ANZCTR search results

In some countries (eg Canada and UK), some patients can receive monoclonal antibody (MAB) treatment at home, under the supervision of an appropriately trained registered nurse. However, we are not aware of any comparable studies examining the safety of natalizumab and flexible delivery (i.e. treatment at home, or in a community setting) for people with multiple sclerosis (MS). Therefore, the broad objective of this study is to investigate the flexible delivery of natalizumab. In many cases, it is anticipated that flexible delivery will entail delivery in the patient’s own home. The study will compare the flexible delivery of natalizumab with usual care (attendance in an outpatient department) and answer whether it is acceptable to patients, is effective and safe, and is cost effective. The study will comprise a pilot study to better understand feasibility and safety, and to inform a larger, proposed full-scale study. The primary objective of the study is to determine whether the flexible delivery of natalizumab is safe for people with MS. The additional objectives of this study in this study population are as follows: (a) Is the flexible delivery of natalizumab acceptable to patients and healthcare staff? (b) Is the flexible delivery of natalizumab as effective in treating symptoms? (c) Is the flexible delivery of natalizumab cost effective?

Prolonged periods of sitting are prevalent in the modern office workplace and adversely impact on cardiometabolic risk factors including blood glucose and insulin concentrations. Acute aerobic exercise can transiently improve these risk factors. Evidence suggests that the pattern of exercise accumulation throughout a day and the timing of exercise in relation to meals modulates the beneficial effects it has on these markers. However, the role of exercise timing throughout a day on cardiometabolic risk factors has not been evaluated. The aim of this study is to compare the impact of a morning and evening bout of aerobic exercise on blood glucose and insulin metabolism throughout a day of prolonged sitting. Young overweight or obese men and women with a familial history of type 2 diabetes will be recruited for this study. As this demographic are at an increased risk of developing type 2 diabetes they represent a relevant target population for the prevention of type 2 diabetes. We hypothesise that aerobic exercise performed in the morning, prior to a prolonged bout of sitting and the ingestion of meals will more effectively improve glycaemic control compared to an identical evening bout.

The primary purpose of this study is to implement an integrated eHealth platform to support and enable cancer survivors to achieve and maintain improved health and well-being and better cancer outcomes, and to assess the functionality and acceptability of the system. Who is it for? You may be eligible to join this study if you are aged 18 or over and are either currently receiving cancer care (including follow-up care), or have recently been diagnosed with cancer and scheduled to commence cancer treatment at one of the participating sites. Study details Participants will have access to the eHealth system which assesses symptoms, emotional well-being and unmet needs. Participants will have access to a range of self-management websites based on their survey responses. Staff will receive a patient report with clinical recommendations. Patients and oncology staff will have access to the system for 6 months. Patients will then be asked to complete a survey and an interview regarding their use and acceptability of the eHealth system. Staff will be asked to complete an interview only. A sub-set of participants who are on-treatment at the commencement of the study and transition to follow-up care during the study will receive a Treatment Summary and Survivorship Care Plan that will also be provided to their GP.

This study is important in defining the baseline physiological state of patients presenting for outpatient endoscopy. It has been observed that intravenous fluids do not prevent hypotension in patients who are undergoing endoscopy. One possible explanation for this is that patients are not intravascularly deplete after bowel preparation solution. This study will determine what the rate of intravascular depletion in patients undergoing endoscopy after bowel preparation solution is.

Levels of perceived stress have indeed been found to have increase considerably over the past decades. Chronic stress is considered to be incredibly toxic, resulting in long-term psychological and physiological changes such that maladaptive emotional states, like depression, increase along with inflammation, while immune functioning decreases. Consequently, stress is among the leading causes for the global burden of disease, entailing heavy costs for both health care systems and the private economy. Alongside this “stress-epidemic” the popularity of yoga is growing exponentially. In addition to reported stress relief, Hatha yoga has been suggested to decrease levels of inflammation as advanced practitioners were found to have lower levels of inflammation than beginners (Kiecolt-Glaser et al., 2010). A randomised control trial on heart failure patients suggested that the practice of Hatha yoga significantly lowered inflammation within a two month period (Pullen et al., 2008). While the empirical evidence for the practice of yoga as a therapeutic technique is promising (Chandratreya, 2011), the literature has reported methodological limitations. Such limitations include small sample sizes (insufficient to obtain power); a lack of standardised protocols in conducting interventions (making studies difficult to replicate); and a general lack of the use of biological markers (considered to be more objective than psychological measures alone). In order to be able to definitively conclude that yoga offers a benefit to chronically stressed individuals biomedical studies that are adequately powered, and use standardised protocols, are required. Hence, this investigation has been designed to address the aforementioned limitations in a randomised controlled trial (RCT). A standardised protocol of yoga will be administered for 16 sessions. We hypothesise that yoga participation in the yoga intervention will benefit participants psychologically, physiologically, and biochemically.

