ANZCTR search results

Transcutaneous electrical nerve stimulation (TENS) is recognised as a safe, effective and non-invasive method of pain relief that works via stimulation of sensory fibres. Several studies have identified that TENS can significantly reduce exercise induced pain. Given that exercise-induced leg pain is a major barrier to physical activity for patients with peripheral artery diease and intermittent claudication (PAD-IC), further investigation of the benefits of TENS application for these patients could identify a simple therapy to reduce the pain associated with physical activity. The aim of this project is to examine the influence of TENS on walking capacity (via 6-minute walking test) in PAD-IC patients. Identification of a simple therapy to increase walking capacity will enhance patient mobility and independence that may contribute to improved levels of physical activity, quality of life and subsequent physical health.

Stroke is a potential devastating complication of cardiac surgery occurring in up to 3-4% of patients undergoing combined aortic valve replacement (AVR) and coronary artery bypass grafting (CABG). Peri-operative stroke is often multifactorial and resulting from debris from the heart-lung machine and the sites of heart-lung machine into the blood-stream. Traditionally the first part of the main blood vessel leaving the heart (the aorta) punctured to provide oxygen-rich blood inflow from the heart lung machine for patients undergoing heart surgery. In patients with significant aortic atheroma, the risk of stroke may be minimised by reducing manipulation of diseased aorta. Alternative cannulation sites that do not require a puncture of the aorta include: right axillary cannulation (right arm artery) and common femoral cannulation (upper leg artery). Right axillary cannulation is increasingly being used for major aortic surgery due to a proven reduction in stroke. It has not yet been shown if this benefit will extend to other aspects of cardiac surgery that have a higher risk of stroke. This study comparing cannulation strategy to determine if there is a reduction in stroke. Patients undergoing combined aortic valve replacement + coronary artery bypass surgery, who are deemed intermediate or high risk of stroke are randomly assigned to receive either right axillary cannulation or central aortic cannulation Patients in the intervention arm will have arterial cannulation via the right axillary artery. Right axillary cannulation involves an approximately 5cm incision below the right collar bone to get access to the artery used for inflow to the heart-lung machine. The vessel is assessed for suitability to ensure it is suitable for use and if so they are connected to the heart-lung machine via this artery. Patients in the control arm will be have the arterial inflow from the heart lung machine via the aorta as is conventionally done. The remainder of the procedure is unchanged regardless of cannulation strategy. In order to determine a difference in stroke the participant will have an MRI scan of the brain and an assessment performed in the hospital prior to the operation, this will also be repeated within seven days after the operation. The participant will also be required to follow up with a neurologist 3 months after the operation in addition to the routine post-operative review with the cardiothoracic surgeon.

The primary purpose of this trial is to compare the efficacy of an internet program for insomnia to an internet program for anxiety in individuals with comorbid anxiety and insomnia. . Insomnia frequently co-occurs with anxiety and mood disorders, and gives rise to more complications and greater burden than any disorder alone. Internet cognitive behavioural therapy (iCBT) for insomnia has been found to be more effective than iCBT for depression in reducing insomnia symptoms, and equally effective in reducing depression symptoms. This suggests that in the case of comorbid insomnia and depression, it may be particularly valuable to target the insomnia symptoms, at least in the first instance. To the best of our knowledge, this same question has not been examined in the case of comorbid insomnia and anxiety. Thus the aim of the current study is to compare the efficacy of our online iCBT insomnia course to our online iCBT course for anxiety in a sample of individuals with comorbid insomnia and anxiety. Study details All participants enrolled in this study will be randomly allocated (by chance) to either a cognitive behavioural program for insomnia or anxiety. For the internet-based cognitive behavioural program for insomnia, there are four lessons to complete over up to 8 weeks. It includes psycho-education about insomnia and how it is maintained, as well as specific strategies to manage insomnia and change unhelpful behaviours and thinking patterns which maintain poor sleep. For the internet-based cognitive behavioural program for anxiety, there are four lessons to complete over up to 8 weeks. It includes psycho-education about anxiety and how it is maintained, as well as specific strategies to manage anxiety and change unhelpful behaviours and thinking patterns which maintain anxiety. Participants will complete a number of questionnaires to assess their insomnia, anxiety, depression and sleep difficulties among other psychological factors, at the beginning of the program, mid-way through, at the end of the program, and 3 months after finishing the program. Participants will undergo a diagnostic telephone interview prior to treatment. Participants will also be asked to complete a sleep diary before and after the program. It is hoped that the findings of this trial will provide information regarding the relative efficacy of internet interventions for insomnia and anxiety in reducing these symptoms in a comorbid sample.

Type 2 diabetes mellitus (T2DM) is a progressive multisystem disease. Despite the large amount of oral antidiabetic agents available, current therapy is not optimal. More than 60% of people with T2DM have inadequately controlled glucose levels. DCB-DM101 is a new botanical investigational drug which has been developed by Development Centre for Biotechnology (DCB) in Taiwan. DCB-DM101 is hoped to offer an alternate approach to the management of many aspects of T2DM. The aim of this Phase I study is to assess the safety and efficacy profile of DCB-DM101 (the "study drug") when given in combination with existing antidiabetic treatments (metformin and Januvia (sitagliptin) or metformin and Jardiance (empagliflozin)) to participants who have inadequately controlled T2DM. Two groups of participants will be recruited and take a daily oral dose of DCB-DM101 (330 mg/day) for 7 consecutive days in addition to their standard antidiabetic treatment (metformin and sitagliptin or metformin and empagliflozin). A third comparative group of participants will be administered empagliflozin (instead of DCB-DM101) in addition to their standard antidiabetic treatment of metformin and sitagliptin.

