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Elevated blood glucose levels developing for the first time in pregnancy (Gestational Diabetes Mellitus; GDM) is a common complication of pregnancy in our local community. In most cases, the diabetes will resolve after the baby is delivered, although it may return years later (type 2 diabetes). However, we have found that in certain women there is a high chance that the blood glucose levels will remain elevated after pregnancy, with adverse effects on the health of the woman in the long-term, and potentially also on the baby during a subsequent pregnancy. There is strong evidence that diabetes in individuals at high risk can be prevented through lifestyle intervention with diet and exercise. Our study will determine whether in high-risk women with GDM, we can prevent elevated blood glucose levels in the first year after their pregnancy by offering them one-on-one advice about a healthy lifestyle by a health coach (a nurse or other allied health professional) during their pregnancy and for the first year after giving birth. The women who participate in this trial will mostly see their health coach during routine antenatal visits so that inconvenience to the patient will be minimized. We will compare high risk women who had a health coach to those who did not i.e. outcomes during pregnancy and in the first year after giving birth. If our trial is successful, we believe our program could easily be incorporated into routine clinical care in our antenatal clinics..

To our knowledge there have been no studies examining problem-solving therapy (PST) specifically in people with diabetic retinopathy (DR), yet from our first study we established that this group face the greatest risk of depression and reduced quality of life (QoL) as well as showing poorer diabetic control compared to those without DR. PST has been shown to be an essential skill for effective diabetes management and effective in reducing diabetes related emotional distress and depressive symptoms. However there is a need for more research that integrates problem-focused and emotion focused interventions in diabetes management. Addressing diabetes specific distress, stress management and healthy coping, some of the key underlying subjective QoL experiences, may improve glycaemic outcomes. This study also would provide novel research specific to those that have ophthalmological diabetic complications. We propose to adopt a PST designed for primary care that teaches problem solving skills and assists individuals with DR to find practical solutions to vision-related and diabetes-related problems. In doing so we anticipate that participants will adopt a more positive problem solving orientation that will hopefully empower them to subsequently improve their psychological well-being. It has been previously established that developing a problem solving pattern and working through individual solutions assists with perpetuating more positive behavioural habit loops. As a result, this intervention may also have knock on effects in improving diabetes self-management behaviours as this has been shown in previous studies. Hypothesis Individuals with diabetic retinopathy who receive tailored problem solving training will show improved quality of life and psychological well-being compared to individuals undergoing usual care. Aim 1: To develop a tailored, problem solving based program that targets individual quality of life difficulties. Aim 2: To assess, using a randomised control trial, the effectiveness of this program in improving participants’ quality of life and psychological well-being (reducing diabetes related distress and depressive symptoms). Investigation will also be undertaken to assess whether enhancing problem solving skills have a direct influence on a participant’s ability to self-manage their diabetes including improving overall glycaemic control and adopting recommended lifestyle practices.

In Australia, hypoxic peripartum death (stillbirth or neonatal death of mature infants after the onset of labour in an otherwise healthy pregnancy) is one of the top three causes of mortality in singleton term pregnancies. In addition, there is significant neonatal morbidity (neonatal encephalopathy, respiratory distress, acidosis, admission to the neonatal intensive care unit) associated with intrapartum hypoxia. Furthermore, these babies frequently require rapid delivery by emergency caesarean section which carries considerably more maternal and neonatal risk than less urgent procedures. We have found that combining the fetal cerebro-umbilical ratio (CUR) (measured by ultrasound) as a functional measure of fetal wellbeing, and maternal serum placental growth factor (PlGF) as a biomarker of placental function, at >37 weeks of gestation defines women at greatest risk of fetal compromise in labour. We therefore propose a pilot randomised controlled trial (RCT) to test whether introduction of this test can reduce intrapartum fetal compromise at term. Our primary outcome measure of fetal compromise will be a composite of emergency caesarean section for fetal compromise or severe adverse neonatal outcomes (cord arterial pH <7.1 and/or Lactate >6 mmol/L or Base Excess >12 or Apgar <5 at 5 minutes) or fetal/neonatal death. A pre-labour test which identifies babies most at risk of compromise in labour will address a critically unmet need in obstetrics as there is currently no good antenatal test for the prediction or risk assessment for intrapartum fetal compromise at term.

Changing the scheduling of existing programs in childcare centres may represent an effective strategy which is suitable to ‘scale-up’ for population-wide implementation. Unstructured outdoor free play (as opposed to structured, staff-guided play) has been consistently associated with greater child physical activity. The study hypothesises that when compared to children attending control services, where continuous indoor/outdoor play is scheduled, children attending intervention services will spend an additional 10 minutes in moderate-to-vigorous physical activity per day at childcare. An increase of 10 minutes of moderate-to-vigorous physical activity in preschool-aged children has been found to have clinically important effects on fat mass and peak bone mass.

The primary purpose of this study is to evaluate the impact of androgen deprivation therapy (ADT) on cognitive function in men with prostate cancer. Who is it for? You may be eligible to enroll in this study if you are aged 18 or over and have been diagnosed with prostate cancer for which you have received no ADT previously. You must either be scheduled to begin ADT in the next month, or have no ADT planned. Study details All participants in this study will complete a screening questionnaire and then if eligible, an assessment session at enrolment and again 9 months later. Each assessment session is expected to last 45-80 minutes and will involve computer-based testing, pen and paper tasks, plus a number of paper questionnaires. It is hoped that this study will improve understanding of the cognitive effects of ADT in men with prostate cancer.

