ANZCTR search results

Feeling informed about research seems to correlate with positive attitudes towards researchers and greater trust in researchers. However, many people feel they are not informed enough about ongoing research. 86% of the Australian population seems to be somewhat or very interested in health and medical research suggesting that the population would be rather receptive if we present the information in an acceptable way. Formal peer reviewed publications are lacking in this topic. Recruitment of participants to research projects depends on a reasonable interest for research among the general population. The interest for research among the general population in north Queensland is not yet elucidated. Furthermore, any activity that may increase the general population's interest in health care related research might have a positive influence on recruitment to future research projects. This project aim to estimate: 1) What proportion of patients in an ED waiting room in North Queensland express an interest in knowing about current health and medical research in their surroundings? 2) Do patients express any appreciation of being informed about current health and medical research in the surroundings by an automated information presentation? 3) What is the potential effect on interest in health related research by actively presenting information to the general public using large TV screens?

Chronic Kidney Disease (CKD) is increasingly being recognised as a global public health problem with increasing incidence and prevalence, contributing to significant morbidity and mortality. Dietary intervention is a pivotal aspect of care for people with all stages of CKD and can significantly improve the morbidity and mortality of these patients. However, it is a complex diet that is frequently met with resistance from patients. Improving patient engagement and education regarding diet and lifestyle is vital to improve patient outcomes and reduce the burden on the healthcare system. Using mobile phone technology, such as text messaging, offers a novel way of engaging with patients on dialysis. This randomised controlled trial aims to determine the feasibility and clinical impact of using text messages to improve nutrition-related behaviours in the haemodialysis population. The primary aim of this study is to assess of the feasibility of using a mobile phone text message intervention to improve dietary adherence in a haemodialysis population.

This project will involve a FMS program that will be implemented at the UNSW Early Years Childcare Centres. PLAYFUN will be a cluster randomised controlled trial in preschool aged children to be conducted over a 12-week period with fundamental motor skill testing to be completed at the beginning and end of the 12 weeks, with follow-up testing to be completed 12-weeks after the program has finished. If the program is shown to be beneficial, children in the control group will be offered the exercise program free of charge at the end of the study. Therefore, initially the control groups will be allocated as wait list for the program. The primary outcome measure will be FMS measured using the Test of Gross Motor Development 2 (TGMD-2). Secondary outcome measures include both perceived and actual physical activity (PA) levels and anthropometric data (BMI).

Retrospective descriptive analysis of the safety of maternal vaccination utilising 4 datasets: ‘FluMum’, ‘PneuMum’, ‘1+1HS’ and a population based de-identified NT birth cohort. Combined datasets ~85,000 mother-infant pairs, of which ~30% identify as Aboriginal and/or Torres Strait Islander. There is no active participant recruitment, no blood tests or specimen collections and no direct contact with any participants. Results will be presented as large aggregate data with no potential for identifying information. Results will contribute novel information on adverse maternal and infant perinatal outcomes over a 21 year period (1994-2015) .We will calculate ‘Observed-to-Expected’ ratios to describe the risk of an adverse outcome occurring following maternal vaccination in pregnancy with influenza, pertussis or pneumococcal vaccines.

Background: Endoscopic ultrasound fine needle aspiration (EUS FNA) allows cytologic and/or histologic diagnosis of lesions within or adjacent to the gastrointestinal tract (GIT). Several studies have shown this approach to be cost-effective and safe with complication rates less than 2%. EUS FNA also carries a high-diagnostic yield with accuracy ranging from approximately 80-95%. Currently there are multiple different needle types, including the recent development of fine needle biopsy (FNB) needles, which aim to increase the amount of tissue acquired. Studies comparing needles have mainly focused on diagnostic yield as well as complication rates. However any differences, if found, have frequently been non-significant. The quantity of diagnostic tissue obtained is becoming increasingly important in the work up of cancer patients, where personalised therapy is a goal. Treatment can now be influenced not only by histological subtype, but also based on the presence of molecular markers. In order to sub classify tumours further, adequate tissue samples are needed for both diagnosis and molecular testing. Therefore, when comparing different needle types or sizes, studies should also look at the amount of tissue obtained. The Echo Tip ProCore is a FNB device with a side-bevel designed to obtain histological cores of tissue. It is well-established, has been extensively studied and shown to be safe and highly accurate. The 19G EZ Shot 3 Plus needle is a newer needle that is also designed to obtain a histological core, with the addition of the flexibility one would expect from a smaller gauge needle. It has been approved by the Australian Register of Therapeutic Goods. Hypothesis: The 19G EZ shot 3 Plus needle will obtain equal diagnostic tissue quantity to the ProCore needle in solid pancreatic lesions. Aim: To compare the diagnostic accuracy and obtained tissue quantity of 19G EZ shot 3 Plus needle versus the ProCore needle in the investigation of solid pancreatic masses. Design: This is a non-inferior paired, prospective, single-centre study involving patients undergoing EUS evaluation of solid pancreatic masses. It will involve 66 patients who will each have a single pass using the EZ shot 3 Plus and ProCore needles (2 passes total).

Temper outbursts are a leading cause of morbidity for individuals with Prader-Willi syndrome (PWS). Despite this, there is currently no known treatment. Meditation on the Soles of the Feet (SoF) is a mindfulness-based intervention designed to help individuals with intellectual disability (ID) regulate their emotions during times of distress. Three single-case experimental studies suggest SoF can reduce physical and verbal aggression in adolescents with PWS. The present study aims to evaluate the feasibility and acceptability of the SoF intervention and data collection. Information collected in this study will be used to direct a wait-list randomised controlled trial.

