ANZCTR search results

The Infant Development Team at the Child Development Unit, Women's & Children's Hospital provides a team approach to the assessment of babies and children under three years who have developmental difficulties and provides support for their families. This study aims to evaluate the developmental outcome and the prevalence of persisting developmental difficulties in children who were assessed by the Infant Development Team at the Child Development Unit in 2013 and 2014. This will help identify the ongoing needs, The Infant Development Team at the Child Development Unit, Women's & Children's Hospital provides a team approach to the assessment of babies and children under three years who have developmental difficulties and provides support for their families. This study aims to evaluate the developmental outcome and the prevalence of persisting developmental difficulties in children who were assessed by the Infant Development Team atthe Child Development Unit in 2013 and 2014. This will help identify the ongoing needs, particularly the need for follow up and developmental monitoring, for this group of children.

Low back pain commonly occurs in the general population, making it an important target for intervention. ThermaCare HeatWraps may prevent and relieve pain in regions such as the low back through continuous, low-level, direct heat therapy. The objective of this Investigator Initiated study is to evaluate the effectiveness of ThermaCare HeatWraps in improving flexibility and low back muscle relaxation, and in patients experiencing pain, reducing pain during movement. This study is an intervention trial on two discrete subject samples; (1) people with recent back pain, and (2) people who regularly play sport. ViMove wearable sensors provide precise objective measurements of low back muscle activity and movement in real time and can capture a patient’s reporting of pain during movement. Outcomes will be assessed through standard ViMove protocols in conjunction with multiple validated measures of pain, perception of change, and function.

This study will investigate the potential of commercially available nutraceutical supplement (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') is similar to the dipeptidyl peptidase-4 (DPP-4) inhibitor group, also known as gliptins, which are second line anti-diabetic drugs after metformin and sulfonylureas. The gliptins block the action of DPP-4, an enzyme which inhibits a group of gastrointestinal hormones called incretins which stimulate the production of insulin post meal and reduce the production of glucagon by the liver during digestion. DPP-4 inhibitors help regulate blood glucose levels by inhibiting incretins reducing the financial burden for antidiabetic medicine equivalent to AU$193.8 million per year. This study aim:- To determine the effect of nutraceutical supplement (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') as natural DPP-4 inhibitor on glycemic control in patients with type 2 diabetes mellitus. The study will include a total of 80 T2D participants recruited from the community. After an overnight fast (12-hr), participants will attend the clinical areas of the Medical Science Precinct, and the School of Health Sciences, University of Tasmania (UTAS) to undergo the following: 1) Medical & lifestyle questionnaires 2) Anthropometrics 3) Blood tests to measure blood glucose, HbA1c, serum lipids, insulin, & oxidative markers. 4) Glucose metabolism (2hr oral glucose tolerance test). 5) Hemodynamic measures (blood pressure, heart rate & ECG). 6) Urinary electrolytes & kidney function. 7) Pregnancy test for woman during their reproductive life. Venous blood & urine samples will be collected at the start and end of the two phases of the study. Nutraceutical supplements will be provided to the participants for 12 weeks. These natural products possess anti-diabetic activities & the suggested course of supplements will maintain a constant level of dosage of these nutraceutical supplements to improve the overall metabolic functions in T2D cohort. Biomarkers of metabolic response included in this study include measuring 8-hydroxy deoxyguanosine (8-OHdG) (oxidative DNA damage), total lipid peroxidation (lipid peroxidation) & resistin (adipocytokine response).

This study aims to determine the benefit of using sensor augmented insulin pump (with a predictive suspend before low feature) therapy to determine if tighter control of diabetes with less hypoglycaemia can be achieved and have an impact on maternal and foetal outcomes when compared to non sensor augmented pump therapy and multiple daily injections in pregnant women with type 1 diabetes. Outcomes will be benchmarked against historical outcomes in women with Type 1 diabetes in pregnancy who have delivered in the hospital and health service prior to the study. It will assess if women using this therapy are more satisfied with their treatment, whether it has an impact on other maternal and foetal outcomes and economic implications for the use of this technology. The study will generate data about glycaemia and insulin requirements after diagnosis of pre eclampsia, during labour and early breastfeeding.

Delayed or slow graft function (DGF), i.e. the requirement for dialysis, or poor kidney transplant graft function early after transplantation, affects 20-50% of deceased donor kidney transplants, and increases the risk of graft failure and mortality. DGF reflects acute kidney injury caused by ischaemia-reperfusion injury during transplantation, and is driven by donor, recipient and transplant factors. Intravenous fluids are a critical, albeit inexpensive, aspect of care that impacts early transplant function. Currently, isotonic sodium chloride (‘normal’ or 0.9% saline) is standard of care at the majority of transplant centres. However, 0.9% saline may be harmful due to its high chloride content relative to plasma, which causes metabolic acidosis and may promote acute kidney injury, and thus DGF. Studies of low-chloride balanced solutions versus normal saline in transplantation have shown reduced acidosis, but have been too small to show differences in transplant outcomes. The BEST-Fluids study (Better Evidence for Selecting Transplant Fluids) is a clinical trial investigating the difference between two standard practice fluids (Plasmalyte and normal saline) used before, during and after surgery in improving the lives of people who have a kidney transplant. The primary outcome investigates the requirement of dialysis in participants with delayed graft function (proportion of participants who require dialysis within first seven days) . Secondary outcomes include graft function, survival, and cost-effectiveness. This trial will show if Plasmalyte is better to normal saline in kidney transplantation, may result in cost savings and will rapidly translate into clinical practice.

