ANZCTR search results

The scientific literature shows that there is an increased risk of developing AF in patients implanted with a pacemaker due to sinus node dysfunction. To overcome this, advance algorithms were developed to reduce the AF burden. The purpose of this study is to evaluate whether the specific pacemaker algorithms in question contribute to the suppression of AF. It is expected that the finding of this research will aid in the development of best practice guidelines for patients with pacemaker devices.

This study will measure the efficacy of valproic acid (VPA), a well established anti-seizure medication with known histone deacetylase (HDAC) inhibitor activity capable of restricting proliferation and inducing differentiation and apoptosis in cancer cells in patients with brain tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with high grade glioblastoma and are having surgical therapy. Study details All participants will undergo their standard treatment of resection/ radiation therapy and chemotherapy with temozolomide as usual. Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive valproate in the standard dose used for epilepsy as well as standard care which includes chemotherapy and radiation therapy and surgery as usual. Whilst participants in the other group will receive usual care which includes chemotherapy and radiotherapy and surgery as usual. Participants will undergo diagnostic imaging using 3,4-dihydroxy-6-[18F]-fluoro-L-phenylalanine (FDOPA) PET post surgery and 4 weeks after radiation/chemotherapy has finished, which is the same time as the end of the valproate treatment. Changes on the PET scan which measures activity of the tumour will be measured. Effects of valproate on brain cancer biology will be measured by examining the brain tissue and by measuring cancer markers in the blood.

The primary purpose of the study is to develop and evaluate the effectiveness of a mindfulness app for weight loss and changing weight related behaviors (diet/physical activity) in college students. This research will aim to determine if a mindfulness app is feasible, acceptable, and effective for weight loss and weight related behaviors than a standard control group receiving an information leaflet on diet/physical activity. The research will also aim to determine if the intervention reduces stress as a secondary outcome of interest. It is anticipated that the mindfulness app intervention will be more effective for improving these outcomes than the control.

Patients with peripheral vascular disease are a nutritionally vulnerable group of patients and current management strategies for addressing nutritional health are sub-optimal. The importance of good nutritional health in achieving optimal clinical outcomes is well established. This project will therefore implement an established student-led model of nutritional care to manage the unique nutritional requirements of patients with peripheral vascular disease. Our evaluation of this model of care in other patient groups has demonstrated improved satisfaction and outcomes from a student, clinician and patient perspective. Transferring this model of care to those with peripheral vascular disease has the potential to have similar outcomes and we have designed this project to specifically identify improvements in cardiovascular health. The primary aim of this pilot RCT is to determine the feasibility of implementing a 12 week student-led nutrition service, for adults with PVD attending the Southern Adelaide Local Health Network (SALHN) Vascular Surgery Claudication Clinic and observe any clinically and statistically significant improvements in the cardiovascular health and quality of life of participants who receive individualised nutritional advice compared to usual care. 1. Study design: This intervention will be a Randomised Controlled Trial, where participants will be allocated to either an intervention (n=20) or control group (n=20). Participants in the control group will receive usual care, where patients typically receive general nutrition advice from Vascular Surgery Consultant or Registrar and the option of attending a 30 minute group seminar by a Dietitian. The study will be of 12 weeks duration.

The aim of this study is to determine if daily treatment with an oral preparation containing a multi-strain synbiotic is effective in reducing severity of atopic dermatitis (AD) in food allergic children. A synbiotic is a combination of a probiotic and a prebiotic. Probiotics are living microorganisms that, when ingested in adequate amounts, can modulate gut microbiota. Prebiotics are indigestible oligosaccharides that give beneficial bacterial strains a selective advantage to thrive. When pre- and probiotics are given in the same preparation they have a synergistic effect, hence the name synbiotic. Studies using pre- and probiotics to prevent or treat AD have shown inconsistent results over the last 20 years. A recent meta-analysis of randomised controlled trials has concluded that synbiotics do have a role in the treatment of AD especially multi-strain synbiotics. (Chang et al, 2016) Infants and children 6 – 36 months who have attended allergy clinic at the Lady Cilento Children’s Hospital (LCCH) with moderate-to-severe atopic dermatitis and at least one food allergy will be eligible for the the SynAD study. Once recruited, families will attend 3 appointments - week 0, 6 and 12 at the Center for Children's Health Research (CCHR) where dietary, growth and skin assessment will occur. Questionnaires assessing food intake and quality of life will be collected at weeks 0 and 12. Stool samples will be collected for analysis for gut microbiota assessment at Weeks 0 and 12. There will be no change to standard care provided at LCCH. Patients will be randomised into either of two groups: an intervention and a placebo group. All study participants and investigators will be blinded to which intervention each patient is receiving until the end of the study. Families will be provided the intervention (either placebo or multi-strain synbiotic) with instructions on how to administer each day to their infant or child during appointments in week 0 and week 6. The aim of the study is to see a greater improvement in AD in the intervention compared to placebo group. Improvement in symptoms of AD will be measured by assessing severity of AD and the impact of AD on quality of life using two validated tools: *Scoring of Atopic Dermatitis (SCORAD) and *The Infant’s Dermatology Quality of Life Questionnaire (IDQOL) Chang, Y.S., M.K. Trivedi, and A. Jha, Synbiotics for prevention and treatment of atopic dermatitis - a meta-analysis of randomised clinical trials. JAMA Pediatr, 2016. 170(3): p. 236-242

The purpose of the study is to determine if using a standardized method of RTUI improves reliability of measuring the thickness and activation of a muscle in the abdomen (transverse abdominis). The standardized method uses a device that controls for the force and orientation of the US probe. Reliability will be compared in an experienced an an inexperienced examiner. Currently, the reliability of this measure is based mainly on poor quality studies and much of the research does not look at muscle activation. Dysfunction of this muscle has been observed in patients with low back pain, thus their ability to activate is clinically relevant. It is hypothesized that both inter- and intra-rater reliability will be significantly increased when force and orientation of the probe is controlled. Secondly, it is hypothesized that a significantly greater increase in intra-rater reliability will be observed with an inexperienced clinician using this device.

