ANZCTR search results

Australian women have high rates of poorly controlled cardiovascular risk factors. In turn, cardiovascular (CV) disease is responsible for the death of 22 women every day in Australia. The ‘Heart Health Check’ is an MBS item number allowing general practitioners to be reimbursed for performing a formal CV risk assessment on a patient. Currently only around 1.1% of eligible NSW women have a formal ‘Heart Health Check’ each year with their GP. This study aims to understand the value of promoting CV risk assessment outside traditional health care settings among female attendees of NSW hairdressing salons. The researchers hypothesise that the intervention will: (i) Increase the proportion of women having a Medicare-rebated Heart Health Check; (ii) Increase the proportion with at-risk levels of cardiovascular risk factors identified; and (iii) Increase the use of medications for cardiovascular risk management

Currently, there is no effective therapy for the management of weight loss/reduction in the post-liver transplant population, who are at a higher risk of obesity and cardiovascular disease as a result of the effect of immunosuppressive medications required in the post-transplant setting. The aim of this study is to investigate the safety and effectiveness of semaglutide, which has documented effectiveness for weight management in the non-transplant setting. The study aims to recruit 100 patients who have undergone liver transplant more than 6 months but less than 5 years ago who are overweight (BMI >27kg/m2) with metabolic risk factors or obese (BMI >30kg/m2) with or without metabolic risk factors to a double-blind placebo-controlled trial for a period of 68 weeks (16 months). Clinical, laboratory and radiology data will be measured throughout the study to assess effectiveness. It is anticipated that semaglutide will be effective in achieving 5% or greater weight loss, and will have beneficial impacts on risk factors for cardiovascular disease.

Cardiovascular disease is the number one killer of Australian women. Yet CVD is preventable with early initiation of the right lifestyle and medical interventions. Current primary prevention relies on 'traditional' risk prediction tools. But almost all women under 65 are categorised as low risk, the vast majority of women who have coronary events are not identified, and novel, female-specific risk factors (e.g pre­ eclampsia, hypertensive disorders of pregnancy, gestational diabetes or premature menopause) are not considered. On top of this, women receive less primary prevention medical therapy, compared to men. These issues are even more pronounced in Aboriginal and Torres Strait Islander women (hereafter respectfully referred to as Aboriginal women). who have a larger burden of female-specific risk factors, and are even less likely to receive appropriate primary prevention. The CAC-Women's Trial aims to use a calcium score, measured via a simple, quick and widely available CT scan, to prompt lifestyle changes and medication use in women who are low-intermediate risk but have female-specific, risk-enhancing factors. in a randomised controlled trial (RCT) will evaluate the overall potential, feasibility and acceptability of a CAC-guided approach to primary prevention of CVD in women, and its impact on cardiovascular risk factor control. The CAC-WOMEN Trial will be a multi-site, randomised controlled trial assessing the effectiveness of a CAC-guided primary prevention intervention on cardiovascular risk factor control and healthy lifestyle adherence compared to usual care. The study aims to recruit 522 patients. Asymptomatic women without CVD aged 40-65 years (35-65 years for Aboriginal and Torres Strait Islander women) will be recruited from the community. Women will undergo blinded CT calcium scoring followed by 1:1 randomisation to intervention (CAC-guided care) or control (standard care). In the intervention group, women undergo a risk factor counselling session. This is performed by the study nurse/coordinator (and/or Aboriginal healthcare worker, where appropriate) with a private, one-on-one, CVD risk factor counselling session. The Study nurse/coordinator will provide printed and electronic information containing standardised recommendations consistent with current guidelines, on how to improve CVD risk profiles. The risk factor counselling session will be aided by the use of the CT-CAC result. Patients will receive a follow up telephone call by the study nurse at 1, 3 months, to monitor risk factor modification. In the control group women remain under the care of their primary care physician and are blinded to the CAC result for the 6month period. The participant is provided with a letter detailing the results of the baseline examination and pathology and are encouraged to see their GP for a discussion of risk factor treatment in accordance with standard care. All participants will be sent electronic survey follow up at 12m.

The research study aims to evaluate the effect of two different commercially available eye drops on the outermost layer (epithelium) of the cornea (clear, front surface of the eye), compared to saline, in subjects with dry eye. The corneal epithelium is more irregular in subjects with dry eye compared to non-dry eye populations. Therefore, this study will investigate whether the study eye drops improve corneal epithelial irregularity and how quickly this occurs following treatment.. Participants will be randomly allocated (like flipping a coin) to the eye drops to be used in this study four times daily. Assessments will be conducted 48 hours, 2 weeks and 4 weeks after the study eye drops are dispensed. Subjective comfort will also be measured before and at each follow-up visit using questionnaires. The primary timepoint is 2 weeks, but outcomes up to 4 weeks after starting treatment, including the 48 hour timepoint, will be analysed.

