ANZCTR search results

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

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32856 results sorted by trial registration date.
  • Risk screening in the emergency department and educating older people of future falls.

    Hospital emergency departments (EDs) treat a high proportion of older people, many as a direct consequence of falling. Many of these people have fallen in the past year and are a high risk of future falls. At Sir Charles Gairdner Hospital (SCGH) ED, at least 1500 patients are diagnosed with a ‘Fall’ per annum. This accounts for nearly 3% of ED diagnoses at SCGH, although many more patients present ‘at risk’ of falls. The SCGH ED Care Coordination Team (CCT) which includes Occupational Therapists and Physiotherapists, primary aim is to assess and provide early interventions to patients who have presented with a fall. The CCT plans discharge by determining if the patient is able to safely return home and refers to hospital and community falls services. Studies show patients who have presented to ED with a fall are at high risk for recurrent fall and that they do not generally receive the care required avoid further falls. Additionally priorities within the ED dictate that the immediate clinical and functional consequences of a fall are dealt with and there is limited time available to consider future falls and injury prevention strategies. The CCT are targeting falls risk factors, providing education and referring patients to be followed up with Falls specific services. However the outcomes of these patients and the effectiveness of this falls risk assessment and education is unknown. This study aims to review the efficacy of a simple, quick to administer screening tool for discriminating between future fallers and non-fallers that is feasible for use in the busy ED setting. Additionally this study may allow us to gain insight into the effectiveness of falls education in the ED environment. Patients would be randomised to receive additional feedback on their falls risk assessment score and increased falls prevention education versus usual care. It will measure the effect by describing difference in the proportion and number of falls during the six month follow up period (measured with monthly phone calls), changes in physical status, medical history and community service use.

  • Iron infusion in iron-deficient patients undergoing surgery for colorectal cancer who are anaemic versus not anaemic in order to improve physical fitness as determined by exercise testing and a quality of life questionnaire.

    This pilot study aims to test if an iron infusion to iron-deficient patients planned for surgery for colorectal cancer who are anaemic versus not anaemic will improve physical fitness. Who is it for? You may be eligible to join this study if you are aged 18 years and above, have histologically confirmed colorectal cancer and Ferritin of less than 100mcg/l or between 100-300mcg/L with a transferrin saturation of less than %20. Study details Consenting participants will be randomly (by chance) allocated to either receive an infusion enriched with 1000mg iron (Ferric Carboxymaltose) or saline solution of similar appearance. All participants will receive maximum of 250mls of 0.9% saline solution with or without iron (depending on group) over a 15 minute period. All patients will be monitored for 30 minutes following completion of the infusion. No further blood tests will be required on the day of the infusion. This project is a pilot study, and if feasible, may be extended to a larger study in the future. This project is being conducted at Peter MacCallum Cancer Centre and Epworth Health Care.

  • Cognitive behavioural therapy for sleep disturbance and fatigue after traumatic brain injury

    Sleepiness and fatigue are frequent debilitating problems following traumatic brain injury (TBI). Medications have not provided long-term solutions for these symptoms and there is little research into psychological treatments. Cognitive Behaviour Therapy (CBT) is a well-established treatment for insomnia and chronic fatigue in those without a brain injury. The Monash-Epworth Rehabilitation Research Centre is conducting a world first study to investigate whether CBT can be effectively adapted to reduce symptoms of fatigue and sleepiness after TBI. A randomised controlled trial is used to compare participants receiving 8 sessions of CBT with a neuropsychologist to waitlisted participants who receive routine care as usual.

  • Integrated e-Screening for Postnatal Depression and Anxiety

    One in seven women will experience depression or anxiety after the birth of their baby; however 60% of cases will go undetected. The identification of postnatal depression (PND) or anxiety is not part of the routine care provided by health care systems, meaning that only 10% of women experiencing these difficulties will receive treatment. This is mainly due to not screening for, and identifying, postnatal depression or anxiety. Although methods to identify PND exist, they are inconsistently carried out, and are prone to error as primary care professionals lack time as well as a clear system when making decisions on how to manage depression. We have co-developed a tablet-based application (e-screening tool) to screen for postnatal depression and to conduct a broad assessment of a woman’s well-being. This tool will help health professionals to identify postnatal depression and/or anxiety easily, accurately and consistently and provide best-practice guidance tailored to women’s responses. To determine whether our e-screening tool will be useful for health professionals in identifying PND, we will compare it to the existing method of screening and identification that is currently used by health professionals. The success of the new system will be measured by its capacity to deliver real improvements to the healthcare system. The new e-screening tool aims to be quicker, more accurate, involve less staff time and resources, be used more frequently, and lead to improvements in treatment and recovery rates for depressed women. Ultimately, this trial could lead to a cost-effective and sustainable new system.

