ANZCTR search results

Our primary aim is to assess the effects of reducing sitting time during childcare on Executive Functions in a cluster randomised controlled trial in Australian toddlers from low socio-economic families. We hypothesise that at 15-month follow-up, toddlers in centres allocated to the intervention group will have improved their cognitive development by 0.5 SD more than toddlers in childcare centres randomly allocated to the control group. The secondary aims are to examine the effects of the intervention (i) on time spent in total sitting and bouts of sitting (ii) on time spent in total physical activity and moderate-to-vigorous physical activity (iii) on bone mineral density and (iv) and on cardiovascular health.

To determine if sleep-related reductions in upper airway muscle activity during sleep will be higher after a combined noradrenergic/antimuscarinic intervention compared to placebo.

In this study we aim to address patient safety in relation to first responders’ ‘failure to rescue’ deteriorating patients with a focus on enhancing the assessment and management of clinical deterioration. Over the last 7 years we have developed a face-to-face and web based educational program known as First2Act(Web) http://first2actweb.com/ which has had a demonstrated impact on educational outcomes and in a preliminary study a significant impact on clinical performance. The objectives of this study are to measure and compare the cost- effectiveness and clinical impact of in-situ face-to-face and web-based simulation programs in the management of patient deterioration and related patient outcomes. Based on these programs our intentions are to train nurse participants in primary responses to emergencies (the first 8 minutes) in medical wards at Monash Health and St John of God Health Care and other hospitals, using either in-situ face-to-face or web based version of First2Act. The impact of these interventions will be determined through quantitative and qualitative approaches; economic analyses and patient notes review (time series analyses) to measure quality of care and patient outcomes. This will enable us to determine the clinical impact of the intervention programs in relation to resource implications. It is anticipated that this program will reduce the number of in-hospital adverse events, length of stay and hospital costs whilst adding to our understanding of the barriers and enablers to effective decision-making in clinical deterioration and the utility of simulation in the preparation of first responders. Subsequent recommendations and final programs will be made available to the Victorian and International communities

Negative outcomes for the person living with dementia and their family carer can be anticipated from inadequate carer support. The Further Enabling Care at Home program involves systematic assessment of the carer’s support needs plus guidance to access existing services. We aim to test this program with family carers of people with dementia upon hospital discharge. Objectives are to: 1. Test how well the Further Enabling Care at Home program supports preparedness to care – and subsequent caregiving sustainability - in family carers of people living with dementia. 2. Determine the feasibility of translating the program into routine practice. Hypotheses for this study are that the program will help prepare families to sustain their caregiving role and reduce hospital/residential care use by the people with dementia receiving their care; also that costs of providing the program will be outweighed by savings. Research plan The 154 included dyads will each comprise a person living with dementia being discharged home from hospital and their family carer. In a single-blind randomised controlled trial, dyads will be assigned to receive either usual care or usual care plus the new program. Data will be collected from all carers at discharge, 5 weeks post-discharge, and 10 weeks post-discharge using questionnaires administered over the telephone. The primary outcome evaluated for carers is their preparedness to provide care. Carer data will establish patients’ use of health/residential services during the 10-week period. Intention-to-treat regression analyses will determine differences in carer and patient outcomes over time associated with group assignment. Cost consequence analyses plus qualitative and process evaluations will further inform recommendations for translation into practice.