This study is aiming to determine whether one of two needles (that are approved by the Therapeutics and Goods Administration) is better than the other for taking samples from mediastinal (chest) lymph nodes for the diagnosis of lung cancers. Who is it for? You may be eligible for this study if you are aged 18 or older and you have been referred by your doctor to undergo a chest lymph node biopsy procedure known as Transbronchial Node Aspiration by Endoscopic Ultrasound. Participants may have a known cancer diagnosis or will be undergoing this procedure to determine a final diagnosis such as, but not limited to, lung cancer, sarcoidosis or tuberculosis. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin), to undergo a biopsy by one needle (Acquire), or the other (ViziShot). The biopsy procedure will involve giving anaesthetics then examining airways using a camera passed via vocal cords. Both procedures will be the same, the only difference will be which needle is used. 7- 10 days after the procedure, a member of the research team will phone all participants to check if they have experienced any side effects potentially related to the procedure, including going to the emergency department. It is hoped this research will determine whether one needle is superior to the other, and this may then improve current practice by reducing the number of biopsies needed.

Suicide is the leading cause of death for young people in Australia and hospital treated self-harm is the strongest risk factor for subsequent suicide. Brief contact interventions (BCI) after patients have been discharged have been shown to reduce repeat self-harm. RAFT is an SMS-based BCI that links patients with self-guided therapeutic content. This study will recruit individuals who have recently attended a hospital or emergency department for self-harm. Participants will be assigned to an intervention arm or a treatment-as-usual (TAU) control group. Participants assigned to the intervention arm will receive supportive text messages over 12 months. Adopting a 2x2 factorial design, half the participants assigned to the intervention arm will receive access to the self-guided therapeutic content. Additionally, half the participants assigned to the intervention arm will have the option to nominate a support person to receive information about self-harm and suicide. RAFT is aimed at reducing suicidal ideation and self-harm. This trial will assess whether RAFT is effective compared to treatment as usual, with exploration of the most effective combination of RAFT features. It is hypothesised that participants in the intervention arm will demonstrate greater reductions in suicidal ideation and the event rate of repeat self-harm relative to the control group. Self-report data will be collected remotely via online questionnaires at baseline, 5 weeks, 6 months and 12 months.

Post-Traumatic Stress Disorder (PTSD) is a debilitating and costly condition. Conventional treatments are insufficient and fail to adequately address comorbid conditions such as coronary heart disease and diabetes. Dietary intervention is a well-established approach in the treatment of physical conditions whereas building evidence suggests improving diet quality may address factors that are maintaining and exacerbating PTSD. However, current research in dietary improvement programs for those at risk of PTSD is limited in quantity and quality. We aim to develop and assess the acceptability, engagement and feasibility of a codesigned digital dietary improvement program for those at risk of current PTSD. We will use data collected from a previous study that adapted the My Food and Mood app for adults at risk of PTSD, This information will be used to inform an initial prototype for the Healthy Eating Lifestyle Program (HELP) app. We will pilot HELP with 300 adults at risk of current PTSD. HELP prototypes will be iteratively co-developed with cohorts of 100 participants, based on data analytics and consumer follow up surveys. Changes to PTSD symptoms and diet quality will be also be assessed. This study targets the co-development and optimisation of a digital program targeting diet quality improvement for those at risk of PTSD. Given the relatively high prevalence of PTSD and its enormous individual and societal costs, the online self-help approach could provide a pragmatic and effective adjunct treatment strategy. Outcomes of the project will inform funding applications for a large online RCT to establish the comparative efficacy of dietary interventions for PTSD populations.

The primary objective of this project is to evaluate the effectiveness of the "Tell Your Story" (TYS) intervention for male and female Arabic-speaking refugees by conducting a randomized controlled trial (RCT). It is hypothesized that participants in the TYS condition will show reduced self-stigma and increased help-seeking relative to a waitlist control group. The secondary aim of this project is to investigate the psychological mechanisms underpinning changes in self-stigma and help-seeking. It is hypothesized that TYS increases help-seeking by decreasing negative stigma related beliefs about help-seeking and by reducing self-stigma via psychological mechanisms (future self-efficacy, self-esteem and help-seeking beliefs).

Gout has effective, safe and readily available therapies. Yet it continues to be sub-optimally managed in the community. This is due to poor adherence to medication taking. We want to examine the relationship between self-monitoring of urate and urate-lowering medication taking behaviour. We hypothesise that self-monitoring of urate concentrations enhances adherence to urate-lowering medicines. That is, patient measuring their urate and seeing the results will encourage them to take medications as prescribed. We are conducting a proof-of-concept study with 30 people with gout. They are provided with the point-of-care uric acid monitoring meter, the HumaSens2.0plus, for self-monitoring throughout the year. Adherence to medication (MEMS), gout flare occurrence, and urate will monitor throughout the year.

Supervised Injectable Opioid Treatment (SIOT) is an evidence-based treatment for dependent opioid injectors who have not responded to conventional, oral treatment. This project will implement SIOT as an adjunct to oral methadone and explore whether benefits observed during injectable treatment are sustained after transfer to standard methadone treatment. The 2-year, open-label non-controlled study will be located in a methadone clinic. We will recruit 20-30 long-term injectors of street opioids, prescribe a combination of parenteral hydromorphone and oral methadone, then around 18 months gradually transfer to oral methadone only. The project will provide data to assess the acceptability (to staff and participants), safety, outcomes, and direct costs of SIOT. We will monitor non-prescribed drug use, health, psychological state and quality of life before, during, and after ceasing injectable treatment by performing qualitative interviews with participants, staff and policy makers.