ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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33055 results sorted by trial registration date.
  • Investigating a novel technological solution to prevent falls in older people in hospital

    Background: Although current best practice recommendations contribute to falls prevention in hospital, falls and injury rates remain high. There is a need to explore new interventions to reduce falls rates, especially in geriatric and general medical wards where older patients and those with cognitive impairment are managed. Design and Methods: A 3-cluster stepped wedge pragmatic trial of the Ambient Intelligent Geriatric Management (AmbIGeM) (wearable sensor device to alert staff of patients undertaking at-risk activities) system for preventing falls in older patients compared to standard care. The trial will be conducted on three acute/subacute wards in two hospitals in Adelaide and Perth, Australia. Participants: Patients aged >65 years admitted to study wards. A waiver and opt-out of consent was obtained for this study. Patients requiring palliative care will be excluded. Outcomes: The primary outcome is falls rate; secondary outcome measures are: i) proportion of participants falling, ii) rate of injurious in-patient falls/1000 participant bed-days, iii) acceptability and safety of the interventions from patients and clinical staff perspectives, and iv) hospital costs, mortality and use of residential care to 3 months post-discharge from study wards. Discussion: This study investigates a novel technological approach to preventing falls in hospitalised older people. We hypothesize that the AmbIGeM intervention will reduce falls and injury rates in participating wards, with an economic benefit attributable to the intervention. If successful, the AmbIGeM system will be a useful addition to falls prevention in hospital wards with high proportions of older people and people with cognitive impairment.

  • Rethinking model of specialist diabetes care utilising eHealth to improve clinical outcomes in complex type 2 diabetes

    Current service model for specialist diabetes care is based in a tertiary setting and involves care by a multidisciplinary team led by the endocrinologist. Continuation of conventional approaches with unchanged outcomes will require dramatic and potentially unaffordable expansion of current services to meet the increasing demand. The primary aim of this proposal is to determine the clinical efficacy of a new model of care employing mHealth (mobile Health) intervention in diabetes patients with suboptimal glycaemic control attending an outpatient specialist clinic as compared to usual care. This study follows on from a proof of concept and feasibility of mobile-based remote monitoring for stabilisation of insulin therapy in type 2 diabetes. Mobilehealth (Use of mobile technology like smartphone in health care management) create an opportunity to redesign outpatient services and meet unmet demands of existing healthcare. Collaboration between Diabetes and Endocrinology Department at Princess Alexandra Hospital (PAH), the UQ Centre for Online Health and the CSIRO has led to the development of a mobile-based remote monitoring system to support the management of complex outpatient diabetes patients. This system utilises a Bluetooth-enabled glucose meter to automatically transfer blood glucose levels to a clinician dashboard via an application installed on the patient’s smartphone. This will enable the endocrinologist/diabetes nurse to remotely monitor blood glucose levels and communicate with the patient in real time. The clinical data shall only be reviewed at set times decided by the clinician or on patient request and will not be continuously monitored. Patients receive individual alerts based on the frequency of BGL testing and BGL values. Individual patient screens enable a review of progress in advance of conventional outpatient encounters or during telephone consultations. Type 2 diabetes patients attending the outpatient diabetes clinic at the PAH shall be invited to attend. They shall be randomised to the intervention or control group with both groups followed up for a year. Control group shall receive routine care. The intervention group shall use the mobile-based remote monitoring system. Based on the data received in the intervention group, the endocrinologist in liaison with the patient shall decide to substitute scheduled face to face clinic consultation with virtual clinics ( via videoconference or telephone at home) if required. They will be required to get recommended pathology tests before their consultation as per routine practice. The patients have the option to enter via an online survey, relevant details before their intended clinic appointment. The participants will be followed for 12 months. We expect the new model of care will improve diabetes-related clinical outcomes, with improvement in patient and health care provider satisfaction at similar or lower costs.

  • Measuring cognitive function at admission to hospital: the first step towards reducing delirium.

    The ACQSHC introduced the Delirium Clinical Standard to prevent development of delirium in hospital and improvement management. Implementation of this standard involves educating nursing staff to use a validated cognitive assessment tool at the time of admission for those over the age of 65 years to assess for baseline cognitive decline. If cognitive decline is identified then the patient will be deemed high risk for delirium and daily measurement using a delirium screening tool will occur on the ward so that early treatment can be initiated by a geriatrician. This project aims to introduce the first step, which is the cognitive decline screening once on admission and measure how long this takes. We will also be asking nurses and patients about how easy and acceptable this process is and collecting some simple basic information about the patient. This information will be used to guide a broader roll out of the full Clinical Care Pathway.

