ANZCTR search results

We will investigate whether delivery of positive inflation pressure (PIP) (singly or repeated), triggered by a 3 second pause in respiration, can re-establish breathing efforts in preterm infants on continuous positive airway pressure (CPAP), a form of non-invasive respiratory support. The study will involve infants born at <30 weeks gestation who require CPAP support, and are having episodes of respiratory pauses. We will conduct a 16 hours crossover study comparing the use of a device to generate PIP with standard CPAP support. The study will be in blocks of 4 hours (randomly assigned) in which PIP is delivered singly, repeatedly (up to 3), or not at all (standard CPAP). We hypothesise that PIP will improve the regularity of breathing, and shorten the duration of respiratory pauses.

Pain is an expected problem after haemorrhoidectomy surgery and there have been a number of studies that have examined metronidazole in helping to reduce post-operative pain. The results are conflicting and the purpose of this study is to further examine the role of oral metronidazole plus standardised analgesia in reducing post-heamorrhoidectomy pain and compare its efficacy to placebo plus standardised analgesia.

The purpose of this study is to determine if a nurse-led, distance-delivered, intervention called ‘Engage’ can be used to increase childhood cancer survivors' self-efficacy, and improve their long-term physical and mental health by promoting engagement in survivorship care. Who is it for? You may be eligible if you are over the age of 16 and were treated for cancer at least 5 years prior to participation in this study, or you may be eligible if you are a parent of a cancer survivor who is less than 18 years old. Study details All participants in this study will receive two online or telephone consultations with a clinical nurse consultant, and a medical case review with a multidisciplinary team. The purpose of these consultations is to provide a referral pathway, and survivorship care plan. Participants will also need to complete four questionnaires at 1, 6, 12 and 24 months. How will this research contribute to childhood cancer survivors? It is hoped that this intervention will be used to improve the quality of life of childhood cancer survivors and reduce pressure on healthcare services associated with managing treatment-related late effects.

Physical activity is impaired by chronic pain and there is evidence that the distribution of activities over the course of a day varies between persons with chronic low back pain and healthy individuals. Spinal Cord Stimulation can improve chronic pain which can lead to increased physical activity and improved quality of life in chronic pain patients. The objective measures of physical activity may be more useful than self-report to both patients and providers. The incorporation of accelerometry into Spinal Cord Stimulation, aside from allowing adjustment of stimulation in response to the patient’s position, provides the opportunity to objectively measure activity following Spinal Cord Stimulation implantation. Outcomes, including physical activity, should be evaluated using validated instruments to ensure accuracy and reliability. There is a need for the activity measured by the accelerometer imbedded in the Medtronic Intellis Spinal Cord Stimulator to be validated against credible measurements. Accelerometry is considered gold standard for physical activity measurement and the accelerometer imbedded in the disposable Vital Patch has demonstrated validity. The aim of this study is to test the validity of positional data (mobile, reclining, upright. lying – 4 positions) collected by the Intellis System. Patients who have completed a trial period of spinal cord stimulation and have opted to have a permanent Medtronic Intellis Spinal Cord Stimulator will be recruited into the study. Participants will be asked to wear the VitalPatch, a disposable adhesive device with an embedded accelerometer for five days to collect positional information for comparison with Intellis system. On the first day they will undergo an hour of in-clinic controlled testing of a range of positions (walking, sitting, standing, lying – 4 positions). A diary noting position changes will be kept by participants during the five days of VitalPatch wear. The primary endpoint will be comparison of Intellis positional data against Vital Patch and manual entry during the controlled testing phase. The secondary endpoint will be comparison of Intellis positional data against Vital Patch and ADL Diary during activity of daily living phase.

The aim of this project is to assess the effectiveness of a 10 day intervention of individualised vibrotactile neurofeedback training (iVNT) on balance performance and postural stability in an elderly population with moderate to severe hearing loss and self-reported dizziness. Two-hundred and seven participants will be recruited across Brisbane, Berlin and New York (69 per site) and they will be randomised to one of the three groups: intervention, placebo and control. The first 3 to 5 days of training will occur at the campus location and the following sessions will occur in-home with support provided as needed. The intervention involves the participant wearing a device that delivers vibrotactile neurofeedback during set training tasks. The primary outcome measure will be to determine the effect of training on balance immediately after the two-week intervention period. Secondary outcome measures are to determine the effect of training on balance at six months after the start of training; and on dizziness, gait speed under single and dual task conditions, balance confidence, and physical activity at 2 weeks and six months after the start of training.

