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.
  • Behavioural and Cognitive Changes During Self-Guided Internet-Delivered Cognitive-Behavioural Therapy for Anxiety and Depression: A Randomised Controlled Trial

    This project is part of a research program examining the role that certain cognitions and behaviours play in mediating symptom reduction of internet-delivered cognitive behavioural therapy for depression and anxiety.

  • The Role Of Monitoring Meals On Wheels Recipients To Improve Physical And Mental Health

    Meals on Wheels services provide a key avenue to access some of the most vulnerable and in need members of our community, and is a key strategy to enhance the quality of life for the individual, through supporting and maintaining independent living at home. Ensuring adequate nutrition and preventing unintentional weight loss regardless of starting body weight, diets appropriate for individual medical conditions, and promoting physical activity within community dwelling older individuals, have the potential to be significant factors in maintaining independence, as well as reducing highcost health care services. However, despite all being strongly related to adequate nutritional intake, research regarding how Meals on Wheels services could be best utilised to decrease risk of a decline in physical and mental health, cognitive functioning, functional disability and health care utilisation is missing to date. This project will aim to investigate the consumption patterns of clients in terms of Meals on Wheels meals and other meals, as well as physical activity levels to enable a better understanding of the current recipients of Meals on Wheels. It will also aim to investigate whether a short term intervention focused on assisting the clients with meal ordering and food provision improves the client’s physical and mental health.

  • The impact of non-invasive brain stimulation on motor cortex excitability and cognition in chronic lower back pain

    This project will examine motor cortex excitability and cognition in people with chronic low back pain (CLBP). This project will investigate transcranial direct current stimulation (tDCS) for improving motor cortex excitability and cognition in CLBP. Participant’s motor cortex excitability and cognition will be measured before, and after 4-weeks of tDCS. It is predicted CLBP participants will demonstrate abnormal motor cortex excitability and impaired cognitive function, compared with age and gender-matched controls. It is also predicted that tDCS will restore normal motor cortex excitability and improve cognitive functioning in people with CLBP. The findings will provide a better understanding of the relationship between CLBP and the brain and the therapeutic potential of tDCS for CLBP.

  • The Effects of Regular Peak Flow Meter Utilisation on Asthma Self-Management

    Hypothesis: Adults with asthma using a peak flow meter regularly will improve their involvement in asthma self-management and their confidence in managing asthma. Primary objective: Evaluate whether peak flow meter introduction with appropriate education can improve participants’ engagement and confidence in managing their own asthma symptoms. Secondary objectives: - To review peak expiratory flow results - To assess influence of peak flow meter utilisation on asthma control. - To assess if peak flow meter utilisation aids in recognising breathing difficulties earlier.

  • Reducing Cardiovascular disease (CVD): Translating an evidence based quality improvement tool into ‘real-world’ general practice

    General Practitioners are faced with the daily dilemma of making choices about treating the acute versus the preventive problems of their patient population. They are also faced with regular changes in guidelines and recommendations about what and who to treat. This project seeks to improve the use of existing medical software to translate evidence based guidelines into everyday clinical practice. It is a Quality Improvement initiative that will provide GP's with an integrated desk top tool to help identify the high CVD risk patients and support the General Practice in a "whole of practice" based method of monitoring and improving the prevention strategies used for these patients. The project also aims to set up a Quality Improvement Network of local GP’s that will continue to function post intervention and assist GP’s with long term QI work. Central and Eastern Sydney PHN will be the host facilitator and support coordinator for this project. Each General Practice will be provided with two quality improvement tools: 1. PenCAT Clinical Audit Tool (Trademark) which allows practice staff to download data looking at the practice patient profile (such as demographics, disease statistics and prescribing), and; 2. HealthTracker, a desk top "point of care" tool, which can be used to facilitate the identification of high CVD risk patients and assist in the introduction of "best practice" interventions by the individual GP. In a recent clinical trial (Torpedo) HealthTracker has been proven to assist GP's in this preventive care work. 80 General Practices will be invited to participate in a Quality Improvement Collaborative where they will learn about how to make use of these tools to improve their identification and use of evidence based strategies for patients with high risk of cardiovascular disease. This project is particularly interested in the feasibility of setting up a Quality Improvement Network of local GP’s, facilitated externally by the IWSML, that will enable sustainable, long term quality improvement work in the localised General practice setting. Who is undertaking the project? This project is being conducted by Dr Charlotte Hespe and will form the basis for the degree of PhD at The University of Notre Dame Australia, under the supervision of A/Professor Lucie Rychetnik (UNDA), A/Professor David Peiris (George Institute) and Professor Mark Harris (UNSW).

