ANZCTR search results

The objective of the Pharmacy Diabetes Screening trial funded under the Sixth Community Pharmacy Agreement (6CPA) Pharmacy Trial Program (PTP), and developed in partnership with the University of Sydney and Deakin University is to assess the comparative effectiveness and cost-effectiveness of alternative pharmacy-delivered models of opportunistic assessment for diabetes in an asymptomatic, previously undiagnosed population. The three groups to be compared include: Group A: screening based on Australian Diabetes Risk Assessment Tool (AUSDRISK) alone with referral to a GP if AUSDRISK greater than or equal to 12 Group B: AUSDRISK assessment tool + HbA1c point-of-care (POC) test in patients with AUSDRISK greater than or equal to 12 followed by the referral to a GP if HbA1c greater than or equal to 5.7% (39 mmol/mol is detected Group C: AUSDRISK assessment tool + small capillary blood glucose test (scBGT) in patients with AUSDRISK greater than or equal to 12 followed by the referral to a GP if fasting blood glucose (FBG) greater than or equal to 5.5mmol/L or random blood glucose (RBG)greater than or equal to 7.0mmol/L is detected. The primary outcome is the difference in proportions of newly diagnosed T2DM cases between the two interventions and the comparator arm to be identified by the subsequent GP assessment and blood tests results. The secondary outcomes to be assessed include: a) proportion of new diagnosed cases of pre-diabetes; b) proportion who take up the referral to the GP; and c) proportion of people referred to the GP. It is anticipated that this project will take approximately 20 months during which there will be approximately seven months of service provision. The primary economic objective of the study is to assess the technical efficiency of alternative models of pharmacy-delivered screening for T2DM. The broader objective of determining the value-for-money of pharmacy-delivered screening versus current practice (which does not involve pharmacy-delivered screening/referral), as would, for example, be required in a submission to MSAC requesting subsidy of pharmacy-delivered screening, is not addressed by the trial protocol. There is nonetheless an important value-for-money element to this trial. In the context of opportunistic screening to improve detection of T2DM, the population that visits GPs is different to the population that visits community pharmacies in one important aspect – people can just walk into pharmacies without an appointment, whereas this would be unusual for GPs. This difference in target populations potentially adds an allocative efficiency aspect to the ‘how to screen’ question.

The aim of this study is to examine the feasibility of two variations of a pragmatic behavioural intervention titled “Say No” to reduce the number of indulgent foods or beverages and improve control of eating. The study design is a three arm feasibility randomised controlled trial with participants allocated to a comparator group, the “say no” intervention group or the “say no” intervention plus feedback group. Participants will have measures taken at baseline and eight weeks later. A total of 45 participants (15 in each group) will be asked to record the number of self defined indulgences for seven days at the beginning of the study and for seven days sat the end of the study. Participants will be asked to record the time of the indulgence and a description of the indulgence. The participant’s weight will be measured at baseline and eight weeks and height will be measured at baseline. Other measures that will take place at baseline and eight weeks include completion of the "Control of eating questionnaire"; "Self regulation questionnaire" and "factor of eating questionnaire". We will also ask participants to report any medications they are taking and ask if they have been diagnosed with any comorbidities. This is to enable us to describe the population and to identify whether the inclusion/ exclusion criteria is appropriate. Interventions Group one will be instructed to make ratings of their hunger motivation, mood, control of eating and food cravings in an electronic record every four days. A link to the online record will be by sent by email or text message. Group two will also make ratings of their hunger motivation, mood, control of eating and food cravings in the exact same way as group one. In addition they will be instructed to self-monitor the number of times they have “said no” and what they have “said no” to (self defined indulgences) recording it each day in a booklet. Participants will also be given methods and tips of how to implement the “say no” intervention at baseline. Group 3 will receive the same intervention as group two but will also be asked to send a photograph or detailed description of what they have “said no” to via text message (self-monitoring of behaviour). Participants will then receive feedback about how many kilojoules they have saved by “saying no”. The text messages will be tailored to the individual as this is associated with greater behaviour change than generic messages. As this is a feasibility trial results will be analysed descriptively.

