ANZCTR search results

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

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32856 results sorted by trial registration date.
  • Using e-learning and the theory of planned behaviour to predict behavioural intention in Chronic Kidney Disease screening practices in Australian primary health care nurses: A randomised controlled trial

    Opportunistic screening for chronic kidney disease in the primary care health setting plays an integral role in early detection and subsequent management. However, there are significant deficits in current screening practices despite early identification being a national kidney health priority. Consequently, there is a need to identify strategies to improve screening practices. One potential way is through the education of practice nurses. However equitable access to professional development opportunities, particularly for nurses from rural and remote communities, can be challenging. E-learning provides a potential solution to this challenge. This study will use a single blinded randomised controlled trial to evaluate the effectiveness of an asynchronous e-learning module on learner satisfaction, knowledge acquisition and changes in behavioural intentions related to the primary health care nurses intentions to perform a kidney health check. The primary hypothesis of the study is that participants randomised to an asynchronous e-learning group will have an increase in behavioural intention of at least 0.3 standard deviation within one week follow-up, measured using the theory of planned behaviour, compared with participants randomised to an active control group. Behaviour intention will be evaluated using a an instrument constructed with reference to the Theory of Planned Behaviour and will be the major focus of this study.

  • Decreasing Defensive Responses: Investigating the Safe & Sound Protocol (SSP) to improve emotional regulation, communication, and social engagement with children with Autism.

    Studies are increasingly exploring the neurobiology of Neurodevelopmental Disorders and linking atypical neurophysiological patterns to clinical behaviour. The ability to regulate emotional state has been identified as a core feature of many psychopathologies including anxiety, attention problems, depression neurodevelopmental delays and autism (Beauchaine, 2001). The Polyvagal Theory (PVT) provides a framework for interpreting physiological systems in relation to emotional regulation for adaptive prosocial behavioural responses (S. W. Porges, 2001). Autism Spectrum Disorders (ASD) present with primary dysfunction in social interactions, communication impairments and restricted and repetitive patterns of interests and behaviours (American Psychiatric Association, 2013). Although not typically part of diagnostic criteria, auditory processing or hyperacusis are often evident in ASD and can impact emotional regulation and prosocial behaviours. ASD is a complex neurodevelopmental disorder and therapeutic interventions typically employed utilize behavioural strategies to address the range of behavioural difficulties presented. The Safe & Sound Protocol (SSP) is a novel intervention intended to impact neural systems supporting psychological experience and behaviour. Hypothesis That the Safe and Sound Protocol results in decreased auditory hypersensitivities and improved auditory processing, with associated improved autonomic and cortical neural regulation enabling prosocial behaviors.

  • An investigation of the effectiveness of a self help book with no therapist support in the treatment of multiple anxiety disorders.

    The purpose of this study is to investigate the effectiveness of a self-help workbook “Face Your Fears” (Author Dr. D.F. Tolin). This workbook is written by a leading expert in the field and contains cognitive behavioural therapy skills to equip participants to learn how to address all anxiety disorders.

  • Oral care intervention to reduce aspiration pneumonia risk for people living in residential aged care

    The Wicking Dementia Research and Education Centre at the University of Tasmania has received federal funding to conduct a study into how changes in oral care may reduce aspiration pneumonia risk for adults living in residential aged care, especially adults who have cognitive impairment or dementia. Masonic Care Tasmania, through the Fred French and Peace Haven Homes, has agreed to participate in this oral health study. Aspiration pneumonia is a lung infection for which people are often hospitalised, and people with dementia seem to be particularly vulnerable. Aspiration pneumonia develops when food, liquid and/or saliva containing harmful oral bacteria is misdirected (aspirated) into the airway and then into the lungs and the lungs cannot clear the aspirated material. Studies show that keeping the mouth clean plays a critical role in preventing aspiration pneumonia. Keeping the mouth clean is best done by conducting an oral health screening to see how healthy each person’s mouth is, taking care of any immediate oral and/or dental problems, and then ensuring that people residing in aged care clean their teeth for 2 minutes after each meal or clean their dentures each day and remove them for sleep. Our aim is to see if oral health screening followed by a 3-month intervention period of 2 minutes of teeth cleaning after meals or daily cleaning of dentures with removal for sleep reduces clinical signs of aspiration pneumonia, especially for people with dementia who live at Masonic Care Tasmania/Launceston.

  • CHAMP: Clearing High Risk HPV Among Men who have sex with Men Pilot

    Gay and other men who have sex with men (MSM) with HIV infection have the highest rates of anal cancer. The HPV vaccine is not beneficial for adult MSM with HIV who already have high risk HPV types. As treatment for the precursor to anal cancer (anal intraepithelial neoplasia, or AIN) is both invasive and inefficient, a method of clearing anal HPV before it progresses to AIN is needed for MSM with HIV. The aim of this pilot study is to determine the proportion of MSM with HIV and high risk types of HPV that can tolerate 5% imiquimod cream three times a week for 16 weeks followed by weekly imiquimod cream for 12 months. The secondary aim is to determine the proportion of individuals with HIV and high risk types of HPV who agree to be part of the trial. We will recruit MSM who have HIV from Melbourne Sexual Health Centre when they present to clinic for routine care. Consenting men will be tested for high risk types of HPV in the anus and only those with at least one high risk type will be eligible. Eligible men will receive the HPV vaccine and imiquimod treatment for 3x/week application for 4 months followed by 1 year of 1x/week application. We expect MSM with HIV and high risk HPV will tolerate this treatment and it will clear HPV.

