ANZCTR search results

The overall project aim is to investigate the effectiveness of adding an expert-moderated, peer-to-peer online support group (OSG) to an information website for people with clinically diagnosed knee osteoarthritis (OA). This study will investigate the feasibility of conducting the RCT by exploring fidelity (to trial and intervention protocols), satisfaction and engagement with the planned interventions, outcomes and costs. The primary objective will be to determine the feasibility of delivering the intervention in a trial setting and of recruiting and retaining participants. In terms of outcome measures, we will explore the impact of the intervention on psychological determinants that can explain self-management and lifestyle behaviour change. We will also measure behaviour and health outcomes as part of the feasibility assessment. The study will include two nested qualitative studies that will explore the type and content of posts, and the perceptions and experiences of participants in the OSG. We will conduct a two-arm, pragmatic parallel-design randomised controlled pilot trial (RCT) in 60 volunteers (20 in control group, 40 in intervention group) from around Australia who have clinical knee OA. The study will be run from the Centre for Health, Exercise and Sports Medicine at the University of Melbourne.

This study will compare two versions of the Physically Active Children in Education (PACE) intervention in increasing the minutes of planned weekly physical activity scheduled by classroom teachers. The aim is to determine whether an adapted PACE (i.e., delivery of teacher training by in-school champions rather than expert project officers) is statistically noninferior to the original PACE (i.e., delivery of teacher training by expert project officers). Forty eight schools in the HNE region have been randomly allocated to either the adapted PACE or original PACE group, and follow-up measurements will be taken at 12 months.

The purpose for fluid replacement is to maintain normal body homeostasis (balance). The theoretical advantages of a having normal acid-base balance is a lower incidence of postoperative complications i.e. less breathing difficulties, less heart, kidney and liver complications, improvements in time to mobilize, and a shorter duration of hospital stay. During abdominal surgery fluid losses can occur from evaporative losses from your skin, losses from your urine, and losses from any bleeding that can result from the surgery. In Australia and most countries in the world, the most commonly used clear fluid to replace any fluid loss during major abdominal surgery is Hartmann’s solution. This is standard fluid therapy for all patients undergoing liver major abdominal surgery at Austin Health. Hartmann’s solution has certain limitations in that it contains certain electrolytes (an essential mineral for normal health) as part of its normal content. One of these electrolyte is called lactate. Lactate is however reliant on the liver for its metabolism, which is why this fluid is not used in patients undergoing major liver surgery, including liver transplantation. However, during major abdominal surgery, there can be an additional stress from the surgery on the liver, which can in turn, affect the normal functioning of the liver. If the liver does not function normally, then lactate cannot be completely metabolized (broken down). This can affect normal acid base balance or body homeostasis. In this study we are investigating whether a clear fluid called “bicarbonate buffered solution” is comparable to Hartmann’s solution during major abdominal surgery. The bicarbonate buffered solution contains no “lactate” and may have a more favourable effect on the “acid-base” balance

The purpose for this fluid replacement is to maintain normal body homeostasis (balance). The theoretical advantages of a having normal acid-base balance is a lower incidence of postoperative complications i.e. less breathing difficulties, less heart and kidney complications, improvements in time to mobilise, and a shorter duration of hospital stay. During surgery fluid losses can occur from evaporative losses from your skin, losses from your urine, and losses from any bleeding that can result from the surgery. In Australia and most countries in the world, the most commonly used clear fluid to replace any fluid loss during liver transplantation is Plasmalyte solution. This is standard fluid therapy for all patients undergoing liver transplantation at Austin Health. Plasmlayte solution has certain limitations in that it contains certain electrolytes (also called “anions”) that are reliant on the liver for metabolism. During liver transplantation, as the liver does not function normally, this can affect normal “body-balance”. In this study we are investigating whether a clear fluid called “bicarbonate buffered solution” is comparable to Plamalyte solution during transplantation. This solution contains no “anions” and may have a more favourable effect on the “acid-base” balance.

This is an observational research study to identify markers that can predict poor outcome following a concussion. Following a concussion injury, information will be collected on the individual's injury and medical history, and they will participate in an exercise tolerance test, MRI scan, neuropsychological test and blood test. We hypothesize that performance on tests at the time of the injury will help predict which individuals will likely have a delayed or complicated recovery. Identifying individuals at risk of a poor recovery will help doctors modify their management of the injury appropriately, and save those likely to recovery normally from unnecessary follow-up visits.

This trial aims to investigate the use of psilocybin (a psychedelic compound) in conjunction with psychotherapy for the treatment of anxiety and depression in terminally ill patients. Who is it for? Adults aged between 18-85 years with a life threatening illness and currently under the care of a specialist physician are eligible for the study. Criteria for prospective participants includes psychological distress that was brought on by their life-threatening illness. Study details Participants will be rigorously screened, throughly prepared and supported throughout the treatment with two specialist clinicians present at all times throughout the treatment. Participants will be randomly allocated (50/50 chance) to either receive the active medication (Psilocybin 25mg) Arm 1 or a placebo (Niacin 100mg) in Arm 2. The medication or placebo will be taken once in the first arm of the study and have psychotherapy sessions with a health professional before, during and after the dose of medication/placebo. The next dose is 7 weeks later, where all participants will take the active drug, Psychotherapy sessions will take place before, during and after. All participants are followed for 26 weeks following the second dose and will be involved in interviews and questionnaires throughout the study period. Participants are followed up for 26 weeks after the second dose to ensure that we examine all changes that continue after treatment. Questionnaires and interviews are conducted throughout the study to fully understand the impact of the treatment and to monitor for safety. It is hoped that this research could potentially offer a new treatment for terminally ill patients experiencing depression and anxiety, and hopes to alleviate psychological suffering at end of life.