Functional nuclear medicine imaging techniques such as PET/MRI imaging are commonly used in fields such as oncology to look at the bioactivity and biodistribution of disease. These techniques have previously been applied to infectious diseases, although data is limited. We propose a pilot study to investigate the use of 18F FDG PET/MRI imaging in malaria infection. Participants taking part in malaria challenge studies will be invited to undergo whole body PET/MRI imaging before and after malaria inoculation.

Peripheral Arterial Disease (PAD) is characterised by blockages in the large arteries of the lower limbs. Chronic reductions in leg blood flow leads to microvascular impairment, including a reduction in muscle capillary density. These macro and microvascular impairments are independently associated with a severe reduction in functional (walking) ability. Patients are limited during daily activities by leg muscle pain and discomfort (claudication), and many develop signs of severe critical ischaemia, including rest-pain, tissue ulceration and gangrene. Lower limb revascularization procedures improve claudication symptoms by improving limb blood flow, but do not address the microvascular impairment, and do not fully restore functional capacity. However, when revascularisation procedures are combined with exercise therapy, greater gains are made in functional capacity without further change in large-artery blood flow. Based on evidence that supervised exercise therapy induces skeletal muscle capillary growth, and gains in functional capacity are related to increased muscle capillarisation, we hypothesise that the combination of revascularization plus post-operative supervised exercise therapy will lead to further improvements in outcomes (e.g. exercise tolerance and skeletal muscle microcirculation) compared to revascularisation alone. Therefore, this study aims to compare the efficacy of lower limb revascularisation plus supervised exercise therapy, with revascularisation alone, for improvement of walking capacity and skeletal muscle blood flow in PAD patients. This study will be conducted at the University of Sunshine Coast and the Department of Cardiology at Nambour General Hospital. Patients with PAD and symptoms of intermittent claudication, who are scheduled to undergo lower limb revascularisation, will be randomly assigned to one of two interventions at study entry: (1) standard post-operative care and monitoring (standard care) or (2) standard post-operative care plus an 8-week supervised exercise therapy program. Primary outcome measures will include walking capacity (6 minute walking distance) and calf muscle microvascular blood flow (using contrast-enhanced ultrasound [CEU]). Secondary outcomes will include i) leg muscle function (plantar-flexion strength and fatigue), ii) ankle brachial index, iii) arterial stiffness (augumentation index and carotid-femoral pulse wave velocity), iv) brachial and femoral artery function (flow mediated dilation) and v) leg blood flow (using venous occlusion plethysmography [VOP]). All parameters will be assessed in the limb undergoing revascularisation. Outcome measurements will be performed at baseline prior to revascularisation, then repeated following full recovery from revascularisation (2-6 weeks post-procedure), and then again at the completion of the 8 week post-operative intervention.

Proposed Research Design: We intend to pilot the app to establish its usability and possible effectiveness using an experimental design where 28 young adults are randomly assigned to one of two conditions. 1. Control: these participants use a restricted version of the app to self-monitor their drinking behaviour and related variables (e.g., mood, behaviour of others, etc.). 2. Intervention: in addition to self monitoring, these participants will receive harm minimisation strategies tailored to their goals and behaviours The intervention is delivered through participants’ mobile-phone devices. Kypri and colleagues (2003) found young adults as more receptive to engage with mobile phone interventions in comparison to web-based or one-on-one counselling sessions, as such, this design should minimise attrition rates.

