ANZCTR search results

The proposed research project will answer the key question whether Botulinum toxin injection in post stroke lower limb spasticity improves walking and other functional activities, and quality of life. In addition to injections of the toxin/placebo people, the participants who have had a stroke will also participate in a structured physiotherapy program and a home exercise program (standard care). The research project is designed to show whether, following stroke, botulinum toxin injection in the lower limb spastic muscles combined with an exercise program helps people to walk faster and longer and improves their quality of life.

Social isolation is a major health risk and for many is associated with psychological distress. A new social group intervention, Groups 4 Health (G4H), has strong potential to address this problem. G4H is a five-module, manualized program that seeks to increase social connectedness by building group-based social identifications in the context of an in-vivo group experience. Its effectiveness has already demonstrated in a proof of-concept study (Haslam et al., 2016), but it has yet to be systematically trialled. This randomised controlled trial of G4H will recruit 130 adults presenting with psychological distress (i.e., elevated symptoms of depression or a mental health diagnosis) due to social isolation who will be randomly assigned to G4H or to a wait list control. The primary outcome against which the intervention will be assessed is loneliness and secondary outcomes include depression, social anxiety, and multiple group membership. We hypothesize a greater reduction in loneliness, depression, and anxiety and increase in multiple group membership for those receiving G4H compared to the wait list control.

Little is known about dietary intake at the level of an “eating occasion (EO)”, which includes meals and snacks. Current dietary advice is framed around the amount and types of food populations should consume, rather than a consideration of eating patterns. Eating patterns describe the frequency and temporal distribution of meals and snacks. Eating patterns are likely to be important determinants of adults’ health; however, the cardiometabolic health impacts of EO, meal and snack frequency and temporal eating patterns are inconclusive. The aim of this secondary analyses was to investigate associations of different eating patterns (e.g. frequency of all EOs, meals and snacks; temporal eating patterns) with risk factors for cardiometabolic diseases. The Census and Statistics Act 1905 provides ethics approval for the Australian Bureau of Statistics to conduct household interview components of national surveys, including the National Nutrition and Physical Activity Survey (NNPAS). Participants from the NNPAS were invited to participate in the National Health Measures Survey (NHMS) and were required to give their informed consent to participate in the collection of biomedical blood samples for which ethics approval was granted in February 2011 by the Department of Health and Ageing’s Departmental Ethics Committee. As part of the ethics approval, participants were ensured that they (or their nominated doctor) would be notified of any critical or clinically significant blood test results. As this is a secondary analysis of the NHMS data which is de-identified, an exemption for ethics approval was granted by the Deakin University Human Research Ethics Committee on April 16, 2015. (Project number: 2015-073).

In 1989 Professor John Newnham and colleagues invited more than 3000 pregnant women to join a National Health and Medical Research Council funded research study at King Edward Memorial Hospital to examine the possible beneficial effects of repeated fetal ultrasound imaging studies. Women were allocated at random into one of two groups – Regular Care or Intensive Care. Those in the Regular Care group had a single ultrasound imaging study at 18 weeks gestation, with further scans only if clinically indicated. The women in the Intensive Care group had ultrasound scans at 18, 24, 28, 34 and 38 weeks gestation. Along with Professor Newnham, a group of prominent investigators (Professor Fiona Stanley, Professor Lou Landau and Professor Con Michael) formed a group to establish these families into a cohort study, focusing on the child, to determine how events during pregnancy and childhood influence health in later life. This was initially supported with funding from the Raine Medical Research Foundation. The original cohort of 2868 children (Generation 2), is one of the largest, most successful prospective cohorts of pregnancy, childhood, adolescence and now adulthood to be carried out anywhere in the world. This cohort has provided environmental, developmental and health information over the past 27 years providing a unique and valuable resource covering a wide range of health areas. Follow-up assessment of the cohort has been conducted at birth, 1, 2, 3, 5, 8, 10, 14, 17, 18, 20, 22, 27 and currently 33 years of age by a collaborative team of researchers from The University of Western Australia, Women and Infants Research Foundation, Telethon Kids Institute, Curtin University, Edith Cowan University, the University of Notre Dame, Murdoch University, the Lions Eye Institute, and many other national and international collaborators. The original parents (Generation 1) participated in the assessments as well, providing information about their children and about themselves. Generation 1 has recently participated in assessments of sleep, obesity and activity. In addition, the off-spring (Generation 3) of the original cohort (Generation 2) are currently being recruited and participating in assessments of developmental ability and physical activity. The other (non Raine Study) parent of the Gen 3 participant is also being recruited (Gen 2B).