  • Targeting Technical and Further Education students’ multiple health risk behaviours via proactively-offered online and telephone interventions

    Objective: To examine the effectiveness of proactively offering telephone and online support for reducing health risk behaviours among TAFE students at 6-months follow-up. Design: A cluster randomised controlled trial. Methods: A total of 100 TAFE classes (50 per condition) will take part. TAFE classes will be matched in pairs with one randomly allocated to the intervention and the other to the control condition. Eligible TAFE students will be currently enrolled in a class that runs for at least 12-months, be aged 16 years or older and will not be meeting Australian health guidelines for at least one of the following health risk behaviours - smoking, nutrition, alcohol or physical activity. The same students will be surveyed at baseline and 6-months follow-up. Online and telephone support condition: At the 50 intervention classes, effective online programs (i.e. QuitCoach, Healthy Eating Quiz, THRIVE, 10,000 Steps) and telephone support (i.e. Quitline, Get Healthy Information and Coaching Service, Alcohol Drug Information Service) that target health risk behaviours will be proactively offered to TAFE students during class via the baseline computer tablet. Control condition: The 50 TAFE classes in the control condition will not receive any intervention. Outcome measures: The primary outcomes at the 6-month assessment will assess: 1) tobacco smoking; 2) serves of fruit consumed daily; 3) serves of vegetables consumed daily; 4) standard drinks of alcohol per week and 5) metabolic equivalent minutes of physical activity per week.

  • The CoolKids and Adolescent Health Program: Helping distressed children & adolescents suffering from somatic health complaints

    One-third of youth presenting to GPs and paediatricians complain of physical/somatic problems (e.g., recurring headaches, stomach-aches) that have no physical cause. These complaints are termed functional somatic syndromes (FSS). Importantly, up to 80% of youth with FSS also experience emotional disorders. However, to date, FSS interventions have solely focused on pain management, whilst overlooking the co-occurring anxiety and depressive disturbances. This is problematic given these children are at high-risk for experiencing chronic psychopathology into adulthood. The aim of this RCT is to test the efficacy of the CoolKids and Adolescent Health (psychological therapy) program which is a newly developed program specifically tailored for distressed children (7-17 years) struggling to cope with somatic-health complaints. Given the CoolKids and Adolescent Health program is also designed to concurrently manage both somatic and anxiety/depression symptoms, it is hypothesized that this program is expected to: i) lead to significant reductions in somatic, anxiety and depressive symptoms and improvement in quality-of-life compared to a wait-list control group. ii) The effects will be retained at 6-months and 9-months follow-up.

  • The impact of neuromuscular blocking agents on traction forces during total hip replacement surgery

    Orthopaedic surgeons frequently claim that the administration of muscle relaxants (NMBA) in patients under general anaesthesia facilitate surgery, especially when significant forces may be required (e.g. dislocation of hip joint, femoral realignment during operation of femoral fractures). However, despite the fact that NMBA are frequently used during general anaesthesia for orthopaedic surgery, no evidence for their benefit on operating conditions exists. Therefore, this trial aims to investigate the influence of NMBA on traction forces during hip replacement surgery. 20 Patients scheduled for hip replacement surgery under general anaesthesia will be included in this trial. Patients will receive a standard general anaesthetic. Patients for this form of hip replacement surgery are generally operated on a special operating table with the patients feet placed in shoe-like brackets. This allows the application of significant tension and torque to the patients operated leg in order to enable the surgical preparation of the hip joint for the prosthesis. With the help of a measurement instrument (Newton Meter installed within the traction mechanic of the operating table) we will measure the forces required to extend a patient's leg to facilitate surgery. Thereafter, an NMBA (rocuronium = most often used NMBA at RPH) will be slowly administered to finally achieve muscle paralysis. During the time of paralysis development, traction forces on the leg will be measured. Aim is to investigate whether NMBA can significantly reduce the forces required during hip replacement surgery.