Description of the study: This project entitled ‘Group psychological intervention for people with depression and overweight/obesity’ is a trial of a newly developed group intervention program for people with both depression and overweight concerns. Purpose of the study: The project aims to evaluate the effectiveness of a new group protocol which has been developed specifically to target overweight concerns in people who are experiencing depression. The majority of current approaches for weight loss and weight management focus primarily on dieting and exercise, and while programs for depression often touch on these issues they are generally not the primary focus. Thus the newly developed program targets both problems simultaneously. The main aims are to find out if this will: - Reduce depression - Increase exercise and healthy eating habits - Decrease unhealthy eating habits (such as emotional eating) - Improve stress management - Improve body image and self-confidence - Result in healthy weight loss To be clear, weight loss is not the sole or primary aim of this group program (but is likely to be a secondary outcome). What will I be asked to do? We invite you to participate in a trial of this new program. Participation involves attending ten weekly two-hour group sessions. Participation is voluntary and you may withdraw at any time. Groups will include between eight and twelve participants (ten being optimal), and will be facilitated by two mental health professionals. Sessions have been designed to be highly interactive – they will involve some teaching style presentations, but will mostly be made up of discussions, group exercises, and skills practice. In addition to work conducted in session, participants are expected to practice skills out of session also, to assist with learning and development (for example, monitoring thoughts and emotions, practising relaxation, setting and carrying out goals). Participation in this trial also involves attending several appointments with one of the researchers outside of the program itself for the purpose of assessment and evaluation. The initial appointment held before starting the program will involve a brief face-to-face interview and completion of a number of questionnaires – this appointment is expected to take between 1 and 1.5 hours. The interview component focusses on your level of current depression; the written questionnaires assess other relevant information such as your current activity and eating habits, health beliefs, sleep, self-esteem and body image. This appointment will be repeated at the end of the program, as well as well as at three and twelve months post-program, to help us determine if the new protocol is helpful. We understand that participation in this program involves considerable time commitment on your part. What benefit will I gain from being involved in this study? Our expectation is that by completing this program you are likely to learn new skills and strategies to improve

A large proportion of ED presentations and hospital admissions are preventable as they result from poor self-management skills and subsequently poor judgement of the severity of the manifesting symptoms. Furthermore, some admissions are due to other non-COPD related factors such as loneliness or misattribution of symptoms belonging to other diseases (e.g. anxiety or depression). A pre-triage conducted by trained health professionals who are experienced in detecting the severity of COPD exacerbations has the potential to reduce the number of unnecessary ED presentations. Current best practice management of an exacerbation or flare-up of COPD symptoms is with the use of a written COPD Action Plan and Emergency Pack of medications for early recognition and treatment of symptoms, however evidence demonstrates a minimal reduction in healthcare utilisation or health-related quality of life (Walters, Turnock et al. 2010). An action plan with ongoing support by a case-manager may decrease the impact of exacerbations in health status (Trappenburg, Monninkhof et al. 2011). Therefore this will be a randomised controlled feasibilty trial with the proposed intervention being the addition of 24-hour exacerbation support using existing specialised RNS during business hours and after-hours with SAAS ECP’s. Trained health professionals will assess the patient’s disease status to determine if the patient could be managed at home or requires presentation to a hospital emergency department. Outcomes will review the feasibilty of the study design, hospital utilisation, cost-effectiveness and outcomes of patient self-assessment questionnaires and a semi-structured interview.

This will be a multicentre multisurgeon prospective doubleblinded randomized and controlled trial looking at the effectiveness of single dose intravenous administration of Tranexamic Acid (TXA) in patients undergoing shoulder arthroscopy and rotator cuff repair. The aim of this study is to extend Level I category evidence of the known benefits of TXA to shoulder arthroscopy and rotator cuff repair. The primary objective of this study is to test the hypothesis that systemic use of tranexamic acid decreases postoperative pain and stiffness. All consecutive patients presenting to an elective orthopaedic consultation indicated for shoulder arthroscopy and rotator cuff repair will be considered eligible for this study. After having been screened for inclusion and exclusion criteria, read the information sheet and signed the consent form, patients will be blindly randomized to one of 2 groups: Systemic TXA or Control. Patients’ general demographic characteristics such as age, sex, dominance, diagnosis and other relevant comorbidities will be collected in a deidentified database locked on a password-protected computer. During the surgery, patients will be administered either 2000mg of intravenous TXA or a placebo equivalent (saline solution). Analysed outcome variables will include: occurrence of postoperative haematoma, postoperative pain Visual Analog Scale (pVAS), range of motion at 8 weeks and 24 weeks.

This study aims to determine if a tailored multi-component non-pharmacological delirium prevention intervention is feasible and acceptable for people with advanced cancer in hospital. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have a diagnosis of advanced cancer, and are an inpatient at a participating Australian oncology or palliative care unit. Study details All participants in this study will undergo routine delirium screening and diagnostic assessment. In addition, patients being treated at sites allocated to the intervention will receive a multi-component delirium prevention intervention that includes six domains: preserve natural sleep, maintain optimal vision and hearing, optimise hydration, promote communication, orientation and cognition, optimise mobility and function, and family partnership. Intervention delivery will be tailored to the site, and strategies will be tailored to patient need. Patient, family caregivers, staff and volunteer perspectives about the feasibility and acceptability of the intervention will be obtained using interviews and surveys. The primary outcome is adherence to the intervention, defined as the proportion of patients who achieve at least four completed domains for least five of the first seven days of admission, measured by medical record audit. Secondary outcomes relate to fidelity and feasibility, acceptability and sustainability of the study intervention, processes and measures in this patient population, using quantitative and qualitative measures. The study will inform whether a multi-component non-pharmacological delirium prevention intervention in people with advanced cancer is feasible for testing in a subsequent phase 3 trial.