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.
  • Chewing gum to relieve thirst in chronic heart failure

    Chronic heart failure is a progressive and burdensome syndrome with thirst as a major reason for non-compliance to self- care practices such as fluid restriction. Due to the life threatening effects of non- compliance to fluid restricted therapy, evidence based interventions are needed to manage thirst. Systematic evaluation of available strategies such as chewing gum is essential in ensuring that the best possible management is provided to CHF patients. The purpose of this study is to test the hypothesis that chewing gum can reduce thirst in people with chronic heart failure.

  • Psychosocial Screening for Burns Patients

    The primary objective of this study is to measure and track the psychosocial consequences of a severe burn injury in terms of its impact of patients’ mental health. Screening all severe burns injury patients admitted to the Severe Burns Injury Unit will offer all patients the opportunity for outcome tracking and collect the necessary extensive cohort data on which to base future treatment, policy and advocacy as well as a targeted study on early intervention for PTSD. Burn patients are at risk of developing this disorder, which is associated with increased rates of medical morbidity, poor health-related quality of life, and functional impairment. It is important to note that primary care, rather than specialty mental health services, has been the point of contact with the health care system for the majority of individuals with PTSD. Improving detection of PTSD, adverse coping styles and depression are important steps in addressing the health and mental health burden experienced by these patients.

  • T3 Trial: Triage, Treatment and Transfer of Patients with Stroke in Emergency Departments

    In 2011, members of our research team published the results of the Quality in Acute Stroke Care (QASC) Trial. This cluster randomised controlled trial evaluated the effectiveness of team-building workshops and education to introduce three clinical protocols to manage fever, sugar and swallowing (the FeSS protocols) in the acute stroke unit. We found that patients cared for in stroke units who received our intervention were 16% more likely to be alive and independent 90 days following their stroke. They also had fewer episodes of fever, lower mean temperatures, lower mean blood glucose levels, and better screening for swallowing difficulties. This landmark trial demonstrated that teamwork and good nursing care can improve patient outcomes. Building on this previous work (1) we will evaluate using a cluster randomised controlled trial, an organisational intervention in EDs. Our evidence-based T3 Trial intervention will comprise: A) evidence-based clinical protocols for triage, treatment and transfer in acute stroke comprised of: (Ai) routine assignment of stroke patients to triage Category 1 or 2; (Aii) time-sensitive ‘trigger’ screening for tPA eligibility; (Aiii) instigation of protocols for prompt management of fever, hyperglycaemia and swallowing; (Aiv) rapid transfer of patients from ED to the stroke unit. To support implementation of the protocols we will use: B) an evidence based implementation strategy consisting of: (Bi) workshops to identify local barriers and enablers and to identify clinical champions; (Bii) didactive and interactive education; (Biii) use of local clinical opinion leaders (site clinical champions); and (Biv) reminders in the form of email, telephone and site visits. This trial will be conducted in the EDs of hospitals with pre-existing dedicated stroke units in NSW, Victoria, Queensland and the ACT. EDs will be randomised to receive either the T3 Trial intervention or no additional support. At 90-days post-admission, we will measure death or dependency (mRS) (primary outcome); health status; and quality of life (secondary outcomes). A separate process analysis will examine contextual factors that may influence successful intervention uptake. Our novel and timely intervention will bridge the theory-practice gap aiming to deliver improvements in 90-day health outcomes for a group of patients currently underserved by evidence-based practice Reference 1. Middleton S, McElduff P, Ward J, Grimshaw J, Dale S, D’Este C, Drury P, Griffiths R, Cheung NW, Quinn C, Evans M, Cadilhac D, Levi C. Implementation of evidence-based treatment protocols to manage fever, hyperglycaemia and swallowing dysfunction in acute stroke improves 90-day outcomes: QASC, a cluster randomised controlled trial. The Lancet 2011; 378 (9804): 1699-1706.

  • Nutrition and Lifestyle Modifications to an Internet-based Treatment for Alcohol Misuse - Pilot Study

    The current project aims to conduct a Pilot Study, to obtain qualitative and quantitative data on the impact of a combined treatment, comprising an existing online alcohol support program – OnTrack (www.ontrack.org.au), together with emails and newsletters focusing on nutrition and healthy lifestyle "OnTrack to Cutting Down and Feeling Good" emailed newsletters. Approximately fifteen male and female participants, aged over 18 years and drinking more than 14 standard drinks per week will be recruited in to the OnTrack online alcohol program. They will be assessed on their drinking behaviour, physical activity, and diet at the start of the Pilot Study and then again after participating in OnTrack Alcohol and receiving the emailed "OnTrack to Cutting Down and Feeling Good" newsletters. The participants will also be questioned by phone interview about their experiences using OnTrack Alcohol and the "OnTrack to Cutting Down and Feeling Good" emailed newsletters.

  • Comparison of plastic fistula cannulae versus metal fistula needles in haemodialysis in-centre patients

    Comparison of plastic cannulae and metal fistula needles. The different outcomes associated with the use of plastic fistula cannulae compared with metal fistula needles will be investigated in haemodialysis in-centre patients.