LBD is an aggressive disease with a prevalence of up to 30.5% of all diagnosed dementia cases. Diagnosed individuals not only display symptoms of dementia such as memory loss, dysfunction in problem solving and decision making, but also display symptoms of Parkinsonism such as slow movement (bradykinesia), resting tremor, and freezing of gait while walking. In addition, Individuals with LBD also experience psychotic symptoms such as visual and auditory hallucinations and delusions, as well as autonomic symptoms such as incontinence, orthostatic hypotension (low blood pressure upon standing), and disrupted sleep patterns. The culmination of this cluster of symptoms is a significant reduction in functional independence and a subsequent increase in reliance on caregivers, increasing stress and burden in both individuals. Exercise research is scarce in this population, with very limited and low quality data available. In similar cohorts though, Like Parkinson's disease and other types of dementia, exercise of a variety of modalities has shown efficacy in improving physical function among other variables. Further to this, increasing incidental physical activity around the home has also been reported to improve function in individuals with Parkinson's disease. Logically, exercise could show similar benefits in Lewy Body dementia cohorts. The PRIDE trial will be a world first trial investigating the magnitude of the risk factors that contribute most to a loss in functional independence in individual with LBD, and then using that information in combination with evidence based best practice to design an 8-week exercise intervention to be trailed in community dwelling participants with LBD. PRIDE will include a cross-sectional baseline study of LBD, followed by a 16-week, fixed-period crossover controlled trial of targeted exercise. Participants will be tested at baseline in a cross-sectional analysis of the most important modifiable factors in LBD mediating functional independence. A subset of the recruited cohort who lives in the community will then be enrolled in an 8- wk usual care control period followed by an 8-wk experimental exercise intervention. Randomisation is not possible due to carry- over effects of exercise. All outcomes will be measured at three timepoint: at baseline just before wait-list control period, after 8 weeks of wait-list control, and after 8 weeks of exercise intervention (Week 16) by the same assessor to minimise issues related to inter-rater reliability.

Aim: This study will investigate the potential of a natural dietary antioxidant extract capsule from blueberries and blackcurrants known as anthocyanin in improving haemostatic function and inflammation under oxidative stress conditions in obese men. It is hypothesized that by virtue of anthocyanin's antioxidant properties, it may help block pathways of blood clot formation, endothelial function and inflammation under conditions of oxidative stress in obese men. Research design: Twenty-three healthy, sedentary, obese (BMI>30) male volunteers will be recruited for this randomised, double blind, placebo controlled crossover design, dietary intervention trial. Participation will involve 5 visits to the Haematology research laboratory. During visit 1, each participant will sign an informed consent and complete screening forms (physical activity, health history, and antioxidant questionnaires). After completion of these forms a member of the research team will determine the height, weight, waist to hip ratio, body fat (using a 3 site skin fold assessment technique) and blood pressure of each participant using standard procedures. Participants will then be asked to complete an incremental exercise test on a cycle ergometer using standard procedures. During the incremental exercise test expired gas will be collected by a metabolic cart (ParvoMedics) using standard procedures. During visit 2, a 25 mL baseline blood sample will be collected from the participant's arm vein using standard venepuncture procedures by a trained phlebotomist, followed by body mass, resting heart rate, resting energy expenditure and blood pressure measurements. A constant load exercise test will then be performed at moderate intensity (70% of aerobic capacity) for 60 min. Each test will be preceded by 3 min of unloaded cycling and with an active cool down for 6 min. Another blood sample (25 mL) will be collected using standard procedures after the exercise test. A non-invasive echo-Doppler to assess the flow mediated dilation of the brachial artery will be performed to assess endothelial function before and after the exercise test. The participant will then consume either 320 mg/day of anthocyanin capsules or placebo capsules for 28 days. After 4 weeks of capsule supplementation, i.e. on the 29th day (visit 3), two blood samples will be collected before and after an exercise test (similar to visit 2). After a 2 week wash out period with no supplement intake, a supplementation cross-over will be performed, and exercise intervention and sample collection procedures repeated on day 43 and day 72.

Articular cartilage is aneural, avascular and has limited capacity for self-repair. Articular cartilage defects pre-dispose patients to developing osteoarthritis, and if left un-treated, damage can become so severe that joint replacement is indicated. Autologous Matrix-Induced Chondrogenesis (AMIC) is an enhanced version of the original microfracture technique, in which a type I/III collagen matrix (Chondro-Gide, Registered Trademark) is placed over the cartilage defect to stabilise the fragile bone marrow cell infiltrate and provide infrastructure for tissue repair and regeneration. Currently, the majority of commercially available collagen membranes are manufactured in Europe or the USA from locally-produced source material. Australian-sourced biological materials are valued due to the historically low rate of zoonotic infectious diseases and absence of transmissible spongiform encephalitis. CelGro (Trademark) is manufactured in Australia, using collagen originating from Australian Government veterinarian-certified animals bred and raised in Western Australia, eliminating disease transmission concerns associated with foreign products. This study will use CelGro (Trademark) as the collagen matrix in AMIC treatment for osteochondral defect in the hip.

