ANZCTR search results

Developmental and Epileptic Encephalopathies (DEEs) are the most severe group of epilepsies. Patients have intellectual disability and a range of mental health disorders in more than 70% of individuals, including mood disorders, behavioural problems, psychosis, and autism spectrum disorder; which often go undiagnosed and untreated. Current therapies for epilepsy aim to control seizures but do not address the comorbidities in patients with DEEs. As children with DEEs grow, their mental health comorbidities often eclipse seizures as the problem of greatest concern. This study will pilot the first mental health clinical intervention for children and adults with DEEs. A psychological intervention (MICE) successfully pioneered in the UK has been adapted for adults and children with DEEs (MICE-DEE) to test the feasibility in a pilot study of 40 patients with DEEs compared with 40 patients receiving assessment enhanced standard care.

Physical activity and exercise are important in the treatment of Cystic Fibrosis (CF) and delivering exercise programs via telehealth for people with CF may minimise the risk of cross infection and increase access to exercise. We asked adults with CF what they wanted to include in a telehealth exercise program and together we designed a new telehealth exercise model of care which will be tested in this project. Adults with CF from the Alfred Hospital will be invited to be part of this study which will run for 12 weeks. Participants will be put into an intervention or a control group by chance (at random). Participants in the control group will continue with their usual care such as appointments with their health care team. Participants who are allocated to the intervention group will receive their usual care and take part in the new telehealth model of care. In this intervention group, participants will be given the choice of attending a live supervised exercise group online, or completing an exercise program which they follow themselves with one-to-one check in sessions via telehealth with a Physiotherapist. The main outcome of this study will be to understand whether it is feasible to deliver a telehealth exercise model of care for people with CF.

This is a prospective study with an Umbrella Protocol, where each sub-Protocol investigates a particular condition(s) and challenges to various Vancomycin biosensors and electrode properties. The study will enrol up to 50 healthy participants in the community. The Sub-Protocol described in this registration form is Sub-Protocol #1: Limit of Blank (LoB) Characterisation of Vancomycin Biosensors on the Nutromics Sensor Device across a 24-hour period.

There has been recent interest in understanding the costs associated with post-operative complications of adult non small cell lung cancer (NSCLC) patients undergoing lung resection. Accurately defining the costs of complications allows institutions to make more informed decisions as to what these costs are, and then implement strategies to reduce the incidence of complications, thereby mitigating hospital costs. The aim of this study is to provide a detailed costs analysis for patients who undergo any type of lung resection. Who is it for? You may be eligible for this study if you are an adult with NSCLC who underwent any type of lung resection. Study details This study will be conducted using a review of medical records, and no patient contact is required. The study will review the medical records of adult patients who underwent a radical cystectomy at the Austin Hospital between 1 January 2011 and 31st December 2023. It is hoped that this research will help to provide a better understanding of the costs associated with any type of lung resection surgery.

This will be a pilot trial assessing the feasibility, safety and efficacy of combined high-intensity interval training (C-HIIT) for people with disorders of gut-brain interaction (DGBI). Participants will be recruited from the local Newcastle and Hunter region district (NSW). After consent is provided, participants will undergo testing (including cardiopulmonary exercise testing, body composition, bloods, stool sample, functional strength and a series of questionnaires to capture mental health, gastrointestinal symptoms, overall wellbeing and dietary habits) and then be asked to maintain current dietary and physical activity habits for 8-weeks and then come in to repeat the testing in week 9. Following this, participants will undergo 8- weeks of 3 x weekly, 30-minute C-HIIT sessions, supervised by an accredited exercise physiologist or exercise science student. Participants will then repeat the same testing and will be invited to participate in an interview to better understand their experience with the program.