  • Effect of affordable technology on physical activity levels and mobility outcomes in rehabilitation

    Mobility limitation is common in rehabilitation patients and can be improved by well-designed exercise programs. Exercise in people with mobility limitation is associated with better functional outcomes if the exercises relate closely to functional movements required for daily task independence. The broad aim of this project is to enhance mobility outcomes for people undergoing aged care and neurological rehabilitation. The specific hypothesis of this trial is that the addition of technology-based interactive exercises involving feedback to usual care will lead to better mobility outcomes than usual care alone for people admitted to aged care and neurological rehabilitation wards with mobility limitations. This study also aims to assess the cost-effectiveness of the intervention compared with usual care, establish predictors of greater use of the technologies and enhance understanding of participant experiences of technology use with qualitative methods. Participants will be randomised into a control and intervention group (n=300). Both groups will include hospital patients undertaking a usual rehabilitation program and the intervention group will receive one extra 30 to 60-minute session per day of video and computer or tablet-based interactive exercises. After discharge from the inpatient stay, participants in the intervention group will be encouraged to continue using the technologies at home. The total duration of the intervention will be six months after randomisation. Participants will be loaned necessary technology and trained in the safe use and progression of the games/exercises during a home visit by therapy staff. Weekly support via telephone, email of videoconference will also be provided during this phase of the study. This support will aim to assist study participants to maintain motivation and will identify and address any barriers to technology use at home. A baseline assessment will be conducted and follow-up assessments will occur at 3 and 12 weeks and 6 months after randomisation.

  • Telemedicine for Insulin Treated Gestational Diabetes Mellitus (TeleGDM)

    Gestational diabetes mellitus (GDM) is a condition of poor blood sugar control occurring during pregnancy. The poor sugar control is associated with poorer pregnancy outcomes, such as large babies often leading to caesarean deliveries, other pregnancy complications and diabetes in the future. About half of all women with GDM need insulin to control blood sugars. Special care needs to be provided to this group of women which involves intensive and frequent support for insulin management, adding to increased workloads on limited GDM services. Telemedicine is another way that people can be provided with health services while they are away from the hospital. In this approach patients send their heath monitoring information over the mobile phones or internet to healthcare providers who in turn review the information and provide advice to the patients. This project aims to use telemedicine to support care for women with GDM and it will be carried out at TNH as a major randomised controlled pilot study. Women who agree to be part of this project will monitor their BGL, insulin and symptoms at home. The women will send this information to the hospital via an online system called Online Health Portfolio for review by the GDM care team. If a patient has readings that are outside desired levels, the team at the hospital can then provide advice immediately via text message without the need for the woman to wait for the next hospital appointment. The project will evaluate whether a new new approach (telemedicine) used as part of of usual care, is able to reduce the workload on the GDM service, whether women who receive telemedicine will have better or similar pregnancy outcomes as women who will receive usual care alone and whether telemedicine will result in cost savings.

  • Footwear for treatment of foot pain

    The aim of this study is to investigate the ability for flip-flop style footwear with a moulded foot-bed to reduce foot pain. We will also assess the effect of the flip-flop style footwear on perception of general foot health and assess the comfort of the flip-flop style footwear.

  • 'Keeping them Warm' - A randomised controlled trial of two passive perioperative warming methods

    Inadvertent perioperative hypothermia (IPH) is a common problem for patients undergoing surgery. Heat redistribution from the body’s core to the periphery after induction of anaesthesia is the major contributor to heat loss. Both cotton and reflective blankets are currently in routine use in operating theatres for perioperative warming of patients undergoing short procedures. This study aims to determine if thermal insulation with reflective blankets is more effective than cotton blankets in reducing the temperature gradient from the body’s periphery to the core during the preoperative phase in adult patients undergoing short surgery and thus in reducing the intraoperative drop in core temperature.

  • An experimental study to characterize the in vivo safety and infectivity of the Plasmodium vivax isolate HMPBS02-Pv in humans

    The goal of this single-centre study is to establish a ‘universal’, blood group O bank, of P. vivax infected human red blood cells (RBCs) for use in future malaria challenge studies. The study will use P. vivax HMPBS02-Pv challenge inoculum to infect two healthy participants in order to characterize the safety and infectivity of the parasite isolate P. vivax HMPBS02-Pv in vivo. Each participant will be inoculated on Day 0 with around 100 viable P. vivax-infected RBCs administered intravenously. The participants will be monitored for malaria symptoms firstly by phone, and then on an outpatient basis, for the unexpected early onset of malaria symptoms and for malaria parasites by PCR. On the day designated for commencement of treatment, as determined by PCR results and/or onset of clinical symptoms, participants will be admitted to the study unit and confined for safety monitoring and anti-malarial treatment (Riamet (Registered Trademark')) Following initiation of anti-malarial treatment, the participants will be monitored as in-patients for 48 hours to ensure tolerance of therapy and clinical response. Once clinically well, the participants will be followed up on an out-patient basis for continued dosing of anti-malarial drug, safety and clearance of malaria parasites via PCR. Follow up visits for safety assessments will be performed on Day 28 and Day 90 after malaria infection.

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