ANZCTR search results

The primary purpose of this study is to determine whether offering a screening blood test to people who do not participate with standard faecal-based testing method can increase overall bowel cancer screening participation compared to a program that only offers a faecal occult blood test (FOBT). Who is it for? Participants for this study will be randomly selected from the South Australian electoral roll, all between 50 and 74 years of age, who have not had an FOBT or colonoscopy carried out in the last 12 months. Study details: All participants will be mailed an offer for FOBT, with a reminder letter sent 6 weeks later to non-participants. For those who will not or can not complete the FOBT, they will be randomly allocated (by chance) to receive an immediate offer of screening with a new blood test, or after 12 weeks will receive either another offer for screening with FOBT, or an offer to screen with the blood test. Additional reminder letters will be sent another 6 weeks later to non-participants. A second round of screening offers will be provided in Round 2 of the study 24 months after initial invitation. For the participants who completed either the blood test or FOBT in the first round of the study, they will be offered the same test again to assess adherence to screening. For those who did not complete any test in the first round of the study, they will be randomly allocated (by chance) an offer to screen with the blood test, the FOBT, or have a choice of the tests. Reminder letters will be sent after 6 weeks to people who have not completed a test. Rates of participation with the different tests will be determined 12 weeks after the screening offer. It is hoped that the findings of this trial will aid understanding of whether a screening test for bowel cancer by blood test rather than faecal testing methods shows greater participation rates as well as adherence to ongoing screening, and thus whether this alternative method shows potential for reducing mortality from bowel cancer in the long term.

The trial is the third phase of a complex intervention that by definition, involves large variability in a target population and is a placed-based initiative for highly vulnerable families. Our research is informed by a needs assessment (Phase 1) and feasibility study (Phase 2). We will assess the impact of child nutrition and active play advice delivered in community-based early childhood settings to vulnerable families. We will train Supported Playgroup facilitators and bicultural workers to will deliver six key messages (chosen from 10) about child health and development issues. Building on established relationships between facilitators, bicultural workers and their families, the program is delivered by facilitators in their existing Supported Playgroups using place-based resources, during one school term. We previously found that children attending Supported Playgroups were over-represented among those consuming sweet drinks and ‘packaged’ foods, and viewing excessive hours of television. Parents reported concerns about the safety of their children during active play and some powerlessness in providing healthy food. Supported Playgroup parents also described greater difficulties accessing, understanding, and using health information than other families in the same locations of social disadvantage. Our subsequent feasibility study co-designed by stakeholders demonstrated effective communication about key messages in child nutrition and active play by Supported Playgroup facilitators. More specifically, it resulted in improved knowledge and confidence of SP facilitators and parents, and changes in parenting behaviours. Although key messages in child nutrition and active play have been successfully used in early childhood interventions in Australia, culturally and linguistically diverse and significantly disadvantaged families have not participated. Innovation in effective delivery of child nutrition and active play messages is urgently required for high needs families. Research questions Can early childhood settings be used as a platform to convey key child health and developmental messages to parents of young children living with significant social and economic disadvantage? Can Supported Playgroup facilitators effectively communicate key messages about child nutrition and active play? How can the evidence-based knowledge be best disseminated for specific family and playgroup contexts? What knowledge will families recall away from Supported Playgroups and will it translate into child-health practices and better connections to existing services? To this end, the general hypothesis is that when well-considered and sensitively delivered messages about child nutrition and active play are embedded into Supported Playgroups, parental knowledge will increase and child-health practices will improve. This experience will also increase the social connectedness and ultimately the self-efficacy in parenting of highly disadvantaged parents. Specific Hypotheses 1. That increased parental knowledge and self-efficacy about child nutrition and active play will promote improved child health-related behaviours. 2. That Supported Playgroups are an effective place-based setting to convey child health and development information to vulnerable families. Aim Our overall research goal is to address health and social inequalities among vulnerable families with young children. Specifically this project aims to 1. Improve child nutrition and active play-related behaviours in vulnerable families. 2. Advance knowledge about effective strategies for achieving translation of the research findings into policy in early childhood settings. The trial has not been previously registered. Relevant citations arising from Phase 1 are: Myers, J., K. Gibbons, G. Naughton, et al. (2015). "Early childhood nutrition, active outdoor play and sources of information for families living in highly socially disadvantaged locations." Journal of Paediatrics and Child Health 51(3): 287-293. Myers, J., S. Thorpe, et al. (2014). "Early childhood nutrition concerns, resources and services for Aboriginal families in Victoria." Australian and New Zealand Journal of Public Health 38(4): 370-376.