This research aims to determine the feasibility and effectiveness of intensive showering and dressing retraining delivered for 2 weeks in an inpatient rehabilitation unit. Stroke survivors regularly require assistance with completing self-care tasks at their admission to rehab. This need for assistance often continues following discharge and is associated with poor consumer and carer outcomes. Increased intensity of retraining in rehabilitation continues to show improved outcomes for stroke survivors, therefore we want to test the theory that increasing the intensity of self-care rehabilitation will provide improved outcomes. Each participant will have their level of independence in completing the activities of showering and dressing assessed. They will then receive self-care retraining delivered by an occupational therapist (OT) or an allied health assistant (AHA) either 5 days per week for two weeks (trial intervention), or up to twice per week only for 2 weeks which is currently usual care in the rehabilitation units (control intervention). Re-assessment of their ability to independently complete these tasks will then be completed. The level of improvement will be analysed to determine if there is any increased benefit for those undertaking the trial intervention. The research will also establish whether it is possible, practical and safe to deliver this therapy in inpatient rehabilitation, and if patients like or can manage this level of intensity

There is a wide range of local analgesic techniques available for analgesia following total knee arthroplasty (TKA). In a recent review article, continuous femoral nerve block analgesia has been described as the ‘gold standard’.. A myriad of combinations of these techniques appear in the literature and all have some limitations. Regional anaesthesia techniques provide far superior analgesia to opioid only analgesia following knee arthroplasty. Femoral nerve blocks have previously been considered the gold standard for analgesia however due to the effects on quadriceps strength these infusions have limited patients ability to mobilise and rehabilitate and have thus been of limited duration. Adductor canal block infusions have provided equivalent analgesia to femoral nerve blocks while preserving motor strength. Patients are able to walk independently while these infusions are running with limited pain. This is transforming post-operative care for these patients. We have audited 3 day infusions in this group of patients and found improvements in pain and mobility. We believe that prolonging the infusion duration may provide further benefits to patients. The primary aim of this trial is to assess whether a 5 day ACB infusion is better than a 3 day infusion in terms of quality of analgesia and their walking activity level during the first week following their surgery. Our secondary aims are to evaluate safety of the technique and to ascertain if any benefits are carried over to the 3 month pain, walking level, hip function and satisfaction levels.

This study will map the pain and opioid analgesia experience of patients following inpatient surgical care in a variety of hospitals in Melbourne, Australia. This study will determine if there is a significant opioid pool in the community which is sourced in the acute care setting along with the pain experience of patients undergoing surgical care. Measurement of current handling is the first step in developing an opioid stewardship program.

The aim of the study: Overall Purpose of the research: is to explore scientific basis for preliminary and anecdotal evidence of psychosomatic nature and the pathophysiology of chronic physical diseases and to evaluate a psychological approach to treat physical disease. The primary aim of this study is to assess the effectiveness of a Mindfulness-based program in improving cardiac autonomic nervous stress response in the patients with chronic obstructive pulmonary disease (COPD) and hypertension. The autonomic stress response is measured by measuring heart rate variability (HRV). Statistically significant increase in HRV after the Mindfulness practice compared to after the standard treatment only will be used to measure the effectiveness of the Mindfulness practice. Both the control and intervention will receive their standard treatment for COPD and hypertension. Only the intervention group will receive training in mindfulness practice. Hypothesis: The hypothesis tested in this study is that Mindfulness Practice reduces autonomic stress response in moderate and severe COPD patients and in patients with hypertension. Cohort: Adult male and female participants who are diagnosed to have moderate or severe chronic COPD and hypertension Design: This is a pilot study of a randomised control trial. Phase 1: We intend to recruit 40 moderate and severe COPD patients with uncontrolled hypertension. Half the group will be randomised to attend a weekly mindfulness training program for 8 weeks in addition to their standard treatment. The other half will act as the control group and will receive only the standard treatment. Phase 2: In phase 2, the same study will be expanded to include an additional number of participants based on findings of the pilot study and extended to explore other different non-communicable diseases associated with autonomic dysfunction. The Mindfulness program (MB SMART) Mindfulness program is designed with practices with a specific emphasis on increasing awareness of automatic behaviour following emotional reactivity using the body and emotional awareness. Enhanced awareness of thoughts, emotions and automatic behaviour can reduce psychological reactivity and thereby reduce the autonomic nervous system activity (psycho-neurological sympathetic over-activity). This program is called Mindfulness-Based Self -Managed Auto-Regulation Treatment (MB-SMART).

Does tranexamic acid use in the perioperative period reduce post operative thigh swelling, improve short term functional outcomes and reduce analgesia use following total hip replacement? The secondary question of whether tranexamic acid use decreases blood loss in the anterior approach to total hip replacements will also be addressed.