ANZCTR search results

The primary purpose of this pilot study is to assess the feasibility of successfully conducting a randomised controlled trial that investigates the effect of adding Explain Pain (vs adding sham ultrasound) to an individualised, physiotherapist-led physical activity and general education program in people with painful knee osteoarthritis. Our primary feasibility objectives relate to participant eligibility and recruitment, participant follow-up rates, feasibility of objective physical activity measurement using wrist-based accelerometry in this population (i.e., valid wear time), and the fidelity of intervention delivery. Our primary pilot objectives relate to the perceived credibility of the sham intervention (inactive ultrasound with inert gel) and the acceptability of Explain pain content and its delivery format for participants and treating clinicians. Our secondary objectives are to identify barriers to study participation and to determine treatment effect estimates for pain intensity and physical activity. This information will help us to calculate the required sample size for a full-scale randomised controlled trial. Participants will be randomised to one of two groups: Explain Pain or Standard Education & Sham Ultrasound Control group. Both groups will receive 4, in-person treatment sessions with a physiotherapist, followed by 4 weeks of at-home activities (weekly check-in by physiotherapist). Both groups will receive general education about osteoarthritis and the importance of physical activity for general health and osteoarthritis benefits. Both groups will also receive a graded walking program. The Explain Pain group will receive enhanced pain education to supplement general education. Specifically, the overall aim of Explain Pain is to shift participants’ conceptualisation of pain from that of a marker of tissue damage to that of a marker of the perceived need to protect the body. The Participants will receive the Explain Pain Handbook. During the at-home sessions, participants will complete an interactive workbook called the Protectometer. The Standard Education & Sham Ultrasound group will receive standard education about osteoarthritis, pain and physical activity as per Arthritis Australia recommendations. They will also receive sham ultrasound (inactive ultrasound and inert gel) to 4 locations on the most painful knee (5 mins each). This will be performed to match time with the therapist between groups. Participants will receive the Arthritis Australia osteoarthritis and physical activity handbook. During the at-home sessions, participants will complete an general workbook that asks questions about osteoarthritis and activity. Outcome measures (pain, physical activity, function, pain beliefs, etc..) will be assessed at baseline, at 4 weeks, 8 weeks, and 6 months by an outcome assessor blinded to treatment group. Treatment efficacy will not be evaluated (between group comparisons) given that this is a feasibility study.

The NSW Government’s Active Kids Voucher is a program designed to help families meet the cost of getting their kids into sport and active fitness and recreation activities. The initiative aims to reduce barriers to participation and help change the physical activity behaviours of children and young people in NSW. The NSW Government will provide a $100 voucher to parents/guardians of school enrolled children aged 4.5 to 18 years’ old. The $100 voucher can be used for registration and participation costs for sport and fitness activities and will not be means tested. One voucher will be available for every child in the family annually over the next four years and there will be no limits on the number of applications per family, as long as every child is enrolled in school. From 31 January 2018, parents/guardians/carers with legal responsibility of an eligible child resident in NSW will be able to download a voucher from an online platform, run by Service NSW. Vouchers are valid for redemption in the current calendar year and will expire at the end of each calendar year. The Active Kids Voucher is an opportunity to increase physical activity of children and will therefore be promoted to all schools within the HNE region during usual interaction with schools as part of health service delivery. The identification of strategies to increase the uptake and advantages of the program, are also warranted. The primary aim of this study is to assess the effectiveness of promoting the Active Kids Voucher program to parents using a school based mobile communication platform on voucher redemption. The study will employ a cluster randomised controlled trial (RCT) design including six intervetnion and six control schools. The intervention involves partnering with a third party school app provider - Skoolbag. Skoolbag is an app commonly used by schools to provide a communication platform between school administration and parents. Parents can download the app for free and the school can communicate school events, documentation and messages in a simple, easy to use way. The Skoolbag app will be used to send notifications to parents aimed at increasing uptake of the Active Kids Voucher. The effectiveness of the intervention will be determined by comparing post intervention differences between uptake and redemption of the Active Kids Voucher. The proposed research will be one of the first RCTs of its kind and addresses questions of particular policy relevance.

“Sarcopenia” describes the age-related decline in skeletal muscle mass and function which contributes to increased risk of disability and loss of independence. In the presence of obesity, these effects may be exacerbated, and we have demonstrated that the “sarcopenic obese” population have increased risk for falls and fractures, as well as poor cardiometabolic health. We hypothesise that a 12-week gym-based high-intensity resistance and impact training (HiRIT) program will result in significant improvements in physical function, bone quality, insulin sensitivity and glucose tolerance compared with home-based aerobic exercise program (control) in 60 sarcopenic obese community-dwelling older adults undergoing weight loss through dietary intervention. The findings from OSMOSIS-P will contribute to the development of guidelines for exercise in obese older adults at increased risk for functional decline, falls and fractures.

Patients undergoing bifurcation coronary stenting as part of standard of care and who give informed consent will be included in this study. All of the following are part of standard of care: Participants will be seen in pre-admission clinic or in their hospital bed by the PI. The registry will be discussed and if agreeable informed consent will be obtained. The participant will have a bifurcation stent inserted, discharged from hospital and followed up in the clinic at the Princess Alexandra Hospital. An exercise echocardiogram will be performed at Month 12 and if this is positive a coronary angiogram will be performed. The registry then ends for the participant. Registry research: Data from all of these time points will be collected.

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.