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Development, Feasibility, and Efficacy of a Web-Based Intervention to Reduce Psychological Barriers to Insulin Therapy among Adults with Type 2 Diabetes (Stage 3: Full RCT)
It is estimated that approximately 1.1 million Australians are living with type 2 diabetes (T2D). T2D is characterised by high blood glucose (hyperglycaemia). Prolonged hyperglycaemia increases the risk of developing diabetes-related complications. Managing T2D can involve healthy eating, regular, physical activity, maintaining a healthy weight and taking diabetes medications. These behaviours are all important for maintaining blood glucose levels within the recommended target range. T2D is a progressive condition which means that the type (and/or dose) of medication a person needs to keep their blood glucose levels in target range may change over time. Injecting insulin is a very effective treatment for diabetes. However, around one quarter of adults with T2D report being not at all willing to inject insulin if recommended by their health professional. People with T2D commonly report concerns and negative attitudes about insulin therapy, including a belief that insulin is not effective for T2D, and could negatively affect a person’s health; concerns about injecting insulin, and; feelings of guilt and self-blame about what insulin symbolises about their health and identity. Our research has previously shown that around half of Australians with non- insulin-treated T2D believe that insulin is a punishment or consequence of ‘failing’ to self-manage their diabetes previously. These negative attitudes about insulin are associated with delayed commencement of insulin. Few resources are currently available to people with T2D to help address these negative attitudes about insulin. Existing Australian resources about insulin are not evidence- based and have not been evaluated to test whether they reduce these negative attitudes. Given the size of the Australian population with T2D a resource that is delivered online to enable wide reach is needed. Therefore, this study aims to test if a novel web-based resource (intervention), compared to widely available existing resources (control), is effective for reducing negative attitudes toward insulin therapy, among adults with non-insulin-treated T2D.
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The effect of pine bark extract dietary supplement on physical health outcomes in healthy older adults.
Australia has an ageing population and muscle loss (also known as sarcopenia) is a common condition amongst older adults and is a natural part of the ageing process. Progressive loss of muscle increases the risk of fractures and lowers life expectancy, quality of life as well as limited ability to perform daily tasks with greater levels of fatigue and exhaustion. Changes in the immune system associated with ageing have also been suggested as potential contributing factors to muscle loss and physical frailty. Adequate nutritional intake as well as resistance/balance exercise training and some pharmacological intervention are the current preventative and therapeutic strategies for sarcopenia, however, long-term adherence to complex lifestyle changes that are also physically demanding can be a barrier for some individuals. Therefore, a safe, effective, adjunct therapy with potentially multiple health benefits may improve the well-being of older adults to delay or prevent further muscle loss and potentially improve muscle mass, strength, quality of life and physical function. This study aims to evaluate the health benefits of a dietary supplement containing pine bark extract in healthy older adults. Collection of information and measurements from you will enable us to investigate the health effects of this dietary supplement in older adults to promote healthy ageing.
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Implementation of a nurse-enabled, shared-care follow-up model for early breast cancer survivors (The IBIS-Survivorship Study)
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Mechanisms of action of SGLT2 inhibitors in patients with heart failure with reduced ejection fraction (HFrEF)
While SGLT2inhibitor drugs have been demonstrated to favourably affect outcomes in heart failure, the responsible mechanism(s) are completely unknown. We plan to conduct a single centre, phase 2/3, randomised, double blind, placebo-controlled clinical trial with two parallel arms, to investigate the mechanism of action of dapagliflozin (10mg daily), an SGLT2inhibitor, in non-diabetic or diabetic patients heart failure with reduced ejection fraction. By understanding the mode of action, we will then be able to administer these drugs in a personalized manner and to develop better therapies that specific address the key molecular or physiologic targets.
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Screening for atrial fibrillation in the over-75s with handheld ECG devices
Patient-led screening for atrial fibrillation (AF) using handheld mobile electrocardiogram (ECG) devices at their homes may help in detecting AF. However, there is no established system to facilitate the diagnosis and management of AF when a suspected case is detected. Therefore, we aim to study whether we can implement an AF screening program using handheld mobile ECG devices integrated with a cardiac centre at Westmead Hospital, New South Wales, that is able to confirm the diagnosis and facilitate appropriate management of new AF. Participants are given a handheld mobile ECG device and they will receive training in using the device. They will involve in the study for a period of 12 months. Participants randomised to the intervention group will commence monitoring straight away while participants in the control group will wait for 6 months to receive the handheld ECG device. During the waiting period, they see their general practitioners (GPs) for usual care. Participants record a 30-second daily ECG on weekdays. ECGs will be automatically transmitted to Westmead Cardiology Department and monitored by trained technicians. Participants and their GPs will be notified of ECG abnormality and GPs can access support from cardiologists involved in this research. The primary outcome at 6-month follow-up (or when AF is diagnosed, whichever occurs first) is the proportion of participants’ reporting being very satisfied/satisfied that their heart rhythm was being monitored in the past 6 months in the intervention group compared to the control group.
