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Research Topic : Randomized controlled trial
Australian State/Territory : VIC
Scheme : NHMRC Project Grants
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  • Funded Activity

    Early Intervention For Anxiety And Phobic Disorders In Young Children With Intellectual Disability

    Funder
    National Health and Medical Research Council
    Funding Amount
    $305,674.00
    Summary
    Children with intellectual disability (ID) are 2-3 times more likely to have behavioural and emotional disturbance, including anxiety and fears, than children of normal intellectual ability. Anxiety problems are a source of distress for the child, impair their ability to learn and are a cause of family burden and community cost. Therefore, effective interventions are urgently required. Research with non-disabled children has demonstrated the effectiveness of teaching parents to manage their chil .... Children with intellectual disability (ID) are 2-3 times more likely to have behavioural and emotional disturbance, including anxiety and fears, than children of normal intellectual ability. Anxiety problems are a source of distress for the child, impair their ability to learn and are a cause of family burden and community cost. Therefore, effective interventions are urgently required. Research with non-disabled children has demonstrated the effectiveness of teaching parents to manage their child's anxiety, however the effectiveness of this approach in children with ID has not yet been established. This project aims to compare the relative effectiveness of two intervention conditions compared to a waiting list group, for highly anxious children aged 4-7 years with ID. One intervention will teach parents to help their child deal with anxiety problems, and develop skills to overcome their own associated emotional upset and family and social problems. The other intervention will provide non-directive counselling and support to help the parents understand the nature and causes of ID, associated anxiety problems in the child, and parent and family stress. The long term outcome of these two interventions will be assessed by following the children and their families for two years. A manual of each treatment is produced. This project aims to provide evidence for a relatively inexpensive, feasible and effective early intervention program for young children with ID at risk for developing anxiety problems that can be easily taught to professionals and is acceptable to parents. Widespread use of this intervention has the potential to reduce the added burden and cost to families and the community of persistent severe anxiety in young people with ID.
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    Funded Activity

    A Randomised Controlled Trial Of A Nurse-led Intervention For Less Chronic Heart Failure: The NIL-CHF Study

    Funder
    National Health and Medical Research Council
    Funding Amount
    $1,166,160.00
    Summary
    The overall aim of the unique NIL-CHF Study is to examine the benefits of applying a specialist nurse-led, home and clinic-based intervention to optimise the care of recently discharged hospital patients with heart disease. Involving 950 patients, it will explore whether more flexible and individualised care to apply the best possible medical treatments is able to PREVENT the most deadly and disabling form of heart disease (chronic heart failure - CHF) and save money in the process.
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    Funded Activity

    A Randomised Controlled Trial Examining Stability Of New Types Of Highly Porous Surfaced Acetabular Components In Total Hip Replacement

    Funder
    National Health and Medical Research Council
    Funding Amount
    $216,490.00
    Summary
    Numbers of total hip replacements are steadily increasing. The most common complication of hip replacement is late implant loosening, which can be predicted by early migration. We will examine early migration of a trabecular metal acetabular cup without screws, compared to a titanium fibre metal acetabular cup fixed with screws. Ideally, an acetabular cup would achieve a level of initial stability by press-fit alone without screws, as screws increase the risk of bone loss around the prosthesis.
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    Funded Activity

    A Randomised Placebo-controlled Trial Of Antibiotics To Prevent Urinary Tract Infection In Children

    Funder
    National Health and Medical Research Council
    Funding Amount
    $735,000.00
    Summary
    This study is needed to determine whether a common clinical practice long-term antibiotic treatment for children following urinary tract infection (UTI) - is safe and effective in preventing further UTI and if so, whether all appropriate children are being treated. UTI will affect about 10% of Australian children by high school age (88,000 children per year). Because UTI may damage the kidneys, the management priority for children with UTI has been prevention of further infection. Currently this .... This study is needed to determine whether a common clinical practice long-term antibiotic treatment for children following urinary tract infection (UTI) - is safe and effective in preventing further UTI and if so, whether all appropriate children are being treated. UTI will affect about 10% of Australian children by high school age (88,000 children per year). Because UTI may damage the kidneys, the management priority for children with UTI has been prevention of further infection. Currently this means the identification of children thought to be most at risk of recurrent UTI by renal tract imaging. Those found to have reflux of urine from the bladder to the kidney (present in about 30% of those with UTI) are then placed on antibiotics fro 2-5 years. Unfortunately there has never been a properly designed trial to test whether antibiotics do really prevent UTI and if so, whether children with reflux are the appropriate and only group requiring treatment. Long term antibiotics may in fact do more harm than good because of side effects like skin, bowel and blood problems and because resistant bacteria may develop. The design of this study involves the random allocation of placebo or antibiotic (cotrimoxazole, the usual antibiotic given in this case) to about 800 children after their first symptomatic UTI. These children are treated and followed for one year to determine the rate of futher UTI in both groups. Any difference in outcome between the two groups of children will be because of the antibiotic treatment. This study may prove long-term antibiotics are ineffective and therefore should not be routinely used. In this case investigation of children to detect vesicoureteric reflux would serve little purpose and should be abandoned. Alternatively antibiotic treatment may be shown as effective treatment for preventing further UTI and in this case the study will clearly identify those children who will benefit.
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    Funded Activity

