ANZCTR search results

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

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32712 results sorted by trial registration date.
  • REDUcing the burden of dialysis Catheter ComplicaTIOns in patients with kidney disease: a National approach

    Healthcare associated infections (HAI) threaten the safety of patients and cause significant and life-threatening harm to patients and bring major additional costs to already stretched health budgets. Patients with kidney disease are especially susceptible to HAI, and most prominent among these is the harm associated with central venous haemodialysis catheter use. The absence of a systematic approach to the challenges arising from dialysis catheter use means one of the major patient safety challenges in this susceptible patient group remains very real, poorly measured and the subject of large variations in practice. The REDUCCTION Project Objectives: 1. To define the clinical and economic burden of dialysis catheter exposure and bacteraemia across Australia and New Zealand at a facility level 2. To reduce dialysis catheter related bacteraemia through implementation of an evidence-based and systematic intervention package 3. To establish a framework from the evidence implementation project for monitoring dialysis catheter related bacteraemia and sustaining improvements from the intervention phase

  • The effects of laser therapy on orthodontic root resorption and pain management: A pilot study

    The purpose of this study is to investigate the effectiveness of low-level laser therapy in the management of orthodontic pain during orthodontic therapy and to see if it affects root resorption of teeth. The findings from this study will be compared to other related studies performed previously. By applying pain-free laser therapy on one side next to a tooth we hope to examine its effect on root resorption. This will increase our quality of care and help prevent this damage to patients’ teeth during treatment.

  • Psychosocial outcomes post-major burn injuries in adults – a longitudinal exploratory study.

    This project is an observational prospective longitudinal cohort study with a correlational analysis to quantitatively explore the relationship between burns outcomes and domains such as injury, treatment, personal (individual) and social (environmental) factors. The objective is to identify factors that impede quality of life outcomes post-major burn in adults, in order to inform multidisciplinary clinical models of care that can target the most powerful determinants of outcome. There has been a paucity of research specifically investigating the relationship between the social factors identified to increase risk of burns and the quality of life outcomes associated with these factors. It has been found that injury severity and burns treatment factors are less predictive of injury outcome than social factors such as level of education and income. However, the reliability of this evidence has been limited due to retrospective study designs and small sample sizes. The aim of this study is to prospectively evaluate various factors that have been previously evidenced to influence aspects of recovery such as functional or mental health outcomes. It will endeavour to determine which of the variables are significantly associated with and have the greatest explanatory power to predict long term quality of life outcomes. These will be investigated in terms of individual outcomes as well as broader societal burden of injury outcomes. In this study, patients admitted to the Royal Brisbane and Women’s Hospital following a burn injury will be enrolled with consent. They will be invited to answer a researcher-led 15 minute questionnaire within the first two weeks of their burn injury or when they resume capacity to consent. For a proportion of participants there will be an initial period of incapacity due to sedation and intubation or delirium. This survey will be about life before their burn injury. They will then be phoned by the researcher at 3 months, 6 months and 12 months post-burn to answer further survey questions which are anticipated to take 45 minutes per time-point. Other injury and treatment related information will be sourced from the Royal Brisbane and Women’s Hospital Burns Database and the medical record, with participant consent.

  • The influence of Q-angle, proprioception and kinesiology tape on lower limb landing biomechanics.

    Lower limb pathology is the most common form of disability among sporting populations, accounting for over 50% of all sporting injuries. Kinesiology tape has been marketed as a means of altering muscle activity and improving proprioceptive function, however the research that currently exists around the ability of kinesiology tape to achieve these outcomes is both limited and inconsistent. This study has been developed with two aims. 1) Investigate the relationship between kinesiology tape and muscle activity during a dynamic task, and 2) Investigate the relationship between kinesiology tape and dynamic proprioception. The results of this study will therefore have implications for those currently using kinesiology tape to alter proprioception and muscle activity. This study will be experimental, using a cross-over design. The participants will be randomly assigned to either an intervention or a sham group initially, performing a series of movement tasks with either kinesiology tape or a sham tape applied. Following a wash-out period, each participant will then cross-over and complete the same movement tasks using the alternate taping intervention.

