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Remote blood pressure monitoring in high risk pregnancy – a randomised controlled trial (REMOTE CONTROL trial)
Expand descriptionHypertension is one of the most common complications of pregnancy, affecting 2-10% of pregnant women. It is associated with adverse maternal and fetal outcomes, such as eclampsia, stroke, fetal growth restriction and stillbirth. Maternal mortality approaches 15% globally. Monitoring, early recognition and treatment are key to reducing severe complications and mortality. Traditionally in pregnancy, blood pressure (BP) is monitored routinely at outpatient visits. However, major recent events - the Australian bushfires and the COVID-19 pandemic, limited social movement, and therefore initiated major change to antenatal healthcare delivery. There was widespread uptake of Telehealth services and home monitoring of BP. Patients are recording their own BP, directed by a healthcare professional on the frequency of monitoring, and given criteria as to when to attend the hospital. In non-pregnant populations, ambulatory and home BP measurements have been shown to have a closer association with long-term health effects, compared to clinic BP measurements. This is reflected in international guidelines, such as the American Heart Association, and the European Society of Hypertension guidelines, which emphasises the importance of BP self-monitoring. However, this practice is not validated in the pregnant population, and the effect on maternal and fetal outcomes has not been quantified. Our study is a multi-centre, cluster randomised controlled trial investigating antenatal home-based blood pressure monitoring when compared with usual care, through exploring maternal and perinatal outcomes, cost-effectiveness, compliance and qualitative patient satisfaction data. Home BP monitoring could provide more accurate data for clinicians to use in management strategies, thereby reducing poor fetal and maternal outcomes, and the burden of multiple clinic visits. Additionally, home-based monitoring would be useful in future events that would require our population to limit social movement, such as in bushfires and health pandemics.
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Muscle Relaxation and Endotracheal Intubation: Textbook or Evidence Based? (Relaxed Study)
Expand descriptionWhen patients undergo surgery with general anaesthesia, the anaesthetist places a plastic tube into the windpipe after the patient is put into sleep. At this time, deep muscle relaxation is required to prevent some bad reflex responses to this procedure, such as coughing and bulking on the tube. However, in daily practice it is not practical to monitor every patient so closely who receives the muscle relaxant drugs, especially during the anaesthetic induction period when the tube is placed into the windpipe after patient is anaesthetized, as this is the most intense and stressful period for the anaesthetist. As such, a majority of anaesthetists routinely use the standard dose of the relaxant drugs and place the tube into the windpipe at the set time point according to the drugs’ respective “product information”. Such practice works for most patients, but some patients may have different sensitivity to the muscle relaxant drugs, and thus it may take longer time than normal to have deep muscle relaxation. This time lag may result in the tube being placed into the windpipe too early and thus cause some unwanted body reactions. These reactions may be very bad for certain patients, for example, if the patient has existing high blood pressure. In order to prevent such premature placement of the windpipe tube, we need to first find out how bad the problem is, i.e., how prevalent the premature placement of the windpipe tube is during standard anaesthetics induction, this is measured by a digital peripheral nerve stimulator, quantifying the degree of muscle relaxation. The good time to place the tube into the windpipe is when none of the four twitches appear on Train-Of-Four (TOF) stimulation of a nerve stimulator, applied to the patient's wrist before anaesthesia. The prevalence of premature placement of the windpipe tube is determined by the percentage of patients whose tube is placed before the disappearance of TOF on the nerve stimulator. This is what our study aims to do and only after we have determined the problem's prevalence, we will then be able to make recommendations accordingly so that we can modify and improve our patient care.
