ANZCTR search results

There is limited research on the medium-term recovery and outcomes of patients three months following major upper abdominal surgery. The aim of this study was to explore the functional outcomes and lived experiences in adults three months after major upper abdominal surgery at Royal Perth Hospital in Perth, Western Australia. Data collected from the participants prior to their surgery was compared with data collected from them three months after the procedure.. The measures included clinical frailty and functional independence. At three months post-surgery, information regarding abdominal pain, post-surgical fatigue, and cognition were also gathered in order to explore the association between these variables and the participants level of functional recovery three months following the surgery. Qualitative interviews were also conducted at this time to explore the participants lived experiences and those of their primary carer.

This trial is exploring if an online shared care plan and telehealth improve the frequency and quality of primary and preventive care for people with a lived experience of severe mental illness. It aims to improve the health of people living with mental illness by facilitating their engagement with primary care. It also aims identify more effective and time efficient shared care processes, which are essential given the multiple competing demands on primary care and mental health clinicians. The online shared care plan outlines the preventive care tasks that GPs and SLHD Mental Health Care Coordinators will share. This includes, for example, physical health checks, metabolic blood tests, lifestyle assessment and advice, preventive screening, medication management and referrals to allied health. This pragmatic trial will invite clients of the Sydney Local Health District Community Mental Health Teams and their usual GPs to participate. Participants will be followed for 12 months.

Neuropathic pain (or nerve pain) is a type of pain that can affect people who have had a traumatic incident or surgery that causes damage to nerves. It occurs in bursts and is often severe and chronic. Pain relief can be difficult to achieve in people with this type of pain. Lidocaine is a local anaesthetic drug that can be given by intravenous drip in a hospital setting, to provide a period of relief from neuropathic pain. Pain is a unique experience for the individual person, blending a combination of body and mind factors. The response to intravenous lidocaine varies greatly from almost complete pain relief for months through to no relief or even feeling worse pain after the drip. We don’t know enough about the optimal dose or which people will get the best pain relief from intravenous lidocaine. The Tess Cramond Pain and Research Centre (TCPRC) is a specialised centre for people with chronic pain. Researchers at the TCPRC will compare two different doses of intravenous lidocaine and a placebo dose (saline without lidocaine) for people with neuropathic pain, to see which gives the best pain relief while minimising the risk of side effects over one week. This study also aims to provide more understanding about each individual person, with participants completing a series of questionnaires about their how their pains feel, expectations from the treatment, their thoughts, feelings and physical activity relative to their goals. Sensory assessments will also be measured, involving standardised hot, cold and pressure stimuli at the skin to determine how the person’s nerve sensitivity contributes to their neuropathic pain. The results of this important study will help to guide anaesthetist’s and specialists pain doctor’s decisions about the best dose of intravenous lidocaine to provide, and which patient characteristics of people with neuropathic pain are most likely to get the most effective and sustained pain relief. This will have potential to improve the quality and the efficiency of care provided at the Tess Cramond Pain and Research Centre and potentially at other treatment centres. The results of this study will also provide the foundation for a much larger study across many hospitals, to conclusively determine the dose of intravenous lidocaine and patient characteristics that achieve the best pain relief, to inform the standard for treating post-traumatic neuropathic pain in Australia and overseas.

The aim of this study is to determine how common retrograde ejaculation is in patients following retroperitoneal lymph node dissection for the treatment of testicular cancer and the impacts that this might have on quality of life. Who is it for? You may be eligible for this study if you are aged 18 years or older, have a confirmed diagnosis of a testicular germ cell tumour, have received retroperitoneal lymph node dissection at least 6 months ago. Study details All participants will be invited to complete a once-off series of questionnaires assessing quality of life, which is expected to take around 20 minutes to complete. Additionally, participants will be invited to partake in an optional semi-structured interview, which will last up to 45 minutes and will occur at a later time. It is hoped that this study will contribute important data to help understand the impact of retrograde ejaculation following retroperitoneal lymph node dissection has on survivors of testicular cancer.

This study will to investigate whether using Cyclophosphamide/Anti-Thymocyte Globulin (ATG) will be as safe as Carmustine, Etoposide, Cytarabine and Melphalan (BEAM) with ATG. We also want to know if it is as effective in suppressing your MS. This study will also investigate how a new immune system develops (by studying your blood), including the microbiome (by studying stool and saliva samples), after using these different types of chemotherapy. The AHSCT procedure involves two stages: collecting and then giving back the patients stem cells. In the first stage, the patients blood stem cells are collected by initially giving high dose of intravenous chemotherapy called cyclophosphamide followed by subcutaneous injections of granulocyte stimulating factor to stimulate the stem cells to 'grow in number'. Once the required number of stem cells are detected through blood tests, the patient undergoes undergo daily leukapheresis until minimum number of stem cells are collected. Once this is done, the patient returns after a period of time, the patient is re-hospitalised for the transplantation procedure. Chemotherapy will be given to knock out the current immune system consisting of one of two regimens; Cyclophosphamide/Anti-Thymocyte Globulin (ATG) or Carmustine, Etoposide, Cytarabine and Melphalan with ATG and then reinfusing their own stem cells to ‘grow’ a new immune system. Patients would be enrolled in sequential cohorts to fully assess safety, tolerability and efficacy of both BEAM and cyclophosphamide conditioning with rabbit ATG as outlined below. Patients would be assigned to a cohort (in a block of 15:15 fashion) unless there is a clear medical reason determined by the transplant physician that they should be treated with a particular regimen (eg: history of allergic reaction to one of the drugs). We hypothesize that HSCT will continue to be safe and beneficial (as measured by resolution of disease characteristics) to patients with severe treatment-resistant neuroinflammatory disease whilst using a variation in conditioning regimen. There are three groups being enrolled. Patients enrolled to have a AHSCT will be compared to patients having standard MS treatment and those undergoing a AHSCT for a hematological cancer

