ANZCTR search results

Poor diet is a leading risk factor in global preventable morbidity. It can lead to high blood pressure, high blood cholesterol, obesity and metabolic outcomes, which in turn are associated with a range of chronic illnesses such as coronary heart disease, hypertension, type 2 diabetes and some forms of cancer. One public health intervention aimed at promoting the consumption of a balanced diet that has been widely adopted across the world is the provision of nutrition information on packaged foods. Nutrition information can appear on food in a variety of formats (such as the Nutrition Information Panel, front-of-pack labels and health claims). Although these sources of information often occur together on food packs, most previous studies have focused on the isolated effects of individual forms of nutrition information and either do not include or do not measure the impact of more than one source of nutrition information. An understanding of how consumers process this high volume of information on food packs or how they reconcile contradictory nutrition information is currently lacking. The primary aim of this study is to investigate how nutrition information format, healthiness and price interact to affect the perceived healthiness of a product, consumer purchase intentions and the amount of the product considered desirable/appropriate to eat.

Low back pain (LBP) is one of the most common reasons for people to seek health care. Of those that report LBP, 44-78% experience a re-occurrence within 12 months, and approximately 25% of individuals develop chronic pain. Despite high prevalence, current treatments for chronic LBP demonstrate at best, small effect sizes. One avenue to improve outcomes in chronic LBP is through the application of combined treatments with synergistic clinical and mechanistic effects. Sensorimotor retraining is a novel treatment that incorporates motor control exercise and lumbar tactile retraining and has been shown to be effective in early randomized controlled trials and case studies of chronic LBP. The mechanism underpinning improvements in pain and function with sensorimotor retraining is thought to involve normalization of motor and sensory cortical plasticity and improved pain system function. The addition of a second treatment that targets similar mechanisms may boost the effectiveness of sensorimotor retraining in people with chronic LBP. Transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation, is thought to promote cortical plasticity and improve pain system function through direct effects on the cortex and thalamus, as well as “downstream” effects on the anterior cingulate cortex and upper brainstem. Studies of healthy individuals and people with some forms of chronic pain suggest that anodal tDCS applied to the primary motor cortex can reduce pain. In addition, the cortical effects of tDCS are hypothesised to increase the brain’s receptiveness to other treatments, a phenomenon known as priming. Thus, tDCS may optimise the responsiveness of the brain to sensorimotor retraining and improve outcomes beyond that which can be achieved with sensorimotor retraining alone. Despite this, no study has examined the effect of a combined tDCS and sensorimotor retraining therapy in chronic pain. This pilot RCT protocol will outline study methods, and resources required in order to determine the feasibility, acceptability and safety of tDCS combined with sensorimotor retraining for people with chronic LBP. The specific aims are to i) determine the feasibility, safety, perceived patient response to, and acceptability of, a combined tDCS and sensorimotor training intervention in chronic LBP and ii) provide data to support a sample size calculation for a fully powered trial should trends of effectiveness be present.

This study is trialing the Teachback method to improve service delivery and health communication for the government funded telephone parenting service (Pregnancy, Birth & Baby Helpline, Healthdirect Australia). The primary outcome is assessing the effectiveness of Teachback compared with the usual care delivered through the PBB Helpline on a range of topics, testing chiefly if knowledge, understanding and satisfaction has increased by the Teachback intervention. This is a stepped wedge cluster randomised trial in which all nurses will be invited to participate in the study and will cross over to the intervention according to a training schedule. Both nurses and callers to the PBB Helpline are participants and Teachback will be evaluated by both interviewing callers and feedback from the nurses. Callers to the PBB Helpline will be interviewed one week after their initial call by an independent organisation. Nurses will be asked to reflect on their communication during their calls by completing a short survey throughout their shift. Nurses will also be invited to provide further feedback about the study through qualitative interviews/focus groups.

The study is a randomised controlled trial of an app for cannabis users wishing to reduce/quit their use of cannabis. Specifically, the study involves a randomised controlled trial of three app versions to determine the effectiveness of the app, and its various active components, in helping cannabis users reduce their use.

This study aims to evaluate the effects of an individually-tailored online parenting program on parenting behaviours associated with childhood depression and anxiety disorders, and in turn child anxiety and depressive symptoms. The program is designed to provide parents with (1) personalised feedback about their current parenting, including what they are doing well and areas that they can improve in order to reduce their child' risk of depression and anxiety, and (2) specific modules of the mobile-compatible online parenting intervention, recommended based on their survey responses, to support them in making changes to identified areas for improvement in their parenting.

