ANZCTR search results

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

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31301 results sorted by trial registration date.
  • 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.

  • Monitoring breathing in children during anaesthesia: The Electrical Impedance Tomography study

    Mechanical ventilation is often required to support respiratory function but it can cause lung injury. This risk is well understood in the Intensive Care Unit setting where mechanical ventilation is often required for long periods of time but the impact of short exposure to mechanical ventilation during anaesthesia is unknown. Some populations, in particular neonates and small infants, are at greater risk of this potential detrimental effect. One of the principal factors related to ventilator induced lung injury is the inhomogeneity of lung ventilation. To evaluate lung homogeneity, imaging techniques are usually used, although these are often invasive, intermittent and time consuming. Recently a new technology, called Electrical Impedance Tomography (EIT), has been developed. EIT is a non-invasive, radiation-free monitoring tool that allows real-time continuous imaging of ventilation at the bedside, measuring the impedance of the thorax through a belt placed around patient's chest. This study will use EIT to define the patterns of tidal ventilation within the chest and determine whether mechanical ventilation during general anaesthesia increases the risk of lung inhomogeneity in neonates and small infants. We also hope to determine if there is a correlation between the degree of lung inhomogeneity and different aspects of mechanical ventilation. These results could improve our knowledge about the impact of mechanical ventilation on the neonatal lung and help us to find best management for neonatal ventilation during an anaesthetic.

  • Weighing Practices in the early stages of inpatient treatment for Anorexia and Bulimia Nervosa

    This study aims to compare different weighing practices in the early stages of inpatient treatment for Anorexia Nervosa and Bulimia Nervosa. Specifically, we aim to compare the benefits of “open weighing” (where patients are weighed within the therapy session and their weight is then discussed with the therapist overtly) and “blind weighing” (where patients are weighed by the therapist but this information is not shared with him or her). Despite considerable debate about this issue in the literature, to our knowledge, there has been no systematic comparison of patient outcomes following blind and open weighing. Weighing is a key component in the treatment of eating disorders and specific evidence is needed to determine which approach is most beneficial for patients. The current project aims to fill this gap by comparing weighing methods in a specialised inpatient setting. Participants will be randomised to either open weighing or blind weighing. Following consent (assent for adolescents aged< 18 years), participants will be randomised in blocks. The primary outcome variable will be anxiety levels before and after being weighed. Secondary outcomes include rate of weight gain, body and weight preoccupations, tolerance of uncertainty, meal completion and treatment motivation.

  • Tell Your Story: An Online Intervention for Reducing Stigma in Traumatised Refugees

    Refugee men exhibit elevated rates of Post-traumatic Stress Disorder (PTSD), an impairing psychological disorder. Refugee men are also highly vulnerable to the effects of self-stigma, which is associated with a range of negative outcomes, including unemployment and income loss, interpersonal difficulties, decreased self-esteem, and low treatment-seeking behaviour. This project proposes to test the efficacy of an evidence-based online intervention (“Tell Your Story” website) targeting self-stigma for refugee men with PTSD. Refugee men will be invited to take part in the study, recruited via caseworkers at refugee settlement agencies and advertisements within refugee networks, with 200 men expected to enter the study following telephone eligibility screening, information and consent processes. Participants will be randomly assigned to either receive the intervention immediately (intervention condition) or will be placed on an eight week waiting list (waitlist control condition), before access to the intervention is granted. From then on participants in the waitlist will go through the same procedure as the intervention group, The ‘Tell your Story” online intervention comprises of twelve short interactive web-based modules, containing short videos, activities and integrated measurement tools. It is available in Tamil, Farsi and Arabic. Community consultants from refugee communities have been involved in the design of the study and intervention and will continue to be consulted throughout the project. Participants will complete pre-intervention, post-intervention (4 weeks after commencing intervention) and follow-up (8 weeks after commencing intervention) measures of self-stigma, help-seeking intentions, help-seeking behaviours, PTSD symptoms and mental health-related quality of life online, with telephone support if required. Please see attached document 'Procedure Diagram' for an overview of study flow.

  • Test reliability of the Brief-BESTest in people with chronic obstructive pulmonary disease

    Balance impairments have been demonstrated in people with COPD. Yet measuring balance and incorporating specific balance training components in exercise training is still not part of common practice in pulmonary rehabilitation. The Balance Evaluation System Test (BESTest) is a reliable and responsive test to detect improvement in balance for people with balance impairments and it covers six balance control systems: biomechanical constraints, stability limits / verticality, anticipatory postural adjustments, postural responses, sensory orientation, and stability in gait. Although it has been shown to be a reliable balance assessment tool for people with balance impairments, it can take at least 40 minutes to complete. In response to the limitations of the BESTest, the Brief-BESTest has been developed. It takes less time to complete and requires less equipment which could make the Brief-BESTest more feasible for clinical use. The reliability of the Brief-BESTest has been tested in people with chronic health diseases such as Parkinson’s disease but it has never been tested in people with COPD. Therefore, the aim of this study is to investigate the intra- and inter-assessor reliability of the Brief-BESTest in people with COPD. This is a prospective, single group, interventional study where people with COPD will be recruited from two sites in Sydney – Concord Hospital and Royal Prince Alfred Hospital. All participants will be asked to attend two assessment sessions (in addition to their routine assessment for pulmonary rehabilitation program).

  • A survey on use of supplemental oxygen therapy during pulmonary rehabilitation for people with chronic obstructive pulmonary disease (COPD)

    Exercise-induced oxygen desaturation is common in people with chronic lung diseases who are not on long-term oxygen therapy. Supplemental oxygen therapy is often used during exercise testing and training in pulmonary rehabilitation programs. However, there are no standard Australian guidelines on the use and prescription of supplemental oxygen therapy during exercise testing and training in this patient population so current practice remains unknown. Consequently, we are interested in investigating the use of supplemental oxygen therapy in pulmonary rehabilitation. The study aims to evaluate the current pattern of prescribing and using supplemental oxygen therapy in pulmonary rehabilitation programs in Australia.

  • Getting back to work: a job resource package for adults with spinal cord injury

    Research indicates a low employment rate among adults with spinal cord injury (SCI) despite many feeling capable of engaging in paid employment. Resuming employment after SCI provides an opportunity to interact with others and has been shown to contribute to general wellbeing and life satisfaction. Though specialist vocational rehabilitation services exist, barriers to accessing these services have been identified. These barriers include (but are not limited to): delays in the timeliness of vocational interventions, transportation and/or financial difficulties, and social stigma. In this context, time-efficient, cost-effective and accessible methods of vocational service delivery present clinical appeal. This includes the use of information and communication technologies (i.e. Internet) to supplement face-to-face rehabilitation. Specific aims will of this study will be to: 1. Develop and evaluate an online vocational resource for working-age adults with SCI. 2. Identify facilitators of, and barriers to, online learning We expect to demonstrate that: 1. Vocational rehabilitation can be applied in an online format 2. Access to online services will facilitate and promote vocational behaviours and, potentially, contribute to positive mental health outcomes.

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