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Hepatitis C (HCV) is a blood borne virus which primarily infects and damages the liver. About 75-80% of people who acquired the acute hepatitis C will develop a chronic infection. Out of those about 20% will develop severe liver disease (cirrhosis) in 20-40 years following the acquisition of the disease. About 5% will develop liver failure and liver cancer. It is estimated there were around 264,000 people living with HCV antibodies in Australia in 2005 (range 206,000 to 318,000). 197,000 were estimated to be living with chronic HCV infection (range 154,000 to 238,000). The current treatment for chronic hepatitis C is pegylated interferon and Ribavirin. Interferons are chemicals produced by cells in response to viral infection. Ribavirin is an anti viral medication. The treatment duration is either 6 or 12 months. The treatment results in 50-80% success in eradicating the virus depending on the viral load and subtype of the virus. The success also depends on the total amount of medications taken by the patient. Less than 80% of the medications taken less than 80% of the time will result in significant decrease in the success rate. The Interferons cause psychological side effects including depression, anxiety, anger, mania and psychosis. It is estimated about 30-40% patients will feel one or more of the above symptoms during the course of the therapy with about 20% meeting criteria for major depression. These symptoms significantly reduce the quality of life of the patients who undergo therapy. In addition these can lead to reduction in medication dose, non compliance and premature therapy termination resulting in reduction in success of eradication the virus. Gastroenterologists working in this setting are very aware of the psychiatric adverse effects, routinely inquire about them and at times treat depression and other disorders they may find, and/or refer the patients for psychiatric care. They provide patients with information booklets covering this and other topics to do with interferon therapy. Some patients are symptomatic and are referred for psychiatric care right at the start, before interferon is commenced. The majority, however, are commenced on interferon and referred if and when psychiatric problems emerge. The capacity for gastroenterologists to comprehensively deal with these problems is necessarily limited and, in addition, it is preferable to recognize emerging symptoms and to commence therapy early to minimize the impact of these side effects on overall outcome. Availability of psychiatrists and psychologists is very limited, so the usual practice in hepatitis C treatment centers is to refer patients for psychiatric care if and when problems arise. We propose to conduct a pilot randomized trial to explore the value of early contact with a psychologist in reducing the risk of psychiatric side effects and improving access to psychological and psychiatric care when needed. Study participants will be recruited from the hepatitis C clinics at St Vincent’s Hospital (Melbourne) and will exclude those referred to the psychiatrist at baseline. All other patients will be randomly assigned to two groups at the beginning of interferon therapy. The first group will be offered what we have termed a ‘psychological care gateway’ consisting of two appointments with a psychologist, plus two offers: (i) further appointments with the psychologist as needed and (ii) access to a weekly supportive group on ‘coping with interferon therapy’, all this in addition to ‘treatment as usual’, i.e. attendances at the HCV clinic to see their gastroenterologist and the clinic nurse. The second group will receive ‘treatment as usual’. During the interferon therapy, both the psychologist and gastroenterologists will continue to refer patients to the psychiatrist as usual if the clinical need arises. The main outcome measure will be reduction in psychiatric symptom levels, measured by questionnaire. Secondary outcomes will be the interferon therapy discontinuation rate, rates of clinically diagnosed psychiatric disorder, and quality of life. In addition, we will measure the uptake of the ‘psychological care gateway’, and the extent to which its components are acceptable to and utilized by patients. Psychometric tests will be used to define which patients will benefit from the early psychiatric review. This pilot study is expected to recruit about 48 participants within 24 weeks for randomization and to be completed in 72 weeks. Data gathered in the pilot will guide the design of future trials of provision of psychological care for these patients.

The purpose of this study is to identify whether resistance (weight) training results in improvements in fitness and well being for patients with stable chronic systolic heart failure. Systolic heart failure is a condition where the heart muscle cannot pump blood as vigorously as usual. Resistance exercise training involves the use of muscle groups to push and pull against a smooth hydraulic force. In this study participants are randomly allocated to 3 months of either resistance exercise training or no exercise training. Tests are carried out before, during and after the 3-month period to determine differences between the 2 groups in a number of measures of fitness and well being.

A total of 30 consumers with a previous 6 month history of warfarin use and a long term indication for its future use will be identified by selected community pharmacies. With the consent of their GP they will be trained to perform patient self monitoring of the INR with a portable monitor by a trained accredited pharmacist. Results obtained will be reported back to their GP for dosage adjustment every 2 weeks for 6 months. The views of GP's, pharmacists and patients will be assessed and used to modify the training process prior to a more widespread implementation of the program

Objective: To evaluate whether the development of albuminuria, hypertension or diabetes can be delayed or postponed in high risk Aboriginal people. Design. Double blind, placebo controlled, randomized trial of a long acting angiotensin converting enzyme inhibitor(ACEi), titrated to full dose where tolerated (active arm) vs placebo. Oversight: A steering committee, an independent audit process and a data analysis group. Eligibility criteria: Consenting Aboriginal adults age 18+ years, with BP = 140/90, urine albumin creatinine ratio < 2.2 gm/mol and without diabetes, who are without contraindications to ACEi. Outcomes: The primary outcome is a composite endpoint for BP>140/90 and/or urine ACR>2.2 gm/mol and or diabetes. Weight, waist, lipids and HbA1c levels will also be followed. Cardiovascular events and natural deaths will be documented. Sample size: A total of 150 candidates is proposed: the Tiwi community. These will represent at least 75 in the active arm and 75 in the placebo arm. The sample size is based on factual incidence data in Tiwi. Duration: Five years of active treatment, with an option to discontinue earlier pending significant results Significance: Delay of onset of features of the vascular/metabolic/renal syndrome in populations where annual incidence rates are as high as 15% per year, and prevalence rates by age 50 years are = 80% could save or prevent much morbidity and mortality from definitive disease. Findings will probably be relevant to other high risk population.

