ANZCTR search results

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

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31252 results sorted by trial registration date.
  • A study to test the effectiveness of the I-DECIDED device assessment tool in improving care and prompt removal of intravenous catheters in hospital patients

    Aim: To test the effectiveness of an invasive device assessment and removal tool (I-DECIDED) in improving Intravenous (IV) catheter care in hospital patients. Significance: Each year in Australia, almost 10 million patients are admitted to hospital. Around 70% will need an IV catheter for fluids or medicines. Yet 30-50% of IVs have painful complications or stop working before treatment is finished. Complications leading to failure include infiltration, extravasation, occlusion, accidental removal, or symptoms of phlebitis (pain, redness, swelling, palpable cord, hardness of the vein, red streak along the vein, and/or purulence). The failure of an IV catheter before treatment is completed requires the re-siting of a new device, leading to discomfort for the patient and often delays in treatment. A recent economic analysis of data from a multi-site Queensland randomised trial showed the mean cost of catheter replacement was approximately $70 when staff time and equipment was calculated. Expected outcomes and benefits: As well as being an assessment tool, the I-DECIDED mnemonic encourages patient participation. I-DECIDED is also an audit and education tool, teaching nurses and doctors the essential components of IV care. A structured and comprehensive approach to IV assessment and care would promote early detection of complications, and prompt removal of IV catheters when no longer needed. This will reduce unnecessary pain and suffering for patients, decrease the risk of potentially deadly bloodstream infection, and reduce treatment delays and hospital costs. This could benefit millions of Australians annually. Future directions The proposed study will test the utility of the I-DECIDED tool in guiding assessment and care of peripheral IV catheters. Following the collection of pilot data and feedback from staff and patients, it is likely that the study will be expanded to test the tool for assessing other IV catheters (non-tunnelled central venous catheters, peripherally-inserted central venous catheters) in other hospital units. Additional approvals will be sought at that time, as appropriate. I will work towards I-DECIDED being implemented in partnership with the Australian Commission of Safety & Quality in Healthcare. I-DECIDED will provide a platform for innovation and research projects in other invasive medical devices, including urinary catheters. The mnemonic I-DECIDED works in Spanish, Portuguese, French and Italian, and could be made global. Nurse collaborators from my existing Australian and international research networks have expressed interest in trialling the I-DECIDED tool.

  • Treatment decision making in papillary thyroid cancer: an online discrete choice experiment survey

    Purpose of the study: The proposed study will produce new data on what attributes (including terminology and risks) are driving papillary thyroid cancer treatment preferences, the trade-offs between risks of treatment that people are willing to accept, and how changes in terminology and risks can lead to changes in preferences. This is understanding is important in order to help reduce patient’s anxiety and concern about low-risk conditions and decrease the preference for unnecessary aggressive treatments. The findings will help the medical community understand the power of language which may enable more effect strategies for communication of low-risk disease and its management options. Who is it for?: You may be eligible to join this study if you are aged 18 years or more, have no history of thyroid cancer. Study details: All participants in this study will be presented with a survey which includes 12 hypothetical scenarios that describe the diagnosis of papillary thyroid cancer using various terminology with and without the "cancer" term, and with varying attribute levels. The order in which the scenarios will be provided is random (by chance). Each scenario and the treatment options presented to participants will be identical with the only difference being the terminology used and the levels at which each attribute is set. Following the scenarios participants will be asked a range of socio-demographic questions.

  • OPTimising IMmunisation Using Mixed schedules (OPTIMUM): comparing allergic outcomes in infants following pertussis vaccination

    The rise in atopy, particularly food allergy, over recent decades in Australia has coincided with a change from the routine use of Whole cell pertussis vaccination (DTwP) to Acellular pertussis vaccination (DTaP). These events may be causally related via the differential modulation of the Th1 and Th2 arms of the immune system by the different vaccines. A single first dose of DTwP followed by two doses of DTaP in the infant vaccination schedule may allow a more balanced immune response, and protection from subsequent atopy. Although a full DTwP vaccine course is more reactogenic than a full DTaP vaccine course, this may not be true for a single dose of DTwP given in early infancy. Furthermore, substitution of the first DTaP dose with DTwP may significantly reduce the frequency of extensive limb swelling observed after the 18 month and 4 year old booster doses of DTaP. An assessment of the immune responses of contemporary Australian infants primed with either a mixed DTwP/DTaP or the current DTaP-only schedule is warranted. Infants will receive either a combined Diphtheria-Tetanus-whole cell Pertussis, Hepatitis B, and Haemophilus influenzae type B vaccine (DTwP-HepB-Hib) OR a combined Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type B vaccine (DTaP-HepB-IPV-Hib) as their first vaccine dose at 6- <12 weeks of age as part of the infant vaccine schedule. All infants will then receive DTaP-HepB-IPV-Hib at 4 and 6 months of age and combined Diphtheria-Tetanus-acellular Pertussis (DTPa) and Inactivated Poliovirus at 18 months of age, along with vaccines prescribed by the standard Australian Immunisation Schedule. The dose and route of vaccination will be consistent with the manufacturer’s instruction. The primary objective of the study is to assess the allergy protective benefits of the addition of DTwP into the infant schedule. Infants will be assessed for development of allergic disease and atopic sensitisation. The study will also assess the reactogenicity profile of the whole cell vaccine within stage 1 and the first 150 participants of stage 2 of this two staged trial. If DTwP is found to be acceptable to parents and protective against the development of atopic disease this could have profound implications for vaccine policy in Australia and around the world.

