ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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30455 results sorted by trial registration date.
  • Evaluating the impact of an 8-week outpatient memory clinic program for people living with dementia and their care partner: a pilot study.

    Nurse-led memory clinics have the potential to be complementary models to help address the growing care for those living with dementia and their care partners. However, to date there is limited research evaluating the benefit of nurse-led memory clinics. This research will be a pilot study to evaluate a nurse-led memory clinic, Enhance. Enhance is a nurse-led multidisciplinary clinic with the aim of supporting independence, wellbeing and function of people living with dementia. Both people living with dementia and their care partner will be able to clients at the clinic.

  • Do smart inhalers improve medication adherence and reduce asthma exacerbations for children aged 5-9 years?: A Randomised Controlled Trial

    The primary aim of this pilot randomised controlled trial is to examine if smart inhaler use as part of asthma care for children aged 5-9 years is effective in reducing moderate and severe exacerbations over a 12 month period. The secondary aims of the research are to: i) increase children’s adherence to preventer therapy; ii) decrease use of reliever therapy; iii) increase self-reported asthma control; and iv) decrease healthcare use reacted to asthma (GP and specialist visits, ED presentations and hospital admissions). The feasibility and the acceptability of the intervention will also be examined. A total of 40 children aged 5-9 years with asthma along with one parent/carer will be recruited. Each child- parent dyad will be randomly allocated to the intervention (n=20) or usual care condition (n=20). The intervention includes: a) Provision of smart inhaler devices for reliever and preventer inhalers, and education in use; b) FindAir system facilitated prompts and feedback to children/parents (eg daily medication reminders); c) Researcher support in the use of the FindAir smart devices and the FindAir Asthma Diary App; d) FindAir system facilitated feedback to GPs and GP-based nurses; and FindAir facilitated feedback on asthma care flags to parent/carers and GPs (if applicable). The control group will receive usual care. The control group will also receive FindAir smart devices for their child’s preventer and reliever puffers to enable data collection of the child’s inhaler use; the other functions of the smart inhaler (e.g., medication reminders, feedback) will not be accessible to participants in the control group. Outcome data (number of moderate/ severe exacerbations and preventer adherence) will be collected at baseline, during the 12-month intervention, and 2 months after the intervention in both the intervention and control groups. Intervention feasibility will be determined by examining use of the smart inhaler. Acceptability will be determined via semi- structured interviews with child and parent/guardians in the intervention group and participating clinicians.

  • M-MAT Tele: Maximising Aphasia Treatment and Recovery across Australia through Innovative Group Telerehabilitation

    We are conducting a study testing an online, group intervention for aphasia after stroke. This online intervention is called Multi-Modality Aphasia Therapy Tele, or M-MAT Tele. M-Mat Tele is delivered to a group of three people with aphasia with the aim of improving spoken communication. We hope to learn if M-MAT Tele is feasible and enjoyable compared to usual care, and whether to conduct a large trial that tests how well it works. M-MAT Tele is a new telehealth version of M-MAT (Pierce et al., 2024). Telerehabilitation reduces clinician and client travel and need for treatment space while addressing geographical inequity amongst people who have experience a stroke. We have preliminary evidence that M-MAT may be equally effective at a low-moderate intensity (Pierce et al., 2023). This project explores M-MAT Tele at a clinically implementable low-moderate intensity for people with aphasia of less than one year. Feasibility, acceptability, and preliminary efficacy will be explored. Results of this project will provide crucial data for applications for definitive trials of M-MAT Tele in this setting.

  • Atrial Myopathy and Embolic Stroke (AMES) trial – Prospective Randomised Open Blinded Endpoint (PROBE) clinical trial with parallel cohort study

    This clinical trial will look at patients who have had an acute ischaemic stroke caused by a blood clot, but where doctors can't find a clear reason for it (this is called Embolic Stroke of Uncertain Source, or ESUS). The study will test whether a type of medication called DOAC (a stronger blood thinner) can help prevent future strokes and improve recovery in patients with atrial myopathy, a condition identified through ultrasound showing reduced heart chamber strain. Additionally, there will be a parallel study to confirm current and new tests for atrial myopathy that can help predict the chances of having another stroke.

  • Safety and feasibility of Intramuscular Dexmedetomidine for Delirium

    This is a pilot feasibility randomized clinical trial comparing the novel intramuscular use of dexmedetomidine, an alpha-2 agonist agent, in preventing delirium and improving sleep in older, non-ventilated intensive care patients, compared with usual care. The main aims are to determine if using the drug in this context is safe, and if further, larger studies would be feasible.