  • Evaluation of the effect of daily Chlorhexidine bathing on hospital-acquired infection for patients admitted to the intensive care unit

    The aim of this study is to evaluate the impact of a change to universal patient decolonization in ICU based on emerging evidence. Universal decolonization is the therapeutic administration of bathing with a chlorhexidine impregnated cloth daily to all ICU patients with the goal of decreasing hospital-acquired bloodstream infections and the acquisition of multidrug resistant organisms. Recent studies have shown that such administration of daily chlorhexidine bathing to ICU patients is more effective than targeted decolonization or screening and isolation in reducing rates of MRSA clinical isolates and bloodstream infection from any pathogen. In response to these findings there is now consensus among ICU specialists, infectious diseases specialists and the Pharmacy Department that a policy of universal decolonization should be implemented in the Austin ICU beginning in early 2014. Bathing will be completed according to manufacturer instructions. In brief, washcloths will be used in sequential order to rinse all body surfaces with the exception of the face during bathing with the 2% chlorhexidine-impregnated cloths in order to avoid exposure of the mucous membranes to the eyes and mouth. A manufacturer-produced video will be used to instruct nurses on the application of these cloths. Such washing will be applied within 4-6 hours of admission and, thereafter, daily at practically convenient times and at intervals no greater than 24 hours. Our primary outcome is the incidence of ICU acquired blood stream infections during the observation period. All relevant data on patient characteristics, diagnoses and illness severity will continue to be collected as is routine in ICU. All microbiological data will continue to be collected as is routine or clinically indicated in ICU.

  • The Effects of Bolus and Slow Fluid Infusions in Healthy Volunteers with Shock

    Numerous animal studies have shown that bolus or fast fluid infusion increases blood loss and mortality compared to a slow fluid infusion. Consistently, a high quality human randomised controlled trial also demonstrated that rapid crystalloid infusion increased mortality and complications in children with severe infections compared to those who received no bolus infusion. To date, no human studies have explored the effects of bolus fluid infusions and the duration of these effects on haemodynamic changes, biochemical, immunological and hormonal responses compared to those effects induced by slow infusions. This study is the first human randomised controlled trial to investigate the effects of bolus (fast) and slow infusion of crystalloid (clear) fluids in healthy volunteers. Participants will be randomly assigned to either a bolus (fast) infusion or a slow infusion group. The controlled venesection (removal) of 10 ml/kg Ideal Body Weight of blood will be conducted over a 15 minute period. Following that and after 30 minutes, participants will be resuscitated with 13 ml/kg of a either a bolus (fast) infusion (10 minutes), or a slow infusion (30 minutes) with a balanced crystalloid solution. After a 60-minute measurement period, the participants’ blood will be re-infused over a further 30-minute period. After 2 weeks, the participants will be crossed over to the other arm. Primary end point: Oxygen delivery, which can easily be measured by using a validated non-invasive haemodynamic monitor (Edwards Life Science ClearSight Device), a device that is used routinely as standard of care at Austin Health. Secondary endpoints: The effects of the rate of fluid resuscitation on mean arterial pressure, systemic vascular resistance, vascular reactivity index, biochemical, immunological and hormonal responses will also be investigated in similar timeline. Study Hypothesis: A slow crystalloid infusion has a more beneficial effect on oxygen delivery than a bolus (fast) crystalloid infusion in healthy volunteers (age 18 to 45 years) with induced compensated shock. No of participants: 9 Setting: A single centre University teaching hospital. Safety: Detailed and stringent safety guidelines will be followed in accordance with advice from the Department of Haematology at Austin Hospital, Austin Hospital Blood Bank, Victorian Red Cross, and the Department’s of Anaesthesia and ICU. Each experiment will conducted by a senior anaesthetist, in a theatre environment, with the appropriate monitoring and safety equipment to effectively and safely conduct this study. Clinical significance: These results will used to generate hypotheses and establish outcome benchmarks for future controlled trials that will directly influence how patients with haemorrhagic shock are optimally resuscitated.

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