Background: Clinical placements are a critical component of the training for professional health workers such as occupational therapists. However, with increasing student enrolments and workload pressures on practitioners, it is becoming increasingly difficult to find sufficient suitable placements for all students to satisfy the mandatory 1000 hours of professional practise. The professional accreditation body for occupational therapy in Australia now allows up to 200 of the 1000 professional practice hours to be completed via simulation-based learning activities. The aim of this study is to provide evidence about the use of a simulated clinical placement (SCP) as a partial substitution for a traditional clinical placement (TCP). Objective: This project will evaluate whether ‘early years’ students from entry-level Occupational Therapy programs in Australia can obtain non-inferior professional competency outcomes at ‘acceptable’ costs through a 40 hour (1 week) Simulated Clinical Placement (SCP), when compared to similar students who attend an equal-length Traditional Clinical Placement (TCP). Early years students are defined as those in the first or second year of a four-year undergraduate degree program or first year of a two-year graduate-entry program. Methods: The aim will be met through the conduct a pragmatic, non-inferiority, single-blind, multicentre, two-group randomised controlled trial with nested economic appraisal. We study will evaluate students’ professional occupational therapy competencies and perceptions of their placement experience after completing a SCP and compare these to the same outcomes for students who attend a TCP. It is hypothesised that students attending SCP will achieve non-inferior outcomes when compared to outcomes of students who attend a TCP. Secondary outcomes will include measurement of clinical supervisors’ and educators’ perceptions of the simulated experience, as well as a cost analysis and economic analysis of the delivery of SCPs and TCPs.

1) The primary outcome is to assess the immediate benefits (patient outcomes, health care utilisation costs, program uptake, adherence, and compliance) and longer term benefits (readmission rates, length of hospital stay and time to return to work) of implementing an innovative exercise model (HITT) in cardiac rehabilitation patients compared to current practice. The hypothesis that HITT participants will achieve superior functional capacity changes and strength in 40 mins compared with 60 mins for the control group will be assessed. The hypothesis that it can be completed in less time and be more financially viable will also be assessed. This could lead to a change in rehabilitative exercise practice and positively impact costs associated with this high healthcare burden, whilst improving health service delivery and ultimately patient outcomes. 2) Secondary outcomes are to assess if HIIT using a 2x4 min dosage produces change in Vo2 peak comparable to previous RCTs within the literature.

Obesity and stress are two of the most pressing health concerns facing the modern world today and it is increasingly evident they are related. Stress-induced eating is characterised by the preferential consumption of energy dense snack foods. The physiological mechanisms underlying this behaviour are mediated by both stress and appetite hormones, largely dictated by the body’s desire for pleasure. Given that relaxation is the physiological and psychological opposite of stress, this raises the question of whether relaxation strategies can reduce stress-induced eating. We aim to determine the effect of an 8-week guided relaxation intervention (supplemented by a daily home practice) on stress-induced eating, feelings of appetite (hunger and fullness), the circulating levels of appetite-related hormones, perceived stress and psychological well-being. Identification of a therapeutic effect of relaxation will provide a novel, yet simple and cost effective, patient-centred tool that can be easily implemented to add to the existing strategies aimed at the prevention and management of obesity.

Modern medical care can provide many medications for problems, whether simply short-term medications like antibiotics or longer-term medications like those used to treat high blood pressure. But we do not know enough about ceasing medications, especially in elderly patients. We know that often medications are ceased while a patient is hospitalised; sometimes medications are not ceased. We want to collect data about those patients who had medications stopped and those who did not, and compare the two groups later to look for any differences. Many elderly people complain about being on too many medications. People on lots of medications might wonder what would happen if one or more of their regular medications was ceased. Our purpose is to understand better any benefits for older people to be on fewer regular medications and any unforeseen risks of stopping regular medications in older people. Hospital doctors often cease a regular medication. We will not influence when and how that happens for your loved one, only observe whether or not it does happen, and call you after discharge to find out how he or she is feeling. What does participation in this research involve? Nothing about their hospital care will be different. The patient will be treated just like any other patient. Sometimes a patient is hospitalised as a result of a side effect of a medication which is then stopped. Sometimes a patient is admitted to hospital for a different reason but a medicine needs to be stopped in hospital. And sometimes no medications need to be stopped. These measures are all part of routine hospital care. We simply want to check on your loved one after his or her hospital stay to see how he or she is feeling. What are the possible benefits of taking part? After discharge, the patient will be given extra attention in the form of a follow-up phone call, either to you, the patient, or the patient’s General Practitioner. If, during this phone call, it becomes evident that the patient needs urgent or semi-urgent attention, the re-search assistant will immediately contact the Chief Investigator, who will then contact either the Residential Care Facility where the patient lives, the next of kin (or person responsible), or the General Practitioner to develop a plan to address the patient’s needs. What are the possible risks and disadvantages of taking part? The only burden to you might be a follow-up phone call. If, during this phone call, you seem anxious or distress because of the questions, the interview will be stopped.