Intense congestion, including shared accommodation and compromised hygiene, during mass events such as Hajj pilgrimage amplify the risk of invasive meningococcal disease. Intercontinental spread of serogroup A meningococcal disease in 1987 and serogroup W135 disease in 2000 and 2001 affected thousands of Hajj pilgrims globally. Quadrivalent meningococcal polysaccharide (serogroups A, C, W135 and Y) vaccine was able to bring these epidemics under control, but the vaccine is not effective at reducing pharyngeal carriage of meningococci. A conjugate vaccine can reduce long term meningococcal carriage; for example, the quadrivalent conjugate vaccine has been shown to reduce carriage over 12 months from vaccination in adults aged 18-24 years old. However, the impact of conjugate meningococcal vaccines on meningococcal carriage status among Hajj pilgrims, most of whom are older than 24 years, is not known. We, therefore, believe that a well-powered carriage study in Hajj pilgrims is an urgent need. During the Hajj 2017, we plan to conduct a single-blinded, randomised, controlled trial of quadrivalent meningococcal conjugate vaccine for head-to-head comparison with quadrivalent polysaccharide among pilgrims from Australia, Qatar and Saudi Arabia. Pilgrims from participating countries, planning to attend Hajj in Makkah in 2017 will be randomised to receive either a ‘conjugate vaccine’ or a ‘polysaccharide vaccine’. Following informed consent, pharyngeal swabs will be collected from pilgrims in both arms a few months before their travel to Hajj. The participants will then receive their respective vaccines (observers will remain blind to this selection), a second set of pharyngeal swabs will be collected within sixty days after completion Hajj, preferably within 7 days and a third set of pharyngeal swabs will be collected at 6 to 11 months. Pharyngeal swabs will be processed by standard culture methods to detect meningococcal carriage; isolates will be characterised by serogroup, subtype, serosubtype, and sequence type. The pharyngeal swabs will also be tested for any antimicrobial resistance elements present. Data will be anonymised and analysed for the following end points: a) comparison between the study arms with respect to pharyngeal carriage rates of meningococci after return from Hajj, b) change in pharyngeal carriage rates of meningococci from before to a few months after vaccination, and c) comparison of long term carriage rates at 6 to 11 months after vaccination between study arms, and d) comparison of adverse events related to vaccination between study arms. This research could inform renewed policy on meningococcal vaccination for Hajj pilgrims as well as for attendees of other large events.

The Magnific Study aims to determine if the use of magnetic acupuncture will reduce the stress and pain experienced by infants in newborn intensive care units in response to a very common painful stimulus, heel pricks for blood collection. Babies will be randomised to having 5 magnetic stickers or placebos placed on each ear for 3 days. During this time, the baby's response to a heel prick will be measured using a widely used pain scale, the PIPP score. After three days, the stickers (with and without magnets) will be removed and the PIPP scores will be examined.

The aim of this factorial randomised control trial is evaluate the efficacy of a lunchbox intervention, a physical activity intervention and a combined lunchbox/ physical activity intervention on child physical activity levels and the nutritional content of student lunchboxes.. Twelve primary schools in the Hunter region will be randomly allocated to one of 3 intervention arms or a control group. The final trial endpoint is 9 months.

Quetiapine is a commonly-prescribed drug with a good safety margin that is prescribed in psychotic illnesses, agitation and anxiety. Thyroid function is commonly checked in patients with psychotic disorders and signs of anxiety. We have observed that some patients taking quetiapine have low results on measure of free thyroid hormone level in blood, even though there is no other evidence that their thyroid function is impaired. We suspect this is because the quetiapine is interfering with the laboratory test, but it might actually be a biological effect of the quetiapine and potentially important to quetiapine’s adverse effects on metabolism. In this project, we will first ask 20 patients who are already taking quetiapine to provide us with one specimen of blood each to check thyroid function. In a subsequent part of the study (which has a different registration on the ANZ Clinical Trials Registry), we will also ask a further 20 patients in whom their treating psychiatrist has already made the clinical decision to commence quetiapine as part of their management plan, to provide us with a specimen of blood to check thyroid function on 4 occasions (prior to quetiapine commencement, 1 day following commencement of quetiapine, and at weeks 3 and 6 ). We will firstly check to see whether our impression, that free thyroid hormone tests are reading lower in patients on quetiapine by the current test, is correct. The current test is an immunoassay. Then we will use the same blood specimens to measure free thyroid hormone level by another newer, highly specific test (LCMSMS) that is not open to interference in the way immunoassays may be. A comparison of the results will tell us whether the problem is simply immunoassay interference from quetiapine.

This study aims to investigate if negative practice is more effective in assisting with motor learning of a voice motor skill compared with repetitive drill in the practice phase, among female adults with mildly hyperfunctional vocal patterns. This study will be a randomised controlled trial with three groups including a control group that does not receive any intervention, a repetitive drill group, and a negative practice group. All three groups will have the same number of participants. Negative practice refers to practising the voice task the wrong way, immediately followed by the correct way.