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Micronutrient intake from enteral nutrition in critically ill adult patients
Expand descriptionWhen people are critically ill and require treatment in an Intensive Care Unit, they are often unable to eat food. In this situation the standard treatment is to supply them with food dripped into their stomach or bowel through a feeding tube (termed enteral nutrition). Enteral nutrition provides both macronutrients (carbohydrates, protein and fat) and micronutrients (vitamins, minerals and trace elements). In Australia, enteral nutrition formula composition is guided by the National Health and Medical Research Council (NHMRC). These standards, termed Nutrient Reference Values (NRVs), include the recommended dietary intake (RDI), adequate intake (AI) and upper level of intake (UL). However, there is very little information on the amount of micronutrients delivered to critically ill patients during Intensive Care Unit admission. We are conducting a retrospective observational study to assist in determining the micronutrient intake of vitamins B12, D, C, A, iron, folate, thiamine, zinc, and selenium delivered from enteral nutrition to critically ill adults admitted to Box Hill Hospital Intensive Care Unit (ICU), Melbourne, Australia between January 2018 and January 2020. Micronutrient intake will be assessed for the first seven days of ICU admission and compared to Australian NRVs.
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An evaluation of a Mindfulness and Goal Setting Quality of Life Program and Questionnaire
Expand descriptionThe purpose of the project is to compare the well-being effects of a mindfulness training program versus a mindfulness and goal setting program. Subjects will be randomly allocated to one of the two conditions and there will be a maximum of 60 people per course. Condition 1 is a 2-day version of the mindfulness training section of the previously tested Mindfulness-based Quality of Life and Well-Being Program. Participants will be introduced to general mindfulness theory and principles before being taught techniques and exercises such as progressive muscle relaxation, neutral observation of the breath and present moment awareness. Condition 2 is the full 2-day Mindfulness-based Quality of Life and Well-Being Program which teaches mindfulness and goal setting. In addition to 1 day of mindfulness training, participants will be trained for 1 day in the theory and methods of goal setting applied to major quality of life domains (relationships, work, money, health and leisure). Individuals will be given assessments at the beginning and end of the 2-day workshops, and at 4 weeks follow up.
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What is the safety and feasibility of online therapeutic dancing for people with Parkinson's disease?
Expand descriptionTo conduct a pilot study to evaluate the safety and the feasibility of a pilot on-line, telemedicine therapeutic dancing program (ParkinDANCE online) for people living with Parkinson’s disease (PD). This phase 1 trial will test the safety and feasibility of our online ParkinDANCE program, for an initial four-week period of synchronous (real-time, live) therapeutic dancing. Each participant with PD will be matched to a dance teacher and they shall have sessions of up to one hour’s duration, twice a week for four weeks. This research project will provide evidence to inform online implementation of therapeutic dancing, as a tele-medicine modality. The need for online exercise and dance therapies has become apparent, to provide people living with PD access to safe and evidence-based physical therapies.
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Education and activity programs to improve health in people with painful knee osteoarthritis. A randomised controlled trial with cost-effectiveness analysis
Expand descriptionDespite profound health and disease-specific benefits of physical activity, 9 of 10 people with knee osteoarthritis (OA) are inactive. Here we aim to assess the effect of two types of education programs added to an individualised, physiotherapist-led walking and strengthening program to determine if it can improve overall health. Cost-effectiveness of the treatments will be undertaken, as will mediation analyses to consider the mechanistic underpinnings of the treatments. Using a parallel-group, multicentre randomised controlled trial, participants will be randomised to one of two active treatment groups. Both groups will receive 4 weekly in-person treatment sessions with a physiotherapist, followed by 4 weeks of at-home activities (and weekly check-in by physiotherapist via phone/telehealth), with follow-up sessions at 3 months (via phone/telehealth) and 5 and 9 months (in-person sessions). Primary outcomes are physical activity level (step count via wrist-based accelerometry) and knee symptoms (WOMAC Total score) at 12 months.
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Investigating the effect of integrating complementary medicine therapies including acupuncture, naturopathy, yoga and massage therapy for military veterans with chronic pain.
Expand descriptionTo date there have been no studies examining the impact of integrating CM into healthcare for Australian military personnel and veterans. Although some CM have evidence of positive clinical effects in military personnel and veteran health settings, current Australian funding arrangements do not allow for their inclusion in existing schemes (such as the DVA). This project aims to examine the clinical and societal impact of incorporating evidence-based CM – CMs already integrated into military health overseas – into the care of military personnel and veterans in one of Australia’s largest military-focused multidisciplinary healthcare clinics. This study will compare usual care (individualised routine care as would be delivered to a patient in normal settings) to complementary medicine (CM) in addition to usual care. This study is not testing usual care, it is testing whether the addition of a suite of complementary therapies in addition to usual care improves clinical care in naturalistic settings. In doing so this study will examine whether integrating CM in real-world military and veteran clinical settings proffers clinical improvements, resource or cost savings or other benefits to individual patients or healthcare organizations. CM practices in this study include acupuncture/Chinese medicine, massage therapy, naturopathic medicine, or yoga.
