ANZCTR search results

ADHD is a common neurodevelopmental disorder defined by the persistence of dysregulated attention, activity and impulsivity. The incidence of ADHD in childhood is 6-7%. Some symptoms improve in adolescence, but 2–4% of adults continue to meet the diagnostic criteria. ADHD is recognised in 3 to 4 times as many people seeking help for substance use disorder (SUD) as in the general population. Adults with ADHD who use drugs are often misdiagnosed and cannot access effective, targeted, multidisciplinary care. Individual specialists and specialist services will not treat ADHD in the presence of SUD. This project aims to demonstrate that recognition of ADHD and active management significantly improve quality of life and reduce substance use in people seeking help for SUD.

Mesothelioma is an aggressive cancer with limited treatment options. We have conducted studies of a specific extract from Leptospermum petersonii (QV0; lemon scent tea tree) which showed reduction of cancer activities in the petri dish and also reduction of tumour in mice studies. This project is a first-in-human study of Leptospermum petersonii extract. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with mesothelioma. Study details All participants will be provided with Leptospermum petersonii extract to take by mouth for 6 weeks. Every 6 weeks, the dose of extract will be increased for 24 weeks. During this time, participants will be asked to provide blood, stool and urine samples, complete questionnaires, and will be monitored for side effects. It is hoped that this study will help determine if Leptospermum petersonii extract can be used safely in humans to control cancer by itself or in combination with other conventional treatment in mesothelioma patients

International and local research indicates that Intensive Care Unit (ICU) survivors (patients and families) experience adverse outcomes. In Australia, ICU survivors return home with little or no follow-up. Peer support, which brings survivors together to share experiences, holds potential to improve post-ICU outcomes although this warrants exploration. We have recently developed an in-person peer support model, where we engaged both ICU survivors and staff using a new and innovative method called experience-based co-design (EBCD). We recently tested the feasibility of this co-designed in-person peer support model for ICU survivors via a pilot trial (manuscript under review), that also included an ICU recovery booklet. Despite multiple strategies (including paying for car-parking, and travel costs), there were barriers to participants attending the hospital in-person. Further, the global pandemic necessitated the need to find ways of supporting ICU survivors in their recovery and in a format that did not require in-person attendance at hospital for this program. A further feasibility pilot trial was completed to test a digital format of this co-designed intervention, as well as a digital version of the ICU recovery booklet. This trial found that a digital peer support program and booklet, was feasible to deliver with regards to attendance rates, recruitment, and participant satisfaction. This next study will test these interventions at scale to determine the effectiveness of these interventions across the following two groups: 1. Digital peer support and an ICU recovery booklet; 2. Control care (no formal specialised ICU follow-up or ICU specific recovery information). We hypothesise that the digital peer support program and the recovery booklet will improve the health of participants at 90 days after hospitalisation, with reduced psychological distress, and improved social and informational support and resilience compared to usual care.

Probe-to-bone test (PTB) is a simple bedside clinical test to aid in the diagnosis of diabetic foot osteomyelitis (OM). While it has been shown to be useful (especially in a high-risk cohort), diagnosis of OM is supported by additional tests such as X-rays and blood tests for markers of infection. The gold standard test for diagnosing OM is a bone biopsy, which is often not routinely performed due to the invasiveness of the procedure and the difficulty with accessing clinicians trained in performing this. Patients with diabetic foot ulcers and positive PTB tests are often treated for OM with prolonged courses of antibiotics despite normal X-rays and/or normal biomarkers of infection. This study aims to evaluate the safety and feasibility of treating patients with diabetic foot ulcers and positive PTB test with shorter courses of antibiotic therapy in a low-risk (outpatient) setting.

The Yoga AF study will enrol patients with atrial fibrillation who are undergoing a rhythm control strategy (ie trying to maintain sinus rhythm, the hearts normal rhythm), half of the participants will be randomly chosen to undertake a yoga program, which we believe may help reduce the amount of AF a person has. The aim of the study is to assess the effect of participation in a regular yoga program to see if regular yoga can reduce the number of recurrences and overall amount of atrial fibrillation a person experiences.