  • Investigating the feasibility and acceptability of Smooth Sailing: An online mental health service for depression and anxiety in high school students

    Background: Anxiety, depression, and suicidality are prevalent among high school youth aged 12 – 17 years and help-seeking is low. Current mental health services for this age group are overburdened and lack capacity for mild-moderate symptoms. Alternative service models are needed to improve rates of help-seeking, reduce pressure on current systems, to prevent escalation of mental illness, and reduce the associated morbidity and mortality. Online stepped-care presents a viable alternative. It is based on the premise that simple, cost-effective internet interventions are offered to youth with mild-moderate symptoms, while more costly, intensive face-to-face interventions are reserved for those with more severe and persistent symptoms. Internet interventions can be readily integrated into stepped-care as they are fully automated, acceptable to youth, preserve fidelity of care, and allow for ongoing monitoring and automated feedback. School is an ideal setting for the implementation of online stepped-care as students spend much of their daily lives in school. However, schools currently have a “scattergun” approach to mental health, with some offering a school counsellor, some offering psycho-education programs, and others not having anything at all. The Black Dog Institute was awarded funds to design, build, and evaluate an online mental health clinic (referred to hereon in as “the e-clinic”) targeting help-seeking for depression and anxiety symptoms in high school students. Co-designed with students/schools/parents, the e-clinic delivers mental healthcare using a sophisticated internet program that triages students’ mental health, delivers treatment, monitors progress and links in with the school counsellor and wellbeing team. To reduce the stigma associated with mental illness, this e-clinic service has been named “Smooth Sailing”. Procedure: High school students were recruited to participate in the 6-week long trial. During this time, they registered to the Smooth Sailing service, answered a series of baseline questionnaires, and were allocated to a "Step", corresponding to their level of depression/ anxiety severity. Students were able to log on and use Smooth Sailing over the course of the next 6 weeks, at which time they re-completed the questionnaires at the follow-up assessment. Students that were allocated to the moderately-severe or severe categories at Baseline were followed-up by the School Counsellor within 48 hours. All students were also sent monitoring questionnaires via SMS or email at 14-day intervals, to check-in with how they were feeling and provide a reminder of the Smooth Sailing service. The main objectives of this trial were to: * Evaluate the effectiveness of Smooth Sailing intervention for increasing help-seeking for depression and anxiety among high school students; * Measure the acceptability, feasibility, and demand of this type of service model in high school settings.

  • The effect of a postoperative local anaesthetic pain pump in anterior total hip arthroplasty: A Randomised Control Trial

    This study aims to to determine whether using Local infiltration anaesthetic (LIA) vs LIA + continuous post-operative infusion of local anaesthetic for 48 hours using an elastomeric pump effects pain, opioid usage and, length of stay after a total hip replacement via the anterior approach. Each participant will be randomly selected into one of 2 groups. Group A will receive local infiltration anaesthetic to the surgical site during the operation, whilst Group B will receive local infiltration anaesthetic during the operation as well as an On-Q pump wound catheter that will provide continuous local anaesthetic to the surgical site for 48 hours after the surgery. After 48 hours, the On-Q pump will then be removed by the nursing staff on the ward by simple extraction. The Primary Outcome for this study will be opioid consumption between the 2 cohort groups. This outcome will be measured by calculating the total opioid usage for each participant and converting this to an oral morphine equivalent dose. The Secondary outcomes for this study are length of hospital stay measured from the admission day to the day of discharge from the ward, pain scores measured on the Verbal Analogue Scale (VAS), anti-emetic and laxative usage. The VAS consists of an individual subjective scale where each participant reports their level of pain from 0 to 10 where 0 = no pain, 5 = moderate pain and 10 = severe pain. Research information collected for this study consist of the VAS, opioid consumption, anti-emetic and laxative usage which are all information that is documented on standard protocol forms belonging to St Vincent’s Hospital (Observation Chart and Drug Chart). No new questionnaires or forms have been created for this study. Results from the 2 cohorts will then be collated and compared between the cohorts to see if adding a 48 hour infusion pump does reduce pain, opioid usage and length of stay.

  • Efficacy of a two bag N-acetylcysteine(NAC) regimen to treat paracetamol overdose (2NAC study).

