ANZCTR search results

This research aims to support parents for whom parenting has become difficult by investigating the effect of Holding Hands on child social, emotional and behavioural outcomes. The secondary objective is to investigate the effect of Holding Hands on parent depression, anxiety and stress. Holding Hands combines sessional engagement of parents on their own and direct coaching of parents and their children. As a result of inclusion in this study, it is hypothesised that: Participants will show a reduction in parent-report levels of child behavioural social, emotional and behavioural difficulties from baseline to follow up Participants will show a decrease in self-reported levels of parental depression, anxiety and stress from baseline to follow up.

This is a feasibility study aiming to evaluate the usefulness of a weight bearing monitoring sensor in the rehabilitation of patients who have undergone surgical fixation of an ankle fracture. Rehabilitation of such a fracture involves gradual loading of the foot, as the fracture heals. However it is difficult to quantify the amount of loading that actually goes through the foot during the gait cycle. The proposed study is testing the feasibility of using a sensor (Magnes device) to record the weight bearing load during the gait cycle, and can be monitored by the physiotherapist. It is envisaged that the therapist will be able to tailor make a programme of rehabilitation for each patient with accurate load data and monitor patient adherence to the rehabilitation regime. Advances in technology may even allow for the monitoring to be remote through the use of smartphones thus reducing the patient contact time and need to visit the clinic. This being a feasibility study, it will test this technology on 12 patients recruited via the Royal Brisbane Women's Hospital Orthopaedic department. The observations from this feasibility study are going to inform a larger randomised controlled trial testing the clinical and cost efficacy of this technology in the rehabilitation of ankle fractures post-operatively.

Psilocybin is quickly becoming a promising treatment for mental illness and is being studied widely due to its profound consciousness-altering properties. We want to better understand (1) how the consciousness-altering properties of psilocybin affect the brain and, (2) how contextual factors, such as mindset and environmental setting can impact the psilocybin experience. Healthy adults ages between 18-55 years who are residing in Victoria, Australia are recruited. Eligible adults will be asked to attend our research facilities in Clayton on two occasions to undergo a Magnetic Resonance Imaging (MRI) and Electroencephalography (EEG). On the second visit, participants will be administered a moderate dose of psilocybin before undergoing the MRI and EEG. Throughout the study, participants will also be asked to complete an interview and online questionnaires, where they will be asked about their health and wellbeing. All participants will also be asked to attend one or more sessions designed to prepare participants for the psilocybin experience in a research setting. The main aim of this study is to improve our understanding of the neural mechanisms of psilocybin by applying computational modelling to (structural, functional and diffusion) MRI and EEG data collected from healthy adults while they are experiencing the acute effects of psilocybin. We will also investigate the influence of contextual factors to enhance the comfort of participants, such as the use of music and meditation during administration and meditation training prior to administration of psilocybin.

The primary aim of the current study is to evaluate the clinical usefulness of CNSDose, a pharmacogenetic test, in the treatment of patients with severe mood disorders. This will be a 24-week, single-blinded, randomised control trial. Participants will be randomised to one of two study groups 1) CNSDose-guided group and 2) Standard treatment (unguided) control group. It is hypothesised that a significantly higher proportion of patients in the CNSDose-guided group (Group 1) whose doctors used the CNSDose report will have achieved remission compared to the Unguided group (Group 2).

This proposal aims to answer a critical question in the Diabetic Macular Oedema management, and by testing regularly with conventional and novel ophthalmic imaging to predict early response to anti-vascular endothelial growth factor (VEGF) therapy. This anti-vascular endothelial growth factor (VEGF) therapy, is standard of care approved by the Therapeutic Goods Administration for Diabetic Macular Oedema treatment. Diabetes is a common condition that can result in severe vision loss. The structure of the eye can be considered very similar to a camera and diabetes causes damage to the retina which is analogous to the film in the camera. More specifically, diabetes causes injury to blood vessels in the retina causing them to bleed and leak fluid. A spectrum of these retinal changes can occur in diabetes and is referred to as diabetic retinopathy. Currently, fluorescein angiography (FA) is considered the gold-standard technique for visualising the blood vessels in the retina. It is a more precise technique for detecting retinal vascular changes than clinical examination. FA is a technique that was described over 50 years ago and is still widely used. FA is an invasive technique that involves the injection of fluorescein dye into the human vein with images captured by a camera as the dye circulates through the retina. FA is associated with adverse effects including nausea, dizziness and rarely, death due to anaphylaxis. FA is also an expensive procedure and cannot be repeated frequently. Over the past 3 years, a new technique known as optical coherence tomography angiography (OCTA), has come into widespread use for the clinical management of diabetic retinopathy. OCTA is a non-invasive technique that allows rapid image acquisition (3-5 seconds) of the retinal circulation. It is a commercial technique that is widely used by ophthalmologists today. Most importantly, our own research has shown that OCTA provides greater detail of the order and organisation of retinal capillaries and large vessels than FA. The intervention to be administered is intravitreal aflibercept. This study will help develop ways to detect diabetic changes in the eye at an earlier stage than what is possible with current technology. OCTA data acquired from this study may aid the evaluation and treatment of diabetic retinopathy for the individual diabetic participants.

