ANZCTR search results

Following emergence from coma individuals with traumatic brain injury (TBI) experience a period of confusion, amnesia, and sometimes agitation, termed post-traumatic amnesia (PTA). Guidelines for management of patients in PTA have traditionally recommended that these patients not receive active therapy during this phase. However, this management strategy has never been empirically tested and anecdotal evidence implicates potential benefits from rehabilitation during PTA. Retraining of daily living skills such as personal care activities (e.g., dressing) and domestic tasks (e.g., meal preparation), known as activities of daily living (ADLs), is a core focus of the rehabilitation program in the post-PTA phase. Efficacy of commencing ADL retraining during the PTA phase has never been systematically assessed. The proposed randomised controlled trial is designed to evaluate the efficacy of commencing ADL retraining during the PTA phase after severe TBI (treatment group), as compared to introducing ADL retraining after emergence from PTA (treatment as usual control group).

The aim of the study is to provide guidance to clinicians in relation to the safety and effectiveness of exercise training for pulmonary hypertension (PH) patients. More specifically, the study will have the following aims: 1) To examine the short-term outcomes and safety of exercise training in patients with PH 2) To examine the impact of exercise training on cardiac function at rest and during exercise using cardiac magnetic resonance imaging 3) To examine the long-term outcomes including adverse events and clinical worsening following exercise training. The study hypotheses are: 1) Exercise training will have beneficial effects in terms of improved exercise capacity, quality of life and a reduction in disease severity, with no increase in adverse events 2) Exercise training will result in improved cardiac function as measured using cardiac MRI, both at rest and during submaximal exercise 3) Participants who undertake exercise training will have a longer period without clinical worsening, using a minimum 2-year follow-up period

Immunisations are an important public health intervention for reducing the morbidity and mortality caused by vaccine-preventable diseases in the community. Certain individuals are at higher risk of serious complications following influenza infection, and unfortunately, influenza vaccine has the lowest uptake of any routine vaccination program in Australia. Studies from overseas have shown the use of text message reminders (also called short message service [SMS] reminders) can be an effective method of promoting vaccines to priority groups. The Western Australia Department of Health (WA Health) is interested in creating a program for general practitioners to use during the influenza vaccination season to remind patients they are eligible for government-funded influenza vaccine. To assess whether this activity is an effective and efficient use of resources, WA health intends to evaluate the impact of a prototypic reminder system in a subset of practices.

The overall aim of the project is to demonstrate the utility of the newly developed novel laryngeal mask airway (LMA) device called the LMAGastro (Trademark) which is a first for laryngeal mask airway (LMA) use in upper gastrointestinal endoscopy procedures. The device’s novel design features include firstly a dedicated endoscopic channel for entry into the oesophagus and secondly, a dedicated airway channel and cuff to protect the airway. The hypothesis is: the LMAGastro (Trademark) will have a high endoscopic success rate and provide a clinically satisfactory protected airway during upper gastrointestinal endoscopy procedures under anaesthesia. Gastroenterologists won’t change practice unless endoscopic success rates are very high. We are anticipating that the modified airway device (being developed with TELEFLEX and in collaboration with the Gastroenterology Department of the RHH) will not only provide reliable and superior upper gastro-intestinal access, but also provide airway protection and better anaesthesia monitoring of the patient, both significantly enhancing patient safety leading to a change in practice.

This is a prospective randomized controlled trial (RCT) investigating the graft stiffness of a Double Bundle (DB) remnant sparing Anterior Cruciate Ligament Reconstruction. The patients receiving this graft configuration will be randomized to either an accelerated rehabilitation program or a conventional rehabilitation program. Six months and one and two year graft laxity measures will be used as the primary outcome measure of the graft stiffness and its response to two forms of rehabilitation loads. Our overall hypothesis is that accelerated rehabilitation culminating in a return to sport at 6 months post-surgery will have no adverse effects on the graft laxity after ACLR, evaluated primarily by graft laxity measures at 1 and 2 years and secondarily by the time taken to return to sport, patient satisfaction, validated functional scores and patient-reported outcome (PRO) measures.