The aim of the Omega Kid Study is to investigate the effect of omega-3 supplementation on behavioural outcomes such as self-regulation and executive function in preschool aged children. The study is parallel in design and placebo controlled with the intervention period lasting 12 weeks. Assessments will be conducted at baseline and at 12 weeks, after the intervention period. It is hypothesised that children who receive an active omega-3 supplement will show improvements in self-regulation and executive function, when compared to a matched placebo control group.

This is a randomised, double blinded, placebo controlled trial to assess antiarrhythmic properties of phenytoin and dantrolene, their efficacy and safety for treating arrhythmias and heart failure. The study will compare all the 3 arms together: phenytoin versus dantrolene, phenytoin versus placebo and dantrolene versus placebo. Randomisation will occur after consent is obtained and on enrolment into the study, 105 participants will be randomised in a 1:1:1 ratio to one of 3 arms: • 35 will receive phenytoin • 35 will receive dantrolene • 35 will receive placebo The participants then will be followed in a 2 month interval visits. The visit numbers can increase if there are any concerns regarding the procedure or medication adverse effects (AEs). Repeat blood tests (liver function test and biochemistry profile, medications serum level) and device data collection will be performed prior to office visits. At these office visits, blood test results, occurrence of ventricular arrhythmia, heart failure symptoms (assessed by New York Heart Association (NYHA) functional class and Minnesota Living with Heart Failure Questionnaire) and medications adverse effects will be reviewed. Participants will also have Six-Minute Walk Test (6MWT) at the screening visit, 6 months visit and the last visit of the study.

In Australians 65 years and older, 19% of hospital admissions to medical wards are associated with serious side-effects from medications. Almost 90% of these admissions are preventable through safer use of medicines. The research team have developed a novel method of identifying people at risk of these problems. In this study hospital pharmacists will assess the risk of serious side-effects in people admitted to hospital and make recommendations to reduce this risk to hospital staff, general practitioners and pharmacists. We will test whether this strategy reduces the risk of these events compared to standard care in the 12 months following hospital discharge. We hypothesize that ADR risk assessment on admission to hospital and communication of this risk, with recommendations that target the specific risk factors identified, will reduce the incidence of ADRs occurring during admission and in the 12-months post-discharge.

This study aims to investigate the biopsychosocial impacts of visual arts on individuals with chronic pain. Twenty participants on the waiting list of pain management program at Royal Prince Alfred Hospital will be recruited and randomised into intervention and control groups. The intervention group will receive five sessions (3hrs/session) of art observation and reflective art creation at the Art Gallery of NSW. Stress and inflammatory bio-marker (saliva cortisol-level) and several patient reported outcome measures will be recorded before, during and after the intervention. Each art-making session will be followed by a semi-structured group discussion. The discussions will be recorded for further analysis. The control group will continue with their usual medical care. We hypothesise that this research will identify : (a) whether making visual art produces physiological benefits for chronic pain sufferers, and (b) whether art-making is experienced as beneficial by chronic pain sufferers and identify why or why not.

There is an urgent and growing need to minimise iatrogenic harm from potentially inappropriate polypharmacy (PIP) in ageing populations with multimorbidity. ‘Deprescribing’ aims to minimise PIP. It is the process of clinician-supervised identification and withdrawal (or dose reduction) of medicines where the harms exceed the benefits in the context of an individual patient’s care goals, current function, life expectancy, values and preferences. General practitioners (GPs), with tacit knowledge of, and an ongoing relationship with, their patients, play a central role in coordinating and delivering healthcare to older patients who are prescribed medicines for multiple health conditions. Research suggests that patients are receptive to discontinuing medicines if their general practitioner feels it is appropriate and worthwhile. This study aimed to assess the feasibility, effectiveness and safety of a multi-faceted GP-led intervention to minimise PIP in community-living older Australians. Unlike most other deprescribing studies, this intervention leveraged the existing therapeutic relationship between GPs and their usual patients and used an individually-tailored versus a drug class-specific approach to deprescribing. Recognising the time constraints for GPs in routine care and the potential facilitative role of pharmacists in deprescribing, GPs had the option of referring patients to one of the participating pharmacists for a Home Medicines Review to augment the deprescribing process in this study.