ANZCTR search results

Our research team has recently been awarded an Australian Mental Health Award by Beyondblue and the Movember Foundation that will fund a program of research aimed at developing and evaluating a range of new e-health interventions for male dominated industries. Necessary preliminary steps include the pilot-testing of these interventions to ensure the programs are acceptable and feasible. This application is intended to cover the conducting of a pilot testing of the interventions. The working title for this new smartphone application is ‘Headgear.’ This project aims to develop an App which will enable workers in male-dominated industries to identify and problem solve aspects of mental health, triggers and lifestyle related factors, and develop personalised goals and strategies. Objectives include: (1) Developing and testing a high quality wellbeing phone App for working men and women; and (2) Conducting a mixed-methods study of the acceptability of the App. With the pilot testing and feedback, we aim to design and prototype an app that is engaging for workers in the target industries. It is hoped that by engaging users throughout the development process, we will be able to produce a range of e-health products that these individuals will be able to engage with. Data Collection: Eligible participants will be directed to the program’s website in order to provide consent via the online participant information statement. From here they will complete a battery of assessment measures including: 1. Demographic information (age, gender, education, occupational status, and industry group; email, phone number) 2. Mood and anxiety symptoms (K6 questionnaire) 2. Wellbeing (WHO 5 Well-being Index) 3. Psychological strength and resilience (Connors-Davidson Resilience Scale (CD-RISC 10)) 4. Stress (Perceived Stress Scale (PSS-10)) Participants will then be invited to download the app via the Testflight application and are encouraged to use the app for 30 days. At which point participants will be contacted via phone and email by research assistants to complete the follow-up survey comprised of the same measures in the initial battery with the addition of the acceptability/usability questionnaire (comprised of adapted items from the System Usability Scale, Post Study System Usability Questionnaire, Technology Assessment Model Measurement Scales, and Usefulness, Satisfaction, and Ease questionnaire. Usage data will be automatically collected by the app including time spent in app, number of logins, and specific responses to exercises. This data will be used to examine program engagement and usage.

Mindfulness is an important emotion regulation strategy that has shown promise as a prevention program for anxiety and depressive symptoms. Acceptance and commitment therapy (ACT), a mindfulness-based therapy, has yet to be evaluated in this capacity. This study examines the feasibility of using an ACT-based prevention program in a sample of Year 10 (aged 14 to 16 years) high school students from Sydney, Australia. Participants were allocated to either their usual classes or to the ACT-based mindfulness condition. Participants were followed for a period of 5 months post-intervention and completed the Flourishing Scale, Depression Anxiety Stress Scale, and a program evaluation questionnaire.

This study aims to examine the feasibility, safety, and patient satisfaction of a high speed resistance training program with and without balance exercises in people with knee osteoarthritis compared to a control group. Given the pain associated with knee osteoarthritis, it is crucial to determine what effect high speed resistance training that focuses on muscle power has on knee pain. The effect of the exercise interventions on strength, physiological and functional risk factors for falls, pain, and executive function will also be assessed.

This was a pilot randomised controlled trial that examined the feasibility of a three months ‘internet-based intervention’ as a possible tool to enhance recovery and to examine how the intervention be perceived and if potential benefits can be identified. The potential effect of the internet-based intervention on knee pain, function, self efficacy and fear of pain were also assessed. The study would provide preliminary results, which could then help to determine whether such intervention is appropriate for further testing on a larger scale

It is known that modern Australian society is trending towards an ageing population combined with a poor intake of foods rich in dietary fibre such as wholegrains, fruits and vegetables. Therefore, as diverticulitis is highly prevalent in older adults, it is predicted to become even more prevalent in the future. In addition, it is also suggested that the disease is now occurring more commonly in younger ages. Furthermore, the evidence that is in existence to support current dietary managements is inconsistent, of poor quality and lacking in Australia. Therefore, observational research is warranted to explore the impact of current clinical practice in Australia upon patient and healthcare related outcomes. In adults admitted to an acute-care hospital with acute, uncomplicated diverticulitis in South-East Queensland, Australia, it is hypothesised that: 1). Participants who are prescribed and adhere to liberalised diets during hospital admission have less healthcare use and no difference in gastrointestinal symptom scores compared to those prescribed restricted (fluid only) diets. 2). Participants who follow a high fibre diet following discharge have lower healthcare use and gastrointestinal symptom scores than those following a standard diet. A Low or Negligible Risk (LNR) research application for ethical approval has been submitted as this study intends to be of low risk to research participants as the likelihood and severity of any risks to the patient is low. Possible risks include using vulnerable, sick patients as the study population as well as fatigue, inconvenience or discomfort of talking about personal issues. To minimise risks, high risk patients will be excluded from the study, patient involvement will be as minimal as possible by accessing medical records and eligible participants will be asked to provide informed consent. Data will also be gathered and kept in a de-identifiable format where possible with identifiable data stored in password protected electronic files or a locked filing cabinet. Researchers will be the only ones to have access to this information. The intended outcomes of this study include a greater understanding of acute uncomplicated diverticulitis. Future research that can stem from findings of this study, may then help to formulate best practice guidelines for the dietary management of acute, uncomplicated diverticulitis as such is currently non-existent. This would help to achieve cohesion across treating doctors and dietitians. It is believed that theses outcomes and associated potential benefits that this study can provide will far outweigh the possible minimal risks.

