ANZCTR search results

This is a prospective, observational cohort study assessing patient outcomes after joint replacement surgery. The purpose of this study is to assess clinical outcomes within the Investigator’s practice. The primary objective of this protocol is the implementation of an ongoing registry to collate and store patient outcomes collected routinely as part of the standard clinical pathway for hip and knee arthroplasty at the Investigator’s practice. Outcomes will include objective joint function, pain, satisfaction, quality of life, radiology and revision surgery. The secondary objective is to integrate the clinical outcomes with analyses provided by the Australian National Joint Replacement Registry. Recruitment will include all patients electing to undergo hip or knee arthroplasty surgery within the investigator's practice. Patients will undergo standard of care preoperative work-up, including the collection of demographic, medical history, radiology, pathology, and functional analysis. Patients will be required to complete the; EQ-5D 5L, and specific joint function outcomes will include Harris Hip Score (HHS), Oxford Hip Score (OHS), Oxford Knee Score (OKS), International Knee Society score (IKSS). Patient evaluation will be completed at the following time points: preoperatively and postoperatively at 2 to 6 weeks, 3 months, 12 months, 24 months and 5 years. The clinical outcomes of individual patients will be monitored up to 5 years postoperatively.

The aim of this study is to determine if pulmonary rehabilitation will effect cognitive function in people with COPD Participants will be invited to participate in the study when they perform the initial assessment for rehabilitation. All outcomes described will be collected (T1) They will then attend rehabilitation twice a week for 8 weeks and perform exercise training and self-management education. Exercise training involved 20 minutes of cycling and 20 minutes of walking plus upper and lower limb strength training. At completion of the rehabilitation program all outcomes will be reassessed (T3) and at six-months following the completion of pulmonary rehabilitation (T4)

Exercise has proven health benefits for older people regardless of age, ability or disease status. However, for many older people, there are substantial barriers to regular exercise participation. These include access to facilities and age-appropriate programs and restricted transport options that prevent older people from attending both social and physical activities.The aim of this study is to evaluate a model of care which has a preventative focus and will enable long-term exercise delivery and support within existing in-home care funding. The primary aim of this study is to improve the functional capacity of participants thereby increasing their ability to engage in activities of daily living.

Vancomycin is an intravenous antibiotic used in the treatment of serious infections, commonly seen in the Intensive and Critical Care Unit (ICCU). Unlike many antibiotics, vancomycin requires serum drug concentration monitoring to ensure both efficacy and safety. Traditionally vancomycin is dosed as an intravenous intermittent infusion every 8-12 hours. However, critically ill patients experience greater pharmacokinetic changes which can have a major impact on the dosage of vancomycin required to treat infection. There is emerging evidence to suggest that the administration of vancomycin by a continuous infusion may be more efficacious in achieving therapeutic serum concentrations, doing so promptly, and limiting nephrotoxicity which is a known adverse effect of the drug. The aims of this project are as follows 1. To evaluate the current practice administering vancomycin by intermittent infusion within the ICCU at Flinders Medical Centre (FMC)- phase one/Before 2. To develop and implement a protocol for the administration of vancomycin by continuous infusion- phase two/Implementation 3. By using a Before-and-After study design evaluate the efficacy of a protocol for the administration of vancomycin by continuous infusions, when compared to standard practice within the ICCU at FMC- phase three/After Data on the current practice of vancomycin dosing via intermittent infusion was commenced in February 2015, this data formed the basis for the Before group. The protocol was developed, using a dosing nomogram derived from a series of published studies identified from a literature review on the topic. This protocol underwent beta-testing and was implemented into the ICCU in March 2016 with concurrent education sessions. Prospective post-implementation data collection was undertaken, making up the After group.