The primary objective of this project is to determine if balance-enhancing shoes are more acceptable than minimalist shoes in older women. The secondary objective is to determine if balance-enhancing shoes are more effective at improving balance performance and perceived risk of falls than minimalist shoes in older women. This study will utilise a randomised crossover study design. Participants will be women aged 65 years or older who are free from any conditions which may negatively impact their balance or ability to walk independently. Participants will be randomly allocated to two shoe conditions and will be required to wear the shoes from each condition for six weeks before crossing over to the alternate condition. Participants will attend the university for assessments over four sessions. We hypothesize that participants will find the balance-enhancing indoor shoes more acceptable than the minimalist indoor shoes

This study aims to evaluate the acceptability of a coach-supported, individually-tailored online parenting program for parents of adolescents who experience anxious and/or depressive symptoms following a traumatic event. The program aims to increase parental self-efficacy to support their teenage child by providing personalised feedback about their current parenting and equipping them with evidence-based parenting strategies to respond to trauma, anxiety and depression. The intervention is delivered online and comprised of up to 12 parent-led, online modules covering different topics. Online modules are supplemented by up to 8 one-on-one videoconferencing sessions with a therapist-coach to support parents in making changes in their parenting. In this study we aim to understand how acceptable the program was to receive, and how the acceptability of the program could be enhanced. We also aim to gather preliminary indications of how effective the program was in improving 1) parental self-efficacy to respond to trauma, and 2) parenting behaviours to reduce teen anxiety and/or depression. Due to the exploratory and mixed-methods nature of the study, no hypotheses have been specified.

Nurse-led memory clinics have the potential to be complementary models to help address the growing care for those living with dementia and their care partners. However, to date there is limited research evaluating the benefit of nurse-led memory clinics. This research will be a pilot study to evaluate a nurse-led memory clinic, Enhance. Enhance is a nurse-led multidisciplinary clinic with the aim of supporting independence, wellbeing and function of people living with dementia. Both people living with dementia and their care partner will be able to clients at the clinic.

The primary aim of this pilot randomised controlled trial is to examine if smart inhaler use as part of asthma care for children aged 5-9 years is effective in reducing moderate and severe exacerbations over a 12 month period. The secondary aims of the research are to: i) increase children’s adherence to preventer therapy; ii) decrease use of reliever therapy; iii) increase self-reported asthma control; and iv) decrease healthcare use reacted to asthma (GP and specialist visits, ED presentations and hospital admissions). The feasibility and the acceptability of the intervention will also be examined. A total of 40 children aged 5-9 years with asthma along with one parent/carer will be recruited. Each child- parent dyad will be randomly allocated to the intervention (n=20) or usual care condition (n=20). The intervention includes: a) Provision of smart inhaler devices for reliever and preventer inhalers, and education in use; b) FindAir system facilitated prompts and feedback to children/parents (eg daily medication reminders); c) Researcher support in the use of the FindAir smart devices and the FindAir Asthma Diary App; d) FindAir system facilitated feedback to GPs and GP-based nurses; and FindAir facilitated feedback on asthma care flags to parent/carers and GPs (if applicable). The control group will receive usual care. The control group will also receive FindAir smart devices for their child’s preventer and reliever puffers to enable data collection of the child’s inhaler use; the other functions of the smart inhaler (e.g., medication reminders, feedback) will not be accessible to participants in the control group. Outcome data (number of moderate/ severe exacerbations and preventer adherence) will be collected at baseline, during the 12-month intervention, and 2 months after the intervention in both the intervention and control groups. Intervention feasibility will be determined by examining use of the smart inhaler. Acceptability will be determined via semi- structured interviews with child and parent/guardians in the intervention group and participating clinicians.

We are conducting a study testing an online, group intervention for aphasia after stroke. This online intervention is called Multi-Modality Aphasia Therapy Tele, or M-MAT Tele. M-Mat Tele is delivered to a group of three people with aphasia with the aim of improving spoken communication. We hope to learn if M-MAT Tele is feasible and enjoyable compared to usual care, and whether to conduct a large trial that tests how well it works. M-MAT Tele is a new telehealth version of M-MAT (Pierce et al., 2024). Telerehabilitation reduces clinician and client travel and need for treatment space while addressing geographical inequity amongst people who have experience a stroke. We have preliminary evidence that M-MAT may be equally effective at a low-moderate intensity (Pierce et al., 2023). This project explores M-MAT Tele at a clinically implementable low-moderate intensity for people with aphasia of less than one year. Feasibility, acceptability, and preliminary efficacy will be explored. Results of this project will provide crucial data for applications for definitive trials of M-MAT Tele in this setting.