Sleep disturbance is experienced by the majority of child-bearing women during the pregnancy and post-partum periods. Physiological changes related to pregnancy and birth-giving (e.g., hormonal changes), and post-partum nighttime infant care are common factors that reduce/disrupt sleep opportunity. In addition, some women (~17%) experience clinically significant insomnia symptoms. The resulting sleep complaints have been associated with a range of poor maternal outcomes (e.g., mood disturbance, worse birth outcomes, poorer maternal-infant attachment). Integrated behavioral and educational interventions have been consistently shown to improve sleep, and have lasting effects on sleep and wellbeing. Cognitive Behavioral Therapy for Insomnia (CBT-I) is an effective insomnia treatment, and recently has been tailored to, and piloted on, women with comorbid postpartum depression and insomnia with significant improvements to sleep and mood. Given the proven efficacy of CBT-I and the need to prioritize treatment accessibility in the community, the lack of a flexible delivery service platform for healthy sleep strategies represents a significant gap in clinical translation. Given the high prevalence of sleep disturbance in perinatal periods, a platform that can be easily integrated into routine perinatal care, as well as being accessible to a broad community is desirable. However, expectant mothers in most of Australia are not currently receiving evidence-based information and recommendations to prepare and support them through the many changes to sleep/wake cycles during the transition into motherhood. This study will adapt an existing evidence-based perinatal sleep intervention for use in an Australian public hospital setting and include features that allow for sustainable integration into routine care, promoting eventual wider dissemination. The primary aims of the study are to obtain pilot data on 1) the feasibility of integrating this adaptation in outpatient perinatal care, and 2) its treatment effect on sleep and wellbeing in mothers and infants. To achieve this aim, a comparison group, Diet SEED will be used. A secondary aim of the study is exploratory, and assesses potential benefits of Diet SEED on participants' diet. From a diet perspective, the Sleep SEED group will be treatment as usual (as outpatients). Currently, diet related information is given to women in a text-dense booklet. By adapting content of this booklet to digestible sizes that are delivered at important perinatal milestones, Diet SEED has the potential to improve women's diet behaviors significantly compared to treatment as usual. Therefore, to achieve this aim, dietary measures will be compared between Sleep and Diet SEED groups.

This this NHMRC-funded Partnership Project was co-developed with our partner organisations - MDFA and Carers NSW with the objective of improving the design and delivery of their existing support services and programs, in a way that makes it easier for family carers to have timely access to a coordinated, multi-component intervention targeting drivers of caregiver stress and burden. We will evaluate the implementation of a comprehensive support service comprising: 1) mail-delivered cognitive behavioural therapy (M-CBT), designed to improve psychological adjustment and adaptive coping skills; 2) telephone-delivered group counselling sessions - allows carers to explore the impacts of caring and share their experiences; and 3) education on available community services/resources, financial benefits, and respite services. This study will be a randomised controlled trial with economic evaluation; which will determine whether this intervention is cost-effective compared with the usual care in terms of outcomes for caregivers (i.e. good value for money).

Pain confers a survival advantage by drawing our attention to injury. Yet this attention bias towards pain-related cues can become maladaptive in people with chronic pain. Importantly, the direction of attention can be modified using a method known as attention bias modification (ABM). Preliminary research suggests this approach may be effective for the treatment of chronic pain. This is the first study to examine its effectiveness in a military population. This study aims to determine whether multiple sessions of an ABM using pain cues will reduce attention bias to pain cues, reduce pain severity and related disability (e.g., pain interference) and improve mental health in ADF members with chronic pain. The study will be a parallel-groups randomized superiority trial comparing 5 sessions of ABM (using pain-related word cue attention modification training via a modified dot-probe task) versus sham training (i.e., placebo control condition, via a dot-probe task) in 100 Defence personnel who self-report chronic pain experience lasting at least 3 months. 100 Australian Defence Force members who report chronic pain (persisting at least 3 months) will be recruited and randomly allocated to undergo either ABM training or sham training (placebo control comparison). Pre- and post-intervention attention biases will be assessed via a computerised task (<10 mins) where reaction times for different categories of pain words will be measured. At each of the five training sessions, participants in the intervention group will undergo a modified version of this computerised task (< 10 mins) which implicitly trains participants to direct their attention away from these target cues. Control group participants will complete an equivalent task without the training contingencies. Questionnaires assessing demographic and key outcome variables will be completed via an online survey prior to the first training session (baseline) and at 1-month follow-up. During the 5-week intervention period, a brief (5-10 mins) online survey will be completed the next day following each training session to assess incremental changes in mood and pain ratings.

Functional nuclear medicine imaging techniques such as PET/MRI imaging are commonly used in fields such as oncology to look at the bioactivity and biodistribution of disease. These techniques have previously been applied to infectious diseases, although data is limited. We propose a pilot study to investigate the use of 18F FDG PET/MRI imaging in malaria infection. Participants taking part in malaria challenge studies will be invited to undergo whole body PET/MRI imaging before and after malaria inoculation.

Blood ketone measurement has been used in the treatment of diabetic ketoacidosis for some time. However it also provides a monitor of nutritional status. Ketonaemia [elevated blood ketones] occur when the body switches from glucose to fatty acids as the main metabolic substrate. This occurs in starvation, during illness and also with prolonged perioperative fasting. The aim of this study is to establish the prevalence and associations of ketonaemia in acute care patients. Point of care, single drop, blood analysis [similar to blood sugar testing] provides a simple method of detecting ketonaemia. Making measurements on discarded blood during cannulation or routine blood collection and relating the ketone level to factors collected from the electronic medical record [eMR] will enable normal ranges and demographic associations to be established. This observational study will permit use of blood ketone measurement to detect nutritionally vulnerable populations and establish a baseline for studies of specific interventions in the future.