ANZCTR search results

Poor diabetes-treatment adherence is a major contributor to health complications, avoidable hospitalizations and long-term disease in people living with diabetes. Behavioural intervention is not currently part of standard care to improve adherence to conventional medical and lifestyle regimens for patients with complex diabetes. This research aims to demonstrate how personalised behavioural intervention aimed at increasing diabetes self-care and active coping, can lead to improvements in diabetes control and psychological wellbeing. The main purposes of this study are to implement and evaluate the effects of a multicomponent behavioural intervention on diabetes treatment adherence and glycaemic control in patients with complex diabetes and suboptimal control, and identify behavioural and contextual factors associated with the response to intervention. The study aims to demonstrate that: A. Personalised behavioural intervention will improve glycaemic control in complex patients with sub-optimally controlled diabetes, who are already attending a tertiary diabetes clinic. B. Improvements in glycaemic control are modulated via increased adherence to treatment. C. Behavioural intervention reduces diabetes distress and improves quality of life in this complex group of patients. We aim to recruit 60 participants with either type 1 or type 2 diabetes on insulin, attending dedicated outpatient clinics at Fiona Stanley and Fremantle Hospitals for their diabetes management. All participants will receive behavioural intervention either immediately or following a monitoring period of 3months. Current clinical care will continue unchanged. Clinical outcomes including measures of glycaemic control, psychological distress/wellbeing and quality of life will be evaluated every 3months for up to 1 year following study entry to obtain longer term assessment of study outcomes. During the behavioural intervention component of this study, daily self-monitoring of diabetes self-care behaviour will be obtained via a standardized study diary and questionnaire measures including frequency of diabetes self-care activities, psychological distress/wellbeing, coping and quality of life will be collected at specified intervals for assessment of treatment efficacy. We also plan to undertake a health economic analysis to determine costs and benefits of providing behavioural intervention as part of standard diabetes care. The results of this study will provide a foundation for future work to extend this behavioural intervention model to optimize care in the wider population living with diabetes.

This research aims to examine the effectiveness of a six-week cognitive remediation intervention for adults in residential treatment for Alcohol and Other Drug (AOD) use. We aim to primarily investigate whether cognitive remediation will be effective in improving executive functioning and treatment retention rates, compared to treatment-as-usual. In addition, we will examine the effect of cognitive remediation on a number of secondary outcomes, including long-term AOD use, goal attainment, quality of life, health service utilisation and measures of cognition. This will be evaluated by conducting a number of self-report and performance-based measures before and after six weeks of cognitive remediation or treatment-as-usual, and for follow up (2-months, 4-months, 6-months and 8-months). Participants will undergo cognitive remediation in addition to receiving treatment as usual. The cognitive remediation will be administered in a group setting, in one-hour sessions, twice a week for six weeks. The intervention will take a strategy-based approach, with a strong emphasis on the training of executive functioning, and will include traditional instructional pedagogical approaches, modelling, exercises to demonstrate concepts, and role-plays. The intervention will be administered by trained staff at the residential AOD services. The proposed study will be conducted as a prospective stepped wedge cluster randomised trial, where randomisation will occur at the cluster level. The design involves random and sequential crossover of clusters from treatment as usual to Cognitive Remediation until all clusters have implemented the CRiDAS program. It is hypothesised that cognitive remediation will be associated with improved executive functioning and improved treatment retention.

The aims of the project is to examine: 1) the effect of a weight management smartphone application (app) for people living with chronic illnesses on participants’ body weight (primary outcome), Body Mass Index (BMI), activity level, mood and quality of life (secondary outcomes). 2) participants’ appraisal and perceived benefits of the app, and frequency of app use. Project aims: To examine: 1) the effect of a weight management smartphone application (app) for people living with chronic illnesses on participants’ body weight (primary outcome), Body Mass Index (BMI), activity level, mood and quality of life (secondary outcomes). 2) participants’ appraisal and perceived benefits of the app, and frequency of app use. Why is this study needed? Being overweight or obese are major risk factors for many chronic diseases, such as diabetes and cardiovascular diseases, and are dramatically on the rise in urban and rural settings. There are weight loss apps available, but few randomised controlled trials (RCTs) have been conducted to evaluate the effectiveness of these apps. Few apps adopted an evidence-based and theory-based approach in its development. Method: A pilot RCT of an interactive ‘Weight Management Wellness App’. 76 patients who have a diagnosis of chronic illness with BMI greater than or equal to 25 kg/m2 will be randomly allocated to intervention or control groups. The app is developed based on cognitive behavioural therapy (CBT) principles. It contains video, text information, podcast, weight tracker, mood tracker, daily activity tracker, daily questionnaires and resources locator. Outcomes measured at baseline, 6-week, 3-months and 6-months, include: body weight, BMI, activity level, mood and quality of life. Benefits and translation: This study generates reliable evidence using a rigorous RCT design to evaluate an app which contains unique feature – adopting principles of CBT in weight management. This study addresses current gap in information quality and lack of theory underpinning current weight management apps in app stores. The app could reach out to people living with chronic illness with weight management issues, and help reduce the weight- associated comorbidities, thus leading to an enhanced quality of life and minimise the long-term burden of chronic diseases on healthcare system.

