ANZCTR search results

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

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31193 results sorted by trial registration date.
  • A multicentre, cluster randomised, double cross over pragmatic clinical trial comparing the safety and efficacy of enteral olanzapine with quetiapine in critically ill patients with hyperactive delirium

    Critically ill patients in the Intensive Care Unit (ICU) frequently develop delirium. Delirium is extremely distressing to patients and is associated with poor outcomes. There are two forms of delirium, hyperactive and hypoactive (or a mix of both). The hyperactive form is particularly dangerous as patients may become aggressive and remove interventions that are essential for survival and/or injure themselves or staff. Given the urgency with which to treat hyperactive delirium, health care workers frequently administer potent antipsychotic medications to control delirium symptoms. However, we do not know if this is beneficial or harmful or if one antipsychotic medication is a better choice over the other. The purpose of this study is to compare the safety and efficacy (effectiveness) of the two most frequently prescribed antipsychotic medications (quetiapine and olanzapine) for hyperactive (agitated) delirium in critically ill patients.

  • The Parkinson’s disease Getting Out and Active Living (PD-GOAL) program: The effect of behavioural activation therapy on apathy and depression in people with Parkinson’s disease (PD)

    Depression and apathy (feeling low and unmotivated) are common symptoms that accompany Parkinson’s Disease (PD). To date, few mental health programs exist to help people with PD experiencing these symptoms. The Parkinson’s disease Getting Out and Active Living (PD-GOAL) program is a 6-session intervention that aims to alleviate depression and apathy by helping those with PD identify and engage in meaningful and enjoyable activities. The PD-GOAL program is grounded in principles of behavioural activation, an approach that has demonstrated to help people become happier around the world and that is also very effective in treating depression. Together with people living with PD and their support people, the Research Team previously adapted and co-designed the PD-GOAL program for people with PD. Our goal is to test whether the PD-GOAL program alleviates symptoms of depression and apathy in people with PD. We are also interested in opinions and general feedback on the program for future research.

  • Group versus Individual Education for Diabetes Control in Obese Adults.

    National statistics from Australian sources predict normal-weight adults will comprise less than one third of the population by 2025. Evidence suggests there are synergies between obesity and type 2 diabetes mellitus (T2D). Insulin resistance is common in patients with obesity and results in a 7-12 fold increase in the risk of developing T2D. It is not unusual for patients attending the Metabolic and Weight Loss Program at our hospital to have large daily doses of insulin to manage their T2D. These patients often report fatigue, poorly controlled diabetes and difficulty managing their blood glucose level. Evidence from patients indicates lifestyle changes, psychosocial issues, insulin side-effects, dietary perceptions and a lack of confidence in diabetes self-care also influences blood glucose management. Evidence focused on support networks or education programs to improve self-management of T2D for obese patients is difficult to locate. The aim of this study was to determine whether group based education led to a reduction in diabetes distress when compared to usual care.

  • Optimising Time to Thrombectomy in Regional Australia: The Stroke Capable Ambulance (SCA) Program – Part 1

    This is a prospective, non-randomised, cluster cross-over study of paramedic-led, multi-pronged, process of care re-engineering intervention. The intervention will include education, change in care pathways enabling patient bypass and hospital pre-notification of suspected LVO stroke using a defined clinical assessment scoring system (Hunter-8 or ACT-FAST) supported by tele health technology to enable expert consultation where indicated. We will compare process of care times between the original and re-engineered process of care. This is a paramedic-led multi-pronged intervention including education, change in care pathway to enable patient bypass and hospital pre-notification of suspected LVO stroke using a defined clinical assessment scoring system (Hunter-8 or ACT-FAST/MASS), supported by tele health technology to enable expert consultation where indicated. The aim of the study is to test whether implementing a paramedic-based patient bypass model supported by telehealth tools and patient assessments significantly improves the time to arterial puncture for thrombectomy treatment for participants with sufficient indications for such treatments.

  • Does the cultural context impact on mood and stress level? A quasi-experimental pilot study on traditional Chinese medicine five-phase music therapy

    The application of music as an intervention has a long history. Music intervention had rapidly developed and was introduced to healthcare settings in mid twentieth century. In clinical settings, music can be applied to alter mood and stress level, as well as to enhance immunity. Five-phase music therapy (FMT) is a modality of traditional Chinese medicine (TCM), which is a form of music intervention. For FMT, it was proven to have the potential of benefiting mental issues, such as depression, perinatal mental health, and improving the quality of life and symptoms of cancer patients. In addition, cultural background of the participants could affect the impact of music intervention. Cultural background of the participants is important to consider when conducting music intervention as it plays a crucial role in forming ones’ life perceptions, contributing to their presenting problems, and their responses towards music intervention. This study aims at evaluating whether TCM FMT can bring the same influence to people who are familiar with Chinese culture and those who are not. It is hypothesised that cultural background does not influence the impact of TCM FMT on mood and stress level. This can support the application of FMT in diverse cultural contexts. As this is a pilot study, this can also set as a foundation for future full-scale study with similar topics.

