ANZCTR search results

HYPOTHESIS The J2SI Mark II enhanced service model will lead to improved housing, employment, social, and mental health and well-being outcomes for homeless participants when compared to those receiving a standard service. AIMS To break the cycle of chronic long-term homelessness and improve housing outcomes and the health of those experiencing homelessness. The J2SI Mark II research project aims are to: - Evaluate the impact of a new enhanced homelessness intervention compared with existing service provision with regards to outcomes in: Education, Employment and Income; Social Inclusion; Mental Health; Physical health; Housing and; Service Usage. - Examine the cost of the new homelessness program compared with existing service provision and assess the cost-effectiveness of the J2SI service Model – Mark II; and, - Provide a framework for scaling up the intervention pending positive evaluation findings. OBJECTIVES - Investigate the impact of an integrated homelessness prevention intervention on positive mental wellbeing, mental ill health, quality of life and behavioural risk factors at baseline, during and after the study - Identify changes in protective and risk factors for mental health (e.g., social support networks, loneliness) and behavioural risk factors (smoking, alcohol, drug use) at baseline, during and after the intervention - Model the relative and combined contribution of housing support, educational and employment opportunities, access to services and support to the health and wellbeing of participants at baseline, during and after the intervention - Evaluate changes in health outcomes and service usage at baseline, during and after study and - Model the cost effectiveness of the program in relation to service usage, emergency admissions, and contact with justice services.

The aim of the study is to perform a retrospective analysis of the Q Fever Register’s data to determine the profile of individuals included in the Register, and determine the rate of vaccination and whether results from serology testing contribute additional information to support the decision to vaccinate.

Background: Development of anaemia in preterm infants is a common occurrence during hospitalisation as a result of iatrogenic blood loss and poor erythropoiesis. A significant proportion of extremely preterm infants are exposed to one or more RBC transfusions during their neonatal intensive care unit (NICU) stay. The association between red blood cell (RBC) transfusions and the development of necrotizing enterocolitis (NEC) in preterm infants was first recognized in the late 1980’s and has since been increasingly recognized. This association between RBC transfusion and NEC may coincide as a result of the timing of their occurrence, as most preterm infants will receive transfusions within the first 4 weeks of life, which is the same time frame for the development of NEC. Mechanisms related to the development of TANEC are unknown. Several hypotheses have been proposed including the prolonged storage of blood, increased viscosity of blood, perfusion-reperfusion injury and enteral feeding. The effect of enteral feeding during RBC transfusion on the mesenteric perfusion and oxygenation has not been fully elucidated. Due to the association between NEC and feeding practices in the preterm infants, there have been concerns about the effects of feeding during RBC transfusion. As a result, there is a wide variety of feeding practices during RBC transfusion of preterm infants including withholding of feeds to reduce the risk of NEC. Technological advances in near-infrared spectroscopy (NIRS) have allowed for the measurement of oxygenated and deoxygenated haemoglobin within tissue in real time. NIRS is able to measure changes in signals received via the skin sensors and calculate the proportion of haemoglobin in oxygenated and deoxygenated states from a mixed capillary, venous and arterial sample in the tissues approximately 2cm below the sensor placement. This allows for the non-invasive real-time measurement of the balance between oxygen supply and tissue demand. This technology has allowed for the continuous measurement of tissue oxygenation of the cerebral and splanchnic beds and for demonstration of differential tissue perfusion during periods of haemodynamic instability, anaemia and RBC transfusions. Autoregulation of brain perfusion allows for the oxygenation of the brain to be preserved except in the most severe situations. Thus, a ratio of cerebral splanchnic oxygenation has been proposed to be able to measure changes in gut perfusion. Aim: To assess the effect of feeding and withholding of feeding on gut oxygenation and perfusion in preterm infants receiving RBC transfusions. Hypothesis: We hypothesize that mean CSOR and mean mesenteric FOE during RBC transfusion will not be different between preterm infants in the withheld group and the full volume group.

