ANZCTR search results

This research project aims to investigate the feasibility, acceptability and preliminary effectiveness of a computer game and online mentoring program to improve emotion recognition skills among adults on the autism spectrum. Participants will be randomly allocated to either the group with computer game and online mentoring program or a control group without the online mentoring intervention. Each participants will receive approximately 10 hours of intervention over ten weeks.

The purpose of this ‘proof of concept’ study is to investigate a multi-faceted podiatry intervention in people with symptomatic first metatarsophalangeal joint osteoarthritis. Specific aims are: 1. To determine the feasibility, safety and perceived patient response to a multi-faceted podiatry intervention in people with first metatarsophalangeal joint osteoarthritis. 2. To investigate the efficacy of a multi-faceted podiatry intervention on pain and self-reported function compared to usual care in people with first metatarsophalangeal joint osteoarthritis. People with first metatarsophalangeal joint osteoarthritis will receive either the podiatry intervention or usual care of analgesia and advice, and feasibility data, as well as changes in pain and function will be assessed after 12 weeks.

This short-term human dietary intervention trial will provide evidence of the potential of breads containing high amylose wheat to improve indices of metabolic health. The study has been designed to provide preliminary quantitative data on the extent to which the test breads attenuate post prandial glycaemia and improve other indices of metabolic health such as insulin release and associated hormone responses (GLP1, GIP and PYY).

Following acquired brain injury (ABI) caused by stroke or trauma many people cannot move around independently due to motor impairments such as weakness and poor coordination. These people require intensive repetitive practice to improve their ability to move around. Therefore the aim of this study is to determine if a two-week intensive package of functional training improves functional performance more than usual care in people with ABI admitted to a sub-acute ward for rehabilitation. Experimental design: An assessor blinded randomised controlled trial will be conducted. Each participant will be randomly allocated to an experimental or control group using the principles of concealed allocation. Participants allocated to the experimental group will receive usual care and a 2-week package of exercises and strategies that will provide them with additional opportunities to practice a functional task. This package will include a range of strategies individualised to the needs of the participant for increasing the amount of practice of a functional task. Participants allocated to the control group will receive usual care. Usual care for both groups will consist of two one-hour sessions of physiotherapy a day and will include one-to-one or group therapy with a physiotherapist. This therapy will involve strength, endurance, balance and coordination exercises as well as task-specific practice of sitting, sitting-to-standing, standing, and walking. All exercises will be tailored to the needs of each participant. Participants: 30 consecutively admitted patients to a sub-acute general adult rehabilitation unit.

This study will investigate the immediate biomechanical effects of shoe inserts in those with kneecap arthritis, as well as the feasibility of conducting a larger scale clinical trial. Thirty-two participants will be recruited from the Melbourne community, and will remain blinded to the intervention and study hypotheses for the duration of the study. To investigate the immediate biomechanical effects of shoe inserts in those with kneecap arthritis, a within subject, repeated measures study design will be used. The immediate effects of different shoe inserts on lower limb biomechanics will be obtained using a three-dimensional motion capture system during the baseline appointment. Participants will perform walking and stair-stepping tasks while wearing three different shoe insert conditions applied in a random order: (i) own footwear; (ii) own footwear with contoured shoe inserts; and (iii) own footwear with flat shoe inserts. To determine the feasibility of conducting a larger scale clinical trial, a parallel group randomised trial with two groups and a 6 week follow up will be used. Following the study of the immediate biomechanical effects of the shoe inserts, participants will then be randomly assigned to one of two shoe insert conditions (contoured inserts, flat inserts), which they will take home and wear in their usual footwear for 6 weeks. The feasibility of conducting a larger clinical trial will be assessed via willingness of participants to enrol in the study, the number of participants who qualify for the study, adherence with use the allocated shoe inserts, shoe insert diary completion, frequency and types of adverse effects, participant attrition, and treatment credibility. The Podiatrist who fits the shoe inserts will record the number of additional appointments required, prescription notes, and adverse effects during fitting and follow-up appointments (if required). Measures of pain severity, function, quality of life, and overall improvement will inform calculation of sample sizes for future larger-scale clinical trials.

Background: Intensive care doctors make decisions about prevention and treatment of fever every day but their decisions are currently made on the basis of very weak evidence. Although ICU patients often have limited physiological reserves so that their tolerance of the demands on the body created by fever may be limited, clinicians are generally tolerant of relatively high body temperatures in the absence of acute brain pathologies. Study question: Among adults in ICU without acute brain pathologies who are expected to life support (a breathing machine) beyond the day after randomisation, does systematic control of body temperature using regular IV paracetamol combined with physical cooling to treat fever alter mean body temperature compared to standard temperature management? Why this study is being conducted: Understanding whether or not an active approach to prevention and treatment of fever results in a lower mean body temperature than a standard care approach is a necessary prerequisite to evaluating the active approach in a phase 3 clinical trial. Obtaining high level evidence to inform clinical practice in relation to temperature management in patients without acute brain pathologies requiring invasive mechanical ventilation is a high priority because fever is common problem and the best approach to managing fever is uncertain.

