ANZCTR search results

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

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33143 results sorted by trial registration date.
  • The Human Touch: The Influence of Human Support on Adherence to, and Outcomes of, an Online, Lifestyle-based Mental Health Intervention

    Mental health is in global jeopardy and devising efficacious promotive, preventative and curative solutions is paramount. In a progressively digital culture, program designers are replacing face-to-face (F2F) intervention delivery in favour of increasingly sophisticated online and mobile options. The paradigm shift overcomes numerous obstacles of inaccessibility, yet, online delivery poses unique challenges regarding the interrelated factors of adherence and human support. While human interaction is an intrinsic element of F2F interventions, program designers must evaluate how to add the human support component (e.g. dosage, type) back in to online programs to optimise adherence and outcome measures. This study will explore what influence graded levels of human support have on the outcomes of and adherence to an online, lifestyle-based mental health intervention. Participants will be randomly assigned to three Arms, differentiated by variant levels of human support: Arm 1 – standard online program with no additional human support; Arm 2 – same standard program as Arm 1 with additional personalised SMS support; Arm 3 - same standard program as Arm 1 with additional weekly online group discussion (i.e. videoconference). Measures of mental health and wellbeing will be collected for all participants at pre- and post-intervention and comparisons made between the Arms. Adherence to the intervention will also be compared between the Arms. This study will contribute to an evidence-based rationale for intervention planning, to maximise program efficacy through optimal human support and adherence. The study will also inform the optimal levels of human support when administering online interventions.

  • BREATH STUDY: Short and long-term effects of therapeutic exercise in children with bronchiectasis: a multi-centre randomised controlled trial

    Children with bronchiectasis regularly experience exacerbations of their condition resulting in frequent hospitalisations and decreased of quality of life (QoL). Therapeutic exercise may reduce the incidence of acute exacerbations, which is a key predictor of future lung function decline and morbidity. This study aims to determine if a tailored, 8-week therapeutic exercise program delivered to children aged 6 to 12 years with bronchiectasis prevents acute respiratory exacerbations. The primary hypothesis is that children who undergo the exercise program will have fewer exacerbations over a 12-month period than children who do not receive the intervention.

  • What is the effect of a shared leadership system for maternity emergency teams on team performance ?

    Traditionally during maternity emergencies, it is recommended that a single leader take charge. However, in many critical circumstances there may be too many things for a single leader to do. This project aims to test a system where the leadership tasks can be shared between two leaders to determine if this is superior to a singular leadership model.

  • Strategies to increase childcare service registration at healthy menu planning workshops

  • The effect of colchicine on neutrophils in patients presenting with an acute coronary syndrome (ACS)

    Inflammation is central to the development and progression of atherosclerosis. Neutrophils are the most abundant immune cell in circulation and contribute to atherosclerosis-associated inflammation. Colchicine is an anti-inflammatory agent currently approved for the treatment of gout, familial Mediterranean fever and acute/recurrent pericarditis. There is mounting evidence that indicates colchicine is effective at reducing ACS recurrence rates by inhibiting specific inflammatory pathways. An anti-inflammatory effect of colchicine on neutrophils has been noted in patients with vasculitis, although this has not been examined in those with coronary artery disease. Colchicine use has been proven to be safe, well tolerated and is inexpensive and readily available. The aim of this study is to assess the acute effect of colchicine (1.5 mg orally) on neutrophil function in patients with coronary artery disease. We hypothesis that colchicine will inhibit neutrophil hyper-reactivity seen in these patients.

  • Evaluation of a bundled care approach to preventing surgical site infections post caesarean section in an Australian Rural Hospital

    Elective and non-elective caesarean section (CS) rates have been increasing in Australia over the past 20 years. Increasing antenatal morbidity, has meant that surgical site infection (SSI) post CS is an important issue effecting Australian women. Populations most impacted include low socioeconomic and regional communities where high rates of antenatal comorbidity augment the incidence of SSI. Despite a recent trend towards supporting the development of evidence based bundled approaches to SSI reduction, there remains paucity in data proving efficacy and supporting bundle implementation. This study aimed to develop, implement and assess an evidence based caesarean infection prevention “CIP” bundled intervention to reduce SSI rates following CS in a high risk rural population. The study is a pre-post intervention study with 3 phases and included all women undergoing CS at a regional referral hospital between December 1st 2016 and December 31st 2018. A 12 month retrospective pre-intervention review identified all women who developed a post CS SSI. A comprehensive literature review informed the development of the intervention, which was implementation in December 2017. Prospective data collection for a subsequent 12 month period was collected on all women who underwent CS with pre and post comparative data analysis.

  • Understanding and predicting recovery in patients undergoing total knee replacement

    Rehabilitation is an important factor that improves recovery from total knee arthroplasty (knee replacement surgery). However, no clinical guidelines currently exist to inform recovery pathways following surgery, likely due to the lack of evidence to suggest who may benefit from rehabilitation, when and where this service should be delivered, and what services should be provided. This has led to an inconsistent approach to rehabilitation. The aim of this study is to develop a recovery pathways stratification tool based on a comprehensive evaluation of individual patient data, including physical performance assessments and physical, social, and mental health evaluations. Ultimately this tool will allow a personalised approach to refer patients to rehabilitation pathways based on their own needs and circumstances.

  • "What Lies Beneath": Keyhole surgery after previous abdomino-pelvic surgery, and the risk of developing important scar tissue.

  • Does Mycobacterium ulcerans colonise skin prior to clinical Buruli ulcer?

    Buruli ulcer is a destructive disease of the skin and soft tissue that is caused by the bacterium Mycobacterium ulcerans. There is currently a major outbreak of Buruli ulcer in Victoria, specifically in the Mornington and Bellarine Peninsulas. It is unclear how humans acquire the disease. Further information regarding how Buruli ulcer is transmitted may help to prevent the disease and its complications. This study is investigating whether people who live in or visit endemic areas carry the bacteria on their skin. This has implications for how Buruli ulcer is transmitted. Participants will self-collect swabs of their skin (of backs of elbows, wrists, calves and ankles), which will be tested for the presence of Mycobacterium ulcerans DNA by PCR.

  • Early Nutrition Support in Neurosurgical Patients as guided by I-FEED scores

    Early nutrition in spinal surgical patients has been a part of most enhanced recovery protocols but has not been studied independently. Assessment of gastrointestinal function, measurement thereof, and appropriate timing of nutrition initiation have been ambiguous and non-standardized. I-FEED scoring system is a clinical decision making tool devised by the American Society for Enhanced Recovery and Perioperative Quality Initiative.We aim to compare and contrast period of time taken for dietary libertization in the the cohort of patients managed the standard way compared to the cohort having the I-FEED score utilized to assist their early postoperative nutrition. We believe that utilizing the I-FEED score will decrease the time it takes for patients to regain their ability to have full oral intake.

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