ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32707 results sorted by trial registration date.
  • Increasing older adults' physical activity through 'Active For Life', an online intervention with personalised advice

    The purpose of the study is to determine the effectiveness of personally-tailored, web-based physical activity intervention, with and without Fitbit syncing, targeted to inactive older adults (65+ years of age) in a 6-month randomised controlled trial . It is hypothesised that increases in objectively measured physical activity will be greater in both intervention groups compared to the control group and greater in the Fitbit and tailored advice group compared to the tailored advice only group at 12 weeks.

  • Combination Surgical Prophylaxis with Vancomycin versus Standard Prophylaxis for the Prevention of Surgical Site Infections following Elective and Expedited Surgery

    This randomised, double-blind, placebo-controlled, phase 4 trial will compare the incidence of surgical site infection, safety and cost-effectiveness of surgical prophylaxis with cefazolin plus vancomycin to cefazolin plus placebo. The study will be initially undertaken in patients undergoing elective or expedited joint replacement surgery. Dependent on timelines and funding, the study may be expanded to include patients undergoing cardiac surgery.

  • Exploring health professional and patient perspectives of best practice care for people with chronic obstructive pulmonary disease, in the hospital and outpatient setting

    The overall aim of this project is to identify perceived and actual barriers and facilitators to the provision of guideline-concordant care for people with chronic obstructive pulmonary disease in the hospital setting and the community setting, There is a particular interest to understand the experience and perceptions of people with chronic obstructive pulmonary disease and the health professionals that help them manage their condition, with relation to best practice guidelines and technology and outreach nursing services. The information gathered through these interviews will help identify potential strategies to improve motivation to access and use guidelines in practice. This project is a qualitative investigation using semi-structured interviews. The responses gathered from the interviews will be triangulated with quantitative data through use of questionnaires. Once the data is collected it will be analysed to identify themes and patterns which will help to understand the problem and identify potential solutions.

  • Right on Cue: Technologies for Managing Unhealthy Behavioural Cues, A Pilot Study

    We have developed a smartphone application, MunchIO, to help users reduce their consumption of unhealthy snack foods. Users are asked to track their snack food consumption while being provided support to understand and plan against their snacking habits. The novel distinguishing factor of this app is the use of behaviour change techniques known as cue monitoring and implementation intentions. Cue monitoring refers to tracking snacks alongside user affect and context data that can influence individuals to consume snacks. For example, a snacking cue might involve being stressed. Implementation intentions then refer to creating if-then plans that when repeated form a new replacement habit for snacking. For example, if I am stressed, I will go for a walk. This research project will collect data from two phases: Phase I includes data from the smartphone application (see above for outline of the app). Phase II includes data collected from a series of focus group interviews. Overall, the aim of this project is to determine if these apps features have any impact on participant snacking, engagement and retention. Results will further inform the design and deployment of future interventions.

  • Do sensory symptoms impact outcomes of the Alert Program for children with Autism Spectrum Disorder?

