ANZCTR search results

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

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31326 results sorted by trial registration date.
  • An investigation of the effectiveness of internet Cognitive Behaviour Therapy in tertiary students experiencing depression and anxiety as a part of a stepped care student counselling service.

    The proposed project seeks to examine the acceptability, efficacy and feasibility of low-intensity CBT-based treatment program, the UniWellbeing Course, in reducing symptoms of stress, anxiety, low mood and depression in tertiary students attending Macquarie University. The UniWellbeing Course is based on the already established and efficacious Wellbeing and Mood Mechanic Courses (e.g., Titov et al., 2013, PLOS One; Johnston, et al., 2014, Australian and New Zealand Journal of Psychiatry).

  • Self Reported Health Outcomes over 12 months of Patients Undergoing Coronary Angiography for the Evaluation of Chest Pain in South Australia - Coronary Angiogram Database of South Australia (CADOSA) Outcomes Study

    The Coronary Angiogram Database of South Australia (CADOSA) Outcomes Study was established in 2011 to evaluate self-reported health outcomes of patients undergoing coronary angiography for the evaluation of chest pain. The CADOSA Outcomes study assesses baseline, 1 and 12 month health status which includes symptomatic status, physical impairment from their condition, quality of life, and depression) in patients who agree to participate in a 12 month follow-up assessment.

  • Pilot study to assess the effect of Brazil nuts on plasma selenium levels in healthy male volunteers aged 65 years and over

    The purpose of this study is to investigate the efficacy of Brazil nuts in increasing selenium status in healthy males aged 65 years and older, as this is the average age of prostate cancer diagnosis in Australia. Who is it for? You may be eligible to join this study if you are a healthy, non-smoking male aged 65 years or older, who does not have any nut allergies, and does not regularly use a selenium supplement. Study design: Participants in this study will be assigned to 1 of 3 groups and asked to consume 2, 5, or 10 Brazil nuts daily for 30 days. At baseline volunteers will complete a questionnaire on dietary habits, supplement use, and demographic details. Height and weight will also be measured. Volunteers will be asked to avoid selenium enriched foods (e.g. fish, liver, kidney, and additional Brazil nuts) during the study period, but otherwise they will be asked to continue eating as normal. A 24-hour dietary recall and food frequency questionnaire will be used to verify the types of foods consumed at baseline and endpoint of the study period. Participants will also be required to give blood samples at the end of the 30 day study period in order to evaluate blood levels of selenium and other nutritional markers. The Brazil nut (Bertholletia excelsa) is the best source of selenium, a trace element and mineral that is nutritionally essential for human health. This antioxidant is the focus of significant recent research in prostate cancer, as it is proposed that selenium may reduce tumour growth and cancer progression. The data from this study will be explored to inform future nutrition intervention studies in men with advanced prostate cancer.

  • MumBubConnect: Can a Text Message a Week Improve Breastfeeding

    Breastfeeding is recognised as the optimal method for feeding infants with health gains made by reducing infectious diseases in infancy; and chronic diseases, including obesity, in childhood, adolescence and adulthood. Despite this, exclusivity and duration in developed countries remains resistant to improvement. The objectives of this research were to test if an automated mobile phone text messaging intervention, delivering one text message a week, could increase “any” breastfeeding rates and improve breastfeeding self-efficacy and coping.

  • The OPTIONS study. Evaluating a patients' decision tool (OPTIONS tool) for considering treatment choices for the elderly with end stage kidney disease.

    The aim of the study is to examine the effectiveness of an evidence based decision making intervention (OPTIONS tool) for older people considering treatment options for end stage kidney disease. The anticipated study outcome will be reduced decisional conflict and uncertainty, improved knowledge regarding benefits and harms of dialysis and lower decisional regret.

  • A preoperative warming regime versus no preoperative warming for maintenance of normothermia in women receiving intrathecal morphine for caesarean section.

    Women undergoing caesarean section experience high rates of heat loss and hypothermia related to surgery and anaesthesia. As well as causing discomfort, hypothermia experienced during and after anaesthesia and surgery is also associated with many adverse effects, for example increased blood loss. It is also thought that spinal morphine, commonly given during caesarean section for pain relief, may also exacerbate heat loss. This project aims to test warming patients preoperatively via a warming blanket (which utilises heated air) to reduce the amount of heat loss during surgery. A randomised controlled study design will be used: the control group will receive normal care while the intervention group will receive preoperative warming. Potential participants will be identified via the surgical booking process. Recruitment and informed consent will occur at the preoperative assessment appointment. Participants will be randomly assigned, on the day of surgery, to either the control group receiving usual care, or the intervention group receiving preoperative warming. Temperature will be recorded throughout the preoperative period, during surgery and during the postoperative period in the recovery unit. Data will be analysed to investigate differences in the amount of temperature lost (temperature decline) in each group and comparisons made. Thermal comfort experienced by mothers will also be determined, as well as the incidence of shivering. Comparisons will also be made between newborn temperature and Apgar scores (used to assess the health of the newborn).

  • The Younger Women's Wellness after Cancer program: A pilot study of an E-Health Enabled Lifestyle Modification Intervention.

