ANZCTR search results

This project evaluates the short-term efficacy of the Dementia Risk Reduction (DESeRvE) program involving 3 different approaches (Education (ED), Contact (CT), Education plus contact (ED+CT)), in stigma reduction for dementia using a Randomised Controlled Trial (RCT). There will also be an Active Control group which receive information on general health. It is hypothesised that the level of dementia-related stigma and dementia knowledge will be reduced and enhanced respectively for those in the intervention groups more than those in the Active Control group.

This community randomised trial will evaluate whether participation in the Resilient Families program results in improved family relationship, and social emotional wellbeing in disadvantaged secondary schools selected to include high rates of culturally and linguistically diverse families. Fourteen schools will be randomly assigned to intervention and 14 to a usual-practice control condition. Students and their parents will be invited to complete an online longitudinal survey at baseline in 2018 and 3-months post-intervention. The trial is linked to an independent study being completed by the University of Western Sydney and funded by E4L that will evaluate effects on student academic achievement. Resilient Families is a school-based family intervention program (Toumbourou et al., 2013) designed in 2004 by Professor John Toumbourou and currently delivered to schools by a team based at Deakin University. The Resilient Families program includes a student social relationship curricula and parent education components and is designed to be integrated into the normal school processes to assist secondary schools to enhance family-school partnerships. Previous evaluations have shown the Resilient Families program reduces student alcohol use across the whole-school population and depression and antisocial behaviour in vulnerable students.

To study the feasibility of capsule colonoscopy in patients with Crohn's Disease (CD). To compare the results of capsule colonoscopy with conventional colonoscopy in assessing mucosal healing. To correlate the level of faecal calprotectin with the results of capsule colonoscopy and conventional colonoscopy. To document changes in clinical practice attributable to the capsule colonoscopy findings a) concordant with and b) in addition to the parallel findings at colonoscopy and ileoscopy. Patients of the Royal Melbourne Hospital (RMH) and other associated speciality clinics with an established diagnosis of CD who need assessment of mucosal healing and have consented to be part of the study will undergo capsule colonoscopy and conventional colonoscopy after undergoing bowel preparation. The images of both the conventional and capsule colonoscopies will be recorded. In addition calprotectin (an inflammatory marker in faeces) will be measured in a sample of faeces collected by the patients prior to the colonoscopy day. Recorded images will be assessed once the images have been deidentified. Assessment will include the level of mucosal disease. To assess the level of mucosal disease they will use the Simple Endoscopic Score for CD (SESCD). The results of the assessment of mucosal healing obtained from conventional colonoscopy will be compared with those of capsule colonoscopy and levels of faecal calprotectin will then be correlated.

Managing medication regimens is one of the most complex and burdensome tasks performed by older people, and can be prone to errors. The objective of this pilot and feasibility study is to investigate a structured approach to simplify medication regimens for clients receiving community-based home care services. We hypothesise this may reduce the total number of medication administration times and may improve clinical outcomes for clients. This pilot and feasibility study will apply a pre-post design. Research nurses will recruit 50 clients with and without cognitive impairment receiving community-based home care services through aged care providers in South Australia. A clinical pharmacist will undertake medication reconciliation, assess each participant’s capacity to self manage their medication regimen, and apply a structured tool to identify opportunities for medication simplification. The pharmacist will communicate recommendations regarding medication simplification to registered nurses at the community-based home care provider organisation. The primary outcome will be the change in number of medication administration times per day at four months. Secondary outcomes include medication adherence, quality of life, participant satisfaction, medication incidents, falls and health care utilisation. Study findings will be disseminated through conference presentations, consumer summaries and peer-reviewed publications.

Research question: Does an 8-week home-based high intensity inspiratory muscle training (H-IMT) program affect inspiratory muscle strength in healthy adults? Hypothesis (feasibility objectives): To test the feasibility of an 8-week home-based H-IMT program in healthy adults in regards to compliance and satisfaction Aims - feasibility This study aims to explore the feasibility of an 8-week home-based H-IMT program with regard to participant compliance and satisfaction levels. Compliance will be measured by the number of completed training sessions and satisfaction will be measured using a 5 point-scale in reference to the participant’s sense of well-being. Good compliance is defined as completing 80% of the total number of training sessions over the 8-week period. This equates to completing a minimum of 45 of the total 56 sessions. The satisfaction 5 point-scale will include the following options: very satisfied, satisfied, neutral, dissatisfied and very dissatisfied. The intervention will be deemed to be satisfactory from the participant’s point of view if they circle 4 (satisfied) or 5 (very satisfied) for at least 80% all training sessions. Feasibility consideration will extend to investigating the time commitment required by participants for completing assessments and intervention, along with the financial cost of delivering the intervention. Time per training session will be recorded and cost estimates will be calculated for the duration of the intervention period.

Tubal ectopic pregnancies (EPs) are diagnosed earlier in their natural history due to transvaginal ultrasound (TVS) technology. There is no evidence that methotrexate (MTX) is necessary for all these early EPs, as many may resolve spontaneously in the absence of any treatment. Two recent randomised controlled trials demonstrate the safety of expectant management for patients with early EPs. In these studies, patients were randomised and treated with MTX or placebo on the day of diagnosis. By monitoring them expectantly without therapy for 48 hours following diagnosis, it is possible to identify patients with declining hCG levels, representing a subset of patients with spontaneous resolution of the EP. As such, the aim of this study is to verify if MTX is more effective than the placebo in patients with tubal EP and rising/plateauing serum hCG (< 1500 IU/L) levels at a 48-hour mark following definitive diagnosis. Our goal is to study treatment with systemic MTX in a single dose intramuscular regimen in patients with EP and increasing/plateauing serum hCG concentrations, with regards to treatment success, complications and length of follow-up. The primary hypothesis is that single-dose MTX is more effective than a placebo in patients with an early tubal EPs and rising or plateauing hCG.

