outcomes of patient arm and hand movement, health-related quality of life and cost. To understand the challenges faced during the PROMOTE trial, we will conduct a process evaluation alongside the main trial. Then, in partnership with the Stroke Foundation, we will employ implementation science methods to work with consumers and clinicians to develop an implementation strategy. Together these will allow rapid translation of findings into routine stroke care.

The average age of patients presenting for elective surgery is increasing. Frailty and cognitive impairment are two common conditions that can predict poor outcomes in surgery, however these conditions are not screened for. We are running a survey to explore what surgical doctors understand about frailty and cognitive impairment in surgical patients, and what the potential barriers and facilitators are to assessing patients for these conditions.

Physical inactivity is an independent risk factor for all causes of death in people with heart disease. Thus, accurate measurement of physical activity is essential to ensure optimal physical activity levels are achieved. Wearable activity monitors (accelerometers) offer a method for objective quantification of physical activity frequency, duration and intensity, however, a limitation of the few studies that measure physical activity using accelerometers in this population, is the use of inappropriate accelerometer intensity cut-points derived from healthy populations. Given people with heart disease may have reduced exercise capacity resulting in greater effort for the same activities, this may lead to inaccurate intensity classification (i.e., under-reporting) of physical activity levels. Here we will recruit 164 participants with heart disease to complete a treadmill test and a series of activities-of-daily-living with simultaneous measurement of oxygen uptake and activity counts taken from accelerometers, developing heart disease specific cut-point equations for different physical activity intensities. This project will generate new knowledge, allowing the disease-specific relationship between physical activity and health outcomes to be accurately established. This will guide future physical activity recommendations and interventions, helping more people live longer and healthier after a cardiac event.

Eosinophilic oesophagitis (EoE) is a chronic inflammatory condition causing narrowing of the oesophagus manifesting clinically as dysphagia and food bolus impaction (FBO). Two first line medications, namely proton pump inhibitors (PPI’s) and topical corticosteroids (TC’s) are feasible options. we propose an opened label, randomized controlled trial of PPI (Pantoprazole) vs TCs(Jorveza), with a formalized treatment protocol and the ascertainment of symptom scores (questionnaire), endoscopic appearance, histological findings (biopsy), physiological (manometry) and cross sectional (endoscopic ultrasound) data to determine if PPI or Jorveza are superior treatment.

There is no rigorous evidence on the effects of back pain fact sheets among people seeking care for low back pain from their general practitioner. It is uncertain whether a fact sheet resource that focuses more on listing medical management options (JAMA Patient Page- low back pain), can increase a patient’s preparedness for decision-making, compared with a resource that focuses on self-management (Australian Commission for Healthcare Safety and Quality Information for Patients Fact Sheet). Our primary aim is to compare preparation for decision-making among people seeking care for low back pain who are given one of two currently available fact sheets. Secondary aims are to understand recruitment processes and engagement with research fact sheets, examine management intentions, feelings of reassurance about serious pathology and the acceptability of the fact sheets to people seeking care for low back pain. The study hypothesis is that a fact sheet resource which focuses more on listing medical management options (JAMA Patient Page- low back pain), can increase a patient’s preparedness for decision-making more than a fact sheet that focuses on self-management (Australian Commission for Healthcare Safety and Quality Information for Patients Fact Sheet).

GLX-100 is an investigational medical device containing glycosaminoglycan (GAG) designed to coat the inner lining of the bladder and is believed to reduce irritation and pain. The purpose of this research is to test the safety and tolerability of the device GLX-100 in participants with IC/PBS. This research will also evaluate whether GLX-100 can reduce the amount of pain and other symptoms associated with IC/PBS.