  • The Effectiveness of Combining Cognitive Processing Therapy with a Case Formulation Approach in the Treatment of Posttraumatic Stress Disorder - A Randomised Controlled Trial

    Trauma focused cognitive behavioural therapy has long been the standard approach for the treatment of posttraumatic stress disorder (PTSD). Cognitive Processing Therapy (CPT) is a manualised treatment protocol based on a cognitive behavioural therapy approach, typically delivered over 12 sessions. Whilst CBT approaches have good efficacy in the treatment of PTSD, the non-response to treatment and dropout rates remain substantial. This study is for the purposes of a PhD, and examines the combination of CPT with a case formulation approach (CPT+CF), which individualises therapy based on the needs of the client and allows for deviation from the standard treatment protocol. It is hypothesised that this approach will be superior to the standard CPT protocol, resulting in greater reductions of PTSD symptoms, less dropout, and better good end-state functioning. It is anticipated that CPT+CF will be most beneficial in the face of complicated client presentations, that is, treatment outcomes will be moderated by client complexity.

  • Comparison of patient outcomes following total hip arthroplasty via an anterior or posterior approach: a prospective randomised controlled trial

    To compare patient outcomes between patients admitted for total hip replacement surgery via a posterior approach compared to total hip replacement surgery via an anterior approach. The study hypothesis is that an anterior approach to total hip replacement may lead to a reduced stay in hospital compared to the traditionalposterior approach to hip replacement

  • Agreement between TEG6S(Registered) and TEG5000(Registered) devices

    Thromboelastography (TEG) allows rapid, comprehensive and accurate identification of an individual’s haemostasis condition in a laboratory or point-of-care setting. Until now, different TEG assays had to be performed individually, with each assay requiring lengthy preparation and calibrated pipetting. TEG6s and TEG5000 (Haemonetics Corp, USA) are commercial haemostasis analysers that measure viscoelasticity properties of whole blood. Both use different mechanisms to assess identical coagulation variables. The aim of this study was to assess agreement and clinical interchangeability between the TEG6s and TEG5000 analysers. After Ethics Committee approval, we systematically collected 3.5mL whole blood in citrated tubes from 25 adult patients in a tertiary level intensive care unit (ICU). A trained operator, proficient in the use of both the TEG6S and TEG5000 systems performed all the measurements. Interdevice agreement between the TEG6S and TEG5000 analysers was measured using Lin’s condordance coefficient, and further validated this using intraclass correlation coefficients and reduced major axis regression, which allowed separation of the observed bias into fixed and proportional components. As this is an observational device study, no results results will be used by any clinician to influence patient care.

  • Effectiveness of Mindfulness-integrated cognitive behaviour therapy for reducing symptoms of depression, anxiety and stress in patients with common mental health conditions: a randomised controlled trial

    The purpose of the study is to investigate the effectiveness of MiCBT group interventions to improve psychological symptoms such as depression and anxiety for patients with a range of common mental health conditions. It is hypothesised that MiCBT delivered in a private practice setting will lead to clinical symptom improvement in depression, anxiety and stress compared to a wait-list control group at post-intervention and maintained at 6 months follow up. Improvements are also expected in psychological well-being. The mediators of clinical change are expected to be reflected by changes in awareness (metacognitive and interoceptive), non-reactivity, and interpersonal skill.

  • A study that test the effects of a mobile phone application that delivers a psychological health intervention to reduce social anxiety symptoms.

    The aim of the project is to evaluate the effectiveness of a self-help mobilephone application-based health intervention aimed at reducing subclinical and mild social anxiety symptoms. The mobile app program delivers a standalone (without therapist support) version of exposure therapy for social anxiety in 4 mobilephone application-based modules aimed at improving the literacy about exposure therapy, and at providing exercises to prepare and conduct exposure therapy in moments when a person experiences symptoms. The main hypothesis is a mobile application-based health intervention will significantly be more effective in reducing symptoms of social anxiety, anxiety, depression, and stress than an waitlist control group.

  • Pregabalin for acute whiplash

    We will conduct a feasibility study for a randomised controlled trial examining the effectiveness of pregabalin to prevent chronic pain following whiplash injury in ‘at-risk’ individuals. This feasibility study will hone eligibility criteria, test recruitment strategies, and develop a model for recruitment for the subsequent full scale trial. The primary aim of this current study is to assess the feasibility of the RCT by measuring recruitment rates (number of patients approached, number consenting to participate, and number eligible to to be randomised; missing data and participant attrition). and obtaining qualitative feedback from patients and doctors about their experience of the trial and suggestions for improvement. The secondary aims are to: 1) Investigate the effectiveness of pregabalin to decrease disability, depression, posttraumatic stress symptoms, and pain catastrophizing; 2) To conduct an economic evaluation of the pregabalin intervention. We hypothesise that pregabalin used in acute whiplash injury will prevent or modulate pro-nociceptive mechanisms and improve health outcomes for this treatment resistant condition, and that the study will be feasible.

  • The effects of leg resistance training with blood-flow restriction on unrestricted exercising arms: A validation study

    This study comprises part of a PhD project. It aims to investigate whether light-load blood-flow restriction training in the legs can improve the muscle size of an active arm. This will be compared with the non-active arm of these participants that perform blood-flow restriction in the legs as well as either arm of participants who performed traditional light-load strength training. The purpose is to investigate whether muscle size adaptations are transferable between limbs. This will be investigated in a seven week strength training study in participants that perform either blood-flow restriction or traditional strength training in the legs.

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