  • The feasibility and preliminary effectiveness of a machine learning (ML)-based digital assistant to promote physical activity in older adults

    The study aims to evaluate the feasibility and preliminary effectiveness of a machine learning (ML)-based physical activity digital assistant to promote physical activity in older adults 65 years of age or older. The study will use an existing ML-based digital assistant MoveMentor that applies natural language and reinforced learning in an engaging, interactive, and personalised intervention. This study will assess the feasibility (usability, acceptability, and engagement), preliminary effectiveness, and user experience. A feasibility study with non-randomised pre-post measures will be conducted over 14-weeks. At baseline (week 0) participants average step count will be tracked through an activity tracker, then complete a brief online survey to assess participant demographics, self-reported physical activity, and intentions to engage in physical activity. At the end of the intervention (week 13) participants will complete a further online survey to measure changes in self-reported physical activity, intentions to engage in physical activity, and user experience assessed through usability, acceptance and engagement with MoveMentor. The primary outcome is the change in steps recorded from baseline to post-intervention.

  • Examining the effectiveness of Breathwork on increasing resilience and psychological well- being while preventing and attenuating anxiety, depression, insomnia, and stress in emergency responders

    The study is a randomised controlled trial investigating the effect of breathwork on mental health outcomes in student paramedics. It involves two groups, with participants randomised to either the breathwork intervention or a control group, over a three-month period. The primary focus is to assess improvements in mental health metrics such as stress, anxiety, depression, insomnia, resilience and overall well-being. We hypothesise that the breathwork group will experience positive improvements in mental health, resilience and well-being, compared to the control group.

  • Investigating the impact of external factors on diurnal changes to corneal immune cells

    This study is investigating whether ‘time of day’ factors and sleep patterns affect immune cells (cells that protect the eye) in the cornea (transparent front part of the eye). This study will also examine whether different light filtering lenses (that block different wavelengths of light) influence the behaviour of corneal immune cells. The study will aim to enrol 24 participants, with a target of 18 completed participants, aged 18 to 45 years, who have healthy eyes and do not regularly wear contact lenses or spectacles for daily activities. Participants will attend for 8 study visits in total, comprising 3 visits in the morning (08:00 AM-10:00 AM) and 5 visits in the late afternoon (16:00 PM-18:00 PM). Over the course of the study, participants will be asked to wear various forms of eye wear, consisting of an eyepatch and safety glasses with a filtered lens over one eye, overnight and/or throughout the day, as directed by the study team, as well as have some tear and blood samples collected.

  • GRIP (Group Run Virtual Physiotherapy): A pilot study examining the feasibility of providing a physiotherapy-led falls prevention group exercise class via telehealth

    The study will look at the acceptability and suitability of older adults participating in an online group exercise class aimed at reducing the risk of falls. It will explore barriers and faciliators to a virtual falls prevention program. Participants included in the study will be recruited from RPA Virtual Hospital who meet a specific eligibility criteria. They will partake in a 12-week virtual falls prevention service that includes assessment and delivery of exercise. We are hoping that older adults will find the 12 week virtual falls prevention service acceptable and suitable for their needs.

  • TRI-ME: Trimetazidine to treat Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A double-blind, randomised, placebo-controlled efficacy trial

    Existing treatments for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) are inadequate and ME/CFS therapy represents an unmet need of healthcare. Our aim is to assess the efficacy of trimetazidine, a metabolic agent, in treating ME/CFS in a double-blind, randomised, placebo-controlled clinical trial. Mitochondrial dysfunction has long been associated with inflammation and oxidative stress of ME/CFS and may be the potential final common pathway in the pathophysiology of ME/CFS. Trimetazidine increases metabolic efficiency in the mitochondria by promoting glucose oxidation rather than fatty acid oxidation (i.e. increased energy generation) and has anti-inflammatory and antioxidant properties. Importantly, in preclinical rodent studies confirmed trimetazidine increases mitochondrial function in the brain and facilitates longer swimming in the forced swim test without causing hyperactivity in the large open field. Trimetazidine was also identified using an atheoretical drug screening approach that showed trimetazidine to redress mitochondrial dysfunction. The therapeutic potential of trimetazidine is clear, Trimetazidine is highly accessible, affordable, and has regulatory approval to treat angina in Asia and Europe, making it particularly suitable to repurpose for ME/CFS.

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