Despite rapid advances in the field of technology to monitor blood glucose continuously and prevent hypoglycaemia in type 1 diabetes (T1DM), the majority of patients, particularly young children, fail to achieve recommended HbA1C target of 7.5%. Real-time continuous glucose monitoring (RT CGM) offers the opportunity to improve diabetes control by providing a continuous glucose reading every 5 minutes. The most recent generation of RT CGM systems are more accurate in the hypoglycaemic range and have an added feature which allows transmission of the glucose values via bluetooth to a mobile device and share it with caregivers or health care providers. Little is known of the psychosocial impact of these technological advances on the patients and their caregivers. This study aims to evaluate the impact of RT CGM with the added feature of remote monitoring on psychosocial factors such as fear of hypoglycaemia and quality of life measures in young children with type 1 diabetes mellitus (T1DM) and their parents.

Background: People do not engage in sufficient physical activity (PA), and therefore, do not confer health benefits and reduce risk of chronic diseases. Increasing PA levels reduces this risk and is also linked to better quality of life and reduced stress. Healthcare professionals frequently provide guidance on physical activity; however often do not meet the recommendations themselves. There is a need for large-scale coordinated efforts to promote PA at the population level and, in particular, in healthcare professionals who often experience stressful work patterns. Recent developments in technology have been used to promote PA through tailored interventions. The main objective of this study is to develop and test the feasibility, acceptability and efficacy of tailored interventions in healthcare professionals to increase their PA and quality of life, and to reduce work-related stress and absenteeism. The study will also compare the unique and interactive effects of three forms of the tailored intervention on study outcomes based on different techniques from behavioural theory. Methods/Design: Frontline hospital staff (N = 168) will be recruited from four hospitals in Perth, Western Australia via employer’s mailing list, leaflets and posters. Participants will be randomised to one of the four conditions: motivation, self-regulation, habit, and control. Participants in all conditions will be provided with access to a web-based platform that provides a library of short lay-language articles on promoting PA. All intervention groups will receive a tailored intervention administered via the web-based platform with supporting text messages. Theory-based personalised information will be delivered to participants based on their responses to surveys assessing theory-based cognitions (e.g., motivation, self-efficacy). The content of the tailored messages will adopt specific techniques based on behavioural theory. The primary outcome will be PA measured using activity monitors. Secondary outcomes include: self-reported quality of life, stress, anxiety, sleep, and absenteeism from employee records. All outcomes will be assessed pre- and post-intervention (at 3 months). Website engagement, retention and preferences related to each component of the intervention, and potential mediators and moderators of the intervention will be assessed. Discussion: This is the first study to deliver a tailored, technology-supported intervention aiming to increase PA in frontline healthcare professionals. In addition, the inclusion of different techniques based on behavioural theory in different arms of the trial will assist in providing an evidence base assessing the effectiveness of motivational, self-regulatory and habit-forming strategies in promoting PA. The online platform developed in this study has a potential to deliver efficient, scalable and personally-relevant intervention that can be translated to other occupational settings.

This research examines the utility of Let's Talk About Children intervention for its application in Australian mental health services. The objectives of the project are to determine the effectiveness of the Let's Talk program, an innovative, evidence-based program which involves training clinicians in talking to mental health clients about their children. The research will investigate the impact of Let's Talk on parenting confidence and family functioning along with aspects of recovery (e.g. self worth, relationships, independent living) and quality of life, as compared to a control group receiving standard treatment.