  • Optimising care following major surgery to prevent clots: How much intervention is really needed and at what cost?

    Venous thromboembolism (VTE) (blood clotting) is a recognised risk after major surgery. Current methods to reduce this risk include chemical prophylaxis (low molecular weight heparin medication), graduated compression stockings, and intermittent pneumatic compression devices. Australian guidelines currently recommend the use of heparin along with stockings and/or compression devices after surgery, with most Australian surgeons routinely adopting all three methods. Compression devices introduce new clinical risks, increase care burden, are not well tolerated by patients, and are expensive, single-use, disposable plastic items. Further, they may prolong recovery as patients lie immobilised while wearing them. The potential to use just heparin and stockings without compression devices, as occurs in the UK, without impeding patient outcomes would therefore be more practicable and acceptable for patients and health services, as well as having added financial and environmental benefits. Our primary hypothesis: Treatment with heparin and stockings alone results in a proportion of patients with VTE by 30 days that is no greater than 2% higher than the patients randomised to receive heparin, stockings, and compression devices. This study is a clinical trial for patients undergoing major surgery at John Hunter Hospital, Calvary Mater Hospital, Gosford Hospital, Tamworth Hospital and Port Macquarie Hospital. Participants are randomly allocated using a computer to one of two groups: Group A: Participants are treated with low molecular weight heparin (LMWH) plus GCS for standard procedural timeframe plus intermittent pneumatic compression devices (IPCDs) for 5 days. Group B: Participants are treated with low molecular weight heparin (LMWH) as per standard clinical recommendations (dosing regimen depending on participant characteristics). These patients are also given below graduated compression stockings (GCS) to wear. The research nurse will contact each participant by telephone on days 30 and 90 post-surgery to collect outcome data. If participants report that they had symptoms, they will be followed up with GPs and get the ultrasound images and final diagnosis. Outcome data will be recorded for each participant, including the presence of DVT or PE (confirmed by ultrasound), clinical symptoms of DVT or PE, surgical complications, all-cause mortality at Day 30 and Day 90, length of stay in the hospital, days alive and out of the hospital, ED presentations, and any hospital readmissions due to VTE, patient-reported measures including compliance with interventions while an in-patient, sleep disturbance measures (PROMIS-SF), health professional service utilisation, QoL (EQ5D) and WHODAS-12. Removal of compression devices will have benefits for patients, staff and health services, including reduced nursing workload, early patient mobilisation, improved patient experience, reduced needless cost and reduced plastic waste.

  • Determining the reliability and validity of two measures of lower body muscular fitness for adolescents

    The main purpose of this study was to analyse the test-retest reliability of the 30 second sit to stand squat test as a measure of lower body muscular fitness. Secondary outcomes were to assess the validity of the 30 second sit to stand test compared to the highly reliable standing long jump test. Only a few field based tests are available to assess muscular fitness in youth and the 30 second sit to stand test may be a useful addition to the field. Participants aged 14-17 years completed the assessments on two occasions separated by 1 week. On each occasion students completed the 30 second sit to stand test and the standing long jump test as well as anthropometric tests of height and weight.

  • Developing Optimal Psychedelic Assisted Psychotherapy for Obsessive-Compulsive Disorder

    There is increasing evidence that new interventional pharmacotherapies such as psychedelic therapy may be helpful for the treatment of a number of mental health conditions. The purpose of this study is to explore the potential for psychedelic therapy using psilocybin and MDMA to improve symptoms of treatment resistant OCD, and to determine whether there is any pre-post change in electroencephalography (EEG) measurements following psychedelic exposure. To do so, we will carry out a double blind (participant and rater) clinical trial of psilocybin and MDMA assisted psychotherapy in 40 participants (20:20 drug allocation) with treatment resistant OCD. Participants will undergo a series of preparation and integration therapy sessions and 3 drug administration sessions. The results of this study will provide us information about the effectiveness, acceptability, and tolerability of this treatment for this disorder, as well as whether there are any brain activity changes associated with having been exposed to MDMA and psilocybin.

  • The equivalence of electronic and pen-and-paper delivery of patient reported outcome measures in children with burn scars

    This study aims to determine whether there is measurement equivalence between traditional paper-and-pen and electronic delivery of disease-specific patient-reported outcome measures (PROMs) in paediatric burn scar patients and their caregivers. Determining the equivalence of these delivery methods will provide evidence regarding the ability to transition from paper-based administration to electronic based administration of patient-reported outcome measures involving children and caregivers in research and clinical practice based on the comparability of psychometric properties and conceptual base of the measures. We hypothesise that there will be acceptable equivalence between pen-and-paper and electronic completion methods.

  • Use of electroporation for cardiac ablation in patients with atrial fibrillation

    The objective of this study is to provide supporting clinical evidence in particular with regard to the efficacy and safety of the ElePulse electroporation ablation system. It might reveal indicators for hidden risks and trigger further dedicated investigations or tests.

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