    Autism Spectrum Disorder (ASD) affects learning, social participation and daily function across the lifespan. Approximately 35,000 school-aged Australian children live with ASD; 95% of these experience educational restrictions. Available treatments are only moderately successful and are not effective for all children with ASD. Knowledge about what (intervention) is likely to work for whom is missing from the field. Individuals with ASD and their families frequently attribute the significant functional difficulties experienced to sensory symptoms. Sensory symptoms are reflected in behaviours such as hyper-reactivity (e.g. extreme distress in response to an unexpected sound), hypo-reactivity (e.g. failure to respond to a painful stimulus) and unusual sensory interests (e.g. excessive smelling of objects). Sensory symptoms are so common in ASD that they now form one subset of the diagnostic criteria for ASD. Therapies to remediate sensory symptoms are in high demand. In fact, occupational therapy, which is the lead profession providing sensory-directed therapies, is the second most frequently utilised therapy by families of children with ASD. The few controlled studies that examine the efficacy of sensory-directed therapies, however, report inconclusive results. A critical issue limiting previous research in this area is that sensory symptoms have been broadly defined and imprecisely characterised. Our group has developed a method of classifying children with ASD into clinically meaningful subtypes based on their parent-reported sensory symptoms. We observe that children with ASD can be classified into sensory subtypes that vary on the dimensions of sensory reactivity (regulating the intensity of a response to a given stimulus) and multisensory integration (MSI; simultaneous processing of concurrent sensory modalities). Each sensory subtype has been found to display a distinct pattern of behaviour thus providing a novel basis on which to customize treatments. The primary objective of our study is to assess the relative effectiveness of a sensory regulatory intervention - Alert Program for Self-Regulation (AP) - for children with ASD and their caregivers. The hypothesis for the study is that for all participants, engagement in the AP will result in: 1) achievement of caregiver defined goals in self-regulation, 2) reduced physiological sensory reactivity (EEG & ANS cardiac), 3) reduced clinical sensory reactivity, 3) reduced parent stress and caregiving effort and 4) improved adaptive behaviour and anxiety following participation in the AP. We further hypothesise that participants with a sensory subtype indicating more difficulties with sensory reactivity will demonstrate significantly greater improvements on all measures than matched ASD participants whose sensory subtype indicates difficulties in MSI.

  • ICECAP: Intermittent versus Continuous Energy Restriction Compared in an Athlete Population

    Athletes commonly reduce body weight or body fat prior to contest seeking various competitive advantages. Intermittent energy restriction is known to effectively reduce body fat in non-athletes, however evidence in athletic populations is lacking. We thus aim to provide an evidence-based intermittent energy restriction protocol for athletes, by investigating this dietary model in a cohort of resistance trained athletes, using a macronutrient profile thought to maximise retention of fat free mass and performance during energy restriction. We will compare changes in fat mass, fat free mass and performance between a continuous and intermittent dieting approach. Measures of body composition, resting energy expenditure, hunger and satiety, blood hormone levels, and muscle strength and endurance will be taken at a number of time points throughout the study.

  • SNAKES: a pilot trial of Jelly Snakes to prevent postoperative Nausea and Vomiting in Kids after ENT Surgery

    Postoperative nausea and vomiting in children is a common phenomenon, particularly after ear nose and throat (ENT) surgery. While it affects up to 80% of patients who do not receive preventative medication during their operation, more than 1 in 5 children still suffer from postoperative nausea and vomiting after tonsillectomy even when given 2 medications to prevent it (internal audit data). Nausea and vomiting after an operation (postoperatively) particularly following tonsillectomy can be very painful and distressing for the child and their carer. Vomiting may also increase the risk of postoperative bleeding, a serious complication after the surgery. Postoperative nausea and vomiting is not only one of the main reasons for prolonged hospital stay or re-admission in children; it is also one of the main reasons for dissatisfaction with anaesthesia in children and their families. In adults, a pilot study has found that chewing gum postoperatively can significantly reduce postoperative nausea and vomiting. Chewing and swallowing, results in increased activity in the gut and lessens the effects of medications given under anaesthesia that tend to slow the gut. However, for young children particularly following anaesthesia, chewing gum may not be a safe option. Therefore in this pilot study we will investigate if chewing a large jelly confectionary snake after the anaesthetic will help to reduce nausea and vomiting. The children who are enrolled in the study will be randomised to receive a jelly snake or no jelly snake to chew once awake after the surgery. There will be no other changes to the standard management which will be in accordance to institutional guidelines. We will then compare the rates of vomiting between the children who did and did not receive a jelly snake to chew. We will also monitor other oral and food intake and requirements for painkillers, as well as for other potential problems (e.g. delayed discharge) after surgery. The advantage of using a jelly snake is that it is a simple, inexpensive, non-drug treatment. Parents are very keen to avoid the use of drugs for their children and so would be open to the use of this new approach. For children the jelly snake offers something familiar and an enjoyable solution to their discomfort. The use of jelly snakes could also be a simple intervention that parents could do at home following day case surgery for other procedures. While the jelly snakes are high in sugar, they are comparable to the sugar content of a glass of fruit juice, flavoured milk or soft drinks. Generally, in our experience, the willingness of parents to allow their children to receive treats in the postoperative period is very high, particularly since all children have a significant time of fasting (at least 6 hours, often longer) for solid foods prior to surgery.

