ANZCTR search results

Primary purpose of this study is to evaluate the efficacy of manual-based ATT for individuals with BN and BED compared to a waitlist control condition. Brief statement intended for the lay public: Researchers at the University of Sydney and the University of Western Sydney are conducting a study examining the effect of attention training on binge eating. We hope to learn whether Attention Training Therapy (ATT) is helpful in reducing symptoms of binge eating, characteristic of individuals with Bulimia Nervosa and Binge Eating Disorder.

BACKGROUND Stroke is a leading cause of disability and death. Four out of five strokes are due to blockage of blood supply to a part of the brain. Atrial fibrillation (AF) is a common heart rhythm irregularity associated with blood clot formation in the heart that can migrate to the brain and cause strokes. There are proven treatments that can greatly reduce the occurrence of stroke in people with AF. AF can be present intermittently and without any symptoms, therefore can be hard to detect. However, strokes occur just as frequently in people with intermittent AF as in those with continuous AF. Currently stroke sufferers frequently undergo 24 to 48 hours of continuous heart rhythm monitoring using either a non-portable (telemetry) or a portable (Holter) external monitor. However, the cause cannot be determined in a quarter of all strokes despite these tests. The AliveCor Mobile ECG is a novel device that comprises a smart phone case containing 2 electrocardiogram (ECG) electrodes and a smart phone application that generates 30 seconds of ECG (equivalent to lead I of 12-lead ECG) and automatically diagnose the presence of AF with 97% accuracy. We hypothesize the use of AliveCor Mobile ECG by nurses in the stroke unit will be an effective and inexpensive way to increase in-hospital AF detection following stroke. AIMS We aim to compare the number of stroke sufferers with previously undiagnosed intermittent AF that are detected by the AliveCor Mobile ECG to that detected using current standard testing with 12-lead ECG and 24 to 48 hours of Holter monitoring or cardiac telemetry. PROPOSED RESEARCH DESIGN Up to 300 consecutive stroke sufferers without known AF admitted to the participating stroke centers will be included in the study. All nurses working in the participating stroke centers will be trained to use the AliveCor Mobile ECG. All participating stroke sufferers will receive checks with the AliveCor Mobile ECG at the same frequency as all their other regular nursing checks from the time they arrive in the participating stroke centers to the time they are well enough to go home or are transferred to another ward or facility. All participating stroke sufferers will also receive all standard heart monitoring available at each participating stroke center.

Chronic venous leg ulcers are an extremely common and costly problem across the globe. The burden is expected to rise with an ageing population and the growing epidemic of diabetes and obesity. This will increase the therapeutic challenge for treating clinicians. Standard best practice treatment is compression of the lower leg by bandaging to reduce hydrostatic pressure in the leg. Healing rates vary widely and even after two years of compression therapy up to 50% of all chronic VLUs remain unhealed as patient adherence to compression therapy is a continuing challenge, as is best practice management of people with VLUs in the community. Autologous Platelet Gel (APG) together with compression appears to be a promising new intervention for VLU healing. While there is encouraging data from in vitro, animal and clinical studies, strong evidence for its effectiveness from high quality randomised controlled trials is currently lacking. We propose a pilot clinical trial to determine the efficacy, safety and cost-effectiveness of APG gel as an adjunct to compression therapy in healing venous ulcers. We will also assess ulcer recurrence rate of venous ulcers within 3 months of healing.

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.

Primary objectives To determine (1) the feasibility of the KT patient engagement intervention and study design, and (2) the effect of the patient engagement intervention on medication administration error rates. Secondary objectives To determine (1) patients’ and nurses’ perceptions of the acceptability of the KT patient engagement intervention, and (2) the effect of the intervention on nurses’ and patients’ behaviour. The intervention The basis of this knowledge translation (KT) patient engagement intervention will be a patient brochure containing information about the required medication administration checking procedures, developed in consultation with consumer representatives and clinical nurse representatives. Four general wards across two hospitals will be included: two intervention wards (i.e., brochure) and two control wards (i.e., usual practice/no brochure). Research staff will distribute the brochure to patients within 24 hours of their admission to the intervention wards. Their attention will be drawn to the content of the brochure and their right to ask the nurse if the checking procedure has been adhered to. The brochure will remain with the patient for the duration of their inpatient stay. Outcome data Data on medication administration errors will be obtained from three different sources: Medication chart audits: Carried out on all four wards on a single day each month for 3-months prior, 3-months during, and 3-months post intervention. RiskMan medication error data: For all four wards, monthly reports of RiskMan data will be obtained for 4-months prior, 3-months during, and 4-months post intervention. Random observations of nurses’ medication administration practices: For the 3-months pre, during and post intervention, observations of medication administration by nurses will be undertaken on the four wards. Process evaluation data Patient interview: Approximately 48-hours following discharge from intervention wards (consent will be obtained prior to discharge), a telephone interview will be conducted to elicit patients’ perceptions of the brochure and whether it had any effect on their behaviour. Patient survey: Patients discharged from all four wards during the 3-month intervention phase will be invited to complete a survey, primarily focused on their confidence to manage their health and their involvement and engagement in their own care. Staff focus group interview: Registered nurses and medication endorsed enrolled nurses on intervention wards will be invited to participate in a focus group interview to determine their perceptions of the intervention.