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.
  • Is the culturally adapted 9-item Patient Health Questionnaire (aPHQ-9) suitable for use as a screening tool to identify depression in Aboriginal and Torres Strait Islander people attending primary care?

    This cross sectional project will involve 500 Indigenous primary care attendees in Australia’s States and Territories. We will validate (criterion validity) the aPHQ-9 as a screening tool, alone, and in combination with the additional seven questions, against a gold standard structured criterion interview for depression The Mini International Neuropsychiatric Interview (MINI ) 6.0.0 (criterion standard), in Indigenous men and women attending primary health care services across Australia. This will provide the evidence on whether to recommend use of the aPHQ-9 as a screening tool for depression in health services research, clinical care delivery and policy evaluation in Federal and State chronic diseases programmes.

  • Correlation between glycated haemoglobin (HbA1c) and length of stay in hospital in total hip and knee replacements: A prospective observational cohort study

    The main focus of this project is to identify whether a correlation exists between HbA1c levels and the hospital length of stay (LOS) following total hip or total knee replacements at Mackay Base Hospital. Elevated HbA1c blood levels are an indication of poor glucose control over the preceding months and are used as a surrogate marker to predict micro and macro vascular complications in diabetics. We aim to measure HbA1c in all patients within our cohort, and look for a statistically significant correlation with LOS. The practical implication if a positive correlation is established is that improvement of HbA1c with lifestyle and medication prior to major elective surgery such as lower limb total arthroplasty, may significantly lower the cost burden upon the health system by reducing LOS. Research is limited and conflicting in this area, and further elucidation of a correlation would advance understanding and guide further research.

  • Improving quality of patient centred care in cancer

    The aim of the study is to assess the effectiveness of a consumer driven breakthrough action model in improving aspects of cancer treatment systems. Who is it for? You may be eligible to join this study if you are aged 18 years or more and are receiving chemotherapy for a current cancer diagnosis as an outpatient at one of the participating NSW based hospitals. Study details This study is trialling a consumer action model which aims to improve aspects of cancer treatment systems which have been identified as priorities by chemotherapy cancer patients. Hospitals involved in this study will participate in a quality improvement intervention, based on the Breakthrough Series. The Breakthrough Series is a collaborative model of learning developed by the Institute for Healthcare Improvement (IHI). This model focuses on health care systems improving the quality of their health care through sharing and learning from each other’s experiences and resources. This study will adapt the current Breakthrough Series Model to incorporate consumer involvement in identifying priority quality of care concerns, developing solutions and monitoring the success of those solutions. Participants will be asked to complete questionnaires throughout the study in order to evaluate the degree of unmet supportive care needs and quality of life.

  • The effect of fibre supplementation on the frequency of eating occasions

    The primary aim of this study is to investigate the effect that a viscous fibre supplement, PGX, has on frequency of eating occasions in overweight adults, over a 12-week period. In addition to this, body weight, waist circumference, blood pressure and fasting venous blood samples will be measured both at baseline and post-intervention. The blood samples will be used to measure glucose, insulin, changes in insulin sensitivity, triglycerides, cholestrol (total, HDL and LDL) and apoB48. Eating occasions will be recorded using a mobile device food record and automatically uploaded to a server for analysis. It is hypothesised that the fibre supplement will reduce the frequency of eating occasions, leading to a subsequent reduction in body weight. OBJECTIVES 1. To investigate the effect of a viscous fibre supplement on frequency of eating occasions in overweight adults, over a 12-week period. 2. To measure body weight, waist circumference, blood pressure and fasting venous blood samples differences between baseline and at the end of the 12-week intervention. Aim 1. To investigate the effect of a viscous fibre supplement has on frequency of eating occasions in overweight adults Hypothesis Overweight adults receiving the viscous soluble fibre (PGX) will significantly reduce their intake of energy-dense nutrient poor foods and number of eating occasions compared with controls

  • Active ageing: a novel dynamic exercise initiative for older people to improve health and well being - a study protocol.

    Falls are a leading cause of disability among older adults. Physical activity has been shown to be effective in reducing the risk of falls in elderly. However, elderly group are not regularly engaged in physical activity. The main objective of this study is to evaluate the effectiveness of an exercise intervention using an exercise park in reducing the risk of falls, improving strength and balance in the elderly. In addition, this research project will evaluate what other benefits, including psychological and psychosocial, can be achieved by using such exercise park. This project also aims to examine how this kind of intervention will be perceived in the community and if potential benefits can be identified, which could then help to determine whether such intervention is appropriate for further testing. This project will be run in collaboration with several community partner organisations in the Western Suburbs including Gateway Social Support Options and Catholic Homes. Sixty older people living in the community aged between 60 and 90 years who have had one fall in the previous 12 months or that are concerned they might fall will be recruited (older people with mild falls risk). Participants will be randomised in two groups: exercise park intervention group and a control group and will undergo a series of physical/physiological tests as well as complete some psychological and psychosocial questionnaires. Tests will be performed at baseline, after 18 weeks and then again after 2 months (26 weeks) for both groups. Participants will be followed up for 12 months via Falls and Physical Activity Calendars. Participants in the intervention group will have 2-3 sessions per week of 1-1.5 hours duration each session) for 18 weeks. Control group will continue with their normal activities for the same period. At the end of this study, the participants will be able to monitor their susceptibility to falls based on the result of the tests used in this study. Additionally, it is expected that, by the experience of working with this population group, some factors which can influence the exercise uptake and its compliance by the elderly may be identified. Furthermore, the research findings may offer some guidance on future investments local councils may make towards this population group.