Background: Despite the high burden of mortality of sepsis, there are no clearly effective strategies to suppress the underlying inflammatory response. Studies have suggested that low-dose aspirin - a cost-effective and safe medication - has a potential role in the prevention and treatment of sepsis. This trial aims to measure the effects of low-dose aspirin on target inflammatory markers; activation of NF-KB, increases in aspirin triggered lipoxins (ATLs) pathway, platelet activation indices, immune cellular markers and the rate of organ dysfunction in septic patients. Method: The MATHS trial is a single-centre, randomised, open label, phase II trial. One hundred and thirty-five septic patients (Sepsis-3 definition) will be randomised to one of three treatment groups: aspirin 100mg, aspirin 300mg both given daily for two days or no treatment. Blood samples will be taken at regular set intervals and assays will be performed to quantify the inflammatory response via NF-KB activation, expression of aspirin triggered lipoxins (ATLs) and various other inflammatory markers. Initial SOFA and APACHE II scores will be calculated, with repeat SOFA scores at 24 and 48 hours. Exploratory analyses, such as the correlation between ATL levels at 24 hours, and deterioration in SOFA scores/mortality/length of stay in ICU, will involve exact tests for comparisons of categorical outcomes (SOFA), log ranked tests for non-parametric data (APACHE II) and ordinal logistic regression for multivariable analysis. Conclusions: The results of this this trial could add further evidence to support the use of low-dose aspirin in sepsis.

An exercise rehabilitation program based in the hospital or home is commonly used to manage patients with congestive heart failure to improve their quality of life. However, the proportion of patients who follow these programs is low. In this project the researchers will assess the use of regular motivational text messaging in keeping you motivated towards your exercise program. This will be looked at using questionnaires about your health and quality of life, and by measuring your walking distance in a 6 minute walking test. The use of physical activity trackers, Fitbits, will also be used to assess your ability as a way of monitoring your health (heart rate and level of exercise) remotely. We will also be measuring your waist circumference and level of key biomarkers in your blood samples at the beginning and end of the study to help monitor your progress, At the end of this study, we hope to have improved our understanding of using these new technologies as a means of improving a patient’s motivation for their rehabilitation programs.

This Phase 1 study entails administration of GS-5801 to subjects with chronic hepatitis B (CHB) for the first time with the objective of evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GS 5801, and thereby determining the clinical pharmacology profile and antiviral activity of GS 5801 to evaluate if it is suitable for further clinical development as a treatment for CHB. The results from this study will form the basis for further evaluation of GS 5801 and dose selection for upcoming studies in subjects with CHB. The study will proceed in two parts, with the first part (Part A) evaluating the safety, tolerability, PK and PD of GS-5801 administered once daily for 7 days in the fasted state via a pre specified dose escalation through 2 cohorts. The second part (Part B) is designed to evaluate the safety, tolerability, PK, and PD of GS-5801 with adaptive dose selection (up to 100 mg administered once daily for 7 days). The doses evaluated in the adaptive cohorts (Part B) will be selected based on safety and available PK and PD data (up to day 14) from Part A (Cohorts 1-2) and available safety, PK and PD data from previously conducted cohorts from Study GS US 405 2064

Utilization of wearable technology in estimation of heart rate has wide reaching implications. Firstly, validation of heart rate measurement using this technology in healthy individuals at rest and exercise is vital for any future research going forward. Secondly, if smart watches prove to be accurate in monitoring heart rate trends among patients with arrhythmias, it could be a useful tool in guiding and monitoring response to pharmacological therapy. Smart watches and wearable technologies also have the ability to provide longer term monitoring of heart rate compared to 24 hour ECG holter monitoring also called ambulatory monitoring or telemetry - the current standard of care. It may be a cost effective and non-invasive method for patients to remotely assess their heart rate trends and communicate any abnormalities with their cardiologist or general practitioner. This would ensure timely assessment and an earlier change in management strategy that could lead to reduced presentations to the emergency department and improve overall patient satisfaction. Moreover, the ability for patients to accurately track their biometric indices may empower them to be more engaged in their health leading to improved clinical outcomes and quality of life. In addition to heart rate analysis, a versatile and validated mobile platform for heart rhythm analysis through the use of a mobile single lead ECG device may lead to more widespread adoption of this technology by the clinician. Methodology Patients that consent for the study will be provided with two smart watches that use wrist PPG technology as well as a hospital grade pulse oximeter for heart rate assessment. The two smart watches intended for use in this study are the Apple Watch and the FitBit Blaze given their popularity and global market share. Heart rate readings in all patients will be documented using data from an ECG linked with the ward telemetry unit (in the case of inpatients) or an ECG ambulatory monitor (in the case of outpatients undergoing stress echo or ECG) as per standard ward or stress testing protocol. Each patient will be monitored for a period of approximately 30 minutes with heart rate data being recorded every fifteen seconds among each different modality. Additional parameters recorded include a blood pressure reading at the start and end of the period of monitoring. Baseline characteristics including cardiovascular risk factors, history of arrhythmias and medication use will be noted. For patients when using the mobile smart phone electrocardiogram, three heart rate recordings using a single lead mobile ECG device (each lasting approximately 30 seconds) will be taken. These readings will be compared to a 12 lead ECG which will be performed during this period as a comparator. For patients undergoing cardioversion, this will be repeated after the cardioversion procedure.

Trial of a procedure specific consent form for laparoscopic cholecystectomy with a set of significant complications listed for discussion vs a standard consent form with no complications listed for discussion. To signify that a complication was discussed on the procedure specific consent form, surgeons/doctors had to tick the complication. We aimed to assess if documentation of these specific complications improved following the introduction of a procedure specific consent form. Participants were randomized to either a procedure specific or standard consent form. Outcomes measured were proportion of consent forms in each cohort with documentation of specific complications.