    The Younger Women's Wellness after Cancer Program (YWWACP) will determine the effect of a 12 week, e-health enabled program, on the health-related quality of life (HRQoL) in women who have received treatment for breast or gynaecological cancer. Who is it for? You may be eligible to join this study if you are a female aged between 20-40 years who has completed surgery, chemotherapy and/or radiotherapy within the past 12 months for early or local breast and/or gynaecological cancer. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in the intervention group are given access to an e-health enabled, structured health promotion program which will include an interactive iBook and website containing health information, planning and goal setting, and three personal conferences with a nurse via video-conferencing over 12 weeks. Participants in the control group will receive usual care which includes only that information and support that is given as part of usual practice through their usual clinic visits. Participants from both groups will be asked to complete questionnaires before the program begins (0 weeks), at 12 weeks, and again at 24 weeks, in order to determine the effect of the program on HRQoL, dietary intake, physical activity levels, sleep quality, levels of stress, anxiety and depression, menopausal symptoms, and sexual function. They will also have their height, weight and other anthropometric measures taken at these timepoints.

  • Effects of Fenofibrate on Intramyocardial Triglyceride Content and Left Ventricular Myocardial Function in patients with Type 2 Diabetes and Hypertriglyceridemia

    This is a single-centre, randomized, double-blind, placebo-controlled clinical trial. Participants will be randomized to receive fenofibrate (145mg daily for 6 months) or placebo in a parallel group, double blind design. Participants will undergo a cardiac MRI, Adenosine stress MRI perfusion, echocardiography and ECG at baseline and 6 months.

  • Improving the mental health of adults with diabetes: A study of an Optimal Health Program (OHP)

    Diabetes mellitus is a National Health Priority Area in Australia because of its impact on the Australian community. The MILES Study of Australian community found that 28% of people with T1DM had severe diabetes-related distress, slightly less for T2DM participants (17.22%). For participants with insulin treated T2DM, 35% reported moderate to severe depressive symptoms compared to 22% in T1DM and 23% of noninsulin treatment T2DM participants. Preliminary findings from our pilot studies at St. Vincent’s support this data highlighting the presence of mental health concerns in this population. Government reports have also highlighted the nationwide burden with The Australian Institute of Health and Welfare Report (2011) found 31.0-41.6% of people with diabetes had either medium, high, or very high levels of psychological distress. Underrecognition and undertreatment of mental health disorders, in particular depression, is common in this field however and there is need for further mental health data specific to diabetes. Individuals and their families can experience difficulties and adjustments following a diagnosis of diabetes. Not only is there shock and adjustment to the diagnosis itself, but also challenges adapting to daily self-management regimens. A person’s sense of identity can be affected as they process what it means to be ‘diabetic’ and any associated social, legal and medical implications. A focus on diabetes is especially needed given increased rates of depression and anxiety as well as a near two fold increase of eating disorders in adolescent females with T1DM compared to the general population. There is strong overlap between mental health and diabetes, yet gaps remain in service provision. A recent report by Marrero et al. highlighted the importance of behavioural medicine in diabetes given the significant impact of behaviour on the disease process and management of diabetes. The authors emphasise that developing behavioural change interventions will be as important as medical advances, as people are living longer and will need to adopt regimens for chronic conditions with ways to manage new information and sophisticated treatments. There is some evidence that psychological/behavioural treatments can assist, and these have been shown to improve metabolic control, selfmanagement, quality of life, and blood glucose awareness. Mental Health in Diabetes Optimal Health Program (MINDS OHP) The MINDS OHP is a multidisciplinary collaborative therapy and self-efficacy intervention supporting people with mental or physical illness. The program promotes hope, growth and partnership by providing a comprehensive therapeutic approach for consumers, clinicians, services and other to work systematically towards the achievement of optimal health outcomes. The concept of self-efficacy and care coordination are integral components of OHP. The OHP model is focused on wellbeing with a capacity to include additional components addressing particular mental or physical health problems. OHP is delivered in nine sequential sessions comprising: i) interagency collaboration; ii) care coordination ; and iii) support information and identifying community supports. The MINDS OHP incorporates diabetes-specific information to support the self-efficacy and wellbeing of people living with diabetes. This purpose of this research study is to compare the benefits of an 8week (plus booster session) MINDS OHP targeting wellbeing versus the current standard treatment that is provided. This program aims to teach coping and planning skills that may reduce anxiety and depression in people with diabetes. This study is part of a wider program of research designed to inform the OHP adaptation to chronic illness settings including carers of people with stroke and dialysis. The self-management foundations of OHP are particularly relevant for adults with diabetes, who are faced daily with managing aspects of diabetes including insulin delivery (for some), carbohydrate counting, monitoring blood sugar levels, and of course coping with the emotional impact of this. The collaborative focus of OHP also provides a growth facilitative environment for patients to develop confidence, learn strategies for self-care, and know where to seek further assistance if required. References available upon request

  • Optimisation of Glycaemic Control in the Setting of Antenatal Corticosteroid Administration in Pregnancies Complicated by Diabetes

    Pregnancy may be complicated by threatened pre-term delivery, which is associated with neonatal respiratory distress syndrome. Antenatal corticosteroids reduce the incidence of neonatal respiratory distress syndrome in preterm delivery but cause acute severe maternal hyperglycaemia in pregnancies complicated by diabetes. Data is limited on the blood glucose profile following corticosteroid administration and guidelines to control hyperglycaemia are lacking. Intravenous (IV) insulin infusions may be utilised but are labour intensive and require significant expertise. This prospective interventional study seeks to prospectively validate in-patient management principles utilising a supplementary subcutaneous (SC) insulin regimen in comparison to IV insulin infusion titrated to predicted maternal hyperglycaemia to reduce hyperglycaemia in diabetic pregnancies.

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