ANZCTR search results

Chronic kidney disease (CKD) is increasingly becoming more common, and is associated with increased disability and death rates. The best predictor for progression to kidney failure is the amount of kidney scarring detected on a biopsy. Biopsies are useful however are limited by their invasive nature and inability to collect large or multiple samples. MRI is used in other organs like the heart and the liver to check for scarring, but is not yet available for the kidney. The NIMBLE-CKD project aims to develop an MRI marker to estimate the amount of kidney scarring by comparing images with biopsy samples. Ultimately this will provide a less intrusive and safer way to detect and monitor CKD, with a hope to guide early treatment and prevent kidney failure.

Patients admitted to ICU commonly experience poor/disrupted sleep. However, there are currently no simple ways of formally assessing sleep quality and quantity. This study aim to: 1) compare the accuracy of a new single forehead sensor in evaluating sleep in the ICU against the gold standard assessment (polysomnography) and 2) investigate the quality/quantity of sleep for patients in the ICU and their circadian (day/night) rhythms. We plan to consent and recruit a feasibility sample of 30 suitable adult patients expected to stay in ICU for at least five days to this pilot study. We will formally evaluate sleep using sensors to record participants brain waves, and analyse blood tests to determine their circadian rhythms. We will introduce an electrical light that mimics natural light and evaluate the impact on patients' sleep / circadian rhythms / recovery. We will also ask patients to complete some questionnaires 6 months after leaving ICU to evaluate how they have recovered, and investigate whether poor sleep / loss of circadian rhythms was associated with poorer outcomes / ongoing sleep problems. If the single forehead sensor is proven to be accurate in evaluating patient's sleep in ICU, this could become a simple method for the treating team to more easily include sleep assessments routinely as part of patient care.

Bone metastasis often results in disabling pain. A standardized evaluation of the pain characteristics and associations may assist in achieving stable pain control. This study required a single 1-hour face-face or telehealth interview using validated tools to assess adult cancer patients with bone metastasis. A description of the pain features and characteristics and their association with opioid consumption will be reported.

Eating an unhealthy diet is a leading risk factor for chronic diseases worldwide. Innovative new programs to improve the diet of millions of Australians at high risk of heart disease, such as those with high blood pressure and type 2 diabetes (T2D), have tremendous potential to save lives and reduce healthcare costs. 'Food is medicine’ programs aim to integrate healthy food provision into the health care system for the prevention, management, and treatment of disease, especially for food-insecure patients and other vulnerable groups. A particularly promising approach is Medically tailored meals (MTM), whereby doctors ‘prescribe’ evidence-based pre-prepared healthy meals for patients. Prescribing healthy meals offers patients a new way of accessing the foods they need and for many disadvantaged patients with chronic diseases this will also make healthy foods more affordable. We will test whether provision of MTM is a feasible and effective way of improving T2D management and reducing heart disease risk in the Australian setting. We will conduct a randomised control trial of an MTM intervention in individuals with undermanaged T2D, who have difficulty buying or eating nutritious food. Over 26 weeks, intervention participants will be prescribed MTM whereas control group participants will continue their usual clinical care. In addition, intervention participants will also receive three consultations with a dietitian. The primary outcome of interest is to understand the impact of the MTM on blood glucose control in participants with T2D. The participants’ dietary intake, medication use, body weight, blood pressure, blood lipids and blood glucose level will also be assessed pre- and post-intervention. Finally, a sub-sample of participants will be interviewed to explore how the program worked (or did not work) for them, and ways the program can be improved and scaled up.