In Australia 33,000 open-heart surgery operations are performed annually via an incision at the breast bone. Chest pain and non-union of the breast bone have been reported as complications following cardiac surgery. This is significant as if patients have pain that persists beyond 6 weeks it is more likely to continue as chronic sternal pain thus highlighting the importance of optimal pain management in the initial post-operative period. Following surgery patients are encouraged to observe sternal precautions that restrict the use of their arms and trunk to prevent these complications. These precautions are applied across Australia and worldwide practice without evidence to support them. Sternal precautions may be overly restrictive and not necessary for all patients as they may delay recovery by impacting on function. Upper limb movements have been shown to reduce post-operative pain and improve function. The aim of this project is to examine whether modified precautions that allow the use of the upper limbs and trunk within safe limits will facilitate recovery and function following cardiac surgery via a median sternotomy.

Atrial fibrillation (AF) is the most common heart rhythm disorder and develops in 20-25% of people over their lifetime. The initial treatment has been medication therapy, however in the past decade, a catheter ablation procedure called pulmonary vein isolation has become increasingly widely practiced and is more effective than medical therapy at treating AF. This is performed by introducing catheters via the groin veins to the heart. There are two methods available in Australia for performing this procedure which aims to electrically isolate the pulmonary veins from the rest of the left atrium to which they connect in the heart as these usually contain abnormal foci that trigger the initiation of AF. The first of the two methods utilises radiofrequency ablation to create burns to the inside of the left atrium to encircle the pulmonary veins and the back wall of the left atrium. From a recent randomised clinical trial, we have found that the use of a large single ring was better than the conventional two separate rings in preventing the recurrence of AF. The second method uses more recent technology and involves a cryoballoon catheter that freezes the tissues around the pulmonary veins to achieve the same effect. Recent studies of this technique has shown it to be a safe and effective means of performing pulmonary vein isolation. It is not known which of the two procedures is more effective. We aim in the present randomised controlled clinical trial to investigate the relative efficacy and safety of the two procedures.

The aim of this study is to examine whether patients who are waiting on a surgical waitlist for Total Knee Replacement, can decrease pain by participating in regular supervised exercise, together with targeted manual therapy. HYPOTHESIS: Patients with severe OA of the knee who participate in a Physiotherapy intervention programme will experience a reduction in knee pain.

This international multicentre prospective observational study, performed at the Royal Women’s Hospital, Melbourne, Australia, and Chelsea & Westminster Hospital, London, UK, and Mowbray Maternity Hospital, Cape Town, South Africa aims to determine the reference range for an exercise test, the six minute walk test, in healthy pregnant women and non-pregnant women of childbearing age. This test is commonly used in non-pregnant adults to determine cardiovascular fitness and as a prognostic test in adults with chronic medical conditions. Its utility has not been investigated in pregnant women. It is hoped that this study will provide the baseline data for further studies investigating the usefulness of this test in pregnant women and non-pregnant women of childbearing age. Specifically, the use of this test to predict women who will develop new onset hypertension in pregnancy, the use of this test as part of a pre-pregnancy exercise intervention program to reduce the likelihood of developing new onset hypertension in pregnancy, and the use of the test to quantify symptoms of fatigue and breathlessness in pregnancy. As part of this study 30 pregnant women in second trimester will undergoing three additional test - the incremental shuttle walk test, cardiopulmonary exercise testing and transthoracic echocardiography. The reason to do this is to determine the relationship between submaximal exercise testing with exercise tests (The Six Minute Walk Test - an unpaced test, and the Incremental Shuttle Walk Test - a paced test) and cardiac function with echocardiography and direct measurement of maximal oxygen utilisation capacity with the cardiopulmonary exercise testing.