The primary purpose of the study is to determine if in patients with Diabetic Maculopathy micropulse laser treatment is better than argon laser treatment, at improving or stabilising visual acuity and reducing retinal oedema. The hypothesis is that the micropulse laser may provide as good or better therapeutic benefit as compared to current treatments but without the damage normally associated with this treatment.

Successful management of type 1 diabetes includes adhering to a complex and often intrusive treatment regimen, which can be especially challenging and stressful for young people. This study aims to adapt and trial a coping skills training program The Best of Coping (Frydenberg & Brandon, 2007) and to assess the program’s efficacy in improving glycaemic control, coping skills, diabetes-specific self-efficacy (confidence in one’s own ability to manage with diabetes), diabetes regimen adherence, and quality of life in adolescents aged 13-16 years with type 1 diabetes. Hypothesis: It is predicted that the BOC program will improve glycaemic control at the 3 and 12 month follow-up compared to the control group. Hypothesis 2: It is predicted that the BOC program will improve productive coping skills, self-efficacy, adherence to the diabetes treatment regimen, stress levels and quality of life compared to the control group at 3 and 12 months after baseline.

In most patients with chronic low back pain, the cause of their pain is unknown. As well, there are very few proven treatments for chronic low back pain, and none of the commonly used treatments are known to relieve pain completely. However, in a small proportion of patients, the source of pain can be traced to one or more small joints in the lumbar spine, called the zygapophysial joints – or “Z” joints for short. Pain from these joints can be relieved by sealing the small nerves that supply the joints. This is done using a probe inserted, under X-ray control, onto each of the nerves. The probe delivers a tiny heat-lesion that seals the nerve. In full, this procedure is called percutaneous lumbar medial branch radiofrequency neurotomy. In short, it is known as radiofrequency, or RF neurotomy. Lumbar RF neurotomy is not an experimental procedure. It has been used in Medicine for nearly 30 years. In Australia, it is recognized in having a Medicare item number. Doctors who use this procedure to treat their patients believe that it works. However, some commentators have questioned if the results of the operation are genuine. They believe that patients report relief because of non-specific effects of the procedure – such as the ceremony of having an operation, or because patients want it to work. They argue that it is not necessary actually to coagulate the nerves in order to achieve a beneficial effect. This argument arises because there has been no rigorous scientific studies of the procedure in the form of controlled trials. In a controlled trial, a computer indicates whether patients should undergo the real treatment or a sham treatment. A sham treatment is one which is just like the real treatment but differs in one critical respect. In the present study, the difference is that in the sham procedure not actually coagulated. If an operation works in such a study, the results obtained from the real treatment emerge as better than those obtained from the sham treatment. The difference in results indicates how powerful the real treatment is. However, if there is no difference in the results, any apparent effectiveness of the treatment is attributed to non-specific influences. Some controlled trials for lumbar RF neurotomy have been conducted, but in each instance the operators used techniques that have been shown to fail to coagulate the target nerves accurately. In the one study in which correct techniques were used, the investigators found that some 80% of patients obtained at least 60% relief of their pain, and 60% of patients obtained at least 80% relief, lasting for at least 12 months after treatment. But these results have been disregarded because the study was not controlled: it provided the real treatment but had no patients who underwent sham treatment. Because of the lack of convincing scientific evidence that lumbar RF neurotomy actually works, some insurance carriers have undertaken to deny this form of treatment to their clients. This has occurred both in the United States and in Australia. In response to the conflict between those doctors who believe that lumbar RF neurotomy works and those who believe it does not, the International Spine Intervention Society has provided funding for study of the procedure, to be conducted in which will look at recruiting 30 patient volunteers.

This study seeks to determine whether the effectiveness of current flu vaccines in protecting people with chronic disease against flu-complications can be improved by addition of a specific compound (adjuvant) which acts by boosting the immune response to the vaccine

The main phase of an academic lead and conducted, international, multi-centre, open label, blinded endpoint, randomised controlled trial to establish the balance of benefits and risks of a treatment strategy of early intensive lowering of blood pressure (BP) compared to a conservative BP lowering policy in patients with acute primary intracerebral haemorrhage (ICH) and co-existing elevated BP without any definite indication or contraindication to treatment.

Health of mothers and infants would improve if breastfeeding rates were closer to the recommendations. Mothers' choices about how to feed their babies depend on information initially, motivation continually, and in the longer term, support. Support is most effective when provided by those skilled in breastfeeding management and good communication. This study proposes that proactive ongoing support from a known and trained primary health professional, namely the General Practice Nurse, using a motivational interviewing approach, can improve breastfeeding duration and delay introduction of solids or other foods.