    Aspirin For The Prevention Of Cognitive Decline In The Elderly: A Neuro-Vascular Imaging Study (ENVIS-ion) From ASPREE

    Funder
    National Health and Medical Research Council
    Funding Amount
    $1,341,232.00
    Summary
    The ENVIS-ion trial will examine whether Aspirin is effective in delaying the onset of worsening of thinking and memory abilities in healthy older adults. Magnetic resonance imaging (MRI) of brain structure will detect markers of early worsening of thinking and memory abilities. Blood vessels in the back of the eye (retina) share many features with vessels in the brain. We will compare whether aspirin lessens changes over time of features shown with brain MRI and retinal photography.
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    Funded Activity

    A Trial Of A Multidisciplinary, Group Based Intervention To Meet The Needs Of Men With Prostate Cancer

    Funder
    National Health and Medical Research Council
    Funding Amount
    $524,285.00
    Summary
    This study will test an innovative approach to meeting the physical and psychosocial needs of men with early stage prostate cancer using a randomised controlled trial. This novel approach involves a combination of individual and group-based consultations which encourages peer-to-peer support, promotes self-care and enhances appropriate multidisciplinary referrals and communication. It provides a new model of care for patients with chronic diseases that can be translated into clinical practice.
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    Funded Activity

    Impact Of A Sleep Intervention In Children With ADHD: A Randomised Controlled Trial

    Funder
    National Health and Medical Research Council
    Funding Amount
    $384,230.00
    Summary
    Attention deficit hyperactivity disorder (ADHD) affects up to 7.5% of Australian children. Between 50 and 70% of parents also report sleep problems (eg night waking, insomnia) in their child with ADHD. Such sleep problems are associated with poorer child behaviour, concentration, and school attendance as well as poorer parent mental health and work attendance. This randomised controlled trial will determine whether treating sleep problems in children with ADHD can improve these outcomes.
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    Funded Activity

    Shared Team Approach Between Nurses And Doctors For Improved Risk Factor Management (STAND FIRM)

    Funder
    National Health and Medical Research Council
    Funding Amount
    $1,945,676.00
    Summary
    There are many proven treatments for preventing people with stroke from having a recurrent event, e.g. maintaining blood pressure at acceptable levels. However, uptake of therapies is poor. We will assess whether patients receiving individualised management plans, prepared and administered by both doctors and nurses will have risk factors controlled better than those receiving usual care. The plan includes education of patients to help them have more control over their own care.
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    Funded Activity

    The Clinical Value Of Serology And Molecular Tests For Diagnosing Invasive Aspergillosis In At-risk Hematology Patients

    Funder
    National Health and Medical Research Council
    Funding Amount
    $1,095,500.00
    Summary
    Aspergillus is a fungus found in soil, on farms and on construction sites. In those whose immune system is impaired it causes severe infection. The people who are particularly at high-risk of Aspergillus infection (called Invasive Aspergillosis) are those with acute leukaemia on chemotherapy or post bone marrow transplantation. Currently 15% of those at high-risk get Invasive Aspergillosis and 58-93% of those infected die. The main reason for this high death rate is that our current diagnostic t .... Aspergillus is a fungus found in soil, on farms and on construction sites. In those whose immune system is impaired it causes severe infection. The people who are particularly at high-risk of Aspergillus infection (called Invasive Aspergillosis) are those with acute leukaemia on chemotherapy or post bone marrow transplantation. Currently 15% of those at high-risk get Invasive Aspergillosis and 58-93% of those infected die. The main reason for this high death rate is that our current diagnostic tests are not good at detecting infection or often only detect the infection at advanced stages when treatment is ineffective. Because of the limitations of current diagnostic tests the current practice is to give empiric antifungal therapy (EAFT) early to treat Invasive Aspergillosis. However studies have demonstrated that this therapy has only resulted in a minor reduction in the mortality rates and it causes significant drug toxicity. It is a suboptimal treatment modality. New tests have been developed to diagnose Invasive Aspergillosis. These tests are for the detection of an Aspergillus protein in blood and for the detection of Aspergillus DNA in the blood. Available data suggests that these new tests are sensitive in the detection of Invasive Aspergillosis. Also other studies suggest that these new tests make an early diagnosis and seem to be able to monitor responses to treatment. However no study has been performed to date which demonstrates that the use of these tests can impact on important patient outcomes. This trial is designed to determine whether the use of the new tests to guide therapy will help improve treatment of Invasive Aspergillosis, reduce drug toxicity and reduce the death rate in the high-risk patients as compared with the current standard method of diagnosis and treatment with EAFT. If the trial is successful then this represents a significant advancement in the treatment and survival of leukaemic and bone marrow transplantation patients.
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    Funded Activity

    Improving Outcomes Of Preschool Language Delay In The Community: Randomised Trial

    Funder
    National Health and Medical Research Council
    Funding Amount
    $927,327.00
    Summary
    7-15% of preschool children have language delay, so are vulnerable to poor lifelong academic, social and economic outcomes. Small trials suggest that intervention helps. This randomized trial aims to find out the population costs and benefits of optimized intervention for 4 year olds following systematic identification of language delay. Because we have studied the 1500 participants since infancy, the trial could also shed light on why some children respond better than others to treatment.
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