About 1 million Australian adults will experience depression each year. GPs play an important role in helping people manage depression. But without assistance, GPs miss about 50% of cases of depression. This study will examine an intervention designed to assist GPs in 1) identifying patients with depression and 2) providing these patients with appropriate care. The study will take place in 24 general practices across NSW and Victoria, with general practices randomly allocated to one of two groups (intervention or control). At each practice, consenting patients will complete a touchscreen computer survey in the waiting room prior to their GP appointment. The survey will focus on assessing if patients might be experiencing signs of depression. GPs in the intervention group will receive: 1) education in mental health care; 2) summarised feedback of patient depression scores as measured by the survey; 3) printed patient self-management brochures to distribute to patients; and 4) access to expert advice on depression management. GPs in the control group will not be offered these intervention strategies, but will continue to provide usual care to their patients. Eligible patients who complete the touchscreen survey will undergo follow up surveys at 3, 6 and 12 months. The study will create new knowledge to inform best practice depression care, with the potential for broad adoption across Australian general practices.

The purpose of this study is to determine the presence of methylene tetrahydrofolate reductase (MTHFR) genetic polymorphisms in platinum resistance and platinum sensitive ovarian cancer patients. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with ovarian, fallopian tube, epithelial or peritoneal cancer. Study details: Participants will be asked to undertake a single blood test and complete the food frequency questionnaire designed by the Cancer Council Victoria. A single interview will also be conducted in order to record a thorough medical and family history, that will take approximately 1 hour. Participants will also be asked to consent to the use of their medical records for information regarding diagnosis and medical history. The project is aimed at providing an insight into the influence of diet in platinum responsiveness in ovarian cancer, and whether MTHFR status can be used as a prognostic biomarker for clinical decisions regarding treatment strategy, for patients at risk of platinum drug toxicity or poor responsiveness.

This project evaluates the short-term efficacy of the Dementia Risk Reduction (DESeRvE) program involving 3 different approaches (Education (ED), Contact (CT), Education plus contact (ED+CT)), in stigma reduction for dementia using a Randomised Controlled Trial (RCT). There will also be an Active Control group which receive information on general health. It is hypothesised that the level of dementia-related stigma and dementia knowledge will be reduced and enhanced respectively for those in the intervention groups more than those in the Active Control group.

This community randomised trial will evaluate whether participation in the Resilient Families program results in improved family relationship, and social emotional wellbeing in disadvantaged secondary schools selected to include high rates of culturally and linguistically diverse families. Fourteen schools will be randomly assigned to intervention and 14 to a usual-practice control condition. Students and their parents will be invited to complete an online longitudinal survey at baseline in 2018 and 3-months post-intervention. The trial is linked to an independent study being completed by the University of Western Sydney and funded by E4L that will evaluate effects on student academic achievement. Resilient Families is a school-based family intervention program (Toumbourou et al., 2013) designed in 2004 by Professor John Toumbourou and currently delivered to schools by a team based at Deakin University. The Resilient Families program includes a student social relationship curricula and parent education components and is designed to be integrated into the normal school processes to assist secondary schools to enhance family-school partnerships. Previous evaluations have shown the Resilient Families program reduces student alcohol use across the whole-school population and depression and antisocial behaviour in vulnerable students.

To study the feasibility of capsule colonoscopy in patients with Crohn's Disease (CD). To compare the results of capsule colonoscopy with conventional colonoscopy in assessing mucosal healing. To correlate the level of faecal calprotectin with the results of capsule colonoscopy and conventional colonoscopy. To document changes in clinical practice attributable to the capsule colonoscopy findings a) concordant with and b) in addition to the parallel findings at colonoscopy and ileoscopy. Patients of the Royal Melbourne Hospital (RMH) and other associated speciality clinics with an established diagnosis of CD who need assessment of mucosal healing and have consented to be part of the study will undergo capsule colonoscopy and conventional colonoscopy after undergoing bowel preparation. The images of both the conventional and capsule colonoscopies will be recorded. In addition calprotectin (an inflammatory marker in faeces) will be measured in a sample of faeces collected by the patients prior to the colonoscopy day. Recorded images will be assessed once the images have been deidentified. Assessment will include the level of mucosal disease. To assess the level of mucosal disease they will use the Simple Endoscopic Score for CD (SESCD). The results of the assessment of mucosal healing obtained from conventional colonoscopy will be compared with those of capsule colonoscopy and levels of faecal calprotectin will then be correlated.

Managing medication regimens is one of the most complex and burdensome tasks performed by older people, and can be prone to errors. The objective of this pilot and feasibility study is to investigate a structured approach to simplify medication regimens for clients receiving community-based home care services. We hypothesise this may reduce the total number of medication administration times and may improve clinical outcomes for clients. This pilot and feasibility study will apply a pre-post design. Research nurses will recruit 50 clients with and without cognitive impairment receiving community-based home care services through aged care providers in South Australia. A clinical pharmacist will undertake medication reconciliation, assess each participant’s capacity to self manage their medication regimen, and apply a structured tool to identify opportunities for medication simplification. The pharmacist will communicate recommendations regarding medication simplification to registered nurses at the community-based home care provider organisation. The primary outcome will be the change in number of medication administration times per day at four months. Secondary outcomes include medication adherence, quality of life, participant satisfaction, medication incidents, falls and health care utilisation. Study findings will be disseminated through conference presentations, consumer summaries and peer-reviewed publications.