ANZCTR search results

"Sarcopenia" describes the age-related decline in skeletal muscle mass and function which contributes to increased risk of disability and loss of independence. In the presence of obesity, these effects may be exacerbated, and we have demonstrated that the "sarcopenic obese" population have increased risk for falls and fractures. We hypothesise that targeted exercise can significantly improve muscle strength, balance and bone health in sarcopenic obese older adults. We will test this hypothesis by conducting a pilot randomised controlled trial (RCT) of a multi-component exercise intervention in 56 obese older adults with poor physical performance. The findings from this pilot RCT will contribute to the development of guidelines for exercise in obese older adults at increased risk for falls and fractures.

Failure to recognise and appropriately respond to clinical deterioration in patients admitted to mental health units has been highlighted as a significant factor in a number of adverse events within these settings. Reasons for this are multifactorial but likely related to the relative infrequency of acute physiological deterioration in mental health settings, for example, deterioration in cardiovascular and respiratory function, evidenced by changes in blood pressure and respiratory rate. As a consequence, staff lack experience in recognising signs of physiological deterioration and responding effectively. Evidence also suggests staff commonly undertake observations from a distance (for example, shining a torch through a window during the night while undertaking observation rounds) and on the basis of appearances only (as opposed to what has been learned through direct engagement with a patient). This is reflected in medical records and during verbal handover with comments such as ‘patient appears settled’, ‘patient appears to be resting’ and ‘no change observed’. These actions by staff have been implicated in and heighten the failure to detect clinically-deteriorating patients. Further, evidence suggests managing physiological deterioration in mental health settings is often suboptimal due to poor communication between multiple healthcare providers from more than one team, and across different locations. In the proposed study setting, 32% of Medical Emergency Team (MET) calls (due to clinical deterioration of patients) result in the transfer of patients to critical care, with some of these patients dying. In most cases, earlier recognition of deterioration could have prevented these outcomes. The aim of this study is to evaluate the effectiveness of a positive workplace culture program designed to develop effective workplace cultures and nursing leadership within adult inpatient mental health units. This culture change program aims to (i) ensure the delivery of compassionate, safe, patient-centred care through the early recognition of, and response to, clinical deterioration and (ii) build on the work undertaken as part of the Productive Mental Health ward by increasing the amount of time nursing staff spend engaging with patients.

The aim of the study is to better identify the care needs of individuals with end stage kidney disease commencing dialysis. Commencing dialysis impacts individuals beyond their physical health. Participants will be asked to complete a questionnaire and undergo physical function tests over the first 6 months of their dialysis treatment. Quality of life, psychological and physical function, gastro-intestinal health, nutrition and health literacy will be measured. Results of this study will help inform the development of this standard protocol and allow for modifications to be developed to address the needs of patients.

This research project is a pre-post comparative cohort study of a pharmacist led decision support protocol in anaemia management vs. the current physician based treatment system. The cohort will include dialysis dependent stage 5 chronic kidney disease patients within 3 dialysis units of Fraser Coast renal service (FCRS), within Wide Bay Hospital and Health Service South (WBBHS South). The intervention group will be based in Hervey Bay Hospital (HBH), Maryborough Hospital (MBH) and the Fraser Coast home haemodialysis unit. The current patients being treated in the Fraser Coast renal service will act as their own control. Post hoc data will be collected for four previous months of standard physician based treatment. FCRS mostly use Darbepoetin alfa and Iron polymaltose as part of the current anaemia treatment plan. A t-test will be used to statistically compare the clinical parameters in the two arms of treatment. The main outcomes will be the impact of the pharmacist involvement in optimising anaemia management. This will be summarised by looking at the target haemoglobin and iron stores for the patients. Patients are best stabilised with a haemoglobin between 95-115mg/L (9.5-11.5g/DL). Ferritin targets should maintain between 200-500µg/L and transferrin saturation between 20-40%9,10,11,12,17. A t-test will examine the null hypothesis (H0) comparing the 2 treatment arms. Primary outcome will investigate if a pharmacist led decision support protocol in anaemia management will adequately maintain the haemoglobin within the target range. Secondary outcome will measure stability in Ferritin, TSAT%, the appropriate and safe use of iron and erythropoietin stimulating agents (ESA), and the efficiency of medication use. Aim The aim of this study is to evaluate the impact of a pharmacist led decision support protocol in anaemia management in a regional haemodialysis unit, using an anaemia management work unit guideline, under the supervision of the consultant nephrologist. • H0 = The implementation of a pharmacist led decision support protocol in anaemia management service will result in no change in optimising clinical parameters related to iron and Hb compared to the current treatment of a physician based anaemia treatment in dialysis dependent stage 5 kidney disease. • H1 = The implementation of a pharmacist led decision support protocol in anaemia management will show change in optimising clinical parameters related to iron and Hb compared to the current treatment of a physician based anaemia treatment in dialysis dependent stage 5 kidney disease. The primary outcome will investigate whether a pharmacist led decision support protocol in anaemia management will adequately maintain the haemoglobin within the target range. This will be summarised by looking at the target haemoglobin and iron stores for patients on dialysis. Patients are best stabilised with a haemoglobin between 95-115mg/L (9.5-11.5g/DL).