While the role of dietary fibre for the maintenance of gut health is well recognised, typical dietary consumption in Australian adults remains below recommendations. Further, there are many types of dietary fibre, each with different health benefits. In particular, fermentable fibres such as beta glucan and fructans that can impact gut microbe activity, are less likely to be consumed than standard stool bulking agent fibres such as cellulose. This study uses bread as the test product, a common source of dietary fibre for Australians, to pose the question of whether the simple replacement of white fibre bread with a highly fermentable fibre (barleyMAX) bread is achievable and effective in increasing the fibre intake and gut health of Australian parents/caregivers, a group whose busy lifestyle often can result in less favourable dietary patterns, and who can be tested as ideal role models for increasing dietary fibre consumption for the whole family unit.

High-intensity interval training (HIIT) is an effective strategy for improving a variety of health outcomes within the school setting, but there is limited research on integrating HIIT within the health and physical education (HPE) curriculum. The aims of the study are to examine the (a) process and (b) impact of co-designing HIIT workouts with students and teachers within HPE. We hypothesize that students who are involved in the HIIT workouts will have improved fitness and executive function and that students who are involved in the co-design process will have greater motivation, enjoyment, and self-efficacy toward HIIT. Three schools will participate. Three different groups of classes will be formed: 1) Co-Designers and HIIT; 2) HIIT Only; and 3) Control. Each group will include two Year 7 or 8 classes from school two and three. The first school will be a pilot with fewer participants. The study will be split into two phases. In phase one, Group 1 will co-design HIIT workouts as a part of the HPE curriculum across 6 lessons using an iterative process with the researcher, teacher, and students as collaborators. This process will be evaluated using student discussions and teacher interviews. In phase two, Group 1 and Group 2 will use the co-designed 10-minute HIIT workouts in HPE for 8-weeks. The HIIT workouts will be delivered by HPE teachers. Group 3 will continue their regular HPE class. All students will participate in the pre-intervention and post-intervention assessments for cardiorespiratory fitness, muscular fitness, and executive function. Additionally, they will complete questionnaires on motivation, enjoyment, and self-efficacy toward HIIT. Heart rate and rating of perceived exertion will be collected during each HIIT session and HPE lessons.

Phosphate is a very important electrolyte and, as such, low phosphate serum levels must be treated promptly. In the Intensive Care Unit (ICU) critically ill patients are at risk of low phosphate levels and phosphate ions are frequently administered via the enteral or parenteral (intravenous) route. There is little data on which route is best but there is a tenfold cost differential between the enteral and parental preparations. In addition, there may be more healthcare waste associated with the parenteral route. Given the potential but unproven advantages of the enteral route, this study aims compare the safety and effectiveness of phosphate replacement via the enteral and paraenteral routes.

The aim of this study is to undertake a feasibility trial of a novel co-designed online training program for circus coaches 'CirqAll: preschool circus for premmies', to determine: I. The effectiveness of study recruitment strategies to enrol sufficient appropriate coaches, II. The acceptability of the intervention to participating circus coaches, III. The implementation fidelity of the intervention, and IV. Limited efficacy testing on a key outcome of interest: coaches' implementation behaviour. Despite the demonstrated benefits of PA, and circus training specifically, there is a scarcity of literature on how to tailor these activities to address the participation gap between children born preterm and their term born peers at the preschool age. A recent study by the authors of this protocol was carried out to identify the preferences of key stakeholders regarding recreational physical activities for children born preterm (<28 weeks' gestation). This study identified that parents of preterm children require greater understanding of the preterm experience, which could be addressed by additional training for coaches. Furthermore, parents' heightened vigilance, risk aversion and diverse needs of their children requires tailoring of programs to support initial engagement, and ongoing participation, in recreational physical activities. Using this information, a circus-based intervention was co-designed with key stakeholders to address the needs identified. The co-designed intervention was named 'CirqAll: preschool circus for premmies'. The current study aims to test the feasibility of the CirqAll online training program for circus coaches. If there are few previously published studies or existing data using a specific intervention technique, such as this study which proposes a novel intervention (Bowen et al., 2009), it is important to assess its feasibility. Intervention effectiveness research can be accelerated if careful feasibility studies are conducted prior to larger trials (Orsmond & Cohn, 2015). To prevent wasted resources (participant and researcher time, funding, administration etc.), it is important to evaluate and prioritize interventions with the greatest likelihood of being efficacious. The purpose of feasibility testing is to produce a set of findings that help determine whether an intervention should be recommended for efficacy testing, and identify not only what—if anything—in the research methods or protocols needs modification but also how changes might occur (Bowen et al., 2009; Orsmond & Cohn, 2015). This case series feasibility study will provide insight into whether this novel intervention can work. Furthermore, it will identify what, and how, changes might occur, thereby preventing wasted resources.

This study will examine the efficacy of delivering an electronic just in time nudge to reduce glucose levels at home in individuals with type 2 diabetes. Delivering an pictographic behavioural nudge by smartphone app (Intui Research) with a SMS reminder proximal to the anticipated time of snacking, compared to non-nudge delivery, will lead to a reduction in the glucose area under the curve after dinner measured by continuous glucose monitors and improved sleep health.