  • Effects of whey protein, on energy intake, appetite, antral area, gastric emptying, amino acids, gut hormones and glucose in healthy, undernourished and obese, young and older, individuals

    Ageing is associated with a physiological reduction of appetite and energy intake, which has been called the “anorexia of ageing”. Dietary supplementation with liquid protein preparations is now used frequently to increase energy and protein intake in older adults in both institutionalized and community-dwelling populations. Although the latter would appear a logical approach, evidence for success of increased energy intake in older individuals is limited. Urgent investigation is warranted to determine the optimal load of protein that can be incorporated into their diet to assist in sparing muscle mass without reducing their appetite. Moreover, weight loss protein-rich diets are often recommended for obese older adults in the same manner as for younger adults. In young adults, obese individuals exhibit a less precise compensatory response to ingested energy than lean individuals. Although only a limited number of studies have examined the effects of state of nutrition in elderly on the regulation of appetite, there is persuasive evidence of substantial differences between undernourished and healthy older people, which may potentially represent an outcome of and/or contribute to the undernourished state. A common strategy to increase energy intake and body weight in undernourished elderly is the use of nutritional supplements, and this is now almost standard practice. Usually such supplements are provided as mixed macronutrient high-energy drinks. Because of the increasing awareness of the major muscle loss that preferentially accompanies weight loss in older people, and its particular adverse effects, there has been a recent, marked, increase in the preferential administration of protein in these supplements and the use of protein-enriched supplements in an attempt to preserve, or even increase, muscle mass, in both institutionalized and community-dwelling populations. Such recommendations and use are, however, largely empirical. Our understanding of the feeding responses, and mechanisms underlying them, of undernourished and obese older people to protein is very limited and will be increased greatly by the proposed study. To aim of the study is to characterise in undernourished and obese, young and older individuals, the effect of different oral protein loads on energy intake, appetite, antral area, gastric emptying, plasma concentrations of amino acids, hormones (i.e. CCK, PYY, ghrelin, GLP-1, GIP, glucagon and insulin) and glucose, and to determine the relationship between the suppression of appetite and energy intake by protein with ‘intragastric’ and ‘small intestinal’ mechanisms.

  • The efficacy of pre-exposure prophylaxis for Human Immunodeficiency Virus (HIV) in high-risk individuals in Victoria, Australia

    Pre Exposure Prophylaxis eXpanded (PrEPX) is a new study that will expand the provision of PrEP to 2,600 Victorians who have a high chance of acquiring HIV. Alfred Health is responsible for conducting the study. Associate Professor Edwina Wright from the Department of Infectious Diseases Alfred Health, Monash University and The Burnet Institute will be the Chief Investigator of this study. The study is sponsored by the Victorian Department of Health and Human Services and, co-sponsored by Alfred Health and the Victorian AIDS Council. The chief research partners are The Burnet Institute and the Centre for Social Research in Health, UNSW. The aims of PrEPX are to: -Reduce the incidence of new HIV infections in Victoria, -Expand access to PrEP in Victoria, including rural and regional locations -Build capacity in the Victorian Health Service system so that the use of PrEP will become a routine option for preventing HIV infection PrEPX will start enrolling people on 26th July 2016 and run for 21 months. We will monitor the rate of new HIV infections in Victoria for a period of 36 months after the PrEPX study commences.

  • The Chronic Conditions Course: A Randomised Controlled Trial of an Online Treatment Program for Adults with Chronic Health Conditions

    The diagnosis of a chronic physical disease can present multiple and significant challenges. It frequently requires adjustment to new and changing circumstances, limitations and treatment regimens that can have a profound impact on all aspects of life. Reflecting this, there is significant comorbidity between chronic physical disease and mental health disorder, particularly anxiety and depressive disorders. Research shows that anxiety and depressive disorders are at least twice as common in people with chronic physical diseases. Chronic physical diseases are one of the strongest risk factors for anxiety and depression and anxiety and depression are some of the strongest modifiable risk factors for deteriorating physical health. Psychological treatments teach patients the skills to understand and manage symptoms and to limit their impact on functional abilities and quality of life.More than sixty years of research has proven cognitive behaviour therapy (CBT) to be effective in treating anxiety and depression. There is strong evidence that suitably tailored CBT significantly reduces disability and improves mental health in adults with chronic physical diseases. Australian epidemiological studies indicate that fewer than 20% of Australians with anxiety and depression access any mental health treatment. Common barriers to treatment include direct and indirect costs, stigma, insufficient numbers of appropriately trained mental health professionals and the decreasing availability of specialist services outside of metropolitan areas. The organisation and limited resources of health services means that mental health is not routinely considered alongside the management of chronic physical disease. Primary health care providers desperately need somewhere they can refer large numbers of patients with the chronic physical diseases for effective mental health treatment. Thus, there is an urgent need for psychological treatments that are accessible, acceptable, efficacious and cost-effective. The proposed project has three primary aims: (1) to evaluate the short-term and long-term clinical efficacy of a new internet-delivered and transdiagnostic psychological treatment, the Chronic Disease Course, in reducing disability and improving emotional wellbeing and quality of life among adults with different chronic physical diseases; (2) to evaluate the treatment cost per patient and the cost-effectiveness of the treatment over the short-term and long-term; and (3) to explore the demographic, disease and patient-related predictors and moderators of treatment response. The hypotheses include: 1. The treatment will result in significant improvements in mental health and improvements in quality of life and disability at the completion of treatment. 2. The treatment will be cost-effective from the health services perspective at the common willingness-to-pay thresholds per Quality-Adjusted Life Year (QALY