    Paracetamol overdose is the most common pharmaceutical poisoning in developed countries and its incidence is increasing in the developing world. Overdose can lead to liver failure, and in the worst circumstances, death. In overdose, the increased production of N-acetyl para-benzoquinoneimine (NAPQI) depletes hepatic glutathione stores and eventually causes hepatocyte injury. Acetylcysteine is administered as the antidote to prevent hepatotoxicity in overdose. The typical three-bag infusion-dosing regimen in Australia is 150 mg/kg over 1 hour, 50 mg/kg over 4 hours and 100 mg/kg over 16 hours. Despite the safety of this regimen, there remains a significant amount of adverse reactions to acetylcysteine and delays between infusions. To this effect, a recent study of over 200 patients who received a two-bag acetylcysteine regimen was recently undertaken. A 200mg/kg loading dose of NAC was infused over four hours with a further 100 mg/kg infused over 16-hours. The incidence and severity of adverse reactions was significantly reduced, compared to the three-bag regimen, from 10% to 4.3%. A similar two-bag regimen has been adopted by various hospitals around Australia. The efficacy of this new two-bag regimen has not been determined. We aim to compare the rate of acute liver injury using a two-bag acetylcysteine regimen and compare this to the three-bag regimen in the setting of paracetamol overdose.

  • Surveying the health of women associated with Universal Medicine

    The current study is part of a larger quantitative, cross-sectional survey of women. A sample of 461 female UM participants from 17 countries responded to 43 questions taken from the Australian Longitudinal Study of Women’s Health (ALSWH). The survey compared health indicators for UM participants with those of ALSWH respondents.

  • Effect of Ashwagandha supplementation on testosterone levels and vitality in healthy, overweight men

    This is a double-blind, placebo-controlled, crossover study assessing the effects of Ashwagandha in 50 overweight adults presenting with mild-to-moderate symptoms of low energy/ vitality. Each participant receives both treatments (8 weeks of an Ashwagandha extract and placebo) and randomisation is used to determine the order in which the participant receives each treatment,( i.e. Ashwagandha followed by placebo, or placebo followed by Ashwagandha ). The Ashwagandha dosage is 2 tablets daily of BIPS technology Shoden (containing 10.5 mg of withanolide glycosides per tablet). Changes in mood, energy and vitality will be assessed via the completion of self-report measures, The effects of Ashwagandha on salivary levels of testosterone, cortisol, oestradiol, and DHEAs will also be examined.

  • Targeted gluteal exercise program versus sham exercise program for people with hip osteoarthritis (the GHOST trial (Gluteal exercise for Hip OSTeoarthritis): A randomized controlled trial

    Osteoarthritis (OA) is a common condition affecting many people. The number of people affected with hip OA is expected to rise exponentially over the coming years due to the ageing population and growing obesity rates. Conservative, targeted interventions (including exercise) are theoretically considered important in order to negate the economic cost and potential adverse events related to the typical intervention for end-stage hip OA; total hip replacement. However, recent studies conclude that current rehabilitation programs are limited in terms of improving hip function and reducing pain. It is suggested that current programs are ineffective due to their inability to target the right muscles, and they don't align with progressive resistance strength and conditioning principles, limiting their scope to cause effective change in muscle function over time. Our research team has devised an innovative exercise program that targets the hip muscles that are most affected in people with hip OA. Using these techniques, in combination with contemporary strength and conditioning principles, we wish to investigate whether this program has better success in improving function, pain and quality of life than a standard exercise program. This study is being conducted jointly by La Trobe University, University of Queensland and University of Otago and will recruit 90 participants over 4 sites (Bendigo, Melbourne, Brisbane and Dunedin). This research is funded by Arthritis Australia and La Trobe University.

  • A prospective randomised study on outcomes of a single-session combined balloon and capsule enteroscopies against capsule endoscopy alone in the management of obscure overt gastrointestinal bleeding

    The purpose of this study is to determine the best approach to investigate and treat the source of bleeding from your small intestine, which may have attributed to your low blood count (ie. anemia). Currently, the source of bleeding in the small intestine can be visualized by two endoscopic techniques. The first is called capsule endoscopy (CE), where the camera is miniaturized into a small capsule with a dimension of 20x8mm. Once swallowed, the CE is able to take pictures of gastrointestinal lining as it is spontaneously moves though the gastrointestinal tract. Whilst the pictures taken from the CE can reveal the potential causes of the gastrointestinal bleeding, it is not able to provide a tissue diagnosis or interventions to stop the bleeding. Furthermore, the locations of the potential bleeding spots are poorly located by estimation of the time taken from ingestion to the time at which the CE reaches the bleeding point. Push-pull enteroscopy is the second established technique used to visualize the small intestine by using a very long endoscope pushing its way along the intestinal tract. To improve the depth of insertion, various types of overtube with balloon(s) attached at the end of the tube are used. We used a single balloon overtube-enteroscope system at our centre. In addition to identify the bleeding focus, the major advantages of push-pull enteroscopy are the ability to obtain biopsy for diagnosis and provide endoscopic treatment to stop the bleeding. The disadvantage of this technique, however, is the inability to visualize the whole small intestine. At best, push-pull enteroscopy can only visualize half of the small intestinal tract.

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