ANZCTR search results

The present study aims to measure the effectiveness of a group, manual-based therapy (Metacognitive Interpersonal Therapy in group, MIT-G) at improving interpersonal functioning and psychological symptoms in patients with personality disorders (PDs). It is also intended to examine whether this approach yields gains in one core mechanism of change, which is metacognition and if these gains in metacognitive abilities are correlated with improvements in interpersonal functioning and psychological symptoms. Methods/Design: MIT-G will be evaluated in an international and multicentre randomized controlled trial. Several therapists in mental health institutions of Spain, Norway, Australia, Italy and United Kingdom will participate in this trial. Patients will be randomly assigned to either MIT-G plus treatment as usual (TAU) or a waiting list control group plus TAU. Discussion: If MIT-G proven effective, it can be a useful addition to the care for PDs patients. The design brings along some methodological difficulties, these issues are addressed in the discussion of this paper.

The research project is testing a new way of managing Parkinson’s Disease. The new way of managing this involves the use of the Parkinson’s Kinetigraph (PKG) system, which includes a small, smart-watch like device that measures movements, worn on the wrist for 7 days. In diseases such as diabetes or heart disease, “targets” exist (e.g. blood sugar levels, cholesterol levels) in order to obtain optimal health. We believe that by “measuring” Parkinson’s Disease using the PKG, we can develop targets around the movement problems in PD. These targets help us define whether a person with PD has controlled or uncontrolled movements. Previous research studies demonstrate that the PKG can identify uncontrolled symptoms and lead to changes which improve quality of life. The aim of this project is to demonstrate that by utilising these targets, we can identify people with uncontrolled PD and treat them accordingly. If we can improve movement difficulties, we can hopefully improve quality of life.

The clinical trial aims to learn about the short-term effect on the eye surface of a caffeine-based eye-drop in a number of concentrations. Caffeine eye-drops have been used in humans to study their effect on reducing the development of eye-conditions such as cataract and glaucoma. Caffeine may also be useful in potentially slowing the increase in short-sightedness as it has been shown to slow the increase in short-sightedness in a primate model of myopia. Participants will be randomly assigned an eye-drop and will instil one drop in each eye two times per day, Once in the morning and once before bed for a minimum of 5 days (maximum 7 days). Four types of eye drops will be trialled over the course of the study with two days in-between eye-drops where there will be no use of eye-drops.

The purpose of this study is to establish the safety and tolerability of orally administered FP-045 in healthy subjects following multiple-dose escalation. This Phase 1 study will support dose selection for future studies in patients with Peripheral arterial disease.

The purpose of this research is to assess the acceptability and feasibility of a nurse-led distance-delivered intervention for childhood cancer survivors who have become disengaged with their cancer follow-up. Who is it for? You may be eligible for this study if you are a childhood cancer survivor over the age of 16 or are parents of a childhood cancer survivor currently under the age of 18. Study details: Each participant will be provided with two nurse-led consultations aiming to facilitate access to care for survivors of childhood cancer who have not been followed up in the last 2 years. These consultations will be offered to the participant via WebEx – similar to Skype - or on the phone (as chosen by the participant). After the first consultation with the nurse, the participant’s medical case will be reviewed by a multi-disciplinary team to determine the appropriate route of care. All participants will be invited to complete a questionnaire prior to the intervention and questionnaires at two intervals subsequent to the delivery of the intervention: 1 and 6 months. This study will help to determine the acceptability of the consultations to participants, and we hope will also offer survivors whom currently have no access to healthcare, a new and low-burden way to improve their health.

Despite adequate treatment with two or more antiepileptic drugs, about one third of patients diagnosed as having epilepsy are not seizure-free. It is imperative to promptly diagnose and manage these patients, as recurrent seizures are correlated with important clinical, cognitive and socioeconomic consequences. The current project aims to recruit patients with temporal lobe epilepsy and idiopathic generalised epilepsy, and to study the connectivity measures of a resting-state brain network called the Default Mode Network (DMN) in these patients via functional Magnetic Resonance Imaging (fMRI). In addition, the concentration of various metabolites in one the key nodes of this network will be measured via Magnetic Resonance Spectroscopy (MRS). The results of these scans will be compared to data already collected from healthy controls to create a predictive model that will facilitate the diagnosis of patients with different types of epilepsy, and to distinguish between drug-resistant and drug-responsive cases, via a brief MRI scan.

"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).