Culturally appropriate healthcare is needed to support safe medication use by Aboriginal and Torres Strait Islander Australians. This feasibility study, partnered by Griffith University, the National Aboriginal Community Controlled Health Organisation, and the Pharmacy Guild, seeks to provide a culturally responsive, individualised, medication review service delivered collaboratively by community pharmacists and Aboriginal and Torres Strait Islander health services (both Aboriginal Community Controlled Health Services [ACCHS] and government Indigenous Health Services [IHS]. Researchers will pilot and evaluate the service to ensure delivery is feasible across diverse locations. A total of 540 adults with long-term conditions, or who are pregnant, or within two years postpartum AND who are at risk of medication-related problems will work with pharmacists and staff from nine ACCHO/IHSs across Queensland, New South Wales and the Northern Territory to resolve medication-related problems. Stakeholder feedback will refine service development, training and outcome measures for a future randomised controlled trial.

Myopia (short sightedness) is a refractive condition where the distance from the front to the back of the eye is too long for the refractive strength of the eye, leading to light being focussed in front of the retina (light sensitive layer on the inside back of the eye) and subsequently causing blurred vision. Myopia typically develops in childhood while the eye is growing and is believed to be accelerated by correcting the myopia with glasses. When myopia first presents the child complains of poor distance vision which is corrected by glasses. Unfortunately, myopia continues to progress requiring the child to return at regular intervals to get ever stronger glasses, until they reach adulthood. Orthokeratology (OK) lenses are specialised contact lenses that are worn during sleep to reshape the front surface of the eye to temporarily correct myopia. Recent research has shown that OK lenses are effective at slowing progression of myopia by 50%. These encouraging results have led contact lens manufacturers to develop OK lens designs with greater effectivity in slowing progression of myopia. While these ‘Myopia Control’ OK lenses are now being supplied to optometry practices and marketed as being more effective in slowing progression of myopia compared to standard OK lens designs, there is no scientific evidence to support that they are any more effective than standard OK designs. The aim of this project is to increase understanding on how myopia control OK lens designs will affect known stimuluses for myopia progression compared to standard OK lens designs. The scientific literature reveals that OK causes peripheral light rays to be focussed further towards the front of the eye than central light rays, which is termed peripheral myopic defocus. Peripheral myopic defocus has been shown to slow progression of myopia in animal models, and this same mechanism is believed to be the reason why OK lenses slow progression of myopia. The manufacturers of myopia control OK lens designs claim that they are more effective at slowing progression of myopia compared to standard OK lens designs because they create a greater amount of peripheral myopic defocus. We are going to investigate the potential for greater slowing of myopia progression with myopia control OK lens designs, by measuring the effect that the different OK designs have on myopic defocus in young adults over 1 week of wear, which is the reported shortest duration of time for the full refractive effect to be achieved. This study is important as optometrists need to know the true effect that OK lenses marketed to slow myopia progression have on refractive mechanisms that have been shown to retard progression of myopia, if they are to be effective in managing myopia in their child patients. Outcomes will also assist the design of future longitudinal studies using standard and myopia control OK lens designs.

This project aims to evaluate the results of a relatively inexpensive, noninvasive Liver MRI using an algorithm called “Proton Density Fat Fraction MRI (PDFF)” which uses “multi-peak spectral modelling and R2*”, and compare them against an alternative, more expensive technology called “Liver Ferriscan®” (Resonance Health, Western Australia), which is accepted as a reference standard for determining liver iron content.

