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A study trialling the drug Gastrografin for use in patients with a bowel obstruction due to cancer.
Expand descriptionThe primary purpose of this pilot trial is to evaluate whether a full-scale clinical trial for gastrografin is feasible, and to provide an initial estimate of the efficacy of gastrografin for the resolution of malignant bowel obstruction (MBO). 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 MBO. Study details All participants enrolled in this pilot trial will receive the same treatment. This involves a single oral dose of gastrografin administered as a 100ml solution. Participants will then be followed up for 5 days to assess whether the treatment has reached the bowel, whether it has been effective in clearing the obstruction and any side effects which may have occurred. It is hoped that the findings from this trial can be used to inform future clinical trials on the use of gastrografin in palliative care.
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Insulin Pump therapy for Reducing Diabetic complications (InsPyReD) study
Expand descriptionThis study aims to determine whether insulin pump therapy can prevent nerve injury in patients with type 1 diabetes Who is it for? You can join this study if you have type 1 diabetes, aged 18-45 years and have not received insulin pump therapy before Trial details In this study, participants are randomly (by chance) divided into two groups. One group will receive an insulin pump free of charge for a period of 2 years. The other group will receive standard insulin injection therapy. Participants will undergo non-invasive nerve and eye tests to determine their suitability for the trial and when enrolled, will undergo these follow-up assessments at 6, 12, 18 and 24 months, coinciding with their usual endocrinology appointments. Both groups will receive continuous glucose monitoring at the beginning and end of the trial to determine the effect of glucose variability on nerve function. Participants will also undergo assessments of their quality of life specific to any nerve damage they may have.
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Can thinking about movement improve movement speed in older adults?
Expand descriptionMotor imagery is an imagining of an action without its physical execution; it is a dynamic state during which the representation of a given motor act is internally rehearsed or imagined within working memory without any overt muscle activation. Motor imagery activates brain regions that are activated during actual task performance and motor imagery training has been found to improve task performance. Motor imagery has been found to improve static balance in the elderly but its effect on dynamic balance or functional performance in older adults is unknown. The aim of this study is to determine whether imagining certain movements repeatedly promotes improvements in mobility. It is hypothesised that motor imagery will improve mobility but a point of diminishing gains will occur after multiple repetitions.
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Does telehealth delivery of the 'Care of People with dementia in their Environments' (COPE) program provide a non-inferior alternative to face-to-face treatment for community dwelling people with cognitive impairment?
Expand descriptionThe "COPE" program is a structured program provided by occupational therapists for people with dementia and their carers. The program aims to improve independence and support the caregiver to manage stress and provide care. The program has been shown to be effective in a large randomised trial in the United States. However, neither the COPE program, nor similar evidence based occupational therapy programs for people with dementia have been translated into clinical practices. One of the main barriers is that these programs involve up to ten home visits; this is too resource intensive for many organisations and can not be delivered in the country. This project is a randomised controlled trial. The aim of this project is to compare two methods of delivering the COPE program: 1) traditional facetoface delivery, and 2) telehealth delivery. The content of the program will be the same but the method of delivery will be different. 174 participants will be randomised into the two groups of the trial and outcomes will be assessed at the end of intervention and at 9 months (following randomisation).
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Victorian study of Echocardiographic detection of Left ventricular dysFunction (Vic-ELF)
Expand descriptionHeart failure (HF) is a problem that is assuming epidemic proportions, especially among the elderly. Unfortunately, its clinical diagnosis is associated with late-stage disease, which has a poor prognosis and responds poorly to medical therapy. At present, there is no effective strategy for identifying and preventing HF, with the result that patients present late in the course of the disease where hospitalisation is inevitable and treatment responses are poor. The Vic-ELF study (Victorian Study of Echocardiographic detection of Left ventricular dysfunction) study is a randomised trial to explore the benefits of screening selected patients at risk of developing heart failure. We will do this with a special new imaging technique (strain imaging), in which we at Baker IDI Heart and Diabetes Institute have special expertise. Screening of "at risk" patients with a combination of clinical scores and echo imaging is able to identify patients who are liable to develop HF. The question that now needs to be answered is whether surveillance with GLS could change HF outcomes in at risk patients. We anticipate that the prompt initiation of therapy in these patients that are recognized to have the earliest phase of HF will result in improvement in their functional capacity, and arrest in the subsequent progression to HF.
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The 200-Rep Trial: 200 repetitions of isolated muscle contractions for partially-paralysed muscles
Expand descriptionAn important goal of physiotherapy for people with spinal cord injuries is to increase strength. In those who are very weak (with muscle groups of less than grade 3 strength), physiotherapists tend to rely on repetitious contractions to increase strength. This is based on theories about neural plasticity and the need for repeated movement to prompt neural recovery. Despite the widespread use of repetitious contractions to increase strength in very weak muscles, it is not known whether this is an effective training paradigm. The trial will be a pragmatic multi-centre, assessor-blinded between participant randomised controlled trial. The aim of our project is to determine the best way of providing physiotherapy treatment, specifically to compare the therapeutic benefits of repetitious practise with usual care, to usual care alone to increase strength in very weak partially-paralysed muscles of people with recent spinal cord injury. One target muscle group with less than grade 3 strength will be selected on one side of the body from the following muscles: the elbow flexors, elbow extensors, wrist flexors, wrist extensors, knee flexors, knee extensors, ankle dorsiflexors or ankle plantarflexors. Eligible participants will be randomised to either the Treatment group or the Control group. Participants allocated to the Treatment group will do 200 repetitions of isolated contractions of the target muscle on one side of their body as well as usual care. Participants allocated to the Control group will receive usual care alone. The intervention will be provided for 8 weeks. All outcomes will be collected at baseline and at 8 weeks.
