ANZCTR search results

A single site, open-label pilot study to examine the feasibility of a randomised controlled trial of N-Acetylcysteine (NAC) on loss of control eating. All eligible participants will receive NAC orally at a daily dose of 2400 mg for 12 weeks. Outcome assessment will be made at baseline and at 12 week using questionnaires and ecological momentary assessment (EMA)

Text-message based programmes have proven to be an effective public health approach to improve adolescent health behaviours, including tobacco use, and so may have promise as an approach to influence adolescent e-cigarette behaviours. Given this potential, we aim to conduct a randomised controlled trial to examine the potential effect of a text-message program to prevent adolescent e-cigarette use. Over 12 weeks, adolescents will receive text messages designed to address the factors identified that increase the risk of their use (e.g. to modify perceived social norms, or correct misconceptions of risk). Adolescent intentions to use e-cigarettes will be the primary outcome, assessed via a survey.

Clozapine is an antipsychotic drug given to people with psychosis (schizophrenia and schizoaffective disorder) that in addition to reducing psychotic symptoms can also prevent certain cancers and age-related diseases, but can also cause weight changes. How clozapine causes these effects is unknown. Evidence suggests that disruptions in autophagy, a natural process of repair that occurs inside all cells of the body and slows the ageing process, could contribute to the development of those side effects. For this reason, this research project is aiming to see if clozapine changes a person’s autophagy. This study is the first of its kind, and the results of this pilot study could lead to a better understanding of the currently unknown mechanisms of clozapine’s actions to better assist those being treated with clozapine, and also to help inform the clinical applications of clozapine in additional settings.

The ACUMEN For ALL trial will examine the feasibility and safety of telehealth delivery of supervised exercise and outcome assessment in a subset of women treated for gynaecological cancer living in demographically-challenged circumstances that preclude face-to-face delivery and outcome assessment. Assess the preliminary effectiveness of telehealth-delivered intervention to improve quality of life in women and preliminary utility of telehealth-mediated outcome assessment. Understand the factors that indicate implementation potential. Who is it for? If you are an adult woman who has been diagnosed with gynaecological cancer in the last 60 months, and it has been over a month since you finished an intensive cancer treatment (including surgery, radiotherapy, chemotherapy), within more remote areas of Queensland or those who have access to the internet but are limited by transportation and/or location and would otherwise be ineligible for the main ACUMEN trial. Women will be identified for inclusion in this sub-study if they are unable or unwilling to attend face-to-face exercise training and objective outcome assessment. Study details Participants in this study will be randomly allocated to receive a video-delivered exercise intervention or delayed intervention control after 12 weeks. This comprises a video-delivered baseline assessment (including subjective and objective outcomes) with a trained accredited exercise physiologist or physiotherapist to determine their current fitness levels, after this time, all outcomes will be reassessed via video-delivery in the same manner as at 12 weeks, and repeated 12 weeks later (at Week 24). Participants in this first group will then be prescribed a personalised exercise program that they will follow for the next 12 weeks. The exercise program will include both aerobic and resistance training and participants will be asked to complete 3x 60 minute sessions each week for the 12 week period which will include supervised and unsupervised sessions. The second group will receive a delayed commencement of the personalised exercise program 12 weeks later. Participants in both groups will complete a series of questionnaires, and fitness assessments before and after the intervention. After the intervention, questionnaires, and fitness assessments will occur at two time-points (week 12 and week 24). It is hoped this research will determine whether a personalised exercise program can lead to improved long-term health outcomes for women who have been treated for gynaecological cancer.

This research project aims to enhance our understanding of the association between acute pain management in the emergency department (ED) and hospital acquired complications in older adults (aged 65 years and over). Acute pain is the most common primary complaint for patients presenting to the ED. Despite previous efforts made to improve the quality of acute pain management, recent publications continue to show pain under-treatment remains prevalent, especially among elderly patients. We will be introducing the ED-exit pain score supported by staff education to evaluate its impact on our current acute pain treatment regimen and its feasibility in clinical practice. Outcomes including types and total amount of pain modalities used, the incidence of delirium and other hospital acquired complications specific to older patient population will be collected during the pre- and post-intervention periods. The project findings will fill knowledge gaps in the field and present a strategy that can be easily incorporated in EDs across NSW.