Emergency service personnel are exposed to major stressors in the line of their work. They are at elevated risk of developing posttraumatic stress disorder (PTSD), with approximately 10% of police suffering the condition. The nature and pattern of trauma exposure amongst Emergency service personnel is different to those experienced by other populations. They suffer repeated exposure to trauma, may witness individuals who have been badly hurt, directly threatened themselves or be required to seriously wound others. Hence, their response to trauma is often anger and guilt, rather than the fear often described by members of the general population exposed to one off, trauma. There is currently limited evidence of optimal treatment of PTSD in emergency service personnel. In the absence of evidence, there is a critical need for controlled trials of optimal interventions to assist emergency service personnel with PTSD. This study conducts a randomized controlled trial of cognitive behavior therapy for (CBT) in emergency service personnel to determine the optimal means to enhance treatment response.. This study will provide the much-needed evidence to shape policy and practice. Emergency service personnel with PTSD will be randomized to receive either 12 sessions of cognitive behaviour therapy delivered by clinical psychologists Treatment is based on 12 weekly 1-hour sessions. Emergency service personnel will be randomised to either CBT, which involves focusing on reliving trauma memories, as well as teaching strategies to reframe common maladaptive appraisals. Alternately, emergency service personnel will be randomised to a modified version of CBT that will also include depression treatment strategies. Participants will be assessed prior to treatment, immediately following treatment, and again 6 months later. These data will provide much-needed evidence for treating Emergency service personnel and provide police, fire-fighting, and ambulance services direction on how to limit PTSD in their organisations.

Pain management amongst patients with cognitive dysfunction is problematic, particularly in those cases where the carer is given the responsibility of determining whether or not pain relief is required. Numerous pain scales have been developed to assist carers assess patients’ pain status; most of which include items derived from widely accepted guidelines of persistent pain . This study aims to develop and assess the feasibility of using face recognition software linked to those pain indicators on a Samsung Note 3 to enhance pain management amongst a population of cognitive impaired residential aged care residents. Surrogate markers of pain control will be used including cognition and behaviour.

The primary objectives of the study is to examine the feasibility, safety and efficacy of cannabidiol (CBD) in the management of concurrent mood and cannabis use disorders in young people, in a randomized controlled study. Specifically, the study will assess recruitment rates, retention rates, adverse events, the quantity and frequency of cannabis use, and the impact of CBD on patient mental health outcomes and well-being. Current treatments for anxiety and depression are of limited efficacy in a considerable proportion of patients (30% of depressed patients are pharmacoresistant) and are associated with troublesome side effects that reduce compliance; the development of novel, improved therapeutic treatments would fill a considerable unmet medical need. CBD has emerged as one of the most promising candidates in treating psychiatric disorders. Research suggests that greater rates of mental health problems in cannabis users are related to increased use of high THC/low CBD varieties of cannabis. In various animal and human laboratory and clinical studies, CBD has been found to reduce the intoxicating and psychotomimetic effects of THC, while CBD given alone has also been found to relieve anxiety and nausea and to have anti-inflammatory and antipsychotic effects. Thirty participants (male and female) will be recruited over a period of 9 months. The study will be conducted in the Department of Addiction Medicine at St Vincent's Hospital Melbourne. Participants will complete an initial assessment as per normal clinical practice. Eligible participants will be contacted to attend a baseline assessment and informed consent.. Participants will be randomized into either a CBD or placebo treatment group for a period of 12 weeks with follow-up at 14 weeks. All participants will be offered up to 6 sessions of manualised psychotherapy as per standard clinical practice.

The primary purpose of the NOMINATOR research study is to determine if new techniques for gene sequencing can be used in the treatment of rare cancers. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with a rare cancer which has few standard treatment options and is associated with poor outcome. Study details: All participants enrolled in this trial will provide samples of blood and tumour tissue either via retrieval of stored tumour sample from another lab/biobank if this is available or by undergoing a biopsy procedure to obtain fresh samples of tumour. These samples will be used for the gene sequencing test. We will also collect health information from the participant (either via direct questioning by their doctor or from their medical records), in order to help researchers interpret the genomic sequencing results which are obtained from testing. A panel of cancer experts will review the genomic sequencing results and provide advice about treatments that could potentially be more effective as a result of those findings. The patient will then have the option to receive the results of this testing (this is optional), and their doctor may be able to use these tests results to better determine an effective treatment and management plan for their disease. It is hoped that understanding a cancer’s genomic profile may help doctors to select appropriate treatment options, according to the particular genomic profile of that person’s cancer. This trial will provide information on whether this is feasible in practice.

This pilot intervention was tested in a randomised controlled trial involving approximately 100 families. It involves an innovative intervention remotely-delivered to parents (via mobile phone text messaging and online) which aims to increase physical activity (active play) and reduce screentime in their young children (1-3 years of age). A wait-list control design was implemented where control families received the intervention following a wait-list period. This design involved data collection at 3 time points, baseline (0 weeks), post intervention (6 weeks) and follow up/post wait list control receiving intervention (12 weeks). Children's physical activity and time spent in screen-based behaviors was measured via parent proxy reported surveys and also measured objectively using accelerometers at the 3 time points throughout the study. Measures of parental physical activity-related parenting practices, confidence, knowledge and modelling (parents' own physical activity and screen viewing) were also collected by self report. Being a pilot-trial, measures of feasibility and acceptability including retention and parent evaluation of the study components were also collected.