Shoulder pain affects 7-26% of people at any given time[1] and is the third most common musculoskeletal condition seen in primary care[2]. Rotator cuff disease is an umbrella diagnosis that captures 85% of shoulder pain cases[3]. Diagnostic labels influence management preferences for rotator cuff disease. Our online randomised controlled trial (n=1,308) found that people who were told they had a rotator cuff tear had higher perceived need for shoulder surgery and imaging compared to those told they had bursitis[4]. However, we only investigated the isolated effect of labels. In clinical practice, some health professionals could give patients a diagnostic label followed by positive prognostic information and simple management advice (e.g. temporarily avoid activities that aggravate the pain, continue to move the arm). Others could give patients a diagnostic label followed by advice (e.g. take prolonged rest, stop going to work) that increase patients’ fear and perceived need for unnecessary care (e.g. surgery). The primary aim of this online randomised controlled trial is to examine the effects of diagnostic labels and advice on people with rotator cuff disease, and interactions between labels and advice, on perceived need for shoulder surgery. Secondary outcomes include perceived need for imaging, perceived need for an injection, perceived need for a second opinion, perceived need to see a specialist, perceived seriousness of the condition, recovery expectations, and perceived impact on attendance and performance at work. We hypothesise that both the bursitis label (compared to rotator cuff tear) and evidence-based advice (compared to standard advice) will reduce perceived need for surgery. We also hypothesise that there will be a supra-additive effect of providing both evidence-based advice and the bursitis label. References 1. Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, et al. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. 2. Rekola KE, Keinanen-Kiukaanniemi S, Takala J. Use of primary health services in sparsely populated country districts by patients with musculoskeletal symptoms: consultations with a physician. J Epidemiol Community Health. 1993;47(2):153-7. 3. Ostor AJ, Richards CA, Prevost AT, Speed CA, Hazleman BL. Diagnosis and relation to general health of shoulder disorders presenting to primary care. Rheumatology (Oxford). 2005;44(6):800-5. 4. Zadro JR, O’Keeffe M, Ferreira GE, Haas R, Harris IA, Buchbinder R, et al. Diagnostic Labels for Rotator Cuff Disease Can Increase People’s Perceived Need for Shoulder Surgery: An Online Randomized Controlled Experiment. Journal of Orthopaedic & Sports Physical Therapy.0(0):1-45.

The Bionics Institute Rigidity Device (BiRD) is a palm-worn device intended to be used to measure the severity of movement problems seen in people with Parkinson's disease, including uncontrollable shaking (tremor), slowness of movement (bradykinesia) and joint stiffness (rigidity). The aim of the study is to evaluate its performance through a clinical feasibility study. This will involve 20 healthy adults and 60 people with Parkinson's disease, where half the participants with Parkinson's disease are treated with medication and the other half are primarily treated with deep brain stimulation (DBS). Participants will be asked to make a series of postures and movements as guided by standard clinical tests while wearing the device. Testing will occur under different treatment scenarios to ensure it works in each situation. Some tests will last about half an hour, whereas other tests will take approximately three hours. The data from the device will be compared to regular clinical assessments completed by a health professional to ensure they tell us similar information about the movement problems. A previous pilot study has suggested that information extracted from the device will relate to clinical assessments and is safe to use.

Stage 2 is a follow up study which implements a pilot Model of Care developed from Stage 1 (ACTRN12621000739819) where participants (n=80) are recruited, and will complete a study period of 24 weeks, with study follow-ups at weeks 2, 4, 8, 12 and 24. Approximately 10-20 psychiatrists, who are involved in the care of patient participants, will be enrolled in the study, to complete online questionnaires. Stage 3 involves economic evaluation of the pilot Model of Care. Approximately 80 GPs, who are involved in the care of patient participants, will be enrolled in the study, to complete online questionnaires. This Model of Care is hypothesised to enhance the feasibility and clinical utility of pharmacogenomics testing to guided pharmacotherapy into routine clinical care of patients with mental illness.

The aim of this study is to compare the opportunistic use of chest computed tomography (CT) scans obtained as part of the International Lung Screening Trial (ILST) and clinical fracture risk prediction tools, against the reference standard dual-energy X-ray absorptiometry (DXA) scan to detect osteoporosis in lung cancer screenees. Who is it for? You may be eligible for this study if you are a lung cancer screening participant currently enrolled in the Queensland site (based at The Prince Charles Hospital) of the Osteoporosis Sub-study of the International Lung Screening Trial (ILST), and you are either due to have your second CT scan soon or have had your second CT scan within the past 6 months. Study details In addition to the CT scan received as part of the ILST trial and the osteoporosis questionnaires completed as part of the Osteoporosis sub-study of the ILST, all participants enrolled in this study will be requested to have a single DXA scan, This DXA scan will be performed either on the same day or different day to your CT scan, but should be within 6 months of the CT scan. The DXA study should only take up to 20 minutes and will be performed at The Prince Charles Hospital. It is hoped that this study will demonstrate that CT-based methods will be highly accurate, and have higher discriminative ability compared to clinical risk tools, in classifying DXA-defined osteoporosis, and therefore may validate their use in diagnosing osteoporosis in lung cancer screenees. This, in turn, may help to facilitate early diagnosis and treatment in this high-risk group of lung cancer screening participants.

The primary purpose of this study is to assess the feasibility, safety, and activity of vaginal oestriol in preventing vaginal stenosis in women receiving radiotherapy for gynecological, rectal and anal malignancies. Who is it for? You may be eligible for this study if you are a woman aged 18 years or above, who has received external beam radiotherapy, with curative intent to the pelvis, for treatment of a confirmed diagnosis of gynaecological, rectal or anal cancer. Study details Participants will be asked to regularly apply vaginal oestriol cream following completion of pelvic radiotherapy, and will be followed up for safety and effectiveness. It is hoped that information from this study will help improve health-related quality of life for women after cancer treatment for gynecological, rectal and anal malignancies.