Heart failure is a condition where the heart’s pumping cycle does not function as it should. There are two types of heart failure, with about half of patients with the condition falling into each group. One where the pump/contraction function of the heart is reduced. That is called systolic heart failure. In the other type, the heart does not fully relax, so it does not fill properly with blood. This is called diastolic heart failure or “heart failure with normal pump function”. The official medical term is “heart failure with preserved ejection fraction”, and is abbreviated as HFPEF. At the moment, there are no established medical therapies for HFPEF. Our research has shown that people with HFPEF develop breathlessness very quickly during physical activity because the heart muscle cannot relax normally. In this study we want to test the effect of a medicine, CRD-102, on the pressure in the heart during exercise in HFPEF patients. The use of CRD-102 tablets in this study is considered experimental. CRD-102 tablets have not been approved for marketing by the Therapeutics Goods Administration (TGA) in Australia. Because of its actions on the heart we hope that it may be helpful in patients with diastolic heart failure.

Medical scribes are clerical assistants to doctors. ED docs currently spend 48% of their time on clerical data entry into computers. Scribes undertake secretarial/clerical data entry tasks in Emergency departments to enable the doctor to leave their desk and get back to the bedside to treat more patients in a safe, cost-effective way. There is economic equipoise about whether the scribe role should be introduced to Australia. Work to date has been undertaken at Cabrini ED and shows promise. There is a need for a mulit-centre public ED evaluation of the role. There is no equivalent study anywhere in the world. We are undertaking a multi-centre randomised controlled trial of scribes, using Australian scribes we have trained at Cabrini this year in a research capacity. Cabrini is auspicing the study and the principle investigator is Dr Katie Walker. Scribes will be randomly allocated to consenting doctors to work at each site for 5 months FTE (100 scribed shifts and 100 control shifts at each site) and administrative data on consultations per hour per doctor will be gathered. We will evaluate the role and its impact on medical productivity in four sites which represent typical public Emergency departments across Victoria and Australia. The sites are Bendigo, Austin, Monash Paeds and Dandenong. We have gathered a team of national and international experts who work in Victoria to ensure robust delivery of the project with expert methodology and execution. We have the only medical scribe workforce available in Australia ready to participate. This will enable a determination on whether scribes provide a cost-effective way of delivering medical care in Australian EDs.

In some countries (eg Canada and UK), some patients can receive monoclonal antibody (MAB) treatment at home, under the supervision of an appropriately trained registered nurse. However, we are not aware of any comparable studies examining the safety of natalizumab and flexible delivery (i.e. treatment at home, or in a community setting) for people with multiple sclerosis (MS). Therefore, the broad objective of this study is to investigate the flexible delivery of natalizumab. In many cases, it is anticipated that flexible delivery will entail delivery in the patient’s own home. The study will compare the flexible delivery of natalizumab with usual care (attendance in an outpatient department) and answer whether it is acceptable to patients, is effective and safe, and is cost effective. The study will comprise a pilot study to better understand feasibility and safety, and to inform a larger, proposed full-scale study. The primary objective of the study is to determine whether the flexible delivery of natalizumab is safe for people with MS. The additional objectives of this study in this study population are as follows: (a) Is the flexible delivery of natalizumab acceptable to patients and healthcare staff? (b) Is the flexible delivery of natalizumab as effective in treating symptoms? (c) Is the flexible delivery of natalizumab cost effective?

Prolonged periods of sitting are prevalent in the modern office workplace and adversely impact on cardiometabolic risk factors including blood glucose and insulin concentrations. Acute aerobic exercise can transiently improve these risk factors. Evidence suggests that the pattern of exercise accumulation throughout a day and the timing of exercise in relation to meals modulates the beneficial effects it has on these markers. However, the role of exercise timing throughout a day on cardiometabolic risk factors has not been evaluated. The aim of this study is to compare the impact of a morning and evening bout of aerobic exercise on blood glucose and insulin metabolism throughout a day of prolonged sitting. Young overweight or obese men and women with a familial history of type 2 diabetes will be recruited for this study. As this demographic are at an increased risk of developing type 2 diabetes they represent a relevant target population for the prevention of type 2 diabetes. We hypothesise that aerobic exercise performed in the morning, prior to a prolonged bout of sitting and the ingestion of meals will more effectively improve glycaemic control compared to an identical evening bout.

The primary purpose of this study is to implement an integrated eHealth platform to support and enable cancer survivors to achieve and maintain improved health and well-being and better cancer outcomes, and to assess the functionality and acceptability of the system. Who is it for? You may be eligible to join this study if you are aged 18 or over and are either currently receiving cancer care (including follow-up care), or have recently been diagnosed with cancer and scheduled to commence cancer treatment at one of the participating sites. Study details Participants will have access to the eHealth system which assesses symptoms, emotional well-being and unmet needs. Participants will have access to a range of self-management websites based on their survey responses. Staff will receive a patient report with clinical recommendations. Patients and oncology staff will have access to the system for 6 months. Patients will then be asked to complete a survey and an interview regarding their use and acceptability of the eHealth system. Staff will be asked to complete an interview only. A sub-set of participants who are on-treatment at the commencement of the study and transition to follow-up care during the study will receive a Treatment Summary and Survivorship Care Plan that will also be provided to their GP.