ANZCTR search results

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

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31198 results sorted by trial registration date.
  • Exploring the value of peer mentoring on the psychosocial wellbeing of junior doctors: a qualitative randomised controlled study

    Objective To evaluate the impact of a peer mentoring program for newly qualified interns on psychological wellbeing, and assess the demand for such a program within an Australian hospital setting. Design, Setting and Participants Through a randomised controlled study, interns in a tertiary teaching hospital (Perth, Western Australia) were recruited to be mentees and resident junior doctors were selected to be mentors. Methods and Main Outcome Measure Interns were randomised 1:1 to receive, or not to receive, a mentor. Mentors were recruited. Qualitative outcome data was collected using semi-structured interviews and focus groups at 12 months and used to assess psychosocial wellbeing and job satisfaction. Results Fifty-three interns applied to participate in the program. Twenty-six mentor-mentee pairs were matched. Twenty-seven interns were allocated to not receive a mentor. Through iterative data analysis, the overarching themes concluded the value of the program in aiding navigation through the complex healthcare system while enhancing a sense of community. Participants with mentors reported high satisfaction with a positive impact on stress levels, morale, sense of support, job satisfaction, and psychosocial wellbeing. Conclusion A peer mentoring program enhances junior doctor support structures, builds a sense of community and helps interns navigate their new professional environment. To our knowledge, this is the first research of its kind involving Australian prevocational junior doctors and provides a feasibility model that may be adapted regionally or nationally.

  • Continuous Video EEG Monitoring in Acute Paediatric Ischaemic Stroke

    There is a retrospective and prospective component to the study. Retrospective patients will be identified through the LCCH clinical stroke database, the Paediatric Intensive Care Unit database and a hospital ICD code search. Appropriate data will be collected and interpreted retrospectively. No additional Video-EEg monitoring will occur. The patients will be followed (neurovascular outpatient clinic and the Queensland Paediatric Rehabilitation Service). This will mainly include standard outpatient appointments. Outcome measures will include the Paediatric Stroke Outcome Measure (PSOM), development of epilepsy and standardized speech and language and cognitive assessments. Outcome will also be comparative to allow for possible baseline developmental delay. Prospective patients will be notified to the study team by neurology, neurosurgery, the emergency department or the paediatric intensive care unit. Study duration will be 2 years. Retrospective patients will be identified from the 2 years preceding the study start date. Follow up is planned for the usual stroke clinic care and for 5 and 10 years. For prospective patients, Video EEG monitoring will occur alongside standard paediatric stroke care. Stroke management will be based on the Australian Paediatric Stroke Guidelines (currently in draft format). Duration of video EEG monitoring will be a minimum of 24hrs. Standardised data will also be collected on all patients with ischaemic stroke over the 2-year study period. The treating clinician will use their discretion to delay or remove the video EEG monitoring if it impedes standard clinical care. The decision whether or not to treat sub-clinical and clinical seizures is at the discretion of the treating clinician however guidance is provided in the Australian Paediatric Stroke Guidelines. Acute neuroimaging (MRI brain) will be reported as per current clinical practice. For study purposes, a second paediatric radiologist will review the imaging. This radiologist will be blinded to the occurrence of clinical or sub-clinical seizures. Neuroimaging analysis will include stroke type and location, presence or absence of haemorrhage and vascular imaging analysis. Where possible volumetric analysis will be performed. Stroke severity will be assessed based the pedNIHSS (Pediatric National Institute of Health Stroke Scale) in concordance with the Australian Paediatric Stroke Guidelines. For the retrospective component of the study the PedNIHSS will be applied retrospectively. Follow-up (outpatient clinic setting) will occur through the neurovascular outpatient clinic and the Queensland Paediatric Rehabilitation Service. Outcome measures will include the Paediatric Stroke Outcome Measure (PSOM), development of epilepsy and standardized speech and language and cognitive assessments. Patients will be treated as per usual standard of care and the only difference for prospective patients will be the duration of the Video-EEG monitoring.

  • Utilisation of ambulatory pumps in the inpatient setting to administer long term antibiotic therapy: A patient risk reduction and rehabilitation Strategy (The MOBILISE Study)

    The MOBILISE study is a randomised control trial comparing antibiotic administration via a small pump with a continuous antibiotic infusion to the traditional method of a hospital pump and pole with multiple daily dosing of antibiotics.

  • Predictors of clinical outcomes in patients admitted with influenza and whether troponin levels during hospital admission predicts clinical outcomes in patients with influenza?

