ANZCTR search results

The Australian Epilepsy Project (AEP) is a large scale project with a planned 4000 participants using a package of both established and experimental testing in epilepsy to improve our ability to both provide accurate prognosis and diagnose surgically-curable disease. The package will include advanced MRI, neuropsychological assessment and genetic testing.

Patients who engage with behavioural pain management strategies (e.g., relaxation, thought management) have better pain relief and use less opioids. However, delivering these strategies in hospital settings can be costly and often is not feasible during acute pain service rounds. Emerging research indicates that behavioural pain management education can effectively be delivered using low-cost digital technology. The aim of this study is to test the hypothesis that patients who receive an mHealth intervention (educational video + supportive daily text messages) will utilise lower doses of opioids across the first week of hospitalisation and one week after discharge compared to those who receive the education video only.

People with dementia and their caregivers often experience loneliness and depression, which can impact their quality of life and caregiver burden. One promising social intervention is choir singing - an accessible and enjoyable activity that benefits memory and thinking, social connectedness, and mental wellbeing of older adults. Previous studies have reported varying results about the extent to which choirs improve quality of life, mood, and wellbeing for people with dementia and their carers. We are partnering with Bulimba community centre to evaluate the Sing Sing Sing choir program for people with dementia and their caregivers living in the community. We will survey people in the early days of joining the choir (0-3 months post starting intervention) and follow them up once 6-8 months after their first survey to determine whether choir participation improves the quality of life, wellbeing, mood and loneliness of people with dementia and their carers; and whether it reduces burden for carers of people with dementia. We will also interview the participants to ask them about what they have experienced as the most significant change for them since taking part in the choir. By building on the growing body of research into choirs for people living with dementia, we will develop an evidence base to understand how to make these interventions most effective.

The purpose of this study is to determine the feasibility of the research protocol, as well as assess the potential effectiveness of the study medication (combination of doxycyline and ambroxol) in slowing the progression of Dementia with Lewy Bodies. Treatment effectiveness will be evaluated by means of clinical disease rating scales and questionnaires that evaluate participants’ DLB-related symptoms, quality of life and general health. The results of this study may help identify future disease modifying strategies for DLB, as well as provide the clinical trial framework with which to further investigate their effects on the disease. Participants will be assigned to either the active treatment group, or a placebo group. To try to ensure the groups are allocated fairly, each participant is put into a group by chance (randomisation).

The rate of hospitalisations for persons living with dementia has increased in recent years, and the average length of stay is 13 days (five times the average hospitalisation) (AIHW, 2021). Persons with dementia can often experience behavioural and psychological symptoms of dementia (BPSD) including agitation while in hospital. Agitation experienced by patients with dementia is associated with poor health outcomes, long-term hospitalisation, overuse of medication, and increased health care costs (Cerejeira et al, 2012). Medical-grade therapeutic weighted blankets may be safe, and feasible to reduce agitation experienced by patients with dementia during hospitalisation. This research aims to evaluate the feasibility, safety and efficacy of using therapeutic weighted blankets to reduce agitation in patients with dementia in acute care settings. Objectives: To report the safety of using weighted blankets for patients who have a dementia diagnosis in acute healthcare settings. To report the feasibility of using weighted blankets for patients who have a dementia diagnosis in acute healthcare settings. To report the efficacy of using weighted blankets for patients who have a dementia diagnosis in acute healthcare settings.

This study aims to assess the effect of notifying women participating in population-based breast cancer screening of their breast density on their psychosocial outcomes and health services use; and to determine whether using different modes of communication (hard-copy vs online) alters these effects. Study details: You may be eligible for this study if you are a woman attending BreastScreen Queensland Sunshine Coast Service for a mammogram and are found to have dense breasts (BI-RADS category C or D - heterogeneously dense or extremely dense). Please note that this study is not enrolling women who have been diagnosed with breast cancer or ductal carcinoma in-situ. Participants will be randomly allocated to one of three arms: 1) standard care in BreastScreen Australia (no notification of breast density) vs. 2) notification of breast density plus a hard-copy written health literacy sensitive information vs. 3) notification of breast density plus online written and video-based health literacy sensitive information. Participants will then be followed up for over 2 years and be asked to complete questionnaires assessing their anxiety, health service usage and changes in knowledge and breast screening habits. It is hoped that findings from this study will help determine the utility and effects of providing breast density information to women as part of population-based breast screening.

