ANZCTR search results

This study seeks to evaluate the safety and effectiveness of an experimental type of spinal cord stimulator. The device is not yet approved for use in Australia for the treatment of Painful Diabetic Neuropathy. The experimental device is used for 15 days and is then removed. The experimental stimulator delivers a different wavelength that other traditional spinal cord stimulators and it may help to alleviate pain.

Reflective groups for doctors to reduce burnout. The hypothesis is that sharing difficult work-related experiences in a safe and supportive group environment will develop psychological preparedness for similar experiences in the future, via imaginal exposure and and enhance the ability to regulate associated stress by and normalise appropriate communicate about stressful experiences, which will encourage ongoing use of reflection and communication after the intervention ends. The primary aim to is reduce burnout and secondary aim is for participants to experience the treatment as helpful and supportive.

Background: Genetic factors play an important role in contributing to the variability in response to pharmacological agents. For example, genetic variants can affect the activity of enzymes involved in drug metabolism, either reducing or enhancing drug exposure and thus altering drug response and toxicity profiles. Despite the evidence, Australia has been slow in adopting PG testing to guide therapy. A recent Australian Parliamentary Inquiry into the Management of Healthcare Delivery in NSW, in its published report 8/56 in September 2018, expressed concerns that PG testing is not being adequately utilised in the public mental health system. It further identified PG testing as one of the key mental health priorities and made recommendations that NSW Health actively pursues and funds the increased use of PG testing as a means of improving treatment for patients with mental illness. Primary purpose: To develop a model of care which will be informed by the attitudes and acceptability of PG, as well as the support and resource requirements, amongst potential ends users which includes clinicians and patients. Study objectives: The primary objective of this project is to assess patient and clinician experiences, opinions and reported outcomes when utilising PG testing results, as well as barriers encountered in using PG. The secondary objective is to investigate potential impact of PG, by retrospectively auditing PG testing results, and determining the average number of major versus moderate DGI per patient, the incidence of actionable DGI (defined as one that would trigger a change in prescription), as well as the proportion of patients having at least one actionable DGI for a medication they were taking at the time of PG testing or have taken in the past. The proportion of patients whose experience of medication side effects and/or ADR may be explained by their PG results will also be determined.

This is a first-in-human (FIH) study to evaluate the safety and immunogenicity of IVX-411 in 84 healthy SARS-CoV-2-seronegative adults 18 to 69 years of age. The study will also investigate whether an adjuvant is required in the formulation to enhance immune responses to IVX-411. The selected adjuvant, MF59®, is an oil-in-water emulsion that has shown to increase immunogenicity and is associated with a good safety and tolerability profile. The stopping rules and safety will be monitored by an internal safety review committee (iSRC) and a Safety Monitoring Committee.

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 peer support model for ICU survivors via a pilot RCT (ACTRN12618000615280 manuscript in progress). Despite multiple strategies, there were barriers to participants attending 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 return to hospital. This study aims to test via a pilot RCT, our previously developed peer support model, delivered via a virtual format. Feasibility of the virtual format will be assessed via attendance rates, participant satisfaction, and participant recruitment, as well as any impact on disability, psychological and quality of life outcomes. This is a small pilot study and the results of this study will inform a larger, multi-site randomized study.

This trial aims to assess the implementation of a supervised telehealth group exercise program for patients with a cancer diagnosis. Who is it for? You may be eligible for this study if you are aged 18 or above, have been diagnosed with cancer, and are receiving or have received treatment at Princess Alexandra Hospital, Queensland. Study details All participants will receive 12 weeks of twice weekly, supervised 50-minute exercise sessions via the online platform Virtual Clinic, as well as a home exercise program to complete once per week using the app PhysiApp. Participants will also wear a fitness watch for 7 days at the beginning and end of the exercise program to monitor physical activity. Both before and after completion of the exercise program, participants will complete a number of questionnaires and tests of physical fitness, as well as a survey regarding perceptions of the program and cost incurred or saved as part of the program. It is hoped that this study may demonstrate that a telehealth group exercise program is feasible, acceptable, and effective for improving physical fitness in patients with a cancer diagnosis.

This study aims to determine the effect of a hot springs bathing program (balneotherapy) on sleep and mood state among healthy adults, at a major commercial hot springs destination in Australia, Peninsula Hot Springs. Parallel to the study's main aim, the measures and different groupings will also enable comparison of various commonly practiced bathing behaviours in the outcomes. The potential for habituation is to be explored in the results, with first bathing session results compared to the total program outcomes. Hypothesis: All bathing interventions will show significantly improved mood, cardiovascular function and sleep quality compared to 'quiet time' control intervention.

The TOP UP Trial will investigate the effectiveness, value for money, and acceptability of physiotherapy-led exercise programs delivered via telehealth for older Australians. This research will answer key questions about how technology can be used to reduce falls, enhance mobility and quality of life of older people receiving aged care services in their home or in residential aged care. The study hypothesis is that the TOP UP intervention will result in significantly higher mobility performance at 6 months compared to usual care. This trial will recruit 240 people aged 65 years and older who are receiving aged care services, can walk at least 10m, with and without dementia, and who have sufficient English language and sensory skills to participate in the trial. The intervention group will receive 10 video conferencing physiotherapy sessions over 6 months and will receive an individual balance and strengthening exercise program based on previous successful exercise programs. The physiotherapists will introduce the participants to online exercise programs that aim to improve their adherence to the required exercise dosage of 2 hours per week. The control group will continue with usual care during the trial period and be offered the intervention in 2022. The trial outcomes will investigate the effect of the intervention on mobility, falls, and quality of life. Participants, physiotherapists, carers, and other aged care staff will be interviewed to explore the barriers and facilitators that would influence the roll-out and sustainability of this program if the trial were proven to be effective.

Insomnia is the most prevalent sleep disorder, affecting around 10% of Australians. The symptoms include difficulties getting to sleep, difficulties staying asleep, or early-morning awakenings with an inability to return to sleep. Insomnia may also be associated with problems with memory and attention, and increased feelings of depression, anxiety and stress. Insomnia can be treated effectively without medication, such as cognitive behavioural therapy for insomnia with a psychologist. However, there remain a large proportion of individuals who do not seek help possibly due to barriers such as geographical location or time constraints, or they do not wish to use pharmacological treatments for sleep. Further evidence for alternative therapies for insomnia, particularly those with milder forms of the disorder, are needed. Potential significance of the research project: Insomnia is a highly prevalent but neglected sleep disorder, with serious health consequences for patients and large financial costs to the health system. The use of a supplement for sleep in those with milder forms of the disorder could potentially provide a low cost, widely accessible, and effective treatment solution for people with insomnia across Australia, who would otherwise rely on sleep medication for better sleep. The aim of this project is to conduct a clinical trial to examine the effectiveness of a supplement compared to placebo for improving sleep outcomes in individuals with subclinical insomnia over a four week period. It is hypothesised that the supplement will reduce the severity of insomnia symptoms, and improve subjective and objective sleep quality, quantity, and associated daytime symptoms, compared to placebo.

This study will explore the impact of an immersive virtual reality (VR) experience for patients attending a north Queensland haemodialysis service and provide information to inform a multi-centre randomised controlled trial (RCT). Over the 4-week intervention period, participants will be offered a headset with video of choice. Outcomes will be measured by participants’: attendance at scheduled dialysis sessions and adherence to lifestyle modifications; wellbeing, anxiety and depression; acceptability and usability of VR; cultural acceptability and adverse events such as nausea. The feasibility and acceptability of the equipment from the clinicians’ perspectives will also be explored.