ANZCTR search results

A behavioural intervention targeting reducing sedentary behaviour and increasing physical activity will be rolled out across Victorian primary schools. This is a scale up of a previously registered successful trial: Transform-Us! an intervention promoting children’s health (ACTRN12609000715279). To determine real world effectiveness and maintenance (at the individual level), a quasi-experimental pre post non-equivalent group design with follow up will be used. A sub-sample of 20 schools from different socioeconomic urban and rural areas of Victoria will be selected and 20 schools of similar size and area-level disadvantage in NSW not implementing similar health or physical activity-related programs will be recruited as matched controls. Our findings will determine the effectiveness of implementing an efficacious program at scale so that it can be rolled out nationally and become part of routine best practice.

AIMS: The aim of the vanguard Co-POC trial is to assess the safety and feasibility of the trial protocol and to obtain important preliminary data on the effect that colchicine 0.5mg once daily for up to 3 days pre-operatively and 30 days post-operatively has on the incidence and extent of post-operative myocardial injury after coronary artery bypass graft (CABG) surgery. DESIGN AND METHODS: The Co-POC vanguard trial is a RCT of colchicine v placebo nested in the Australian VISION Cardiac Surgery cohort. Eligible patients recruited into the VISION Cardiac Surgery study who are undergoing isolated coronary artery bypass graft surgery will be offered the opportunity to participate in the vanguard Co-POC trial. We will recruit 204 patients into this pilot trial (1:1 recruitment). Patients will be randomised to colchicine 0.5mg once daily or matching placebo. Treatment will be commenced 3 days prior to surgery (but can be commenced up to 24 hours pre-operatively if necessary) and will be continued for 1 month after surgery. Medications will be provided by Aspen Pharmacare Australia according to the US Food and Drug Administration current good manufacturing practice regulations. All concomitant medications will be provided at the discretion of treating clinicians and in keeping with clinical guidelines. Patients will have blood samples collected for hs-cTnI <4 hours pre-operatively and post-operatively at 6-12 hours and on days 1 to 3 (in keeping with the VISION Cardiac Surgery protocol). Analysis plan: All analyses will be by intention to treat. Groups will be compared using the Mann-Whitney U and chi-square tests as appropriate. Kaplan Meier curves will be used to demonstrate event free survival and groups compared using the log-rank test.

The primary purpose of this trial is to assess whether the addition of datatumumab to a velcade, cyclophosphamide and dexamethasone treatment regime will cause an improvement in disease progression free survival. Who is it for? You may be eligible to participate in this trial if you are aged 18 years or over, have been newly diagnosed with multiple myeloma and are not a candidate for high dose chemotherapy and autologous stem cell transplant. Study details Eligible participants will be assigned to either a velcade, cyclophosphamide and dexamethasone (VCD) or velcade, cyclophosphamide, dexamethasone and daratumumab (VCDD) treatment arm. Both arms will receive 9 35 day cycles of treatment with the VCDD arm continuing on daratumumab maintenance monthly until disease progression, unacceptable toxicity, or withdrawal of consent. Paricipants will be required to have blood samples taken at the beginning of each cycle along with a medical exam in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma. It is hoped that the findings of this trial will establish the benefits of daratumumab in combination with VCD for the treatment of multiple myeloma patients early in the course of their disease.

The aim of this study is to assess whether in patients who have surgery of the first ray, a flat rigid soled shoe, when compared to a reverse camber offloading shoe is associated with the level of post operative pain, satisfaction and bony healing. (union and maintenance of correction.)

Obstructive sleep apnoea (OSA) is a sleep disorder where patients stop breathing or have extremely shallow breathing during sleep. Excess weight increases the risk of OSA. However, the majority of patients with OSA that present for weight loss surgery are unaware that they have OSA. The first aim of this study is to see how common it is for patients to present for weight loss surgery with undiagnosed OSA. Before their operation, patients will answer a questionnaire (STOP-BANG) and will undergo a home sleep test (ApneaLink). Continuous positive airway pressure (CPAP) is the preferred everyday treatment for OSA. However, it is unknown whether the application of CPAP prevents complications, following weight loss surgery. The other aims of this study are to see if auto-titrated CPAP (APAP), following weight loss surgery: 1. Decreases the number of times a patient stops breathing or has extremely shallow breathing during sleep; 2. Improves oxygen levels in the blood; and 3. Prevents complications. Following their operation, patients with moderate or severe OSA (diagnosed from their ApneaLink home sleep testing) will be randomised to either: 1. Control group a. Overnight ApneaLink monitoring b. Oxygen and OSA monitoring c. Additional oxygen if required 2. APAP group a. Overnight APAP b. Oxygen and OSA monitoring c. Additional oxygen if required The number of times per hour that a patient stops breathing or has extremely shallow breathing during sleep (i.e. AHI) will be compared between the control and APAP groups. The two groups will also be compared regarding their blood oxygen levels (SpO2), additional oxygen requirement and complications, such as unplanned admissions to critical care.