Borderline Personality Disorder (BPD) is a common, yet complex, mental illness. People with a diagnosis of BPD experience significant distress due to difficulties relating to other people and the world around them, disruptions to family, social and work life. Symptoms of BPD may include difficulty regulating emotions, impulsive behaviours, self-harm, suicidal ideation/ attempts, feelings of detachment from their own experiences, and/or intense and unstable relationships. Although BPD is a long-term condition with high rates of relapse and crisis, recovery is possible with suitable therapy. Treatment approaches for people living with BPD are often intensive and lengthy, which can mean long waiting periods for patients to enter programs. Additionally, a lengthy treatment period may not be suitable for all individuals with BPD seeking treatment. Borderline Personality Disorder Collaborative (BPD Co) has developed a short term group therapy program (Road Maps) informed by common factors across evidence-based approaches to assist South Australians living with BPD to achieve optimal quality of life and experience recovery. Road Maps aims to help people living with BPD understand and connect their emotional, cognitive and behavioural experiences. The Road Maps Pilot Study will assess the feasibility and appropriateness of the Road Maps program. Furthermore, the effectiveness of the program will be assessed by comparing the severity of psychological symptoms before and after attendance to the program. Additionally, the impact of the program on participant use of other health services such as mental health services and emergency department (ED) presentations will be assessed. The investigators hypothesise that participants in the intervention group will report a significantly greater reduction in borderline symptom severity, impulsive and self-destructive behaviour, psychosocial distress, self and interpersonal dysfunction compared to the group on the waitlist. It is also anticipated that therapeutic gains will be maintained 6 months post-intervention, with an expectation that this will be associated with linkage to ongoing therapeutic supports over this time period in line with the philosophy of the stepped care model.

This research aims to collect outcome data from group-based treatment for school-aged children who stutter. The results will be analysed to identify what factors lead to successful and unsuccessful outcomes in school-aged children who stutter. These factors will be compared to existing data to create theories that can explain what factors create optimal outcomes in school-aged children who stutter. There will be 2-3 groups within the treatment program, with 4-6 participants in each group. Children will learn ways to speak more fluently, learn about coping strategies and have a chance to practice these skills. During the group treatment sessions children will be asked to participate in group discussions and activities and complete some homework activities between treatment sessions (10-15 minutes per day). Prior to the group starting, immediately post-treatment and 6 months after treatment, participants will be asked to give a 10 minute speech sample (child), and complete some questionnaires (parent and child). One month after treatment, both the parent and child will participate in an interview about their treatment experiences.

Non-standard work hours in shift work lead to a misalignment between circadian timing and daily behaviours with well-documented adverse consequences for health and safety. Circadian misalignment is implicated in sleep disorders, impaired memory and executive functioning, and poor mental health.A combination of age-dependent cognitive decline, chronicity in circadian misalignment and a higher rate of impaired sleep amplify these risks in older shift workers. Older shift workers perform worse on cognitive tasks, have greater morbidity and experience up to 2.5 times higher risk of dementia in comparison to age-matched day workers.Older adults make a sizeable proportion of shift workers in Australia, including healthcare industry, providing them support can help with improving their health and wellbeing. In this study, we seek to examine the efficacy of an app-based intervention that delivers sleep recommendations based on shift schedules and personal commitments. These recommendations are evidence-based and tested in lab and real-world settings for safety and efficacy. We also aim to examine whether the app is effective in improving sleep, mental health and performance in both younger and older nurses (i.e. 45 years or above).

Following abdominal surgery, low oxygen levels are common and may be an early sign of breathing complications. Physiotherapy treatments following surgery may improve oxygen levels and prevent breathing complications. Physiotherapy treatments often include early walking, deep breathing exercises, education about the best things a patient can do themselves to help recovery, and sometimes assisted breathing with a machine. We hypothesize that it is feasible to deliver physiotherapy treatments including education, breathing exercises, early walking, and non-invasive ventilation to patients with low oxygen levels following abdominal surgery.