The primary purpose of this study is to determine if being part of an afterschool Aboriginal cultural activity program, which is developed and run by Aboriginal people, can make children healthier. Specifically, this study aims to evaluate the feasibility, acceptability and potential efficacy of an afterschool cultural program in promoting culture connectedness, positive healthy behaviours and educational outcomes, including physical activity, healthy eating, spiritual and socio-emotional well-being and positive school- and home-related behaviours, among Aboriginal children and their siblings aged 5-13 years. It is hypothesised that the afterschool cultural program will give children opportunities to learn culture, connect to Country and engage in activities that promote physical, social, emotional and spiritual health.

Cardiac rehabilitation (CR) is a secondary prevention program for cardiovascular disease with physical activity (PA) being a core component. Despite this, studies have found that PA levels are low and sedentary behaviour (SB) is high in CR patients. The aim of this randomised control trial (RCT) is: 1) to test the efficacy of a behavioural smartphone application (Vire DoACTIVE) and a 6-month online behaviour change program (ToDo-CR) in decreasing SB and increasing PA levels in CR participants (compared to routine CR alone); 2) to explore if this behavioural change intervention is effective at reducing the risk of repeat cardiac events, all cause hospital admissions and emergency department visits over 12-months post commencing CR. We propose to conduct a multi-centre RCT over 12-months with 144 participants from the Canberra Hospital, Calvary Public Hospital Bruce and National Capital Private Hospital CR programs. It is hypothesised that the intervention will increase PA levels, decrease SB and reduce repeat cardiac events, readmissions to hospital and emergency department visits.

Newly diagnosed individuals with T2D can be managed primarily by alterations to diet and physical activity (exercise) patterns, which are used to help control blood glucose. However, uptake and adherence to any behaviour change strategy is typically challenging and therefore low. Recently, time-restricted eating (TRE) has emerged as a promising therapeutic strategy that allows meals to be consumed alongside societal norms. Rather than stipulating the composition of meals, TRE aims to reduce the ‘eating window’ to facilitate a longer overnight fast (i.e. eating between 10 am-6 pm, rather than over periods longer than 12 h). Via TRE, meal timing can be aligned with the biological circadian rhythm. Specifically, an earlier dinner may contribute to better glucose control due to the known deterioration of the hormone insulin to regulate glucose declining over the day. In those with T2D, a later breakfast may also be beneficial to avoid eating at the same time as the morning spike in fasting glucose, which is known as the ‘dawn phenomenon’ in individuals with T2D and coincides with the increased circadian concentrations of cortisol, known to stimulate the liver to release glucose into the circulation. Acutely, to our knowledge, TRE has not been measured in individuals with type 2 diabetes. TRE performed over a period of weeks has been shown to effectively reduce post-meal insulin, blood pressure, and evening appetite; if continued for up to one year it has been demonstrated to result in sustained weight loss. However, there are a lack of studies investigating the acute, one-day effects of TRE, particularly in the context of other behaviours that might influence circadian rhythm. Exercise, for example, is a potent stimulus known to influence both circadian rhythm and glucose control. For individuals with T2D, just 10 minutes of walking in each of the 1 hour post-prandial period across a day is enough to improve blood glucose control. However, it is unknown whether strategically-timed exercise combined with TRE would result in an additive benefit to glucose control over the course of a day. In addition, it is unknown whether the benefits of exercise for glucose control would mitigate the detrimental effect of an extended feeding window on glucose control.

This study aimed to investigate the current vaccination coverage for influenza, pneumococcus, and herpes zoster amongst patients affected by immune-mediated inflammatory disease (IMID) and increase vaccination rates using targeted electronic and printed patient immunisation reminders, electronic health practitioner immunisation reminders, and educational activities in Australian general practice. Patients affected by IMID (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or inflammatory bowel disease) attending Australian general practice will be included in the study. Current vaccination coverage will be estimated based on de-identified data on influenza, pneumococcus and herpes zoster vaccinations for patients with IMID from all practices using the Doctors Control Panel (DCP) for 2013-2018, which accept to be part of the study. DCP is a well-established software package that retrieves medical information from electronic medical records and identifies preventive health care activities that are due. In the second part of the study, DCP will generate targeted electronic (SMS text message upon consultation booking and another on the day of the appointment) and printed (read in the waiting room) patient immunisation reminders to inform them about their higher risk of viral and bacterial infections and generate advice about recommended vaccines. All communication will be via the recruited practices, without intervention by the researchers. Patients who have agreed to receive SMS messages from the practice will receive a generic reminder SMS upon booking, and another generic reminder SMS on the day of their appointment. They will also receive a printed letter if they arrive for an in-person consultation. Patients who have refused to receive SMS messages from the practice or who don’t have a mobile telephone will not receive SMS text messages but will receive a printed reminder letter from the receptionist if their consultation with the GP is in the clinic. The DCP will also generate electronic GP immunisation reminders (GP computer) to inform them about patient's status regarding immunisation. The outcome measures at the end of the intervention (18 months including two influenza vaccination seasons) are 1) recorded administration of influenza, pneumococcus, and herpes zoster vaccines to patients with IMID, and 2) documented contraindications to, or refusal of, those vaccines. Compared to the baseline (Stage 1), we expect an improvement of at least 20% in vaccination coverage after the intervention (Stage 2).