  • Investigating the impact of short automated text message reminder system in improving influenza vaccine uptake in children with chronic lung conditions: a randomised controlled trial

    Influenza vaccination coverage in children with chronic lung conditions has been poor in Australia. This study aims to find out whether text message reminder system is effective in improving influenza vaccination uptake in these children. Parents of children with chronic lung diseases who attended the Sydney Children's Hospital Randwick during 2010-16 will be recruited to participate in this study, which will be carried out between May and October 2018. Participants will be randomised into 3 groups i.e. one control and 2 intervention groups. For those in the intervention groups, they will receive an education flyer with information about influenza vaccination via postal mail at the beginning of the flu season. In addition,one of the intervention groups will receive vaccination reminder text message twice a month during the study period. No education flyer or text message will be sent to participants in the control arm. At the end of the study period, a link to an online survey will be delivered to all participants via text messages. Differences in influenza vaccination rate will be compared among the three groups using chi square exact tests and attitudes toward influenza vaccine and reminder system will be examined.

  • BAN-Dep: A Trial to Decrease the Prevalence of Depression in Australian Nursing Homes.

    Depression is an exceedingly common and debilitating disorder among older adults living in Residential Aged Care Facility (RACF). To date, attempts to decrease its prevalence have relied largely on assertive case-finding (directly or through the training of care staff) and treatment of those affected with antidepressants or psychological interventions, although the benefits for residents seem to have been limited and difficult to sustain over time. Existing data have shown that up-skilling RACF staff to assess and diagnose depression is helpful, as is the use of structured behavioural interventions. There is also evidence, from community studies, that Behaviour Activation (BA) is a simple, inexpensive and effective intervention to treat and prevent depression in later life, particularly when delivered in a collaborative care context. In addition, RACF interventions focused on older adults with dementia have shown the importance of supported local leadership (“Dementia Champions”) to promote and sustain the acquisition of practical knowledge about dementia assessment and care. In other words, it is possible that the absence of supported local leadership could have contributed to limit the benefits of interventions designed to decrease the prevalence of depression in RACF. The present study will build on the beyondblue e-learning Professional Education to Aged Care (PEAC) package. PEAC increases knowledge about depression and enhances the self-efficacy of staff working in RACF. We will test if the systematic training and supervision of a nominated ‘Mental Health Champion’ (MHC) on the principles and delivery of a BA program can contribute to enhance and improve the sustainability of the reported benefits associated with PEAC. Specific aim of trial: To determine whether training a local staff member in the use of a structured BA program enhances the benefits of the beyondblue e-learning PEAC program and decreases the prevalence of depression among older adults living in RACF.

  • An exploration of the feasibility of an attachment based intervention for Eating Disorders

    This study is evaluating a group therapy, Experiential Awareness Therapy, for people experiencing disordered eating. Experiential Awareness Therapy is an evidenced based therapy aimed at enhancing psychological functioning for eating disorder recovery. Benefits of participating This therapy will aim to: • Increase participants ability to regulate their emotions • Increase participants sense of self-worth and support a realistic and functional understanding of others • Enhance participants ability to identify and understand their emotions and feelings and also identify others intentions, emotions and feelings. • To facilitate an understanding of how these areas of psychological functioning impact eating disordered symptomology. Enhancing these abilities has been shown to be supportive of recovery from disorder eating and also enhance quality of life.

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