  • A Single-Center, Randomized, Open-Label, Two-Period, Cross Over, Pharmacokinetic Study to Assess the Relative Bioavailability of Nicotine Delivered by the Chrono Quit Smoking Solution (CQSS1) versus NicoDerm (Registered Trademark) CQ (Registered Trademark) Patch

    Phase 2, single-center, randomized, open-label, two-period, cross-over, PK study to assess the relative bioavailability of nicotine in non-treatment seeking healthy smokers following 1 day of nicotine from the drug delivery system (CQSS1) and the NicoDerm CQ Patch. Additionally, the steady-state PK profile of nicotine delivered by the CQSS1 will be determined following 3 days of nicotine delivery. Skin adhesion, application site location, taping, safety, and tolerability will be evaluated

  • Effectiveness of an emergency nurse practitioner service for adults presenting to rural hospitals with chest pain

    The overall aims of this study were to examine the effectiveness of the rural ENP service model. Specific aims were to: i) Examine the safety and quality of the ENP service model in the provision of care in the rural environment, and ii) Evaluate the effectiveness of ENP service in the management of patients presenting with undifferentiated chest pain. In order to achieve the study aims we investigated several outcomes in order to address the following research questions: * What are the health service structures that influence the ENP delivery of safe, quality care for patients presenting to rural EDs with chest pain? * Are the processes of care for patients who present to rural EDs with chest pain equivalent for patients managed by an ENP service to those managed in the standard model of care? * Are the comparative outcomes for patients who present to rural EDs with chest pain equivalent for patients managed by an ENP service to those managed in the standard model of care? To address the research questions the following null hypotheses were tested: Hypothesis One – Primary outcome For patients presenting to rural emergency departments with suspected or confirmed acute coronary syndrome who are managed by the ENP service or standard medical care, there will be no difference in: (i) Use of evidence based guidelines for management of care as measured by the extent to which this is demonstrated in the clinical record and, (ii) Diagnostic accuracy as measured by accuracy of electrocardiogram (ECG) interpretation. Hypothesis Two For patients presenting to rural emergency departments with undifferentiated chest pain who are managed by an ENP or standard medical care, there will be no difference in: (i) Service indicators of a. Median waiting times b. Overall Length-of-stay in the emergency department for all patients presenting with chest pain c. Did-not-wait rates (ii) Diagnostic accuracy as measured by rates of unplanned representation within seven-days Hypothesis Three For patients presenting to rural emergency departments with undifferentiated chest pain who are managed by ENP service or standard care there will be no difference in levels of patient-reported outcomes related to: i) Satisfaction with care ii) Quality-of-Life (QoL) iii) Functional status

  • Examining the impact of targeting sleep on child physical activity levels

    Previous research to improve physical activity in preschool aged children have resulted in only small improvements in child activity levels. Efforts to improve the impact of physical activity interventions may need to consider targeting other potential determinants of child activity. In the recent years, the relationship between sleep duration and obesity, as well as it's related modifiable risk factors (nutrition and physical activity) has received considerable attention. The current evidence examining the association between sleep duration and physical activity in children however have reported mixed findings and consists primarily of cross-sectional studies. Randomised trials provide an opportunity to explore the causal relationship between sleep and child physical activity. The proposed study therefore aims to examine the impact of an intervention targeting sleep duration on child activity levels. The research seeks to answer this question by supporting parents to modify sleep routines in their home and measures the potential impact of such an intervention on child PA and sleep. This study will use a randomised controlled trial study design with 150 children aged between 3-5 years old. Parents of 3- to 5-year-old children attending randomly selected childcare centres in the Hunter New England region of New South Wales, Australia will be approached to participate and randomised to receive an intervention targeting sleep practices and a no intervention control group. Parents in the intervention arm will receive a 3-month intervention consisting of a pre-recorded video module outlining practical tips for establishing and implementing strategies conducive to supporting sleep for their child, one follow up support call to support implementation of those strategies and two text messages to reinforce messages provided in the web link and video. The primary outcome of the trial will be the number of minutes the child spends in moderate to vigorous physical activity assessed using an accelerometer. Secondary outcomes include total time in physical activity, sleep duration and child BMI. All data collection will occur at baseline and approximately 3-months follow up.

  • Evaluation of Gold Coast Integrated Care for patients with chronic disease through a non-randomised controlled clinical trial