Female anterior pelvic organ prolapse (POP) is common. In POP, the vaginal tissues become weak, causing descent of vaginal walls. In moderate to severe anterior POP, conservative treatments may be unsuccessful. In these cases surgical treatments can include: *Surgical repair with a patient’s own tissue (anterior colporrhaphy) *Surgical repair with reinforcement using a tissue graft to provide additional support. The aim of this study is to compare two established surgical techniques for anterior POP to determine which has the best result. The primary outcome will be measured using the following criteria. All three must be met qualify as success: 1) objective measures (anatomical), 2) subjective measures (validated quality of life questionnaire), 3) participant not having repeat procedure for anterior POP recurrence. The primary outcome will be assessed at one year after surgery. This is a multicentre blinded prospective randomised trial. Participants will be randomised to: 1. Anterior colporrhaphy 2. Xenform anterior vaginal repair Both procedures are routinely performed by urogynaecologists in the private and public sectors. Xenform Matrix (Boston Scientific, Marlborough, MA, USA) is used in Australia and by the urogynaecologists in Perth in the private and public sectors for surgical repair of POP. Xenform has been approved since 2010 for POP repair by the Australian Therapeutic Goods Administration. For the participants at Hollywood Private Hospital, they will be recruited from the surgeon’s private rooms. Participants will be eligible if they have symptomatic anterior POP to the level of the hymen and desire surgical treatment. At recruitment, participants will have a pelvic examination to assess pelvic organ prolapse quantification (POP-Q as per International Continence Society). A validated quality of life questionnaire (QoL) (Pelvic Floor Distress Inventory Short Form 20) will also be administered. POP-Q and PFDI-20 will be repeated one year after the operation.

This project aims to test the feasibility and effectiveness of incentives for promoting increased physical activity, decreased sedentary behaviour, and improvements in heart health risk factors among adults. We hypothesised that an intervention involving relatively small, intermittent incentives in the form of points exchangeable for gift vouchers, offered over a 4-month period, and supplemented by an initial motivational interview and regular motivational text (mobile-phone SMS) messages, will lead to significant increases in time spent in physical activity; decreases in time spent in sedentary behaviours; and decreases in BMI and blood pressure, among middle-aged (40-65 year old) adults. Participants receive one point per minute, capped at 30 minutes per day, for engaging in physical activity; and one point per minute, also capped at 30 minutes per day, for reducing their sedentary time. Physical activity and sedentary time are monitored using a Fitbit One device provided to participants and linked to a purpose-designed study website that records points.

Rehabilitation can be a long process for people after stroke, and needs to be intensive to drive functional recovery. Computer gaming is proposed as a way for people to increase their therapeutic time while engaged in enjoyable activities during their rehabilitation stay. This project will investigate if computing gaming, through the use of the OrbIT Gaming System, has benefits for people during their stroke rehabilitation. Particularly, we are interested in finding out if participation in computer gaming will improve movement and sensation in the affected upper limb following a stroke. The study will also ask participants and staff about their experiences using this system. This study is being conducted as part of a Physiotherapy student honours project. Participants are allocated (by chance) to one of two groups. Both groups will participate in the computer gaming activity using a novel controller and laptop, which will be readily available over a three-week period. The controller requires bimanual use – thus “forcing” the affected hand and arm to participate in directing motion of the unit. Further it is capable of delivering a haptic stimulation (vibration) to the affected hand only to theortically increase awareness of the affected hand. This will be used as an additional rehabilitation tool during each participant's stay at Hampstead Rehabilitation Centre, allowing as much use as possible. The games have been designed to be of broad appeal and easy to play (no experience required). Participants will also receive the usual rehabilitation ('standard care'). All participants (regardless of group) will be asked to undergo assessment at the beginning of the study and after the three-week period (1 hour for each assessment). All participants will be asked specific questions after the three-week intervention through a written questionnaire. This will enable us to compare the effects of computer gaming.

This study is a multicentre, parallel design, randomised controlled trial, at La Trobe University using cardiology patients from two major Hospitals in Melbourne. The intervention will be 6 months in length with a follow up at 12 months. There will be two groups, the Mediterranean diet intervention arm versus the standard care diet (low fat, National Heart Foundation guidelines) control arm. The aim of this study is to determine whether the Mediterranean diet compared to standard diet intervention can prevent secondary cardiac events and improve cardiometabolic risk factors (lipid profile, inflammatory markers, metabolic parameters, anthropometry, body composition) in a multi-ethnic Australian population.

Type 2 diabetes is linked with many complications such as heart disease, eye disease and kidney disease. People with Type 2 diabetes also have higher rates of diseases of the nervous system in the body including dementia and may have poorer memory and thinking ability compared to people without Type 2 Diabetes. Older people with Type 2 Diabetes are at higher risk for poorer brain function. Diet plays an important role in mental well-being and brain function as the brain needs nutrients found in foods to function well. Omega 3 fatty acids such as those found in fish oils, are found in the brain tissue in large amounts. Increasing dietary intake of fish oils can increase the amount of fish oils in the brain. The aim of this study is to determine if an increase in dietary fish oils can improve the function of the brain in older people with Type 2 diabetes. This pilot study will fill a gap as it is not known if an increase in dietary Omega 3 fatty acids can improve brain function in older people with type 2 diabetes. This is important as the number of older people with diabetes is increasing and currently there are no effective treatments for poor brain function. Eligible volunteers who participate in the study will be given a 6 month supply of fish oil or placebo capsules to take daily. Mental function will be measure by a verbal and computerized tests at the beginning, middle and end of the trial. A blood test, height, weight, and waist circumference will also be collected as well as information about the food you eat and drink at the beginning middle and end of the study. Neither you or the clinician conducting the research will know if you receive the fish oil or the placebo treatment, but a confidential record of which treatment you received will be kept by the chief investigator in the unlikely event you have an adverse reaction.