Waiting for publicly funded hip or knee joint replacements (arthroplasty) can take over 12 months, and low physical activity levels while waiting for surgery may contribute to development of secondary diseases and reduce health benefits post-surgery. The aim of the project is to quantify the benefits of combining a group exercise training program with targeted behaviour change counselling on ongoing physical activity participation and health related outcomes in patients on the hip or knee arthroplasty wait list. The objectives are to compare the effectiveness of this unique intervention compared to a usual care control group on daily physical activity (daily step count and percentage of day spent in sedentary activities), pain ratings and function as well as changes in clinical markers linked with potential common chronic diseases (diabetes and cardiovascular disease). This study seeks to determine if a novel intervention that combines effective behaviour change based on Social Cognitive Theory (SCT) with an exercise training program can elicit long term increases in physical activity in patients requiring hip or knee arthroplasty, and reduce comorbidity development while waiting for surgery. Such a model is likely to be of benefit through decreased disability, reductions in multi-morbidities, reduced pain and medication use, and earlier return to activities of daily living post-surgery. These benefits capitalise on the investment cost associated with surgery.

In this study, we plan to compare two different techniques of supplying oxygen to patients before they go to sleep under general anaesthesia for neurosurgical operation. The usual way of doing this procedure involves breathing oxygen through a facemask. In this study, a computer program will randomly allocate them to receive either oxygen via the facemask, or to have humidified oxygen delivered at high flow via two prongs in the nose. The study aims to test if the nasal oxygen method keeps oxygen levels higher compared to the usual practice, which is oxygen via the facemask. The nasal oxygen method has been used extensively in other parts of the hospital for many years. It has now become increasingly popular to be used in the operating theatre. However, there are limited studies on the use of this device in anaesthetic setting.

This research project will investigate the effect of physiotherapy treatments massage and acupuncture/dry needling on the symptoms of scars such as pain and itch. This study will provide treatment for symptomatic scars. It aims to assess change in scar symptoms over a four week period, with follow up at one and two months after that time. This will help us to evaluate these methods are for treating scar symptoms, and guide future treatment improvements. Participants will be randomly divided into two groups, both groups will receive scar massage, acupuncture and advice on self-massage, stretching and exercising. The only difference between the two groups will be the type of acupuncture/dry needling. During the study participants will be asked to complete surveys regarding their scar, and general wellbeing. They will also be asked to complete these one and two months after completion of physical treatments, and return the surveys by post or email. We expect that the scar being treated may show changes in physical characteristics and symptoms, but this is not guaranteed as everyone responds differently to treatment. The outcomes of the research may guide treatment of future patients with scars.

Sleep is important for health, quality of life and general well being. Patients in rehabilitation often sleep poorly but the reasons for this are not well understood. It is important to better understand why patients sleep poorly in rehabilitation and how this can be managed. Through this study, it is hoped that a “clinical pathway” which consists of guides for clinicians will help clinicians understand and better address sleep problems. Patients will be divided into two groups randomly, with one group receiving care based on the “clinical pathway” and the other group receiving usual care without use of the “clinical pathway”. Sleep is starting to emerge as an important consideration in the overall management of rehabilitation patients however there is paucity of current literature relating to the efficacy of treatment of sleep disorders to guide treatment. For clinicians who actively manage sleep issues, most rely on evidence obtained in non-rehabilitation patients and commonly use hypnotic agents, Behavioural interventions and where appropriate devices such as continuous positive airway pressure (CPAP). Currently available clinical pathways for the treatment of sleep disorders focus predominantly on the management of obstructive sleep apnoea and do not extrapolate well to sleep disorders in a rehabilitation setting. This study aims to determine the feasibility and effectiveness of a sleep optimisation clinical pathway within the rehabilitation setting when compared to usual care on sleep quality, patient satisfaction with sleep, engagement with rehabilitation therapy, fatigue and length of inpatient rehabilitation stay through a randomized controlled trial with blinded patients and outcome assessors.

The aim of this study is to evaluate whether a two-step distress screening process and a referral model can improve individuals’ use of supportive services and reduce their levels of distress after contacting the Cancer Council 13 11 20 Information and Support line. Who is it for? You may be eligible to join this study if you aged 18 years or above, have been diagnosed with cancer or care for someone with cancer, reside in Victoria or New South Wales, and are telephoning the Cancer Council 13 11 20 line. Study details Individuals affected by cancer (patients, family members, or friends) who call the Cancer Council New South Wales (NSW) or Victoria 13 11 20 services will receive distress screening as part of routine practice. CIS consultants will be randomised to deliver either: i) Treatment as Usual - provision of information, referral to emotional support or instrumental services based on a single distress question and consultants’ judgement; or ii) Structured care – an additional 4 screening questions and a referral model, based on the caller’s level of distress. Participants will be contacted at 3 and 6 months after this call to complete a survey exploring distress levels, service use, and the impact of health education. Structured care is not yet a feature of community-level cancer support services. The new knowledge that would be produced by this study will directly inform decisions about whether or not such a model is adopted by Cancer Councils in NSW and Victoria. The project will directly contribute to improving the performance of telephone support services for cancer patients nationally and internationally.