    The Gold Coast Hospital and Health Service together with the Gold Coast Medicare Local have jointly developed the Gold Coast Integrated Care Delivery Model. This model of care will be delivered mainly in the primary care sector to provide the most cost effective solution for the holistic management of high risk patients such as the elderly and those with chronic, complex and com-morbid conditions such as diabetes, chronic obstructive pulmonary disease, renal and cardiac disease. The patient-centred model will bring together the multi-professional teams within the Gold Coast Hospital and Health Service with General Practice and community based teams to produce a single system that can minimise duplication and maximise care coordination within a holistic framework. It is expected that a total of approximately 1,500 high risk patients will be recruited from the participating GP clinics for the intervention arm of the trial. The approximately 3,000 participants of the control arm will be selected based from patients of non-participating GP clinics, with matching age, gender and health characteristics to the intervention group. A Coordination Centre will be established for the four-year pilot phase and will navigate and co-ordinate health services, linking the patient and GPs with all other relevant services. To determine the effectiveness of this new model of care an evaluation is proposed and will involve three components: (1) Process evaluation to examine the development and implementation of the integrated care pilot including reach, program processes and strategies, (2) Impact evaluation to assess changes in participants clinical outcomes, health service utilisation, quality of life and satisfaction, and (3) Outcome evaluation to measure the long term effectiveness of the integrated care program in reducing unplanned admissions, improving quality of life and patient/staff satisfaction. The primary aim is to evaluate whether the model delivered best patient outcomes at the lowest cost for high risk patients.

  • PLeural Effusion and Symptom Evaluation (PLEASE) study on the pathophysiology of breathlessness in patients with symptomatic pleural effusions

    Introduction: Pleural effusion is a common clinical problem that can complicate many medical conditions. Breathlessness is the most common symptom of pleural effusion of any cause and the commonest reason for pleural drainage. However, improvement in breathlessness following drainage of the effusion is variable, with some patients experiencing either no benefit or worsening of their symptoms. The physiological mechanisms underpinning breathlessness in pleural effusion patients are complex and likely multi-factorial, with patient and effusion-related factors likely contributing. Comprehensively studying the physiological and symptom responses to pleural effusion drainage will provide a better understanding of the condition and could potentially identify predictors of benefit from drainage. The ability to identify those patients, whose breathlessness will improve from pleural fluid drainage from those who will not, will help avoid unnecessary pleural drainage procedures and their associated morbidities and cost. The PLeural Effusion and Symptom Evaluation (PLEASE) study will be the first prospective study to comprehensively evaluate the factors contributing to pleural effusion-related breathlessness. Methods and analysis: The PLEASE study is a single centre prospective study of 150 patients with symptomatic pleural effusions that require therapeutic drainage. The study aims to identify key factors that underlie breathlessness in pleural effusion patients and develop predictors of improvement in breathlessness following effusion drainage. Participants will undergo evaluation pre- and post-effusion drainage to assess functional impairment at rest and during exercise, respiratory and other physiological responses and respiratory muscle mechanics. Pre- and post-drainage parameters will be collected and compared to identify the key factors and mechanisms that correlate with symptom improvement.

  • A parent-delivered intervention for infants with social and communication delay

    Autism Spectrum Disorder (ASD) is a lifelong developmental disorder affecting more than 1% of people. Social and communication therapies during early childhood are critical for promoting favourable longer-term outcomes in ASD. However, until very recently we have not had interventions tailored towards infants (<14 months of age) who are at increased risk for ASD. iBASIS-VIPP is a parent-mediated intervention in which therapists use video-feedback to help parents adapt to their infants’ interactive styles and promote optimal social and communicative development. Previous research has also shown that the iBASIS-VIPP protocol has preliminary efficacy for improving the developmental outcomes among infants who are at high risk of developing ASD because an older sibling had the condition. The next stage of this research programme is to test the iBASIS-VIPP intervention with infants presenting to a clinical setting with ASD risk-behaviours, such as social and communication delays. The study design is a two-site (Perth, Melbourne), two-arm (‘Treatment as Usual’, ‘iBASIS-VIPP'), single-blind (rater) randomized controlled trial (RCT). We will recruit 132 infants (n = 66 at each site) who are between 9 and 14-months of age and showing ASD-risk behaviours (social and/or communication difficulties). Consenting families will be randomized into receiving either the ‘iBASIS-VIPP Therapy’ (n = 66) or ‘Treatment as Usual’. Families in the ‘iBASIS-VIPP Therapy’ group will receive 10 home-based sessions with a Speech Pathologist or Psychologist over five months, and undertake 30-minutes daily home practice. Families in the ‘Treatment as Usual’ group may receive a parent information seminar, the provision of reading material on infant development, or developmental monitoring, which is the current ‘best practice’ protocol for these infants. Infants in both groups will be re-assessed follow-up points, time-locked to baseline assessments: (1) 6 months post-baseline (i.e., immediately post ‘treatment’ period), (2) 12- months post-baseline, and (3) 24-months post-baseline. The primary outcome will be autistic symptom severity immediately post treatment (measured by the AOSI). Secondary outcomes will be a range of social and communicative behaviours relevant to ASD at each of the three follow-up points.

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