  • Ondansetron to reduce vomiting in children receiving intranasal fentanyl and inhaled nitrous oxide for procedural sedation: a double blind, randomised placebo controlled trial

    We set out to assess the impact of ondansetron on the incidence of vomiting in children undergoing procedural sedation and analgesia (PSA) with the combination of intranasal fentanyl (INF) and inhaled nitrous oxide (N2O) compared with placebo. We hypothesize that ondansetron can significantly decrease the rate of vomiting associated with the combination of INF and N2O. Currently, there exists no report of any strategy to reduce the occurrence of vomiting in patients receiving INF and N2O. This is a phase III, double-blinded, placebo-controlled superiority trial of ondansetron for prevention of vomiting associated with PSA with the combination of INF and N2O. Participants will be randomized to receive one dose of ondansetron oral syrup (4 mg for patients 15-30 kg; 8 mg for patients >30 kg) or matched placebo during PSA. The treatment period will be limited to the participants’ emergency visit requiring PSA. The follow-up period will be of a maximum of one week (aiming for less than 72 hours) for each individual, ending at the time of the phone follow-up. The primary outcome is to determine if ondansetron decreases the incidence of vomiting during PSA with the combination of INF and N2O in children aged between 3 and less than 18 years compared with placebo. Secondary outcomes are to determine the effect of ondansetron compared with placebo on: a. Number of vomits during PSA b. Vomiting in the PED after PSA d. Vomiting within 24 hours of the start of the procedure c. Retching during PSA d. Procedure duration e. Procedure abandonment f. PSA-associated adverse events during the emergency visit g. To explore parental satisfaction h. To explore value parents put on vomiting

  • The Evaluation of iNdividualized Telehealth Intensive Coaching to promote healthy Eating and lifestyle in Chronic Kidney Disease

    Diet and lifestyle have been identified as the leading modifiable risk factors in chronic disease, of particular relevance considering the cardiovascular burden in chronic kidney disease (CKD). People with CKD identify diet and lifestyle programs for preventing deteriorating kidney function as their highest ranked research priorities. However, dietary change can be considered complex for patients with CKD. Patients are frequently advised on the manipulation of single nutrients, which often conflicts with associated co-morbidities and advice from other health professionals. Evidence from our recent systematic reviews have indicated: healthy eating patterns in CKD are associated with lower risk of mortality; current evidence from clinical trials to support dietary change in CKD are limited. CKD patients prefer a repeated, coaching approach with frequent feedback to support dietary change; and telehealth strategies enhance adherence to dietary change compared with traditional models. This randomised controlled trial aims to determine the feasibility, patient acceptance, and clinical impact of telephone-based contact with additional or standalone tailored text messages compared with usual care to support dietary adherence among patients with chronic kidney disease.

  • Effectiveness of Cognitive Behavior Therapy for Post-Stroke Fatigue and Sleep Disturbance

    Fatigue occurs in around 50% of individuals post-stroke often co-existing with sleep problems, which contribute to fatigue. Fatigue is further correlated with cognitive and functional disability and is associated with depression, anxiety, pain, sleep disturbance, unemployment and reduced quality of life. Despite this, there has been little empirical investigation into the management of fatigue and sleep disturbance following stroke and no treatments are indicated for use following stroke. Pharmacotherapy is ineffective in the long-term and may cause adverse effects. Graded exercise has shown modest gains in fatigue post-stroke. A review of chronic fatigue syndrome treatment studies concluded graded exercise and CBT were effective, but CBT was more effective where anxiety and depression were also present. To date there have been no controlled trials of CBT addressing fatigue and sleep disturbance following stroke. If successful, CBT for fatigue and sleep will result in reductions in fatigue, improved sleep quality, increased activity levels and thus improved quality of life and functional outcomes.

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