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Comparing blood concentrations of intravenous and nebulized sedatives and analgesics in patients who are on mechanical ventilation.
Expand descriptionPain and discomfort are commonly associated with all disease conditions especially in critical care. Despite pharmacological developments, the management of pain and discomfort remains suboptimal and often associated with complications. Administering the existing drugs via the inhaled route could achieve better concentration of the drug for effective pain relief and sedation while avoiding side effects. Previous studies have demonstrated safety and often efficacy of inhaled sedatives and pain relief. However, due to the absence of concentration data there is lack of dosing guidelines and hence leading to variable dosing which causes inadequate clinical effect. This is a prospective, open labelled observational Pharmacokinetic (PK) (drug metabolism) study with the aim of describing the comparative concentrations of the single dose sedatives and pain relief agents between intravenous, through the vein and inhaled routes of drug delivery. Blood and urine samples will be studied to assess the concentrations of the sedative and pain relief. The following drugs will be observed: fentanyl, morphine, midazolam, clonidine, dexmedetomidine and ketamine. It is hoped that the knowledge gained from this study will enable the development of dosing regimens for optimal inhaled sedative and pain relief therapy. We plan to recruit at least 10 participants per drug for this study.
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Trial of "Strong & Deadly Futures", a computerised, school-based, alcohol and other drug prevention program for Aboriginal and Torres Strait Islander students
Expand descriptionAlcohol and other drug use is a leading cause of harm for Aboriginal and Torres Strait Islander youth. Despite resilience and a continuous strong connection to culture, the ongoing impacts of colonisation, disempowerment, and inequity have an intergenerational impact on the wellbeing of Aboriginal and Torres Strait Islander adolescents. This intergenerational impact contributes to average initiation of substance use two to six years earlier among Aboriginal and Torres Strait Islander compared to non-Indigenous adolescents. Prevention of youth alcohol and drug use has therefore been identified as a key priority for improving the wellbeing and addressing health inequities between Aboriginal and non-Indigenous Australians. Previous research has found that curriculum programs implemented in secondary school can effectively prevent uptake of these substances by young people, and have flow-on benefits for social and emotional wellbeing, physical health, school attendance, and educational attainment. However, there are currently no school-based drug prevention programs that are culturally-inclusive and effective for Aboriginal and/or Torres Strait Islander students. To address this gap we partnered over the past three years with Gilimbaa, an Indigenous Creative Agency, and four schools in QLD and NSW to develop Strong & Deadly Futures, a cultural adaptation of the effective Climate Schools school-based prevention program. The program was co-developed with school staff and Aboriginal and/or Torres Strait Islander youth, who shared their stories, role models, things they love about their community and positive reasons for not using alcohol and other drugs. These perspectives formed the basis of the story arc for an illustrated story, which communicates the key prevention messages and highlights Aboriginal and/or Torres Strait Islander cultural strengths. The current trial builds on a successful pilot study in four schools, and will be the first RCT of a school-based, culturally-inclusive drug and alcohol program for young Aboriginal and/or Torres Strait Islander peoples. Strong & Deadly Futures will recruit 960 Year 7 and/or 8 students from 24 schools across Australia during 2022. Hypothesised benefits include reduced drug and alcohol use, and improved wellbeing.
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Balance on the Brain: A multi-modal exercise program for people with mild cognitive impairment
Expand descriptionThis study will be a large randomised controlled trial that looks at the benefits of a multi-modal exercise intervention (i.e. balance and walking program) for people with mild cognitive impairment. The primary aim of this research is to determine whether a balance-focused multimodal exercise intervention improves physical health and quality of life; and reduces the rate of cognitive decline and falls for people with mild cognitive impairment. The secondary aim is to evaluate whether a balance-focused multimodal exercise program is cost-effective from a health care perspective.