    Seasonal influenza is responsible for significant morbidity and mortality around the world. It may result in 200,000 to 500,00 deaths per year and numbers can be higher during pandemics. The frequency of myocardial involvement in influenza is variable with rates up to 10% having being reported in literature and depends upon the methods used to detect myocardial involvement. It is unclear how common asymptomatic cardiac involvement of influenza is although it has been reported as anywhere from 0 to 53% of cases. Although influenza is known to be associated with adverse cardiovascular outcomes but limited studies have studied relationship between troponin levels during hospital admission and clinical outcomes and it is unknown whether increased troponin levels can be used to predict clinical outcomes in these patients. The primary objective of this study will be to determine variables associated with adverse clinical outcomes in hospitalized patient admitted with influenza and other objective will be to determine whether troponin levels during admission correlates with length of hospital stay, complications during hospital admission and readmissions within 1 month and 6 months following discharge. This study will involve only retrospective collection of data of all confirmed cases of influenza admitted in Flinders Medical Centre and Royal Adelaide Hospital between January 2014 and October 2017. The anticipated benefits are possibility of finding new variables, which can predict clinical outcomes in patients admitted with influenza and thus may help in directing strategies to high-risk patients in future.

  • Randomised controlled trial of online vocational support for young people with mental ill health

    This research project is investigating online support for young people looking for work. Young people who experience mental ill health often also experience disruption to school and work. This project will look at whether or not online platforms can help young people find and stay in work. Young people who agree to take part in the project will be randomly assigned to use one of two online platforms. These platforms are both designed to help young people find work and stay in work. They include ways to learn about looking for work, work skills, and information about workforce participation. Depending on which platform participants are allocated to, you may also receive online help from vocational support people and/or talk to other young people online about looking for work. Each component of the platforms are optional and there is no minimum time that you have to spend on the platform. You will also be asked to complete questionnaires about yourself (e.g. demographic information, questions about your mental health, questions about hopefulness and how confident you feel about work) and about looking for work and your work history. You will be asked to complete these questionnaires at three times: 1) when you start as a participant in the study (baseline), 2) 26-weeks after baseline, and 3) 25-weeks after baseline. You will also be asked to let us know how many hours you have worked each week for 26 weeks. Each time you complete the questionnaires it will take approximately 45 minutes. You can complete these questions online and will be reimbursed $20 for the questionnaires that are done at the start (baseline), middle (26-weeks), and end of the study (52-weeks). You may also be asked to participate in an interview about your experiences of using the online platform. We will ask you what you thought of different sections of the platform and what it was like in terms of helping you look for and obtain work. This interview would be at the middle of the study (26-weeks) and again close to the end of the study (52-weeks). If you agree to do this, the interview will be audio recorded and transcribed. This is because it is the best way to remember exactly what you said in the interview. When the recording is transcribed any details that identify you (e.g. name) will be removed. The interviews will last approximately 45-60 minutes depending on how much you have to say and you will be reimbursed $30 for your time and travel expenses.

  • Steroid Nasal Spray for Sleep Disordered Breathing in Children

    Breathing problems in sleep (known as sleep disordered breathing - SDB) is a common problem in childhood (seen in up to 10%). SDB can affect children along a spectrum from snoring without sleep disruption, to obstructive sleep apnoea (OSA) with severely disrupted sleep and pauses in breathing. SDB symptoms are now the most common reason for tonsillectomy surgery in children. However, some of these children may benefit from less invasive medical treatment. This study is trying to find out if a nasal steroid spray (INS) (mometasone furoate) can help reduce SDB symptoms. We will ask children 3-12years old to be part of the study. We will do an examination and ask parents to complete questionnaires on their child’s SDB symptoms, and other things related to good sleep such as their child’s emotions and behaviour, and quality of life. We will give them either INS or saline spray (salty water) for 6 weeks, and then repeat the assessments to see the effect of the INS versus saline. We will also monitor who has surgery over the next two years. We expect that INS will reduce the symptoms of SDB, and ultimately reduce the need for surgery, thereby improving the health and quality of life of children with SDB, and also reducing health care costs.

  • Massage and Maternal Anxiety (MAMA) pilot study.

    A significant proportion of women struggle with anxiety and stress during pregnancy, and this can affect the health of both the mother and her baby. Relaxation interventions might be helpful, however the evidence is not conclusive. The purpose of this feasibility study is to explore the potential of two programs aimed at helping to decrease anxiety during pregnancy: 1. a partner delivered relaxation massage program; and 2. a self-directed stress management program. Pregnant women will be invited to participate in the study and randomly assigned to one of the two programs.

