ANZCTR search results

Introduction: This study aimed to measure the prevalence of dehydration and diuretic use in older patients presenting to the Emergency Department of a large metropolitan hospital with falls. Materials and Methods: Subjects were recruited as a convenience sample from all patients aged over sixty years presenting with falls. The mean age of the 204 recruits was 81 years and 65% were female. Demographic, clinical, medication and falls information were collected on admission and the subjects were classified as either robust (101 subjects) or frail (103 subjects) utilising the Edmonton Frail Scale. Results and Conclusions: Compared to robust subjects, frail fallers were more likely to use diuretics (34% frail, 14% robust, p=0.001), to be dehydrated (20% frail, 7% robust, p=0.001) and to have both diuretic use and dehydration (13%, 3% robust, p=0.01). These findings suggest that dehydration, potentially exacerbated by diuretic use, is common amongst older patients admitted after a fall, particularly amongst the frail. These two factors, in the frail elderly in particular, merit further study as potentially modifiable causes of falls.

This is a randomised, parallel, open-label study for patients with hypertension, conducted by George Medicines. Ethical approval has been sought in November 2017, shortly followed by regulatory acknowledgement. This research project aims to understand whether a single pill containing 3 types of blood pressure lowering medications at quarter-standard doses will more effectively lower blood pressure and have fewer side effects compared to a standard dose of a single type of hypertensive medication. This research project will assess two different pill combinations for the treatment of high blood pressure, they are: • Ultra-low dose: telmisartan (10 mg), amlodipine (1.25 mg), and indapamide (0.625 mg) • Low-dose: losartan (25 mg), amlodipine (2.5 mg), and hydrochlorothiazide (12.5 mg)

The burden of end stage kidney disease is growing globally. Much of this growth since the turn of the century has been in elderly patients, a group in whom the outcomes from both dialysis and non-dialysis treatments are poor. Optimal therapy for these older patients with end stage kidney disease is not clear and practice varies widely. Recent literature shows high mortality rates in older patients receiving dialysis, with an average mortality of 27% in the first year. Data on the outcomes from non-dialysis treatment, usually referred to as supportive care, is much less clear. This is because: • There are no registries of patients receiving supporting care • It is difficult to define a clear start-in point for supportive care, as opposed to dialysis initiation • Dialysis patient groups compared to supportive care patients have large differences in co-morbidities • There is crossover between the two patient pathways The only effective way to better understand the effects of the dialysis and the supportive care treatment approaches is to randomly apply the treatments in a clinical trial. This approach allows the issues of lead-time bias, residual confounding and cross-over to be eliminated or managed, thereby producing findings of the highest clinical and scientific value. It is the view of the investigators of the DISCERN Trial that, where clinicians and patients have equipoise around the relative benefits and risks of dialysis and supportive care, to randomly allocate patients to either of these treatment approaches is an appropriate and ethical approach. In a setting for scarce healthcare resources, understanding this balance arising from a resource-intensive treatment such as dialysis is the appropriate path to guide resource allocation. Objectives: The primary null hypothesis of the DISCERN study is that, in highly co-morbid patients aged over 75 years with stage 5 chronic kidney disease, medical management including maintenance dialysis compared to medical treatment alone is associated with no differences in the outcome of mortality. Secondary null hypotheses will examine the effect of the same comparison upon the outcomes of quality of life, burden of hospitalisation and cost-effectiveness. Study Design: The DISCERN study is a randomised, controlled trial with blinding of outcome assessment. Participants will be randomised on a 1:1 basis to the two study arms: Medical treatment with maintenance dialysis, OR medical treatment (with no maintenance dialysis).

People with dementia often experience difficulty in recognising the emotions of other people, such as fear, anger and sadness. This can impact upon relationships and social interactions thus causing distress for the individual living with dementia as well as for family members and friends. This study investigates whether a naturally occurring hormone in the body, oxytocin, can help people with Alzheimer's disease and/or Vascular dementia recognise the emotions of other people better. It is hypothesised that patients who receive the oxytocin nasal spray will demonstrate improved accuracy of emotion recognition, following a single dose and repeated administration over one week. Furthermore, it is also hypothesised carers of patients who receive the oxytocin nasal spray will report improved interactions and reduced caregiver burden.