Tinnitus is a common presentation whereby patients experience a ringing or buzzing sound in the absence of external noise, and these symptoms can be quite debilitating for the affected individual. Pulsatile tinnitus represents a subtype that may be caused by compression exerted by an arterial loop or vein against the vestibulocochlear nerve as it exits the brainstem en-route to the inner ear. Microvascular decompression (MVD) is already routinely performed for the treatment of other neurovascular compression syndromes with positive results, including trigeminal neuralgia (compression of trigeminal nerve), hemifacial spasm (compression of facial nerve) and glossopharyngeal neuralgia (compression of the glossopharyngeal nerve). There is a limited volume of worldwide literature which suggests that surgery (microvascular decompression of the acoustic nerve) to treat this condition may be of benefit in selected cases. The evidence is limited to small case series, and several systematic reviews, but no randomised trials have been performed to date. The objective of this study is to go beyond what we already know from the limited literature by carrying out a randomized multi-centre controlled trial, investigation to results of microvascular decompression of the acoustic nerve. The primary endpoint is treatment efficacy compared to control. The secondary endpoints examine the safety and prognostic factors that would lead to a more favourable outcome following surgery. A small case series of patients recruited from two large health networks in Melbourne (Melbourne Health and Monash Health) will be selected according to the type and severity of their tinnitus. Inclusion criteria include: 1) patients with unilateral pulsatile tinnitus, 2) there is an identifiable compression of their vestibulocochlear nerve by an arterial loop or vein on pre-operative imaging, 3) have suffered from pulsatile tinnitus for > 12 months, 4) have attempted other conservative measures, 5) age 18-75 years and 6) able to consent for participate in the study. Patients meeting the inclusion criteria and who consent to participation in the study will be randomised to either continue with 1) best medical management (control arm) or 2) undergo microvascular decompression via a retrosigmoid craniotomy at either of the two study centres (intervention arm). This surgery involves a general anaesthetic, and posterior fossa craniotomy, identification of the vestibulocochlear nerve and compressing vessel, and removing this vessel away from the nerve to relieve the pressure on it. The primary outcome measure is the surgical efficacy for treating pulsatile tinnitus. Based off the existing literature, it is hypothesised that at least 60% of participants will experience some symptom relief post-surgery.

Baseline data will be obtained from consenting participants at the first screening visit before enrolment into the study. This will occur after eligible participants aged 19 -65 years have expressed interest via e-mail in participating in this study. Participants will be screened using an online demographic characteristics questionnaire (age in years, gender status, ethnicity, family history of AMD, bowel, atrophic, cardiovascular, pancreatic disorders, diabetes and gastrointestinal disease, current or recent supplement use, smoking status, alcohol intake, current or recent use of medications that may affect lipid absorption, currently on a medically related special diet) will be collected. While physical activity level including body mass index and fat will be determined using a body composition analyzer. Initial venous blood sample (20ml) for estimating lutein and zeaxanthin (using high performance liquid chromatography) and omega 3 fatty acids (using gas chromatography – mass spectrometry) including the oxidative stress level (using flow cytometry, a tool used for single cell analysis of immune system) will be collected. Other information on the history of bowel disease, cardiovascular disease, hepatic, diabetes, gastrointestinal or renal disease will be assessed. Anthropometric indices (height, weight, body mass index) will be obtained. After collection of baseline data, study participants will commence a 6-day wash-out. Within this period, they will follow a low carotenoid-omega-3-diet based on the list of foods provided and provide venous blood (day 1 and 7). Participants will be contacted once every week via text/e-mail during the wash-out period to ensure they follow the low carotenoids and omega 3 fatty acid diet. If any participants were not compliant with the low carotenoid and omega 3 fatty acid diets, the wash-out period will either be extended for another week or discontinued from the study. On completing the 7-day wash-out period, participants will commence a 12-day intervention. The control group will receive L+Z supplement and the intervention group will receive L+Z and omega-3-supplements. The changes in lutein and zeaxanthin levels in the blood after the intervention will be recorded; the area under the curve for serum levels of lutein and zeaxanthin with and without omega 3 supplementation will be used for calculation of bioavailability.