ANZCTR search results

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

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31214 results sorted by trial registration date.
  • Educational program for nursing staff on management of resident-to-resident elder mistreatment (R-REM)

    Although previous studies on aggressive and disruptive behaviours in residential aged care homes (RACHs) suggests that these types of incidents are common, aggressive interactions between residents has received little attention in the research literature. These incidents between residents are referred to as resident-to-resident elder mistreatment (R-REM). RACHs house the frailest of older people, and even small injuries can have major negative consequences. Therefore, it is important to protect older residents from R-REM and nurses should play an essential role in identifying and managing R-REM to prevent serious harm. However, many nurses may not recognise these behaviours as forms of abuse. Thus, the aim of this study is to implement and evaluate an education program for nursing staff caring for older people on recognizing, reporting, managing and preventing R-REM. This is a Cluster Controlled Trial. There will be a control group and an intervention group. Firstly, participants will document, on small note pads provided, incidents of R-REM that occur during all shifts worked for a four-week period. After that, the intervention group will attend three educational sessions of approximately 45 minutes duration that will be held in the Education building at BECC. They will also complete a short questionnaire before and after each educational session and an evaluation after the last educational session. Following the educational sessions, the intervention group will again document, on small note pads provided, all incidents of R-REM for a four-week period. The educational sessions for the control group will be delivered at the end of the research project. In addition, both groups will document, at 1 and 3 months later, an evaluation of the implementation of the R-REM activities to prevent or reduce these types of incidents between older residents. This educational program will improve health and well-being of older resident living in RACHs and it will assist nursing staff in preventing and reducing R-REM by protecting vulnerable older people experiencing R-REM in RACHs.

  • This research study will use Magnetic Resonance Imaging (MRI) techniques to learn whether hearing aids do have an effect on cognitive function and the brain of older adults with hearing loss.

    Background: Sensorineural hearing loss is one of the most prevalent chronic conditions affecting older adults, and its occurrence is expected to increase with advancing age. Hearing aids have been proven to be a successful intervention for alleviating sensorineural hearing loss. Previous Research: A recent neuroimaging study has found that this type of hearing loss may cause parts of the brain to atrophy. Older adults suffering from brain atrophy associated with hearing loss will likely struggle to understand speech. Some of the psychosocial consequences of sensorineural hearing loss include depression and social isolation. There is also evidence that brain atrophy is correlated with the recruitment of compensatory mechanisms for auditory and language processing. Research is needed to focus on determining how this compensatory recruitment relates to cognitive decline. Study Objective: This study will use MRI techniques to determine whether hearing aids do have an effect on brain structure and cognitive function in older adults with sensorineural hearing loss. This will be established using a combination of auditory and visual stimuli to characterise participants hearing abilities. Method: Study participants will consist of older adults between 55 and 90 years with either mild or moderate symmetric sensorineural hearing loss. Consented participants will undergo hearing assessments, complete paper-based questionnaires, perform cognitive tests and undergo MRI scans at the time of recruitment (and again at 6 months). Participants will belong to one of 2 groups: first-time hearing aid users and long term hearing aid users. Study Hypotheses 1. Comparing the results of the cognition tests and the two MRI scans of the long-term and first-time hearing aid users over a 6 month period, it is expected that initially cognitive abilities will be less preserved in first-time hearing aid users than in long-term hearing aid users, but the wearing of hearing aids by first-time hearing aid users is expected to reduce this disadvantage within 6 months. 2. Also, both first-time hearing aid users and long-term hearing aid users are expected to practice lip reading in order to supplement their language processing, resulting in the use of both the auditory and visual components of the brain during the initial MRI sensory integration task. However differences are expected in terms of the plasticity within the visual and auditory cortex of long-term and first-time hearing aid users. 3. After wearing hearing aids for 6 months, it is expected that first-time hearing aid users will experience a decreased reliance on the visual networks of the brain for language processing with no change for long-term hearing aid users. Results from the study will inform strategies for aural rehabilitation, hearing aid delivery and future hearing loss intervention trials and neuroimaging studies. Results of this study will be published in a peer-reviewed journal.

  • Safety of iron polymaltose infusion given over 30 and 15 minutes for treatment of iron deficiency.