Clinical audit data suggests that high frequency electrical stimulation of peripheral nerves is an effective treatment for occipital headaches and chronic pain that develops after peripheral nerve injury. We now wish to investigate effects of this stimulation on pain and sensitivity to painful stimulation in patients with a stimulator implanted along or adjacent to a peripheral nerve. Specifically, we will compare pain and sensitivity to painful stimuli (pressure, sharpness, heat, cold) while the stimulator is switched on and at least 4 hours after the stimulator has been switched off. As stimulation itself produces no detectable sensations, we will use a double blind strategy to investigate effects of stimulation (i.e., neither the participant nor the investigator will know whether the stimulator is switched on or off).

The purpose of this project is to investigate factors associated with healthy eating, physical activity and healthy weight gain during pregnancy, maternal feeding practices post partum and how these may differ according to mothers’ pre-pregnancy weight and pregnancy weight gain. What we are interested in are women’s knowledge, attitudes and beliefs; factors that help women continue with healthy behaviours once they make changes such as support from family, friends and their health care providers and things that are needed to have a healthy lifestyle such as access to healthy foods, new skills and services.

Endovascular treatment of intracranial aneurysm with coils and stents requires procedural anticoagulation, most commonly with unfractionated intravenous heparin (UFH). Where the risk of thromboembolic complications is high (eg post stenting) heparinisation is continued for 24-48hrs post treatment. Post-procedural anticoagulation regimes aim for ‘therapeutic range’ based on repeated laboratory testing of sampled blood. In practice this can be difficult to achieve with consistency using UFH. Low molecular weight heparin (LMWH) offers some theoretical advantages over UFH but there is no published data on its use in neurointervention. We propose to compare post-procedural anticoagulation using UFH with LMWH (enoxaparin) in patients treated electively for intracranial aneurysms. Patients who meet entry criteria will be randomised to one of three regimes: a) UFH - continuous IV infusion, titrated by APTT test results (current standard of care) b) LMWH given as a single dose of 1.5mg/kg by subcutaneous injection at the end of the procedure c) LMWH given 1.0mg/kg by subcutaneous injection at the end of the procedure and at 12hours. The primary outcome will be achievement of therapeutic range as assessed by APTT (UFH) or anti Xa (LMWH) testing. The secondary outcome will be development of a clinically evident thromboembolic event (CETE) or a clinically silent lesion, either ischaemic (CSIL) or hemorrhagic (CSHL), assessed by neurological examination at 24 hours and MRI at 48hrs.

Preventing alcohol misuse was listed amongst the top three Australian preventative health priorities in a national review. Despite evidence that community rates of alcohol related harm are rising, to date, the evidence-based recommendations for the federal government to implement price controls and for state government regulatory controls have not been implemented. In this context, it is important to investigate whether there are feasible and effective intervention alternatives to reduce alcohol-related harm. Evidence from other developed countries and preliminary work in Australia (Rowland et al, 2012) suggests that evidence-based strategies that are coordinated and delivered by communities can be feasible and effective for implementation in Australia. However, in order to be supported for wider dissemination these community delivered alcohol-related harm prevention strategies require comprehensive evaluations of longer-term outcomes and economic benefits. Our team is the major Australian research group working to develop and evaluate effective community delivered strategies that can reduce adolescent alcohol use. In recent years, with support from Australian Research Council (ARC) Linkage funding (ACTRN 12612000384853), we have mounted a randomised community trial that utilised evidence-based supply and demand reduction strategies that have reduced population rates of early adolescent (age 13/14) alcohol use by 26%. Although our 2010-14 trial reveals community intervention is feasible, and our trial has reduced population rates of early adolescent alcohol use, in order for the intervention approach we are using to be recommended in evidence-based health economic reviews , longer-term follow-up and economic evaluation are required. The current proposal is a “Type 2 translation research trial” that the Society for Prevention Research have recently advocated for priority research funding to increase understanding as to how evidence-based interventions can be sustained and expanded into large scale implementations that demonstrate population impacts. Rowland, B., Toumbourou, J.W., Osborn, A., Smith, R., Hall, J., Kremer, P., Kelly, A., Williams, J., Leslie, E. (2012) A clustered randomised trial examining the effect of social marketing and community mobilisation on the age of uptake and levels of alcohol consumption by Australian adolescents: Study protocol. BMJ Open. 24;3(1) doi:10.1136/bmjopen-2012-002423