The ROSEND clinical trial aims to compare standard of care dermatological treatment with a specialised type of radiotherapy called volumetric modulated arc radiotherapy (VMAT) in patients who suffer from chronic, recurrent rosacea. The study hypothesis is that VMAT will lead to a significantly lower rate of return of rosacea in the treatment area within 12 months of randomisation. Who is it for? You may be eligible for this study if you are an adult over the age of 60 who has been diagnosed with chronic, recurrent, moderate to severe rosacea for at least 10 years and have relapsed following treatment with at least one systemic therapy and one topical therapy. Study details Participants will be randomly assigned to either standard of care dermatological treatment or VMAT as part of this study. In Arm A, called the current standard of care, treatment will be one or a combination of the standard dermatological treatments which will involve; topical therapy applied for a minimum of 16 weeks (Metronidazole (0.75%) gel or cream, applied once or twice daily or Ivermectin (1%) cream applied once daily), and/or Vascular laser or Intense pulse light treatment – limited to three episodes of treatment, with a maximum of four weeks between each episode, and/or Oral antibiotic therapy (Doxycycline 50-100 mg per day or Minocycline 50-200 mg per day) taken for a minimum of eight weeks. All patients will complete quality of life and a medication diary. In Arm B, called Volumetric Modulated Arc Therapy (VMAT), participants will be given 20 treatments in once daily fractions delivered within a period of eight (8) weeks in total inclusive of a mid-treatment break of a minimum of two (2) weeks. Each treatment will take around 15 to 20 minutes. A medication diary (for arm A patients only) and questionnaires will be completed at the initial assessment, last day of treatment, 4 weeks after radiotherapy and at 3, 6, 9, 12, 18 and 24 months following the date of randomisation.

This project will test the implementation and clinical utility of neonatal brain MRI at Townsville University Hospital and Cairns Hospital for infants at high-risk for adverse neurodevelopmental outcomes. Infants born preterm, with low birth weight, who have a hypoxic event at birth and/or a brain injury are at high risk for adverse neurodevelopmental outcomes. An MRI can provide detailed and accurate information about brain injury and growth impairments to assist with risk stratification, however, currently, the timing of MRI is variable, with the MRI often performed at an age when general anaesthesia is required (>4 months), posing additional risks and costs. Neonatal MRI performed at term-age (without sedation) diminishes the risks and costs associated with later MRI under general anaesthesia and provides the opportunity to identify infants’ risk status early, enabling earlier and personalized treatment plans. This project aims to test the feasibility and use of neonatal MRI (at term-age) for 42 infants identified as high risk based on the cranial ultrasound or clinical grounds, making use of the learnings from the successful implementation of neonatal MRI protocols at Royal Brisbane Women’s Hospital.

The primary aim is to assess in adults with hypertension, the efficacy of a remote wearable BP-based care strategy to reduce BP in primary care over 12 months, compared to usual care. The secondary aims are to determine if this remote wearable BP-based care strategy: * is acceptable to patients and GPs * is cost-effective * improves medication adherence * improves patient engagement, * is safe, compared to usual care Hypothesis: The remote wearable BP-based care strategy will be superior to usual care in terms of efficacy in BP reduction, acceptability to patients and GPs, and cost-effectiveness.

Mental health disorders bear a significant burden on the health and well-being of young people in Australia and worldwide. Prevention during adolescence is critical for reducing immediate related harms but also preventing the development and onset of chronic mental health disorders through adulthood. The current study aims to evaluate the efficacy of an updated version of the OurFutures Mental Health program by conducting a two-arm cluster randomised controlled trial (RCT) with Year 8 students from 14 secondary schools in NSW. OurFutures Mental Health is a six-lesson, online cartoon-based intervention. It draws on cognitive-behavioural principles and incorporates psychoeducation and self-management and interpersonal skill acquisition. The intervention aims to increase mental health knowledge and, for those who report anxiety and depression symptoms at baseline, reduce anxiety and depression symptoms. This module also aims to improve important secondary social, emotional, and behavioural outcomes, including general well-being and help-seeking. The OurFutures Mental Health module is in the process of being refined to be more LGBTQ+ inclusive and trauma-informed. This cluster randomised controlled trial will involve 7 secondary schools allocated to receive the OurFutures Mental Health intervention, and 7 secondary schools allocated to a control condition who will receive their usual health education curriculum as usual (N=1400 secondary school students). Students will be followed-up for 1 year, with surveys at baseline, and 6- and 12-months. We hypothesise that compared to students in control schools, students in intervention schools will show: i) improved mental health knowledge at 3-months post-baseline ii) reduced depressive symptoms at 3-months post-baseline iii) reduced anxiety symptoms at 3-months post-baseline. We further hypothesise that: iv) compared to students in control schools who report elevated symptoms of depression and/or anxiety at baseline, students in intervention schools who report symptoms of depression and/or anxiety at baseline will show reduced depressive symptoms and reduced anxiety symptoms at 3-months post-baseline