Diabetic ketoacidosis is a metabolic emergency of increased acidity of the blood resulting from a lack of insulin and an accumulation of ketones within the bloodstream. In this study, we will review a cohort of Type 2 Diabetes Mellitus (T2DM) patients regularly taking sodium-glucose co-transporter 2 inhibitors (SGLT2i) who prepare for colonoscopy with SGLT2i cessation, bowel preparation, and starvation across a 12-month period. From this cohort, we will measure pre-procedural serum SGLT2i levels in patients both presenting with ketosis, and without ketosis and to compare residual SGLT2i drug level between patients who are acidotic versus those who are not. We hypothesise that severe ketoacidosis will be due to insufficient clearance of SGLT2i prior to the procedure. Importantly, should we demonstrate a link between residual plasma SGLT2i levels and ketosis, it may suggest longer pre-procedural cessation periods are warranted and ultimately, will decrease morbidity and mortality associated with the admission of patients with diabetes, and the inconvenience of day-of-procedure delays or cancellations, and improved utilisation of healthcare resources.

FIBRE-PD is a prospective parallel-arm open-label randomised controlled study which aims to explore recruitment, adherence, efficacy and safety of implementing psyllium husk to patients receiving PD with constipation compared to standard care. Sixty prevalent PD patients will be recruited from the PD unit at the Princess Alexandra Hospital Participants will be randomly assigned in a 1:1 ratio to receive either Psyllium husk or continue Movicol®. Key objectives to be assessed in this feasibility randomised controlled trial include, whether: 1. Eligible PD patients can be recruited to take psyllium husk 2. PD patients will adhere to psyllium husk administered to maintain gut motility 3. PD patients will withdraw from a randomised controlled trial when Psyllium husk is administered to reduce gastrointestinal symptom burden and to help maintain gut motility 4. Psyllium husks help maintain gut motility, reduce gastrointestinal symptom burden and improve quality of life in PD patients Hypotheses include: 1. The FIBRE-PD study will be able to successfully recruit 60 patients within twelve months. 2. PD patients allocated to receive psyllium husk will adhere to treatment during the study (defined as >80% of treatment administered). 3. PD patients will not withdraw (10% or less withdrawal) from the study examining the safety and efficacy of psyllium husk as a gut health intervention strategy in PD. 4. Psyllium husk in PD patients will result in improved quality of life during the 4-week study period. 5. Psyllium husk supplementation in PD patients will maintain gut motility and reduce the burden of gastrointestinal symptom measured using Bristol stool score, frequency and Gastrointestinal Symptom Rating Scale.

Mental illness is unfortunately common after intensive care. A recent large cohort study of 4,943 ICU survivors in the UK found the prevalence of anxiety, depression, and PTSD to be 46%, 40% and 22% respectively, with 18% meeting criteria for all three conditions. At present, while many hospitals operate a post-ICU clinic, there is no agreement in literature as to the best model of care, and to-date the inclusion of a psychiatric assessment has not been evaluated. This study seeks to assess the feasibility and acceptability of including a psychiatric review in addition to standard cares, as well as estimate the effect size this review might have on symptom burden and quality of life to support power calculations for a fully powered RCT if the intervention is deemed both feasible and acceptable.

Unwell children have a high chance of deteriorating if the right care, in the right place, is delayed. If the right care is at another facility, how and when children are transferred is paramount to protecting the child’s safety. Most paediatric inter-facility transfers within Australia are of unwell children who do not qualify for patient transport via specialist paediatric retrieval services but require transfer to access specialised paediatric care not offered at their current healthcare facility. Patient safety reports of these transfers highlighted children experienced harm due to lack of clear procedures and communication break-down. A strategy aimed to improve the safe transfer of unwell children to a facility where specialist paediatric care is available: Standardised Workflow for Inter-Facility Transfer of Kids [SWIFTKids], has been designed and implemented within the Sunshine Coast district. Findings will inform ongoing revision of paediatric inter-facility transfer processes within the local hospital and health service; and, if found to be economically feasible while improving positive patient outcomes it would be recommended the SWIFTKids strategy be considered state-wide. Hypothesis: A standardised workflow for inter-facility transfer of non-critical but moderately unwell children will improve the safety and efficiency of transfer for children and their families. Methods: Evaluation of the SWIFTKids strategy will be conceptually guided by the Donabedian framework. Factors within the domains of Structure, Process and Outcomes will be explored and measured.

This is a prospective, single-encounter, observational online survey of male and female adults who have chronic low back pain. The main objective is to evaluate the different types of pain experienced using a validated pain questionnaire, and also, respondent satisfaction with different types of pain management experienced by participants who have low back pain.