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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.

Aim: To assess the comparative effects of moderate-intensity walking and stationary cycling exercise programs on early post-operative recovery following coronary artery bypass graft surgery

The most substantial long term morbidity from prostate cancer is sexual dysfunction with consequent adverse changes in couple and intimate relationships. Research to date has not identified an effective way to improve sexual and psychosocial adjustment for both men with prostate cancer and their partners. As well, the efficacy and cost effectiveness of peer counselling as opposed to professional models of service delivery has not yet been empirically tested. Proscan for Couples is a randomised control trial of a couples-based intervention that targets the specific challenges couples experience at diagnosis of localised prostate cancer and after radical prostatectomy. Intervention components include psycho-education; cognitive behavioural strategies; couple relationship education focussed on relationship enhancement and helping the couple to conjointly manage the stresses of cancer diagnosis and treatment; and specific psychosexual education and sexual communication. An audiovisual DVD resource supports the intervention that can be delivered with peer or nurse counselling. We will evaluate the efficacy of this intervention in a three arm randomised controlled trial comparing (1) usual care; (2) eight sessions of peer-delivered telephone support with the audiovisual resource; and (3) eight sessions of oncology nurse-delivered telephone counselling with the audiovisual resource. The trial will involve 210 couples with 70 couples in each condition (420 participants in total).

A randomised controlled trial of a Respiratory Function Monitor during positive pressure ventilation (intervention) compared to positive pressure ventilation (control) (in line with the Australian Resuscitation Council guidelines) during resuscitation of infants. The duration of the trial is 12 months; we anticipate completing recruitment in October 2009. Does the use of a respiratory Function Monitor during positive pressure ventilation reduce face mask leak and improve the target tidal volume in the first ten minutes of life? During the stressful event of neonatal resuscitation neonatologists do not consider the tidal volume (VT) they deliver, or if there is a leak between the face and the mask. We hypothesis that a respiratory function monitor will reduce the face mask leak and support the clinician to deliver the target tidal volume during positive pressure ventilation. Ventilation using a face mask is the main technique used to support infants who breathe inadequately immediately after birth. However, a major problem is the often large and variable gas leak between the mask and face. Face mask leak occurs frequently, even for experienced operators and seriously affects the delivered tidal volume. The tidal volume changes as the leak changes, even though the same inflating pressure is used. In practice this means that for the same inflating pressure the tidal volume may be low, appropriate or excessive depending on the leak. Furthermore immediately after birth it is not possible to deliver an appropriate tidal volume using ventilation with a set pressure because the compliance of the lung varies from infant to infant and during the course of lung aeration. It is therefore necessary to measure and adjust the tidal volumes delivered during positive pressure ventilation in the minutes after birth, especially in very preterm infants. We hypothesis that a respiratory function monitor will reduce the face mask leak and support the clinician to deliver the target tidal volume during positive pressure ventilation.