ANZCTR search results

This Phase II study aims to establish the efficacy of three IPs individually in slowing the progression of motor symptoms of moderate severity PD and in maintaining this effect for 12 weeks after the IP is discontinued. This is to rule out an unexpected symptomatic rather than disease-modifying benefit. Patients with moderate severity PD, on a stable dose of usual PD medication [L-dopa, dopamine agonists, COMT inhibitors, MAO inhibitors and/or amantadine], will be randomised to one of the three IPs or placebo in this parallel-group design study. The IPs will be over-encapsulated for blinding purposes and will be administered along with matching placebos. All patients will receive two oral capsules per day, according to the following schedule: • Twice daily (BID) IP will be taken in the morning and evening (no placebo) • Once daily (QD) IP will be taken in the morning with matching placebo in the evening (as a second “dose”) • Placebo will be taken in the morning and evening

A ‘stepped down’ physical activity (PA) program is one in which clients transition from the care of an allied health professional to self-managed PA. Assisting clients in ‘stepping down’ to self-managed PA may promote a range of positive health outcomes that are associated with regular PA, such as enhanced physical and cognitive function, reduced risk of chronic diseases, improved quality of life and enhanced psycho-social wellbeing. Furthermore, ‘stepped down’ PA programs may help in sustaining the health benefits achieved through allied health treatment. Presently, health care treatment models provided by the Department of Veterans Affairs (DVA) may not enable or create channels for its clients, who are Australian war veterans and war widows, to ‘step down’ to self-managed PA following a course of allied health treatment. There are also questions about improving the sustainability of self-managed PA in DVA clients when undertaken in communities that might facilitate physical and psychological health, social connectivity, and health care savings. To respond to this unmet service need, the Active Choices program was developed for DVA clients who are currently receiving allied health treatment from an exercise physiologist or physiotherapist. Active Choices is a 12-week program that incorporates evidence-based behavioural support strategies (e.g., goal setting, self-monitoring, action planning) to help DVA clients self-manage their PA. The program also links DVA clients to local opportunities for their PA choices, provides financial support to access community PA, and promotes social connectivity within local active communities. This research aims to evaluate the effectiveness, feasibility and acceptability of the Active Choices program in a sample of DVA clients. The impact of the program on self-managed PA, psychological well-being, social connectedness and allied health care utilisation will be assessed. The research will also explore barriers and facilitators to program implementation, aspects of the program that clients did and did not like, and areas in which the program may be improved in future. A single-group trial will be conducted, with all participants allocated to receive the Active Choices program. Measures of program effectiveness will be completed at baseline, end-intervention (12 weeks) and follow-up (24 weeks). Program feasibility and acceptability will be assessed at the end-intervention and follow-up timepoints. It is hypothesised that the Active Choices program will benefit self-managed PA, psychological wellbeing, social connectivity and allied health care utilisation. The findings of this research will provide valuable data to support larger effectiveness trials.

Up to 33.7% of the population will have a diagnosis of an anxiety disorder throughout their lifetime and current treatment approaches are largely ineffective; having moderate effects at best. However, given the substantial economic and personal burden of anxiety new treatments are urgently needed. This project aims to explore a different approach to anxiety: transcranial alternating current stimulation (tACS). tACS is a mild form of non-invasive brain stimulation. This study aims to use tACS to target some brain-based changes found in individuals with anxiety, with the aim of helping to reduce feelings of anxiety in these individuals.

COVID-19 is a global pandemic. So far encouraging results have been shown in different parts of the world with the utilisation of hydroxycloroquine, zinc, and azithromycin, and early studies into some of these, plus some with IV Vitamin C, have also proven beneficial. Vitamin D levels have also been shown to be an important indicator to the severity of symptoms in COVID-19 patients. Anticoagulation has also proven to be highly beneficial in patients hospitalized with COVID-19. This study aims to find the optimal treatment protocol for hospitals to consider in their treatment of COVID-19 patients and their endeavours to save lives. Stage 1 of the outpatient group in Australia is ongoing. Stage 1 of the inpatient/ hospitalised patient group in Turkey has now been published.

Neuropathic pain is a debilitating secondary condition for many individuals with spinal cord injury (SCI). SCI neuropathic pain remains minimally responsive to existing pharmacological and non-pharmacological treatments. A growing body of evidence supports the potential for brain-computer interface (BCI) systems to reduce SCI neuropathic pain via electroencephalography (EEG) neurofeedback. However, further studies are needed to provide more definitive findings regarding the effectiveness of this intervention. We have developed a novel BCI-based neuromodulative (BCI-N) intervention for SCI neuropathic pain. Our BCI-N treatment includes an interactive gaming interface, and a neuromodulation protocol targeted to suppress theta (4-8 Hz) and high beta (20-30 Hz) frequency powers, and enhance alpha (9-12 Hz) frequency power. A single-case experimental design (SCED) with multiple baselines will be used to examine the effectiveness of our self-developed BCI-N intervention for the treatment of SCI neuropathic pain. Three participants with SCI neuropathic pain will be recruited. Each participant will be randomly assigned to a different baseline phase (i.e., 7, 10 or 14 days), which will then be followed by 20 sessions of 30-min BCI-N intervention over a 4-week period. The visual analogue scale assessing average pain intensity will serve as the primary outcome measure. Pain interference will also be assessed as a secondary outcome domain. Generalisation measures will assess quality of life, sleep quality, anxiety and depressive symptoms as well as resting-state EEG and thalamic gamma-aminobutyric acid (GABA) concentration. SCEDs are considered a viable alternative approach to randomised clinical trials to identify evidence-based practices in the field of technology-based health interventions when recruitment of large samples is not feasible.