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Evaluation of a peer and clinician co-facilitated group program for people with borderline personality disorder
To date, there is an absence of specific studies evaluating peer support services for individuals with BPD. This study aims to explore whether a peer support group model is helpful for individuals with BPD. Individuals with BPD will also complete a questionnaire prior to starting the group program to measure mental health symptoms before and after the group program. It is hypothesised that participants in the intervention group will experience an improvement in mental health symptoms and BPD symptoms, and that participants in the waitlist condition will experience no change.
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Safety and feasibility of utilising a novel wearable device (Leo) for assessing respiratory function in children with and without respiratory condition - a pilot early phase clinical study (Phase 1)
This is an early phase pilot study designed to test the safety and feasibility of using a novel, wireless, wearable device (Leo) for assessing respiratory parameters (lung volume, respiration rate, heart rate and indices related to tidal breathing flow volume loop) in children with and without respiratory conditions (such as asthma) There is no product on the market currently that is comparable to this novel Leo device This study is a single visit to evaluate the correlation between breathing signals collected by the Leo device with those collected through lung function tests. 40 children will be included. 20 children with clinically stable asthma and 20 healthy children There will be no disease-specific intervention, nor changes to the participant’s care management program for their asthma
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The PRESIDE TRIAL
The PRESIDE Trial is a double-blind RCT of pharmacogenomically-informed prescribing of antidepressants on depression outcomes in patients with major depressive disorder in primary care. Participants who have depressive symptoms will be randomly allocated to one of two groups and neither they, nor their GP, nor the researchers will be aware of which group they are in. One group will receive recommendations for which antidepressant drugs may be most effective for them based on how their DNA impacts how they break these drugs down. The other group will receive recommendations for antidepressant drugs based on current Australian guidelines. All participants, regardless of which group they are in, will decide with their GP which antidepressant, if any, is best for them. This trial addresses significant knowledge gaps related to how clinically useful this type of pharmacogenomic (DNA) test may be in managing patients with major depressive disorder in primary care. It will create evidence about the efficacy, safety, and cost-effectiveness of this approach, working with health service delivery partners and research end-users to ensure the findings can be implemented into practice as quickly as possible.
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Impact of the Be Well Plan on university students' wellbeing and mental health
The Be Well Plan comprises of five online group sessions (2 hours each) which are delivered by trained facilitaters. The program helps participants identify strategies to build and maintain strong levels of mental health, wellbeing and resilience. A particular strength of the program is that participants develop their own, personalised wellbeing plan including activities that they identify as beneficial during participation in the program. All activities in the Be Well Plan are evidence-based and were selected from an extensive meta-analysis of psychological interventions to improve mental wellbeing conducted by the team members. The proposed research aims to investigate the efficacy of the Be Well Plan in a cohort of Flinders university students. We plan to recruit 120 student who will be randomised to the interactive, online facilitated version of the Be Well Plan intervention or to a wait-list control condition. Validated measures will be used to assess psychological distress (i.e., anxiety, mood and stress), wellbeing (emotional, social and psychological), and resilience in order to evaluate pre- to post-intervention changes.
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The impact of Australian bushfires on pregnant and breastfeeding women in the Mid North Coast Local Health District (MNCLHD) New South Wales.
The 2019/2020 bushfire season has had a widespread impact on the health and wellbeing of people in Australia. Exposure to air pollutions, such as bushfire smoke, during pregnancy and early childhood is associated with health impacts later in childhood. Additionally, pregnant and breastfeeding women with respiratory conditions, such as asthma, are particularly vulnerable to bushfire smoke exposure. The purpose of the research is to investigate the impacts of bushfire smoke exposure on health outcomes of vulnerable groups (pregnant and breastfeeding women) with and without asthma, particularly evaluating the impact of smoke on respiratory symptoms, wellbeing, and maternal concerns and behaviours ( e.g. exposure reduction strategies, medication use, and infant feeding practices). The information from this project will inform guidelines and health messages (developed and disseminated with our partner groups) for pregnant and breastfeeding women with and without asthma, and healthcare providers. Further, it enhances bushfire preparedness and responses by explaining effective preventive strategies to reduce smoke exposure and treatment. Women who agree to participate in this study will fill out a baseline survey online, via telephone or a paper-based copy. After completing the baseline survey, participants will be invited to complete two follow up surveys during and after the next bushfire season in 2020/202. The follow-up surveys will also be via online, via telephone or paper-based options.