Building Bridges Triple P is a parenting program designed to help parents who have an adolescent with a developmental disability. The program aims to assist parents in their caring role and equip them with skills to address their adolescent’s emotional and behavioural problems. Building Bridges consists of four group and four individual telephone sessions, held over eight weeks. The program is open to all carers in the adolescent’s life. The program addresses a number of areas of concern for parents and an accredited Triple P facilitator will run the sessions. The groups will use a mix of discussion, practice and home based activities to address parenting practices, adolescent emotional and behavioural problems and symptoms associated with depression, anxiety and stress. Topics of discussion in the parenting group will include, understanding adolescents’ behaviour, encouraging independence in your adolescent, promoting positive family interactions, managing problematic behaviours, helping adolescents to manage their emotions and self care for carers. We are looking for carers of adolescents between the ages of 12 and 16, diagnosed with autism spectrum disorder. It is important that you are not participating in any parenting interventions at the same time. If you express interest in the program, you will be required to complete a short screening questionnaire over the phone. If you are eligible for the program, you will asked to attend the Curtin University Health and Wellness Clinic to complete a 90 minute interview. During the interview you will complete a booklet of questionnaires and you will be asked to complete the booklet of questionnaires again at two predetermined times following the Building Bridges program. The final booklet of questionnaires will be given to you three months after the parenting group has finished. Each booklet of questionnaires is estimated to take you approximately 60-90 minutes to complete. If you agree to participate, you will be required to attend four parenting group sessions at the Health and Wellness Centre at Curtin University. You will also be asked to complete four telephone sessions with the therapist at the same time as attending the parenting group. Other Triple P programs have demonstrated a variety of benefits for parents of teenagers and children with a disability, including improvements in child behaviours, positive parenting skills, parenting confidence, child relationships, and reduced parental stress. It is anticipated that Building Bridges will result in similar improvements. Results from the study are likely to improve the accessibility of the program to a wide range of parents that require positive parenting assistance.

Over the past 15 years a number of new treatments have proved successful in the treatment of multiple sclerosis. There a remains though a small group of patients who do not respond and who continue to have attacks despite treatment causing further permanent neurological disability in a cumulative fashion. This disability can take the form of muscle weakness, impairing walking ability, visual loss, impaired balance, bladder and bowel dysfunction and loss of higher intellectual faculties. Patients with aggressive forms of MS also have a shortened life span as a result of their disease. Haematopoietic stem cell transplantation (HSCT) is a procedure originally used to treat patients with blood cancers. A high dose of chemotherapy is given which not only kills the malignant cells but also normal healthy bone marrow and blood cells. In order for the patient to survive these cells must be replaced by giving the patient a stem cell infusion following the chemotherapy . The stem cells replenish the bone marrow and a new blood and immune system then grows from it. Over the last 15 years, HSCT has become much safer. At the same time, numerous lines of evidence have emerged suggesting that a small number of patients with severe autoimmune diseases such as MS not controlled by other treatments could also respond to treatment with HSCT. This evidence came initially from patients with a co-existent auto-immune disease (AID) including multiple sclerosis (MS) who had chemotherapy for blood tumours. It was observed that not only did their cancers remain in prolonged remission after HSCT but so did the manifestations of their autoimmune disease. The procedure requires an initial dose of chemotherapy with a drug called cyclophosphamide to help stem cells to be collected via a vein in the arm. Subsequently the patient is admitted into hospital tohave high doses of chemotherapy that intensely suppresses the immune system. At this point the stem cells collected at the earlier time point are reinfused through the vein so they can re-grow a new immune system and protect the patient from the toxic effects of the chemotherapy. It takes about 14 days for the new stem cells to grow and then follow up is conducted carefully over several years to see if this method of immunosuppression and immune reconstitution prevents the reemergence of multiple sclerosis. The procedure is not without risk with the major complications of infection and death. Overall the risk of death where the procedure is done for an autoimmune disease is quoted at between 1-5 %. The Neurology Unit at Austin Health has conducted trials in MS since 1996 and the Haematology Unit performs HSCT on a regular basis for patients with blood malignancies. The unit’s morbidity and mortality results for HSCT are on par with the world’s leading hospitals. We intend to explore therapy in patients with an aggressive form of MS and then follow them in a rigorous fashion over 5 years to gauge its effectiveness.