Our research team is part of a group that has been awarded a grant to establish the Prevention Hub Mental Health Research Program. The Prevention Hub will focus on implementing and evaluating preventative strategies for anxiety and depression in workplace, school, and healthcare settings to achieve the greatest possible impact and reach. This application is for the purpose of conducting a randomised controlled trial (RCT) of a smartphone-based intervention (Anchored) aimed at preventing depression and promoting mental health and wellbeing within Australian workers. Due to the unexpected changes to the workforce brought about by COVID-19 (coronavirus), the app will also be evaluated in Australians who have become unemployed due to the COVID-19 pandemic and would have until recently been part of the working population. The app has undergone pilot testing for feasibility, usability and acceptability with 81 participants. Participants will be randomised to one of two conditions: (1) the Anchored app (a CBT, mindfulness, and behavioral activation-based smartphone app) and (2) a psycho-educational online resource. Post-intervention assessment will occur 30 days after baseline, and follow-up assessment will occur 3 and 6 months after baseline. All assessment will be completed online. Key outcomes include: depression symptoms, anxiety symptoms, stress, wellbeing, resilience, function, burnout, suicidal ideation, and lifestyle elements. This project will build improved workplace wellbeing outcomes for working Australians, and those recently unemployed as a result of the COVID-19 pandemic. This study has the capacity to dramatically change the way individuals manage their health and wellbeing by empowering them through evidence-based MH plans. With the exciting and rapid improvement in e-health technologies, this approach can now be rolled out more broadly, overcoming many of the feasibility, access and help-seeking obstacles often encountered with more traditional face-to-face interventions.

The purpose of this observational study is to evaluate the effects of COVID-19 on the immune system, heart, lung, brain function and mental health of patients of St Vincent’s Hospital, Sydney. Patients will attend the hospital six times over the 12 months following their COVID-19 diagnosis to be monitored by their Doctor and to provide blood samples, collect swabs and complete questionnaires. Overall, the study will increase our knowledge to better understand how the body responds to COVID-19 and provide valuable information to improve care for people with this infection in the future.

The primary objective of The Infant Feeding Study is to determine if cognitive development, as measured with the Bayley Scales of Infant Development, at 365 days (12 months) of age in term-born children is significantly improved in children fed infant formula supplemented with MFGM-rich ingredient, compared to those children fed a standard infant formula.

Injury resulting from falls is a significant contributor to hospitalisation of older Australians. Fractures resulting from falls can also lead to long term health consequences including decreased mobility and independence, reduced quality of life and even increase risk of death. While there is a great deal of research investigating effectiveness of different management strategies for healing of bones, there is limited knowledge on the overall effect of post-surgical management on health outcomes of patients following discharge from hospital. The current evidence does not clearly define which strategy is best in which patients, therefore the different treatment strategies under investigation are all part of current clinical practice. Frailty is defined as a state of reduced physiological reserve due to accumulated deficits which increases the individual’s vulnerability to adverse health outcomes. The current study aims to investigate the effect of different management strategies, during their hospital stay, for patients who have undergone surgery to repair a fracture of their lower limb on the likelihood they will develop frailty. Frailty will be measured using Frailty Index and hand grip strength. We will measure frailty soon after surgery and at 6 and 12 weeks following their surgery to investigate whether the type of treatment increases the likelihood of patients meeting the definition for frailty. This study will observe outcomes in patients grouped according to the treatment prescribed by their treatment team as 1. mobilisation (weight-bearing) 2. partial or 3. total immobilisation (non-weight bearing). The study will not affect the care of the participants.

This study aims to evaluate the efficacy and safety of an enhanced influenza vaccination schedule in immunocompromised children undergoing treatment for cancer. Who is it for? You may be eligible to join the study if you are aged between 6 months and 18 years, and undergoing therapy for cancer or within 6 months of completion of treatment. Study details All participants in this study will receive an influenza vaccine: 3 doses given at least 4 weeks apart for children younger than 9 years and 2 doses given at least 4 weeks apart for children aged 9 years or older. Blood samples will be collected throughout the study to determine immune response to the vaccine. Safety of the enhanced vaccine schedule will be closely monitored in each participant throughout the study. Overall, we aim to establish an optimised and safe influenza immunisation schedule for children and adolescents undergoing treatment for cancer.