The proposed project addresses the need to improve clinical outcomes for the population at risk of uncontrolled asthma, by extending the role of pharmacists in the delivery of primary health care services through a community pharmacy. The proposed intervention involves a simple version of an evidence-based pharmacist-delivered service for patients with uncontrolled asthma, which can easily be integrated into pharmacists’ workflow. This intervention targets three key factors associated with uncontrolled asthma: (i) poor adherence, characterised by underuse of preventer medication and/or overuse of reliever medication, (ii) suboptimal inhaler technique and/or (iii) uncontrolled allergic rhinitis. To deliver the intervention, the pharmacist will undertake three private consultations with the patient over a period of 12 months (at baseline, one month and 12 months), with a six-month telephone check-up mid-program. The number of visits and the time taken for each visit has been streamlined from our previous evidence-based interventions to increase feasibility and sustainability. The trial will use a cluster randomised design to test the clinical and cost effectiveness of a pharmacy based service for asthma patients in the community. Research Question: To compare the efficacy (increase in proportion of patients with controlled asthma) and cost effectiveness of a pharmacist-delivered asthma service comprising consultations with the pharmacist over a 12-months period for people with uncontrolled asthma (group A) with a “low-level” pharmacy intervention comprising identification of uncontrolled asthma with referral to the GP (group B). Hypothesis: The pharmacist-delivered asthma service comprising four consultations with the pharmacist over a 12-months period for people with uncontrolled asthma will be more effective and cost effective than a “low level” pharmacy intervention comprising identification of uncontrolled asthma with referral to the GP.

Short bowel syndrome (SBS) is defined as having insufficient bowel to absorb the necessary nutrition and hydration to maintain weight / sustain growth. The aetiology of short bowel syndrome can be either congenital (in children) or as a result of massive surgical resections. The prevalence of SBS in Australia is not known however it is estimated there are 220 patients on home parenteral nutrition in Australia for which SBS is a major indication. Despite the low prevalence of the condition these patients are complex to manage due to chronic diarrhoea, dehydration, macro and micronutrient deficiencies and electrolyte disturbances. Many rely on home enteral or parenteral nutrition or intravenous fluid and thus have to manage the complications associated with these forms of nutrition support. Despite medical therapy, oral rehydration solutions and a modified diet, the diarrhoea and malabsorption experienced in people with SBS is difficult to manage. This is not only debilitating but may also mean people who suffer from this condition are reliant on intravenous nutrition or hydration, therapies which are associated with a poor quality of life. High Amylase Resistant Starch (HARS) is a form of starch that occurs naturally in food. It is available as a supplement and is frequently added to foods by the food industry to increase fibre content. HARS has no taste and is usually undetectable in food or drinks. HARS has been shown to decrease diarrhoea from a variety of causes including gastroenteritis and cholera. A pilot trial completed at Austin Health showed that adding 50g/d of HARS to the diet of people with SBS significantly reduced the total amount of diarrhoea per day and showed a trend towards a decreased number of bowel actions per day. Larger trials are needed to confirm this effect and determine if there are any improvements in the person’s ability to absorb nutrition / hydration as well as their quality of life. We aim to recruit 50 people with SBS across Australia and supplement their diet with 50g of HARS each day for 2 months. Stool frequency and weight, urine output, body weight, handgrip strength and quality of life will be measured. The end of trial results will be compared to the participant’s baseline results (before they started taking the starch). This study aims to determine if supplementation of HARS to the usual diet of people with short bowel syndrome will reduce the diarrhoea (frequency of bowel actions and improve stool consistency), nutrition/hydration status and quality of life. It is hypothesized that the addition of 50g per day of HARS to the usual diet of people with short bowel syndrome will decrease the amount of diarrhea they experience and in turn improve their nutritional and hydration status as well as quality of life. Any therapy which can improve the quality of life of an individual with a chronic potentially life threatening condition has huge implications for the individual.