Background: Community dwelling older persons with complex care needs may deteriorate rapidly and require hospitalisation if they receive inadequate support for their conditions in the community. This trial aims to assess the acceptability, impact and cost-effectiveness of a comprehensive, multidimensional geriatric assessment with care coordination (the OPEN ARCH intervention) in a community setting. Methods/Design: This multicentre randomised controlled trial uses a stepped wedge cluster design with repeated cross sectional samples. General Practitioners (GPs; n=12) will be randomised as ‘clusters’ at baseline using simple randomisation. Each GP cluster will then recruit 10-12 participants. Data will be collected on each participant at three-month interval (-3, 0, 3, 6 and 9 months). The primary clinical outcomes are Emergency Department (ED) presentations, acute hospital admissions, in-patient bed days, health service (including allied health) and community support service utilization. Secondary outcomes include functional status, Quality of Life (QoL) and participants’ satisfaction. Cost effectiveness of the intervention will be assessed as a change to cost outcomes, including the cost of implementing the intervention and subsequent use of health services; and, the change to health benefits, represented by quality adjusted life years (QALYs). Discussion: The results will have direct implications for the design and wider implementation of this new model of care for community dwelling older persons with complex care needs. Additionally, it will contribute to the evidence base on acceptability, efficacy, and cost-effectiveness of the intervention for this high-risk group of older people.

This study aims to investigate whether an underlying subacute infection at the pars defect is a possible cause of pain in patients requiring lumbar spinal fusion surgery. The study will perform microbiological analysis of the bone, ligamentous, muscle and disc tissue at/adjacent to the pars defect, taken from normally discarded material intraoperatively. The presence of infection will be determined by positive bacterial culture from these sites and results analysed for statistical significance. Detection of bacteria would support an infectious rationale, as a source of back pain, in this population. This research endeavors to clarify the source of back pain in isthmic spondylolithesis patients the search for suitable, reliable and reproducible conservative treatments.

VicPrEP is a demonstration project investigating the adherence, behavioural change, acceptability, safety, and feasibility of the use of HIV PrEP in the Victorian community. The nature of a demonstration study is to study patients who can feasibly be recruited. Based on Australian research undertaken by members of our study team regarding the likelihood of PrEP use in HIV negative gay or bisexual men and the likely uptake of healthy, fertile HIV serodiscordant couples we have estimated that approximately 100 patients willing to accept PrEP could feasibly be recruited into the study over a two year period. This number of patients may reasonably allow us to undertake regression analyses to determine whether a number of baseline covariables are associated with PrEP adherence, behavioural change and acceptability. However the study sample size was necessarily chosen based on feasibility of recruitment and not based upon power calculations.

AIM The aim of this study is to investigate the ability of the Australian Modified Lawton’s IADL scale to differentiate cognitive impairment by determining ‘cut-off’ scores between Normal Cognition (NC), Mild Cognitive Impairment (MCI), and Dementia (D). HYPOTHESIS The Australian Modified Lawton’s IADL scale scores will have significant association with the diagnoses of MCI and D, hence contribute to the assessment and diagnosis of older persons presenting with cognitive decline according to standard diagnostic criteria. STUDY DESIGN This is a prospective single-blind single-centre study of patients newly referred to the Memory Clinic. METHOD The study cohort consists of older persons with no significant physical disability referred for assessment of subjective or objective cognitive decline to the Memory Service. The participants will undergo an occupational therapy (OT) clinic assessment which includes scoring the Australian Modified Lawton’s IADL scale and Timed Up and Go (TUG)assessment. The assessment will consist of a comprehensive interview of usual daily living activities and performance of several ADL based tasks. The carer is invited to be part of the interview. They will be provided with an information sheet on the research project. The occupational therapist is blinded to the diagnosis because the assessment occurs prior to any diagnosis by medical clinicians. The OT assessment is followed by medical assessment including cognitive assessment in the outpatient Memory Clinic. This will include completion of a Mini Mental State Examination (MMSE), according to the standard procedure. The final cognitive diagnosis is determined by the Geriatrician, according to DSM V criteria. The Australian Modified Lawton’s IADL scale scores are then analysed to determine the range of scores on the scale stratified by the three diagnostic groups of NC, MCI and D and to determine the between-group cut off points.

A significant barrier to donation and donor retention is fear of needle pain, pain actually experienced during phlebotomy, and associated anxiety. It is clear from previous research that anticipatory anxiety and/or fear of needle pain does not dissuade all prospective donors, however these inter-related barriers have negative consequences for donor retention. Donors reporting higher levels of anxiety and fear of needle pain are more likely to experience a vasovagal reaction, including full faint and/or presyncopal symptoms such as faintness, dizziness, and light-headedness. A recent study by France et al (2012) found that fear of injections and blood draws had the strongest relationship to post-donation Blood Donor Reaction Inventory (BDRI) scores, a self-rated measure of presyncopal reactions to blood donation. A particularly strong relationship between fear related to blood donation and adverse events was noted for female, first time donors. The findings of this study are consistent with other research showing that pre- donation fear, as measured by a single question about fear of needles, was positively related to post- donation BDRI scores and inversely related to ratings of likelihood of future donation, as well as actual rates of return in the subsequent year. We propose that a pain numbing device called “CoolSense(R)" could be effectively used by the Blood Service to reduce pain and anxiety, and enhance donor satisfaction and retention. CoolSense(R) is a hand-held non- invasive skin numbing applicator that is used to anaesthetise the skin before a painful procedure, without the use of chemicals. With an operating temperature of minus two to minus six degrees Celsius, CoolSense(R) is more effective than ice in numbing pain. In order to use CoolSense(R) in phlebotomy, the applicator must be applied to the skin after disinfection as the site would not remain desensitized for a sufficient period if applied prior to disinfection. Given that this post-disinfection application contravenes current Blood Service protocols, the objective of the bacterial load study is to assess whether the phlebotomy site remains free from microbiological contaminates after application of CoolSense(R)