Adequate iron stores are essential for the ability of the body to produce new red blood cells, and the key component of those red blood cells, haemoglobin. A low blood concentration of haemoglobin is referred to as “anaemia”, and is often due to low iron stores, or an inability for the bone marrow to access them. This latter phenomenon is referred to as “iron deficiency”. Iron deficiency and anaemic may exist in a patient separately, or together. A combination of the two is termed “iron deficiency anaemia”, and patients with the condition are said to be “anaemic”. Iron deficiency anaemia has long been associated with worse outcomes for patients undergoing cardiac surgery. Compared to a normal person, the patient with iron deficiency anaemia has a higher risk of requiring a blood transfusion, sustaining a kidney injury, or dying following their operation. There is another group that, up until now, has been poorly studied: those patients who are iron deficient, but not anaemic. Whilst these patients may have a normal haemoglobin concentration in their blood prior to surgery, inevitable blood loss during surgery and the inflammation during and afterwards causes the haemoglobin concentration to fall. If the patient has inadequate stores of iron, or is unable to access those stores, these patients will be unable to increase their production of haemoglobin. Hypothetically, these patients are at risk of many of the complications that patients with anaemia prior to their operation will face. However, because this research question is yet to be formally studied, it is not known whether or not this is correct. Proposed trial and investigators The IDOCS study has been designed to test this theory. Patients with iron deficiency, but who are not anaemic before their operation will be followed during and after their surgery and compared to a cohort of normal patients (who are iron replete and not anaemic) as a reference point. If the trial hypothesis is correct, patients who are iron deficient but not anaemic will have worse outcomes than those patients who are not anaemic and iron replete. IDOCS will be undertaken at two major tertiary hospitals in Melbourne: The Alfred and the Austin Hospital. Significance If the hypothesis of IDOCS is proven, it will identify a new group of patients who are at risk of poor outcomes following cardiac surgery, opens an exciting new frontier in preparing patients for these procedures, and improving survival and reducing complications from the operation.

Orthokeratology (OK) lenses are rigid contact lenses that are designed to be worn during sleep. Their purpose is to reshape the front surface of the eye (cornea) in order to temporarily correct short-sightedness, also known as myopia. Although their primary aim is to correct myopia and provide clear unaided vision during the day, studies have shown that they also have an effect on slowing or stopping the progression of short-sightedness in children, termed myopia control. Currently, research is underway to understand centration of OK lenses and the optical effects as a result of centration which may promote myopia control. Hence this prospective study aims to understand the effects of peripheral corneal shape on lens decentration by determining treatment zone decentration resulted through lens decentration during OK lens wear. Outcomes of this study would help in designing OK lenses that help in achieving myopia control in a more desired manner.

What is this study about? The purpose of this study is to investigate if ZYN002 applied by massaging it into the upper thighs provides the same amount of drug as when it is applied by massaging it into the arms/shoulders after repeat doses (applied twice daily for 13 days and on the morning of Day 14). Two concentrations of ZYN002 will be tested; one concentration containing 4.2% cannabadiol (CBD) and one containing 7.5% CBD. The study will look at blood levels of the drug in the body after it is administered in these three body locations in different people. How safe and well tolerated ZYN002 is will also be investigated. Who is it for? You may be eligible to join this study if you are aged between 18 and 70 years and are in general good health. Study details: This study will enrol a maximum of 40 participants across 4 treatment groups with 10 participants in each group, and will investigate the amount of ZYN002 detected in blood samples after administration of the treatment. In each group, 8 participants will receive the active drug (ZYN002) and 2 will receive the placebo. A placebo is a gel that looks like ZYN002 but does not contain any active ingredients. You will not have a choice as to whether you receive ZYN002 or the placebo (you will be assigned randomly, like flipping a coin). Neither you nor the study staff will know if you are assigned to receive ZYN002 or the placebo as the allocation will be masked, although in an emergency, the study staff can find out. What does study participation involve? Participation in the study includes a screening visit during the 28 days before the first study treatment. Throughout the study participants will have various medical tests (physical examinations, vital signs measured, ECG measured, C-SSRS assessment and will have several blood and urine samples collected for laboratory analysis. Participants will report to the study centre on the day prior to the first day of treatment (Day 1) and will be required to remain in the study centre overnight for 15 nights, until Day 15. The study treatment will be applied twice daily for 13 days with one treatment on Day 14. Days 1-13, while at the study centre, you will apply your AM and PM treatment of ZYN002 or placebo gel. You will apply the study treatment to the treatment site assigned to you (either your upper arms/shoulders and/or your upper thighs). You will apply your dose of the study drug to clean, dry, intact skin, thoroughly massaging it into the application sites assigned. You will continue to massage study drug into the application site until the application site feels dry to the touch. This will take approximately 2-4 minutes. On Day 14 there will be only an AM dose. You will be discharged on Day 15 and return to the study centre on Day 20 for a follow-up assessment visit.