The aim of this study is to determine if a single session of LymphaTouch® treatment is as effective, than standard manual lymphatic drainage (MLD) in improving lymphoedema outcomes. Who is it for? You may be eligible to join this study if you are a female aged 18-75 years and have secondary arm lymphoedema in one arm only following axillary node dissection from either breast cancer or melanoma of between 6 months and 5 years duration. Study details Study participants will be assigned on a 'chance' basis to receive standard care or an intervention. Those allocated to standard care will receive one session of manual lymphatic drainage. Intervention group participants will be treated with LymphaTouch device during one session. LymphaTouch uses negative pressure, medical technology designed to lift tissues upwards through a vacuum force. Before treatment, immediately after completion of treatment and 24-48 hours later, tissue softness, patient reported outcomes and participant’s satisfaction with treatment will be measured. It is hoped that this study will determine if LymphaTouch® treatment is as effective, than standard manual lymphatic drainage (MLD) in improving lymphoedema outcomes.

The purpose of this study is to investigate whether a new drug called PIN-2 is safe and activates the immune system in patients with advanced solid tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a histologic diagnosis of an advanced solid tumor. Study details All participants in this study will receive one cycle of chemotherapy treatment with the drug, PIN-2 (Precision Immune Stimulants). PIN-2 will be administered intravenously (i.e. directly into the vein) 3 x per week for 2 weeks followed by a one week rest period. If tolerated and deemed beneficial, a second identical course may be administered. No more than 2 courses in total will be given. Participants will be regularly monitored for safety, and asked to provide a number of blood samples across a 5 week period to assess how the body processes and responds to the drug. Tissue samples (tumor and/or lymph node) will also be obtained, if possible, at pre-treatment and again at the conclusion of each treatment cycle for evaluation. Patients who are eligible for and agree to participate in the biopsy will have tumor biopsy prior to treatment and at week 3. This study will help find new methods of treatment for the patients with solid tumors.

There is a great deal of variability in neurodevelopmental outcomes for babies and children born very preterm. A number of antenatal and neonatal complications have been associated with increased risk for adverse neurodevelopmental sequelae. Yet currently there is a paucity of evidence surrounding the effect of parent developmental literacy as a protective enabler for optimal neurodevelopment following very preterm birth. This pilot study seeks to address this knowledge gap by exploring whether a parent education program for mothers and fathers of very preterm infants is effective in improving parent developmental literacy. Our aim is to build practical evidence regarding PEDaL program efficacy, acceptability and feasibility that is specific to the Australian health care service. The study setting is a large metropolitan Neonatal Nursery in South Australia, comprising intensive care and special care units. Sample size = 20 families with babies born at less than 32 completed weeks' gestation and 20 multi-disciplinary staff employed within the Neonatal Nursery. Recruitment period is 4 months. Parent participants will undertake an education program designed to improve their understanding of their baby’s development, and how they can support this in the first months after preterm birth. The program begins early, whilst inpatient in the Neonatal Nursery, and continues until 4 – 6 weeks post discharge. We will use a pre-test post-test study design. Primary outcome is parent developmental literacy. Secondary outcomes include parent sense of competence, parent mental health, program acceptability and satisfaction as assessed by parents and multi-disciplinary neonatal staff. Length of stay and infant readmission to hospital within 30 days of discharge are also secondary outcomes for the study.