  • The Healthy Heart Study: Investigating different ways of explaining cardiovascular disease risk to help people understand their risk and improve their lifestyle

    Who is it for? Participants were eligible to join this study if they were aged between 45-64 years and not already known to be at increased risk of cardiovascular disease (CVD). Study details: Participants completed an online CVD risk assessment and were randomly (by chance) allocated to receive their results as either their 'heart age' or the equivalent percentage risk of a heart attack or stroke over the next 5 years, using three different visual formats. The researchers investigated how different ways of explaining CVD risk affected a range of psychological and behavioural outcomes, including intention to change lifestyle, risk perceptions, and behaviour change after 2 weeks.

  • Predictors of relapse in Polymyalgia Rheumatica patients treated with low-dose glucocorticoid therapy

    Despite the fact that Polymyalgia Rheumatica (PMR) is the most common inflammatory rheumatic disease of the elderly, it is poorly understood. With no diagnostic tests available, diagnosis is dependent upon a history of muscle pain and stiffness in the hip and shoulder regions, combined with raised inflammation levels in the blood. Treatment consists of Prednisolone (commonly referred to as “cortisone”) prescribed in a “one size fits all” approach. However, the way in which PMR patients’ symptoms respond is very variable; some improve almost overnight, whilst other individuals require higher doses for much longer periods of time. Unfortunately, such long-term Prednisolone use can result in many complications including osteoporosis, weight gain, high blood pressure and diabetes. Similarly, uncontrolled PMR is associated with increased risk of heart attacks and stroke. This project aims to identify the characteristics of patients that fail to respond adequately to Prednisolone treatment. It is hypothesized that this information will delineate a distinct subset of “refractory” PMR patients, thereby permitting further study of alternate therapy in this group and minimizing the side effects of Prednisolone use long-term.

  • PRE-TREAT: A window study evaluating short term treatment with tamoxifen or letrozole in oestrogen receptive positive breast cancer

    This study aims to determine the effects of short-term treatment with endocrine therapy (tamoxifen or letrozole) when given to women with newly diagnosed oestrogen receptor positive (ER+) breast cancer. Who is it for? You may be eligible to join this study if you are a woman aged 18 years or above, have been recently diagnosed with oestrogen-receptor positive breast cancer. Eligible candidates must have already provided consent to be part of the Breast Biomarker Project at Royal Melbourne Hospital. Study details All participants in this study will receive endocrine therapy for 5-7 days prior to surgery. Pre- or peri- menopausal women will receive 20mg oral tablet of tamoxifen per day whilst post-menopausal women will receive 2.5mg oral tablet of letrozole per day. Blood and tumour samples taken at the time of diagnosis will be compared to those taken at the time of surgery to determine changes in the tumour cells. The findings from this study will provide valuable information on the changes in breast cancer cells and their "signatures" following short-term exposure to endocrine therapy, and help with development of future breast cancer treatment.

  • BRCA-D, a pilot study evaluating a new breast cancer prevention strategy for BRCA1 and BRCA2 mutation carriers

    This study will determine the effects of Denosumab on normal breast tissue in women with BRCA1 and BRCA2 mutations. Who is it for? You may be eligible to join this study if you are a pre-menopausal woman aged between 18 years to 50 years and have documented BRCA1 or BRCA2 mutation considering prophylactic mastectomy, OR willing to undergo two breast biopsies on separate occasions. Study details This is a proof-of-concept pilot study to determine if short-term treatment with Denosumab is a feasible chemoprevention option against breast cancer for BRCA1 and BRCA2 mutation carriers. All women participating in the study will receive 3 doses of 120mg per dose of Denosumab subcutaneously (injected into the skin) monthly for three months. Women will then proceed to their surgery as planned, or have their second breast biopsy. Participants will be followed up for up to 3 months after the last treatment dose. The change in the number of doses of Denosumab (from 4 to 3) was implemented in September 2015, after 6 patients had been enrolled.

  • Evaluation of a brief parenting discussion group for parents of 3-8 year old children with a disability.

    The current study will trial the effectiveness of the new Stepping Stones Triple P Discussion Group Program. Stepping Stones Triple P has been found to result in a variety of benefits for parents of children with a disability, including improvements in positive parenting skills, parenting confidence, child relationships, reduced parental stress and child problem behaviour. As such, it is anticipated that the Discussion Group program being evaluated in this study will result in similar improvements. Results from the study are likely to improve the accessibility of the program to a wide range of parents that require brief positive parenting assistance.

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