This project will deliver innovative resilience training for older Australians (50+ years). Fifty years of age reflects a point of major work and life transition (National Seniors Australia) and we seek to assist adjustment at this critical life-stage. According to Beyond Blue and government reports, incidences of depression and stress are reported by 10-15% of the population over 50 years of age (Commonwealth Department of Health), with physical and psychological illness ranked the 2nd most common reason for people leaving the workforce prematurely (ABS, 2017). Our project is designed to mitigate these effects by improving psychological resilience among older Australians to keep them in the workforce longer, and to improve psychological outcomes and enhance community engagement among older unemployed Australians. Unlike conventional resilience training that takes a ‘one size fits all’ approach, we have developed a personalised self-reflection strategy to building resilience. This strategy enables participants to identify and build on their individual strengths, and to harness these in the face of challenges. Leveraging our success in fostering resilience in the Australian military, we will tailor our unique approach for older Australians and test its efficacy with two key groups; working and unemployed and retired older adults. This will be the first resilience training tailored to older adults with the objective of preventing mental illness and developing the skills and insights needed to cope with the inevitable adjustments and challenges of ageing. In collaboration with a major national employer and local councils, we will deliver a new tool to support older Australians to lead active and fulfilling lives, while reducing the risk of mental illness that affects Australians over 50.

This feasibility study is aiming to test a mobile phone app (called ‘SunVisor’) to determine its effectiveness, particularly in organ transplant recipients. Who is it for? You may be eligible for this study if you are aged 15 or older, are attending the Australian Transplant Games 2018 and have a mobile phone with internet access. Study details All participants will complete a baseline survey, download and install the SunVisor application and receive a tube of sunscreen. Throughout the period of the Transplant Games, participants will use the application at their discretion. After two weeks participants will partake in a 20 minute telephone interview about their experience using the application. It is hoped this research will show this app improves sun protection strategies and reduces sunburn incidence in this vulnerable population.

This parallel group, blinded, placebo-controlled randomised trial will determine whether 1500mg/day of metformin administered for 6 months improves walking ability in PAD patients. Based on sample size calculations focused on the minimal clinically important difference, 250 PAD patients that do not have diabetes, renal or cardiac failure will be included. The trial will employ an independently run minimisation randomisation system and identical appearance, weight and packaging of drug and placebo to ensure blinding of investigations, patients and assessors, along with balancing of important determinants of outcome. The primary outcome measure will be the 6-month maximum walking distance during a six minute walk test. Secondary outcomes will include physical activity assessed over 7 days with an accelerometer, health-related quality of life, leg blood supply assessed with ankle-brachial pressure index and circulating concentrations of key markers of angiogenesis. Adverse events will be monitored by an independent data monitoring committee. Previous trials indicate metformin is safe for patients without diabetes.

The study aims to evaluate the combined effect of a cognitive rehabilitation group (CRG) with intake of Queen Garnet plum (QGP) juice, to optimise cognition in adults with mild cognitive impairment (MCI). Biomedical measures would contribute to an understanding of the mechanisms of action associated with cognitive improvements. The study would include an 8week, doubleblind randomised controlled trial with two arms, CRG plus placebo, and CRG plus 250mL QGP juice, using MCI patients referred to the ISLHD Geriatric Outpatient Services or Rehabilitation and Medical Psychology Department. Recruitment and research consent of participants will occur within ISLHD clinics, with an aim of 72 subjects. Participants will attend a data collection session at baseline, conducted by Clinical Neuropsychologist and a Research Assistant, where participants will undergo the neuropsychological test battery, collection of demographic data, a food frequency questionnaire and instructions for a 4day food record, and blood collection. Subjects will be provided a 24hour Blood Pressure monitoring device, a urine and faecal sample collection kit, and their supplement/placebo to commence. These assessment procedures will be repeated at 8 weeks.

The objective of this study was to determine the effect of age, prolonged bypass and deep hypothermia on perioperative levels of cefazolin in children undergoing cardiac surgery.

The primary goal of this study is to determine the effects of two drug combinations (known as AD047 and AD282) on sleep apnoea severity (the apnoea/hypopnoea index) compared to a placebo (sugar pill). Other measures of sleep apnoea severity, upper airway function, breathing and symptoms will also be assessed as secondary outcomes.

Congenital aortic stenosis is a lifelong disease often requiring multiple interventions. Valvuloplasty refers to the procedure by which the valve obstruction is relieved by either incising the valve during a surgical procedure or utilising balloon to stretch the valve during an interventional cardiology procedure. We are seeking to determine the early and late outcomes of surgical or balloon aortic valvuloplasty and whether the technique use, influences the long term risk of re-intervention, other morbidities, or death.