  • Use of high flow nasal oxygen in bariatric surgery: a randomised controlled trial

    During general anaesthesia, obese patients are at risk of oxygen levels in the blood rapidly falling when not breathing. This rapid reduction is due to the combination of reduced chest wall and diaphragmatic tone, the increased incidence of lung collapse, and secretion retention. Administering oxygen before general anaesthesia is less effective than in patients with a normal weight and obese patients pose more difficulties with airway management. Transnasal humidified Rapid-insufflation ventilator exchange (THRIVE) has recently gained popularity within anaesthetic practice due to the respiratory safety benefits it provides in patients who are not breathing. THRIVE increases the time in which patients can be not breathing before oxygen levels in the blood begin to fall. The aim of this study is to identify the safety benefits of high-flow nasal oxygen deliver (Transnasal humidified Rapid-insufflation ventilator exchange (THRIVE)) in obese patients undergoing elective bariatric surgery. It may potentially increase the time to hypoxia and increase carbon dioxide elimination in obese patients who are not breathing, who are at higher risk of lung complications.

  • Learning successfully for study and life ("Life"): Teaching gifted young adolescents about minimising the impact of perfectionism on successful learning.

    This study builds on pilot work testing 2- and 3-session perfectionism programmes with early adolescents which found improvements in emotional problems, self-imposed perfectionistic standards (sustained at 4-week follow-up), and well-being, sustained at 3-month follow-up (Fairweather-Schmidt and Wade, 2015; Vekas & Wade, 2017). The modified programme for the current research expands the pilot programme to include an emphasis on the difference in pursuing excellence and pursuing perfection, as gifted students will be offered the intervention. To date no research has examined whether perfectionism interventions can increase intrinsic motivation and academic goal progress. Research objectives 1. To examine the impact of the LIFE curriculum on primary (perfectionism) and secondary (anxiety, depression, wellbeing, self-compassion, academic motivation and satisfaction). 2. To test whether improvements in certain outcome factors (anxiety, depression, well-being, academic motivation and satisfaction) are mediated by the following outcome factors: self-compassion and perfectionism. We hypothesize that the intervention group will experience significantly greater decreases in perfectionism, anxiety, and depression, and significantly greater increases in wellbeing, self-compassion, academic motivation and satisfaction, at follow-up. We also hypothesize that decreases in perfectionism and increases in self-compassion between baseline and end of treatment will mediate the association between group and follow-up changes in anxiety, depression, well-being, academic motivation and satisfaction.

  • Do brain measures predict improvement of hand or arm function following brain stimulation in people with stroke?

    Stroke is a leading cause of long term disability with around 60,000 people experiencing a stroke each year in Australia. In the acute post-stroke period over two thirds of patients experience some level of reduced upper limb function, while 15-30% of stroke survivors suffer permanent motor impairments despite extensive rehabilitation. Although extensive research has been devoted to establishing novel treatment modalities, few have made significant and reliable improvements to stroke rehabilitation and recovery. Brain based interventions which target affected brain networks are likely to be highly effective. Transcranial direct current stimulation (TDCS), a form of non-invasive brain stimulation, has demonstrated some promise for improving upper limb function post stroke. TDCS can facilitate motor learning by increasing network excitability. This raises the possibility that combining TDCS with therapy may lead to functional recovery beyond that normally achieved by therapy alone. However inconsistencies of both physiological and behavioural responses to TDCS suggests a ‘one-size-fits-all’ treatment might not be optimal. The neural sequelae arising from stroke are highly heterogeneous with the extent of subsequent impairment dependent upon lesion location and disruption of brain networks. Therefore individual differences in residual integrity of the lesioned motor network may contribute, at least in part, to variable TDCS responses. Motor network connectivity may be a valuable predictor of those who will benefit from TDCS application in general, or alternatively, benefit for different stimulation approaches (e.g. facilitatory vs inhibitory TDCS or ipsilesional vs contralesional stimulation). Biomarkers predictive of TDCS response would be beneficial to improve clinical translation of this ‘state-of-the-art’ intervention capable of substantially transforming stroke therapy and improving recovery. We hypothesise connectivity of the lesioned motor network will be greater in stroke patients who demonstrate a strong response to TDCS combined with upper limb exercise therapy.

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