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A prospective cohort study evaluating the incidence of and outcomes associated with dose reductions of diabetic medications in a population of older inpatients discharged to a nursing home
Expand descriptionModern medical care can provide many medications for problems, whether simply short-term medications like antibiotics or longer-term medications like those used to treat high blood pressure. But we do not know enough about when medication can and should be ceased, especially in older patients with diabetes. We know that often medications are ceased while a patient is in hospital; sometimes medications are not ceased. We want to collect data about those patients who had medications for diabetes stopped and those who did not, and compare the two groups later to look for any differences. Many older people complain about being on too many medications. People on lots of medications might wonder what would happen if one or more of their regular medications was ceased. Our purpose is to understand better any benefits for older people to be on fewer regular medications, and understand any unforeseen risks of stopping regular medications in older people. Hospital doctors often cease a regular medication. We will not influence when and how that happens for you, only observe whether or not it does happen for you and call you after discharge to find out how you are feeling. Nothing about your hospital care will be different. Sometimes a patient is hospitalised as a result of a side effect of a medication which is then stopped; sometimes a patient is admitted to hospital for a different reason but a medicine needs to be stopped in hospital; sometimes a medicine is stopped because it is no longer beneficial. And sometimes no medications need to be stopped. These measures are all part of routine hospital care. We simply want to check on you after your hospital stay to see how you are feeling. We will also ask your nursing home for information about falls and General Practitioner (GP) call-outs to see you and any changes to your medication since discharge. With your permission we will also contact your GP and ask them to perform a routine diabetes blood test 3 months after you are discharged. This is called a “HbA1c” and it is a blood test that looks at your diabetes control in the last 3 months. Your GP would probably be doing this blood test anyway and we will ask him or her for the result. We will document your age and information such as your list of medications at the time of admission as well as discharge, the reason for your hospitalisation, what over medical conditions you have, whether or not you required another presentation or admission to hospital in the 6 months prior to and after this admission; your glucose (sugar) control before and after the first hospitalisation; the reason for admission if you do require readmission; which medications you are taking at 30 days and 3 months after discharge, to determine if any medications have been restarted that were ceased while you were in hospital the first time and the reason why a medication was restarted; and lastly, how you rate your quality of life.
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Investigating the effectiveness of the Active Team mobile phone application in increasing physical activity
Expand descriptionPhysical inactivity is a leading cause of disease and premature death worldwide. To address this, a growing area of interest is web-based physical activity interventions, which have the potential to reach large numbers of users at relatively low costs, and to effectively change behaviour. At the forefront are interventions capitalising on online social networks and gamification. The current study aims to test the efficacy of 'Active Team', a purpose-built, gamified physical activity intervention that connects users to each other via their Facebook profiles and is delivered via mobile phone application.
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Influence of the Disease Label 'Polycystic Ovary Syndrome' on Intention to have an Ultrasound and Psychosocial Outcomes: A Randomised Online Study in Young Women
Expand descriptionWidening diagnostic criteria and improved imaging sensitivity have increased the number of reproductive-aged women diagnosed with PCOS from 4-8% to up to 21%. Given the increase in prevalence, the uncertain clinical benefit of knowing this diagnosis needs to be weighed against the potential for poor psychological outcomes in women labelled with PCOS. The purpose of this experimental study was to investigate the impact of the disease label PCOS on interest in medical interventions and on psychosocial outcomes. 181 young women were randomised online to receive one of four hypothetical scenarios of a doctor’s visit in a 2 (PCOS disease label vs. no disease label) x 2 (information about unreliability of ultrasounds in clarifying diagnosis vs. no information) design. Participants were university students (mean age: 19.4). After presenting the scenario, intention to have an ultrasound, negative affect, self-esteem, perceived severity of condition, credibility of the doctor, interest in a second opinion and response efficacy and costs of having the ultrasound were measured. Participants were then presented with a second scenario, where the possibility of PCOS overdiagnosis was mentioned. Change in intention and perceived severity were then assessed.
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SurgiSeal (Registered Trademark) (medical adhesive) to prevent ooze and early dressing failure for Peripherally Inserted Central Catheters (PICCs) (The STICC randomised controlled trial)
Expand descriptionThe primary aim of this study is to identify clinical, cost-effective methods to promote haemostasis and prevent PICC dressing failure and associated workloads. The randomised controlled trial also aims to compare current PICC dressing techniques with tissue adhesive (TA) in terms of haemostasis, dressing duration, workload and healthcare costs; and evaluate the acceptability of this product to paediatric and adult patients and health professionals. You may be eligible to participate in this trial if you are receiving treatment in a tertiary health-care setting and a receiving a Peripherally Inserted Central Catheter (PICC) as part of your prescribed care (no age limits). All participants enrolled in this trial will be randomly allocated (by chance) to receive (1) standard care with tissue adhesive (TA) at the PICC insertion site or (2) standard care (with no tissue adhesive). If you are allocated to the Tissue Adhesive (TA) group, the medical-grade glue will be applied at the time of PICC insertion only (one-time application). All participants: standard care dressing and securement will continue to be applied (routinely or as clinically indicated) from device insertion until the time of device removal. Participants will be asked to rate the acceptability of the device and dressing, and the device will be observed closely to examine dressing changes, side effects, device failures and infections. It is hoped that the findings of this trial will provide information of the efficacy and acceptability of medical-grade tissue adhesive to promote haemostatis at the PICC insertion site (to prevent early dressing failure).