This study will compare the effect of two different indwelling pleural catheter (IPC) drainage strategies on breathlessness and quality of life in patients with a malignant pleural effusion (MPE). Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with a symptomatic malignant pleural effusion (MPE) for which drainage is considered appropriate by the managing clinician. Study details All participants in this study will be eligible if they need to have an indwelling Pleural Catheter (IPC) inserted for the management of their malignant pleural effusion. IPC allow fewer invasive procedures and reduced hospitalizations than conventional talc pleurodesis. Participants will then be randomly allocated (by chance) to one of two groups. Participants in one group will be asked to drain their effusions every day for the first 60 days (unless certain criteria are met). For participants in the other group, drainage will only be performed if the patient feels that the effusion-related symptoms (usually breathlessness, cough and/or tightness) have recurred. All participants will be asked to complete regular questionnaires for up to 1 year in order to rate their level of breathlessness and quality of life. Other clinical outcomes, any adverse events, and health care utilisation will also be monitored throughout the study. We hope to determine which regime is superior in improving clinical outcomes so that management of cancer patients with an MPE can be optimised.

This research will evaluate a new parenting program, Tuning in to Toddlers (TOTS), an intervention with goals to prevent the onset of social, emotional and behavioural difficulties in young children. TOTS aims to improve parents’ emotional responsiveness and emotion regulation in order to assist their child to begin to understand and regulate their emotional reactions and to reduce stress for parent and child. There are few available evidence based programs for parents of toddlers and none have taken an emotion-focused approach despite early childhood being a time of intense emotions for parents and a critical time in toddler’s emotional development. TOTS will focus on and promote emotional competencies, strengthening the parent-child relationship that will reduce the likelihood of child emotional or behavioural problems during these early years. The study will recruit 290 parents of a 2-3 year old child through maternal and child health centres, Playgroups Victoria and childcare services in Melbourne. Participants will be randomised to either TOTS or a wait-list control group. TOTS participants will attend a 6-session parenting program while wait-list participants will be offered the program after a 15-month waiting period (unless they require clinical intervention). Participants will complete measures at baseline, immediately post- intervention (intervention participants only) and at 15-month follow-up. To assess the efficacy of TOTS we will use well validated measures including questionnaires about parenting and children’s functioning; a parent-toddler observation task measuring parental emotion coaching, parental emotional responsiveness and toddler emotion regulation; and hair samples to assess parent and toddler stress levels. TOTS is a manualised intervention and measures will be used to determine program acceptability and fidelity. Statistical analyses will compare participants in the two groups at follow-up. Outcomes will be reported in peer-reviewed journals, at conferences and in a facilitator manual of TOTS that will enable program dissemination.

The present study will implement a treatment of gambling problems through use of an online cognitive behavioural therapy (CBT) program. Participants will have access to this internet-based self-directed intervention for a duration of six weeks. The online intervention will allow participants to explore their gambling behaviour and develop ways to change or stop it completely. The current study aims to evaluate the clinical outcomes for problem gamblers completing a self-directed online CBT-based program, one with and one without the addition of a one-off telephone call with a clinician using a motivational interviewing. intervention.

Negative sensitivity is one of the most significant source of error in regards to the tetrapolar method used most commonly in bio-impedance (Grimnes & Martinsem 2006). The tetrapolar method consists of a pair of current carrying electrodes which sends tiny electrical current into a localised area. This current is then detected via another pair of electrodes, which help map out the resistance levels in the area. Numerous studies have been conducted making use of this method to help understand the underlying material composition of the area, without the need for time consuming imagery and surgeries (Oh & Sadleir 2005 and Moretti et al. 2011). Unfortunately a common error which occurs in this method, is the occurrence of negative sensitivity, which acts an opposing force and distorts measurements made with the tetrapolar method. In particular, impedance measurements made around the fingers and wrist area, which has the highest concentration of resistivity in the body (Foster & Lukaski 1996 and Gislason et al. 2010). Moreover, the use of FEM modelling and experimental data to help examine impedance readings have been well documented as a feasible method with good results for understanding the effects of errors in the execution of the tetrapolar method (Jafarppor et. al. 2011). While there are many causes where this error has affected measurements, there has yet to be any definitive research into negative sensitivity itself. Thus we hope to fill in the gaps left in the literature and conduct a pilot study into the origins and circumstances of negative sensitivity, rather than leaving it as an excuse for future error.