Title Microcirculatory DySfunction and Skin Failure in Critically Ill patients: An exploratory study. (SoFIa Study) Aim To explore skin microvascular and macrovascular changes in critically ill patients. Study Design Quantitative, prospective, observational, exploratory design. Planned Sample Size 30 ICU patients meeting the selection criteria. Selection Criteria Inclusion Criteria • Intubated and mechanically ventilated. • 18 years old and over. • Expected length of ICU stay greater than 6 days. • SEM scanner score greater than or equal to 0.5 Exclusion Criteria • Pregnant Women • Imminent Death • Physiological condition prohibiting side positioning e.g. spinal injuries. • Skin conditions at perfusion measurement sites e.g. burns • Community acquired skin breakdown • Droplet precautions Outcome Measures Primary outcome measure Changes in perfusion at a cellular, microvascular and macrovascular levels measured by: • High levels of Syndecan-1 and soluble thrombomodulin in blood analysis, indicative widespread endothelial glycocalyx shedding and endothelial cell compromise. • Global microcirculatory blood flow changes via Incidental Dark Field imaging. • Local cutaneous blood flow changes at the sacrum and heels via Laser Speckle Contrast Imaging. • Macrovascular changes though the assessment of bedside haemodynamic measures. Statistical Analysis Plan Descriptive data will be analysed using frequencies, means as percentages as appropriate for continuous and categorical variables. Relationships between variables will be examined using a mixed effects model. Kaplan-Meier survival analysis will be used to compare time to new skin breakdown events. Duration of the study Commencement date – 21 August 2019; Completion date – 07 November 2019.

Dementia is a disorder with huge, growing, global economic burden. There are no effective treatments as yet, to combat or alter the course of dementia- the development of such treatments is an inter-governmentally agreed global public health priority. Clinicians have long delineated a prodromal condition with cognitive symptoms prior to the onset of dementia and Alzheimer’s disease (AD). This condition is known as Mild Cognitive Impairment (MCI). Individuals in this clinical staging present with subjective cognitive impairments and/or objective evidence of impaired cognitive testing whilst still being able to function. Whilst not all rigorously defined MCI patients progress into dementia, the rate of progression to AD is most probably, while the rate of reversion is least. Cognitive inactivity is estimated to be the most prevalent modifiable dementia risk factor worldwide. Our meta-analysis of 18 prospective longitudinal studies found high levels of complex mental activity was associated with a 46% decreased risk of incident dementia. Similarly, a systematic review based on aggregated data of 47,000 individuals followed for an average of 5 years revealed that lifespan complex mental activity slows the rate of cognitive decline in otherwise healthy older individuals. MCI has been associated with other neuropsychiatric conditions (as have dementia and AD). There is increasing evidence to suggest that sleep quality also plays an important role in cognitive health in ageing. Recently it was revealed that people with MCI are almost twice as likely to have sleep disturbance than those with normal cognition. This study also provides evidence to suggest that sleep disturbance is predictive of cognitive decline in older adults and those with neurodegenerative disorders. It has been identified that changes in sleeping patterns occur in MCI in the form of poor sleep efficiency, fragmented sleep, increased frequency of daytime napping, propensity to fall asleep and wake up earlier, and decreased levels of slow wave sleep. In AD, there are the same alterations in sleeping patterns, but to a higher intensity. One positive aspect of these knowledge combined, is that these are modifiable and manageable risk factors that contribute to hastened cognitive decline. Therefore, by treating these modifiable risk factors, we hypothesise that this may help prevent against the development of dementia and AD. One such intervention that is able to target these risk factors is Computerised Cognitive training (CCT). We hypothesis that by carrying out CCT we will reduce the cognitive deficits associated with MCI and sleep disturbance in individuals with this condition

Aim: To determine if outpatient management (via Hospital in the Home [HITH]) of uncomplicated acute diverticular disease is as safe and effective. Research Design: Patients who present to University Hospital Geelong Emergency Department diagnosed with acute uncomplicated diverticulitis with be randomised into either an intravenous antibiotics group or oral antibiotic group. Both groups will be treated as outpatients with the Hospital in the Home team. Primary Endpoint: Time to resumption of normal activities of daily living. Secondary Endpoints: Pain, Diet, Bowel habit, Patient satisfaction, Biochemical markers, Cost comparison.

Many babies born with a congenital heart condition resulting in only one working heart pumping chamber instead of two undergo a heart operation known as the Fontan procedure. This heart operation enables their heart to function normally however can leave them susceptible to many complications as time goes on, one in particular being kidney damage. There is evidence to suggest (from The ANZ Fontan Registry) that approximately one third of Fontan patients have some degree of kidney damage in the current Australian and New Zealand population. ACEI medications are a class of drugs that have been shown to be effective in improving kidney function and preventing progression of kidney damage, however their effect in Fontan patients is uncertain. This study will evaluate the efficacy of the drug lisinopril, an angiotensin receptor inhibitor (ACEI), on established kidney damage in patients with a Fontan circulation. The main aim of this project is to find out whether initiation of lisinopril is superior to placebo in reducing the degree of kidney damage and preserving kidney function in children and adults with a Fontan circulation. We hypothesise that: 1. Lisinopril initiation will significantly reduce the degree of kidney damage and preserve kidney function after a treatment duration of 6 months. If the hypothesis holds true than it will provide evidence to support the use of ACEI in a subset of Fontan patients with established kidney damage. This would represent a unique group of patients with a clear, testable indication for ACEI therapy after the Fontan procedure. Future implications of this trial would include establishing a model of care for these patients both in terms of screening and treatment of kidney damage and disease hence reducing the burden of this disease for this population group.