Participants are invited to take part in a research study into ‘difficulties with thinking and memory’ in people with COPD. The objective is to investigate the incidence of cognitive impairment (difficulties with thinking and memory) in people with COPD who attend a pulmonary rehabilitation program compared to an age-matched normal population. Participants (those with COPD and the age matched normal population) will be asked to complete a questionnaire designed to assess cognitive function. the questionnaire is the MoCa (described earlier in the application)

Tuning in to Kids is an evidence based program teaching parents skills in emotion coaching where they assist their child to learn about and manage their emotions. Parents also learn to develop their own skills with regulating their emotions. This trial will test out different forms of the program for parents of children with challenging behaviours relative to control participants. A) Aims and Objectives This study will evaluate the effectiveness of three delivery methods (one-to-one, group, online) of an emotion-focused parenting program, Tuning in to Kids (TIK) compared to control with parents of 3-10 year-old children with behaviour problems. There three aims include: • Examine whether the different interventions (relative to control) improve parenting and children’s emotional, social and behavioural functioning. • To examine for whom the program works (moderators) of program outcomes in order to establish which families do best with which intervention delivery method. • To establish the evidence for three different methods of TIK delivery and making this knowledge available to professionals working with families of children with behaviour problems. B) Key Question(s) Key questions are whether the three different versions of TIK are effective in comparison to control and whether any one program is more effective. Specific hypotheses are that at 6-month follow-up, participants in the three intervention conditions (but not the control) will have: • Improved parenting (emotion socialisation, parental sensitivity, warmth, hostility/criticism), via parent self-report and direct observation of parent-child interaction; • Improved parent functioning (emotion regulation and mental health) on parent self-report; • Improved child emotional knowledge and reduced behaviour problems, measured via direct assessment and parent- and teacher-report. C) Research Design The study will use a randomised controlled design with 400 parents of 3-10 year-old children with behaviour problems, randomised into four conditions (one-to-one, group, online delivery, and waitlist control). Measurement will be taken before, immediately after and 6 months after parents participate in a parenting program. Measures include parent and teacher report plus assessment of the child and observation of the parent and child. The Tuning in to Kids program will teach parents how to emotion coach their children in order to improve children's emotional understanding and regulation. D) Analyses and Outcomes Analyses will be conducted with the data to see for whom the program works and on which factors there are changes. Findings will be reported in peer review journals and at conferences. A summary of findings will also be given to all participants.

The primary purpose of this study is to investigate the safety and tolerability of multiple doses of 67Cu-SARTATE administered to participants with meningioma. Who is it for? You may be eligible to join this study if you are aged 50 years or over. Study details: All participants in this study will be injected with a single dose of 64Cu-SARTATE (a drug molecule) to demonstrate how it is absorbed in the body. Then participants will receive individualised doses of 67Cu-MeCOSar-Octreotate ("67Cu-SARTATE")for up to 4 cycles. It is hoped that this research will develop a product, which may help patients with meningioma.

The primary purpose of this pilot RCT is to investigate whether parents of infants at risk of CP with feeding difficulties deem standard care and a new feeding therapy for infants, called “I-EAT” feasible and acceptable interventions. The secondary outcomes are to: • document the range of practices used in the standard care arm. • estimate: o volume of oral consumption, o oral feeding efficiency, o oral feeding and swallowing skills, o measures of health, and o family stress, in infants who are at risk of or have been diagnosed with cerebral palsy and have feeding difficulties, under both the I-EAT program and standard care. • perform exploratory comparisons of feeding and other outcomes between the two study arms with a view to design of a confirmatory study. Hypotheses: • We hypothesise that parents will find both the I-EAT program and standard care feasible and acceptable interventions • We hypothesise that by the end of the intervention infants receiving the I-EAT program will: o consume at least 20% more of their recommended nutrition orally, o consume at least 20% more of their recommended meal during 30 minute mealtime o require a reduction of at least one compensatory strategies required, and o be no worse on growth trajectory, incidence of aspiration pneumonia or feeding related hospitalisations. • We hypothesise that parents receiving the I-EAT program will report an improvement of at least 20% on the Feeding Swallowing Impact Survey