This project aims to compare the effect of a swimming and education program compared to education only control. Adults in Australia will be eligible to participate in the program if they have chronic low back pain, are able to demonstrate water competency and are willing to complete an 8-week program. The participants who are allocated to the swimming and education program will receive an individualized swimming program and access to a local swimming pool over 8 weeks. The swimming program will be delivered and adjusted 4 sessions with a physiotherapist, delivered over telehealth. The primary outcome is function related to low back pain, measured at 8 weeks. Participants allocated to the education only group will be provided with a brief education session, with an optional second session, and compensated for their time to complete surveys using e-gift vouchers.

This pilot study is evaluating the feasibility of providing an oral plus enteral prebiotic fibre supplementation and assess tolerance and whether this can improve the microbiome and reduce complications in patients receiving an allogeneic stem cell transplant Who is it for? You may be eligible to join this study if you are aged 18 years and older undergoing allogeneic myeloablative or reduced intensity myeloablative allogeneic stem cell transplantation at the Royal Brisbane and Women’s Hospital (RBWH). Study details Participants in this study will be randomly allocated by chance (similar to flipping a coin) to the intervention group or the control group. Participants allocated to the intervention will receive an oral prebiotic fibre supplement from a week prior to the start of conditioning therapy and continue it until a month post stem cell transplant (SCT) and prebiotic enteral nutrition (EN) starting day one post SCT until required. The control group will receive a non-fibre EN formula from day one post SCT as per usual care. Participants will then be followed-up and assessed weekly for 4 weeks post SCT to determine feasibility and effectiveness of an oral plus enteral prebiotic fibre supplementation in patients receiving an allogeneic stem cell transplant. It is hoped that this research will support the microbiome and improve health outcomes for participants undergoing allogeneic SCT.

ecofit is a multi-component mHealth intervention aimed at increasing resistance and aerobic physical activity using the outdoor built environment (i.e., outdoor gyms) and social support. We have previously demonstrated the efficacy and effectiveness of the ecofit program in insufficiently active people with (or at risk of) type 2 diabetes and community-dwelling adults, respectively. The objective of this trial is to compare the effects of two implementation support models (i.e., ‘Low’ versus ‘Moderate’) on the reach (primary outcome), uptake, dose received, impact and fidelity of the ecofit program. We hypothesis that there will be more people using the outdoor gym equipment to workout in the outdoor gym locations that received the moderate support package.

Up to 50% of people with chronic plantar heel pain have a bone marrow lesion (BML) in the calcaneus. Calcaneal bone marrow lesions are high signal lesions on MRI that are associated with having chronic plantar heel pain and with poorer longer-term pain and function outcomes. Shockwave therapy is an approved therapeutic device in Australia for treating musculoskeletal pain, including plantar heel pain. It emits high levels of acoustic energy that has been shown to improve pain and shrink bone marrow lesions at other body sites, but it has never been tested for its effect on pain in people with a bone marrow lesion sub-type of chronic plantar heel pain. The primary aim of this study therefore is to determine whether shockwave therapy is effective at improving pain in a BML-positive subgroup of participants with chronic plantar heel pain. Ninety participants will be randomly allocated to either an active or sham shockwave group (45 per arm), each receiving one treatment per week over three weeks. Pain will be assessed by validated questionnaire at baseline, 4- and 12-months to determine if shockwave is effective at reducing pain. Secondary measures for physical function and quality of life will be assessed at baseline, 4- and 12-months and perception of global rating of change assessed at 4- and 12-months. As an exploratory analysis BML size will be measured by MRI at baseline and 4-months to determine if change in BML is associated with change in pain.

The current project involves developing a behaviour change readiness index for predicting health behaviour change in the domain of dietary interventions. This work is heavily evidence-based with the unique conceptualisation that health-related behaviours are the result of an individual’s response to internal cues (e.g., implicit and explicit attitudes, motivation), external environmental cues (e.g., social and physical stimuli) as well as regulating factors such as habit. Previous stage-based health models exist, of which Stages of Change is the most popularised. However, understanding stage of change alone is insufficient given the complex array of attitudinal, experiential, and psychological factors that could underlie an individual’s actual readiness to engage in, and complete a health behaviour. The aim of this study is to further refine and validate a CSIRO behaviour change readiness index (C-BCRI). This will be done by assessing the tool’s utility to predict successful short-term behaviour change in the dietary domain (i.e., reduction in consumption of sweet snacks) but also to better understand the associations and strengths of relevant factors in order to refine this tool into a succinct survey.