    Iron deficiency and anaemia are common conditions. They are treated by increasing your body’s iron levels . The most common way is by mouth as an iron tablet or liquid. Some people may need iron to be given directly into the blood through a vein, and this is called an intravenous (IV) iron infusion. An IV iron infusion is used when tablets or liquids do not work for a person or when they cause side effects such as stomach upset. In the past, iron polymaltose (a type of IV iron) was only given as an IV infusion over 4 hours. These days, it can be given faster and safely over 1 hour (for doses up to 1500 mg) thanks to the results of recent studies. Another type of IV iron, ferric carboxymaltose, is frequently used and can be given over just 15 minutes. However, it is more expensive and can only deliver a maximum dose of 1000 mg per week. Most people need around 1500 mg to completely top-up their iron and to last them for months or even up to a year. Previous studies suggest that how quickly IV iron is given has no effect on how well this treatment is tolerated. For this reason, the goal of this study is to test the safety of iron polymaltose given over 30, and then potentially over 15 minutes. Safety results will be compared to the slower infusions and to the other type of IV iron, ferric carboxymaltose. If no difference in safety is found, then this could be a better option because patients can be treated with a complete iron top-up and have it done over a shorter period of time. Infusion centres and hospitals would also benefit with reduced nursing time, larger number of patients treated and reduced direct medication costs. Iron polymaltose has been approved in Australia to treat iron deficiency anaemia since 27 May 1999. However, it is not approved for infusion rates over 15 or 30 minutes. Therefore, it is an experimental method of giving this treatment for iron deficiency anaemia. This means that it must be tested to see if it is as safe as the usual way of giving it over 1 or 4 hours.

  • Early peritoneal dialysis in infants after heart operation

    Background: Children undergoing heart surgery require cardiopulmonary bypass. This is a technique which takes over the work of the heart and lungs so the surgeon can perform the operation. The use of cardiopulmonary bypass often causes a reaction in the child called systemic inflammatory response (or SIRS for short). Children who develop SIRS are much more likely to have complications in intensive care (cardiac arrest, need for time on a breathing machine, prolonged intensive care stay and even death). Doctors and nurses at the Royal Children’s Hospital are very interested in studying and preventing SIRS. Peritoneal dialysis is a therapy often used in children after heart surgery; it is also used in children and adults to provide artificial kidney function. It involves placing fluid in the abdomen and using the lining to remove fluids and substances. We have observed that the early use of this therapy soon after heart operation is associated with improved outcomes. Peritoneal dialysis might reduce the risk of SIRS. Proposed study: We plan to study the role of early peritoneal dialysis in preventing the complications of SIRS in babies less than six months of age. The study will be conducted in the Cardiac Intensive Care Unit at the Royal Children’s Hospital, Melbourne. We have calculated we will need 312 infants in the study and hope to find out if early peritoneal dialysis helps reduce complications of SIRS following cardiac surgery. Babies will either get early peritoneal dialysis or normal care. Early peritoneal dialysis will start within an hour of arriving in the intensive care unit after heart surgery and will continue for 24 hours. Normal care babies will only get peritoneal dialysis if they need it for artificial kidney function. Potential implications for child health: This study will help to answer the question: “Does early peritoneal dialysis really help babies after heart surgery ?”.It will help make decisions about treatments after heart surgery. This is important for doctors and nurses working in intensive care units around the world. Peritoneal dialysis is a low cost treatment and if early commencement of this therapy after surgery is shown to positively influence outcomes it will have important implications for children born with congenital heart disease.

  • Effect of liraglutide on weight loss in patients with inadequate weight loss following bariatric surgery

    This research project is testing whether a medication called Saxenda (also known as Liraglutide) can help you lose more weight. Saxenda is approved for use as a weight loss therapy in Australia because it has been shown in obese people to cause weight loss after one year of between 5% and 10% body weight. We hypothesize pharmacotherapies can be used to improve weight loss following LAGB

  • Injection of Bromelain and Acetylcysteine in combination into recurrent mucinous tumour or pseudomyxoma peritonei: a phase I/II study

    The aim of this study is to evaluate the effect of Bromelain (Br) and Acetylcysteine (NAC) on mucinous tumour in patients that are unsuitable for repeat surgery. Who is it for? You may be eligible to join this study if you are aged between 18 and 80 years and have pseudomyxoma peritonei (PMP) or other mucinous tumour and you are not suitable for surgery. Study details All participants in this study will receive the treatment under investigation. This will involve injection of the combination drug treatment Bromelain and Acetylcysteine directly into the tumour via a drain. The drain will be aspirated 24 hours after the injection is administered. Repeat drug treatments will be considered. Efficacy will be assessed by volume aspirated and repeat radiological imaging. This study will assist with establishing the how well the drug works (efficacy) and its safety when injecting it into mucinous tumours in patients that are unsuitable for surgery.

  • D-tape for hip pain, does it work?