  • Quality of recovery after propofol vs sevoflurane anaesthesia: A randomised study in lumbar spinal surgery patients

    To compare QoR-40 scores twenty-four hours post-operatively in patients who have undergone general anaesthesia using propofol infusion as maintenance to those in whom sevoflurane inhalation is used as maintenance. To compare rates of nausea and vomiting, pain scores and opioid consumption twenty-four hours post-operatively in patients who have undergone general anaesthesia using intravenous agents only as maintenance to those in whom sevoflurane inhalation is used as maintenance. To achieve this, participants will be asked to complete Visual Analogue Scale (VAS) questionnaires, one for pain and one for nausea, at baseline and at the twenty-four hour post-operative visit.

  • A double-blind randomised controlled trial comparing two physiotherapy interventions to treat hip impingement.

    Femoroacetabular (hip) impingement (FAI) is a painful condition that commonly affects healthy active younger adults. It can limit their ability to continue playing sport and perform normal daily activities. It can be related to extra bone formation at the hip joint known as a cam deformity. Physiotherapy is one treatment people may use to reduce their symptoms and improve their function. This double-blind, randomised controlled trial (RCT) aims to compare the effects of two different physiotherapy treatment interventions to reduce pain and improve function in people with FAI.

  • The Breast Milk Omega-3 Trial: Assessing the uptake of a specific omega-3 supplement into breast milk

    Omega-3 fatty acids, in particular Docosahexaenoic acid (DHA) and Eicosapentaenoic acid (EPA) are known to play a critical role in both maternal health and infant development, and have a particularly important role in protection against preterm delivery and in ensuring the optimal development of the brain and visual system of the fetus and infant (Makrides & Gibson, Med J Aust, 2002; Demmelmair & Koletzko, World Rev Nutr Dietet, 2015). Achieving and maintaining an adequate supply of these fatty acids during pregnancy and breastfeeding is therefore of vital importance for both short and long term health outcomes of the infant. Recent studies have suggested that many women of childbearing age in many countries, including Australia and the US, fail to meet the recommended levels of intake of these fatty acids, and as a result have a low omega-3 status (Meyer, Nutrients, 2016). Therefore, there is a concern that a significant proportion of women have an insufficient omega-3 status during pregnancy and while breastfeeding in order to meet the needs of their infant. In addition, fish consumption in the majority of these countries also remains low, and therefore these women rely predominately on omega-3 supplements in order to increase their omega-3 status. It is also known, however, that the bioavailability of different supplements into human blood and breast milk can vary significantly according to the formulation and form in which the fatty acids are provided. This is particularly important in the case of women who are breastfeeding, since the uptake of supplements into breast milk depends on both the efficiency of uptake into the maternal circulation, and the transfer of these fatty acids to the breast milk. As such, it is vital to directly test the ability of supplements provided to lactating women to be taken up into the breast milk. The primary objective of this study is to assess the effect of supplementing breastfeeding women with the Pronovum formulation PRF-037 (150:500 Ethyl Ester in SMEDDS) on concentrations of DHA and EPA in breast milk after 4 weeks of supplementation.

  • Single dose study of febuxostat (80 mg) in healthy subjects.

    Healthy subjects will be administered a single dose of febuxostat (80 mg) to examine the the pharmacokinetic and pharmacodynamic profiles of febuxostat following the administration of a single dose (80 mg). This study will also investigate the effect of a single dose of febuxostat (80 mg) on the renal handling of urate.

  • Recumbent bike riding for people with fractured neck of femur: A feasibility trial

    Early mobilisation post operatively is a key recommendation for people with fractured neck of femur (NOF). Exercise and early mobilisation may reduce complications post operatively, including delirium, and may lead to shorter length of stay and better outcomes. However, evidence indicates that as few as 50 % of people are able to be mobilised by day 2 post operatively. Barriers to mobilisation include confusion and drowsiness, low blood pressure or an unacceptable level of manual handling risk. Other methods of safely exercising people with fractured NOF who are unable to safely mobilise should be explored. Recumbent bike riding has been used for exercise in other bed bound populations including spinal cord injury and patients from an intensive care unit. Evidence has shown this treatment is feasible and safe in these populations. There is preliminary evidence that recumbent bike riding is associated with reduced incidence of delirium and reduced muscle wasting in people from Intensive Care Units (ICU). Recumbent bike riding has potential to allow early exercise in people with a fractured NOF, however to date this intervention has not been used in this population. Thus the purpose of this study is to demonstrate the feasibility of a trial of recumbent bike riding in people unable to mobilise post fracture NOF. A secondary aim is to obtain preliminary data on the impact of recumbent bike riding on mobility, delirium and length of stay. Fifty people who have received surgical management for a fractured NOF will be recruited within 48 hours of surgery. They will be randomly allocated to receive either usual care or usual care plus up to an hour active recumbent bike cycling. They will continue to receive the intervention until they can walk 15m with assistance of one person for two consecutive day. Primary outcomes include data demonstrating the feasibility of delivering the intervention and conducting the proposed RCT. The primary clinical outcome is mobility seven days post operatively, as measured using the Modified Iowa Level of Assistance Scale. (mILOA) Secondary clinical outcomes include mobility at discharge (measured using the mILOA and gait speed), discharge destination, length of stay and quality of life. Data from this study will inform the design of a larger RCT which will form the basis of applications to NHMRC and other funding bodies.

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