The PARTNER project aims to implement and evaluate a new model of service delivery to improve the health of people with knee osteoarthritis (OA) in Australia. Currently, the day-to-day care of people with OA in Australia is inconsistent with care recommended in established clinical guidelines. Our new model focuses on both the person with OA and their general practitioner (GP). Firstly, the intervention will support GPs to gain an understanding of the effective conservative, non-surgical management options available for treatment of patients with OA. GPs will be provided with professional development and training including audit/feedback, and electronic medical record decision support. Secondly, patients will receive advice and support on issues related to the management of OA including exercise, weight loss, pain management and other self-management behaviours. The intervention will be delivered remotely by a centralised, multidisciplinary team of health professionals trained in best-practice OA management. This ‘Care Support Team’ (CST) will also have skills in health coaching and behavioural change which will support patients to manage their knee OA, and will help the GP facilitate additional healthcare services if required. This project will implement and evaluate the proposed model of service delivery (PARTNER model) in a mixed methods study including a randomised controlled trial (RCT) in two Australian states with economic and qualitative evaluations. This trial will help us to better understand the effectiveness, feasibility, acceptability, sustainability and cost-effectiveness of the model. We are partnering with a range of academic, industry and professional health organisations to ensure optimal delivery of the model and to facilitate long-term implementation into the Australian healthcare system.

The primary objective of this project is to examine the response of isolated rural carers for older people with dementia to a videoconference based peer support and information program. Will participation in the program improve self-efficacy, quality of life, and mental health? Secondary objectives are to develop a videoconference based peer support program for isolated rural carers for older people with dementia, using a co-design approach; and to demonstrate the feasibility of videoconference technology for enhancing social support to family caregivers in their homes. This project will combine the evidence from two recent research projects to collaboratively co-design and evaluate a facilitated videoconference peer support and information program to carers of people with dementia within rural areas. Carers will be recruited through local community health and care providers. Program development will focus on using an information sharing approach to facilitate social interaction. The project will use off-the-shelf technology which will be more accessible than specialised bespoke solutions that are currently popular in this area of research. A mixed methods repeated measures randomised wait list design will be used to evaluate the project. The primary outcomes are self-efficacy, quality of life, and mental health. Secondary outcomes are perceived social support and user satisfaction with the technology and intention to continue videoconference interaction.

Preterm birth (PTB) is a major problem of global importance. Although it has been known for some time that PTBs at the very early gestational ages are often associated with intrauterine inflammation and infection, clinical strategies to treat the infection have largely been unsuccessful. This study aims to undertake a prospective, open-label, randomised clinical trial of a ‘screen and treat’ program aimed at preventing infection-driven spontaneous PTB (sPTB). The design is built upon an earlier European trial which achieved a 40% overall reduction in sPTB rate, and we have added improved efficacy in risk-identification and treatment strategies. The single centre, multi-site study will recruit women with singleton pregnancies, asymptomatic for vaginal infection, attending antenatal clinics at 14-20 weeks’ gestation in two public hospitals within the Perth metropolitan area. A total of 6174 women will be recruited over a 2 year period, randomised after recruitment to either a control or intervention group (n=3087/group). Participants will self-collect a vaginal swab to be screened for microbial risk factors using a unique DNA-based assay. Participants in the control group will receive normal care and results of the tests will not available until after the pregnancy is completed. Intervention group participants will be informed of their result and mailed their antimicrobial therapy plus a vaginal probiotic to reduce relapse rates; re-screening will occur at 22-28 weeks’ to assess treatment efficacy. The primary endpoint is reduction in sPTB <37 weeks’ gestation; secondary endpoints included additional delivery outcomes, maternal morbidities and neonatal mortality and morbidities. The trial is conservatively powered to detect a 30% reduction in overall sPTB rate from 4.83 to 3.38% (80% power, alpha=0.05). If this success were to be translated nationally, the reduction in number of PTBs each year would be approximately 4500 cases.