This is a trial of a capacity building program to build the self-efficacy of Early Childhood Intervention Service staff (known as key workers) to support parental mental wellbeing and therefore their own wellbeing. Strategies to improve the mental health of parents of children with a disability are urgently needed, and are timely given the current rollout of the National Disability Insurance Scheme (NDIS) in Australia. This program is needed to break the vicious cycle of poor mental health in parents of children with a disability that leads to poorer short and long term outcomes for themselves, their child and their family. Staff will receive the program as part of organisational change to improve both parent and staff mental wellbeing. Applying a capacity building framework and assessing changes in self-efficacy of professionals this program was developed to not only benefit the wellbeing of parents of children with a disability but also the wellbeing of their Key Workers.

Surgical site infections are recognised as a common surgical complication, and the use of antibiotic prophylaxis has become an important method of reducing the risk of infection. However, given increasing concerns regarding antibiotic resistance, it is important that the use of antibiotic prophylaxis be evidence based. Local and international guidelines attempt to aid clinicians by outlining the evidence available for prophylaxis for various gynaecological procedures. The current Australian Therapeutic Guidelines recommend antibiotic prophylaxis for hysterectomy, termination of pregnancy and caesarean delivery, with no specific reference to non-hysterectomy complex laparoscopic procedures. Although anaphylactic reactions to cephalosporins are reported to be rare (0.001 to 0.1%), skin reactions such as urticaria, rash, exanthem and pruritis occur in 1-3% of patients. Other reported reactions include serum-sickness-like reaction, fever and immunohematologic reactions. Additionally, the potential costs of antibiotic resistance mean all clinicians have a heightened responsibility to ensure administration of antibiotics is for appropriate indications. Medicare data shows that at least 25000 non-hysterectomy, operative laparoscopic gynaecological procedures were performed in Australia last year. In view of the frequency with which such surgery is performed, there is a clear need for an appropriately powered study to examine whether there is a role for antibiotic prophylaxis for non-hysterectomy laparoscopic surgery in gynaecology. To ensure this a study of this magnitude can be carried out correctly, it is essential to perform this pilot study to assess the feasibility of future studies. Given the potential costs to both patients and the health-care system of post-operative infectious morbidity, as well as the costs of using antibiotics, including the actual cost of drug administration, adverse reactions in individual patients, and potential increases in antibiotic resistance, the results of this study have the potential to significantly impact both local and international policy in this area.

BACKGROUND: Osteoarthritis (OA) is the most common joint disease and frequently involves the hand. Painful hand OA is associated with a significant disease burden and reduced quality of life. Indeed, the effect of symptomatic hand OA on quality of life is comparable to rheumatoid arthritis, but affects considerably more people (prevalence ~20% versus ~1% in older adults). With an ageing population, the burden and health-care costs related to hand OA will increase. Patients often rely on NSAIDs or opiates with concomitant adverse effects in this age group to control pain. Hand OA is a heterogeneous condition with approximately 50% of patients having evidence of synovitis. This phenotype of hand OA with inflammatory signs i.e. those with evidence of synovitis is associated with increased pain. In addition, hand OA joints with synovitis are 3.5 times more likely to experience rapid joint destruction and radiographic progression than those without synovitis. Ultrasound (US) has been shown to reliably detect synovitis in the joints of the hand when performed by an experienced technician. Therefore, this is the subgroup of patients with hand OA that are most in need of evidence-based therapies. Previous study to assess treatments for hand OA using of plaquenil, etanercept or adalimumab found not superior to placebo to alleviate pain. There is possible effect if structural modification with etanercept and adalimumab has been shown to be beneficial in erosive and inflamed hand OA. The cost however of these medications in 20K/per year, therefore there use is an expensive alternative. Currently, there are no proven pharmacological treatments for hand OA. The lack of categorization of hand OA according to inflammatory phenotype may have contributed to previous negative outcomes in clinical trials. Cost-effective therapies targeting synovitis may offer a novel approach for reducing disease burden from hand OA. Colchicine is a low cost drug which has long been used in the anti-inflammatory treatment of acute gout. There has been recent renewed interest in this ancient drug, particularly its effects in cardiovascular diseases such as pericarditis. The primary mechanism of action of colchicine is tubulin disruption leading to subsequent down-regulation of multiple inflammatory pathways and modulation of innate immunity. Preliminary studies in knee OA have indicated that colchicine may have a beneficial effect on pain and a larger randomized clinical trial of colchicine in knee OA is currently underway. No studies of colchicine have been undertaken in hand OA. STUDY AIMS Primary hypothesis: Colchicine decreases pain (assessed by 100mm VAS) by 10mm more than identical placebo over 12 weeks in patients with clinical hand OA. STUDY DESIGN Randomised, placebo-controlled double-blind clinical trial. This study will be carried out at The Queen Elizabeth Hospital and Royal Adelaide Hospital.