    Hip pain is a common condition that results in a reduction of activity, reduced work participation and reduced quality of life. Greater trochanteric pain syndrome (GTPS), considered to be primarily due to gluteal tendinopathy, is a common cause of hip pain in women over the age of 45. Women with GTPS have been shown to have an altered gait which is thought to aggravate, if not perpetuate, the pathology. Cortsone injection is the most common form of treatment for this condition, however, cortisone can cause tissue damage and is frequently associated with poor long term results. We need an alternative to cortisone that will provide pain relief without the long term negative consequences. We plan to undertake a study to test if flexible Dynamic sports tape is able to correct the gait changes seen in this population, and if it can reduce the associated pain reported by people with GTPS. 35 women with a 3 month history of GTPS will be recruited. Their gait will be evaluated via VICOM motion analysis system under three conditions: 1) base line gait, 2) Dyanamic tape applied with a 30% stretch, and 3) Dynamic tape applied without stretch. The latter two will be undertaken in random order. The final application of tape will be left on the participant for one week. One of the researchers will call the participants at the end of the week to ask them to report the level of their hip pain. The main outcome measurement is the amount of hip movement towards the midline – during the standing phase of gait. This is measured in Nm/WB.Ht. We will assess if the Dynamic tape can change this in women with GTPS. The second outcome measure is pain. We will measure this via a verbal rating score of 0 to 10, with 0 being no pain, and 10 being the worst pain imaginable. Women will be asked to rate their pain prior to walking, during each trial, and one week post walking.

  • Investigating the effects of Gynostemma pentaphyllum supplementation on muscle in Males

    Gynostemma pentaphyllum (G. pentaphyllum) is a plant species originating in Asia. Animal and human studies have shown that extracts from the leaf of this plant can decrease fat mass. Evidence from cell culture studies indicates that the decrease of fat mass is mediated via the AMP Kinase (AMPK) signalling pathway, a key pathway involved in both energy supply and performance of muscle. However, it is still unknown whether the supplement of this extract in humans influences the AMPK pathway. Therefore, the aim of this study is to examine the effect of supplementation with a dried leaf extract of G. pentaphyllum for 4 weeks on muscle AMPK activity. Since AMPK is involved in energy supply and performance, and its activity is also altered following exercise, participants following supplementation will undertake aerobic exercise performance tests using two different measures: a combined steady state and time to fatigue test (TtE) and a 20km time trial. Muscle samples will be collected at different times during the steady state exercise to allow measurement of changes in AMPK activity during exercise, while the TtE and the 20km time trial will provide markers of performance. As AMPK also alters glucose uptake in muscle, we will also measure glucose uptake by the muscle. Blood and muscle samples will be collected by an experienced medical doctor following the supplementation period. This study will help to identify whether the leaf extract alters AMPK activity in muscle, which will determine if the extract would be beneficial for improving exercise performance as well as metabolic diseases such as obesity and diabetes.

  • Making Inroads: Trial of an online early intervention to interrupt the cycle of anxiety and drinking in young Australians

    The aim of this project is to evaluate the efficacy of the Inroads program, an innovative, therapist-supported, 5-session cognitive behavioural therapy (CBT)-based online intervention for young adults aged 17 to 24 years that simultaneously targets anxiety symptoms, alcohol use, and the interconnections between them. The impact of the Inroads program on reducing symptoms of anxiety, hazardous alcohol consumption, negative consequences from drinking, and functional impairment will be compared to an assessment and alcohol information control condition. Assessments will be at 8-weeks post-baseline to assess short-term intervention effects, as well as 6-months post-baseline in order to examine the durability of the intervention effects. The project is innovative in two ways: (1) it is the first study of its kind to test the efficacy of an age-appropriate, visually appealing, integrated treatment for co-occurring anxiety and alcohol problems, and (2) it capitalises on the potential of internet-delivery to circumvent common barriers to treat-seeking, and combines this with therapist support to enhance participant engagement and retention.

  • Testing the ability of silver contact lens storage cases to control bacterial contamination

    The study aims to examine the rate and type of microbial contamination rate of silver impregnated and non-silver contact lens storage cases. This study is a prospective, randomized, double-masked, crossover clinical trial with three scheduled visits. A total 51 soft contact lens wearers will be recruited to use the silver impregnated lens cases and non-silver lens case (each for one month) along with a recommended multipurpose disinfecting solution. Participants will be allowed to use their existing lens brand. There will be total 3 visits within 2 months (baseline, 1st month and 2nd month). Routine assessment of contact lens fit and anterior eye health will be conducted at each visit and lens cases will be collected for microbial analysis at the 1st and 2nd month visits. At the end of 1st and 2nd month visits participants will be requested to complete a questionnaire relating to their contact lens use and we expect this activity will take approximately 20-30 minutes to complete. The contact lens case and solution will be provided free of charge during the study and at the end of 3rd study visit when the last lens case will be collected a replacement contact lens case will be provided. Participants will be provided with a $10 vouchers on 2nd and 3rd visits to compensate for their costs incurred in attending the study visits.

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