A cluster-randomised trial was conducted comparing two versions of delivery of the early primary school version of the Exploring Together program; one form had separate child and parent group sessions (Exploring Together-Adapted; ET-Adapted) and the other form included some parent-child group time in the intervention (Exploring Together; ET). The sample analysed consisted of 136 parents and their children (aged 5-10 years) with externalising and/or internalising problems, recruited from government (n = 20) and catholic (n = 4) primary schools from within the south east metropolitan suburbs of Melbourne and Mornington Peninsual region, Victoria. Child outcome measures included parent- and teacher-reported child externalising and internalising problems. Parent outcome measures included parent self-report of positive and negative parenting behaviour, parenting stress, satisfaction and efficacy. All outcomes were assessed post intervention and at 6- and 12-month follow ups. In regard to child outcomes, significant reductions in parent- and teacher-reported child externalising and internalising problems were evident across both treatment groups at post intervention. At the 6- and 12-month follow-ups significant reductions were maintained on parent-reported child externalising and internalising problems only. Change on all child outcome variables did not vary significantly between treatment conditions at any time point. In regard to parent outcomes, significant changes averaged across both treatment groups over time were found for parent-reported negative parenting practices at post intervention (maintained up to 12 month follow-up) and parenting efficacy at post intervention (maintained up to 6-month follow-up). Results showed non-significant changes averaged across both treatment groups over time for parenting stress, positive parenting practices and parenting satisfaction. There was evidence of a significant group (intervention) by time interaction for parenting efficacy at post intervention, with greater improvement for participants in the ET program. There was also evidence of a significant group (intervention) by time interaction for parenting satisfaction at 12-month follow-up, with greater improvements for participants in the ET-Adapted program. Overall, study results did not demonstrate that the inclusion of parent-child interactive groups (ET program) was associated with consistently greater improvements in child behaviour or parenting outcomes relative to the version (ET-Adapted program) that omitted the combined groups.

The project aims to assess whether manual lymphatic drainage (MLD) with non-thermal laser is more effective than MLD alone for reducing pain and swelling in a 43-year old female patient with bilateral lipedema-like symptoms of the legs. The trial is designed as a single-blind, randomised, controlled n-of-1 trial. The trial participant will attend weekly clinic sessions for eight weeks. Weeks 1 and 8 will be assessment sessions. Weeks 2-7 are treatment clinics where the participant will receive either manual lymphatic drainage massage (MLD) plus active laser therapy or MLD plus placebo laser therapy in a randomised sequence. The placebo therapy consists of the laser device without power.

Living a sedentary lifestyle significantly increases the risk of developing cardiovascular disease and having a subsequent cardiovascular event, such as a stroke. People who have had a stroke spend 75% of their waking hours at home sitting down, which is much higher than healthy age-matched individuals without stroke. This sedentary behaviour is damaging for stroke survivors already comprised cardiovascular health, and is likely a significant contributing factor to the recurrent stroke which 30% of survivors have after their initial event. Stroke survivors are very inactive; with very few able to engage in the level of physical activity recommended to improve their cardiovascular health. In people without stroke, breaking up prolonged sitting using regular activity breaks (walking or simple strengthening exercises) significantly improves cardiovascular disease risk factors such as blood pressure and glucose metabolism. Results from our recently completed pilot study indicates that breaking up prolonged sitting time in stroke survivors achieves similar cardiovascular benefits. Breaking up stroke survivor sitting time with simple resistance activities significantly reduced systolic blood pressure (mean 3.6 mmHg reduction). Lowering of blood pressure reduces the risk of hypertension, the leading modifiable risk factor associated with recurrent stroke, and thus has the potential to reduce the risk of recurrent stroke. Therefore, breaking up sitting time is a promising and innovative physical activity alternative to employ with stroke survivors to improve their cardiovascular health and subsequently, reduce recurrent stroke risk. The next important step is to determine the minimum amount and duration of activity breaks (dose) required to improve these cardiovascular risk factors in this population. This study will be the first to determine the optimal dose of simple resistance activities needed to reduce blood pressure and improve glucose metabolism in stroke survivors. Stroke survivors (n = 10 per cohort) living at home who are able to stand and walk will complete a baseline uninterrupted sitting condition followed by 2 dose-escalation conditions. Breaks in sitting will be light-intensity exercise while standing which will increase in 10-min increments each condition. Blood samples will be taken at regular intervals throughout each condition and blood pressure and physical activity will be monitored during and up until 24-hours post-condition. Outcomes of blood pressure (primary), blood glucose, insulin levels (secondary) and safety and feasibility indicators will be collected.