ANZCTR search results

FORENSIC-Australia aims to find out: 1) if lumbar fusion surgery (an operation that fixes spinal bones together) for a carefully selected group of patients with on-going, severe low back pain and spine degeneration, and who have already tried non-surgical treatment, is better than best conservative care (personalised spinal care) at improving back-related disability. Best conservative care is a personalised, patient-focused treatment plan with evidence-based options including advice and education, exercise, combined physical and psychological treatment, and other pain control strategies; 2) if the surgery is good value for money.

Untreated methamphetamine withdrawal is a significant barrier to people meeting their treatment goals. Lisdexamfetamine has the potential to help manage withdrawal from methamphetamine. This study is a randomised controlled trial of a tapering dose of lisdexamfetamine for the treatment of acute methamphetamine withdrawal, over a 7 day period in hospital. We will then follow up participants for 84 days.

The efficacy and safety of digitally delivered pain self-management interventions for reducing pain after surgeries, including total knee replacement (TKR), have been demonstrated in several randomised controlled trials. However, little is known about the feasibility and effectiveness of these interventions in Australian hospital settings. The current project evaluates the implementation and effectiveness of an mHealth intervention designed to support patients’ engagement with pain self-management after TKR surgery. Consenting patients (N = 130) who are scheduled to undergo TKR surgery will be randomised to receive either a psychoeducational video prior to surgery, and one SMS text message per day for 3 weeks after surgery, or the pre-surgery psychoeducational video only. Both groups will continue to receive usual care. Outcome measures including pain intensity (primary), opioid dose, pain-related distress, and perceived social isolation will be recorded at baseline, 3 days, 3 weeks, 6 weeks, 3 months, and 6 months after surgery using self-reported surveys. Pain self-efficacy will be measured at 6 week, 3 months and 6 months post-surgery. Implementation outcomes will be evaluated using mixed (quantitative-qualitative) methods. This trial represents a first step towards the translation of digitally delivered non-pharmacological acute pain management in the Australian healthcare system.

It is difficult for skilled clinicians to diagnose Alzheimer’s disease in the early stages. A diagnosis of Alzheimer’s disease also requires evidence of a particular type of brain pathology by using a specialized brain scan. The EDD study has been devised as a comprehensive solution to address current diagnostic challenges. The EDD study is integrated into existing clinical services, with the aim of providing clinicians with data on pathology, brain damage, and brain function through advanced blood diagnostics, advanced brain-imaging techniques, and in-depth digital cognitive assessments that can be performed via telehealth. This study will assess the accuracy and usefulness of each element of the EDD program using surveys of physicians and patients, and with reference to gold standards.

Objective 1 - Evaluate the potential effectiveness of the stratified care rehabilitation program by assessing the impact on health outcomes pre- to post-intervention,. Objective 2 – To evaluate the acceptability and feasibility of the stratified care rehabilitation program through focus group interviews with trial clients and physiotherapist-participants.

This research through Floreat surgery will trial a new lung health calculator to help detect a common and serious lung condition called Chronic Obstructive Pulmonary Disease (COPD). This calculator called “PRECURSOR” has been designed to be used by adults aged between 40 and 49 years who smoke or have smoked. It forecasts a person’s chance of having COPD in 10-years’ time. Doctors can use this calculator to help people stop smoking and decide on having a breathing test. The findings from this pilot trial will help the researchers understand: 1) whether completing "PRECURSOR" is motivating for patients aged 40-49 who smoke to stop smoking, and 2) how GPs may wish to adopt this COPD calculator in their clinical practice.

Effective haemorrhage control is crucial in cases of limb trauma involving arterial injury, such as shark attacks. International first aid guidelines recommend the use of arterial tourniquets as a primary treatment for life-threatening external bleeding. Manual pressure applied directly over a major artery proximal to the injury (Inguinal Fist Compression, IFC) is more accessible in a first-aid situation than commercial windlass tourniquets (CWTs). Stopping Haemorrhage by Application of Randomised Compression or Tourniquet (SHARC-Two) is a trial designed to examine which of these interventions is superior at reducing arterial blood loss when applied by a member of the general public. Based on a recent pilot study, we anticipate that IFC will achieve a greater reduction in femoral blood flow than a CWT when applied by untrained bystanders after brief infographic exposure.

The primary objective of this study is to undertake a small scale preliminary study (cluster randomised control trial) to identify the effect of DDDAA on depressive symptoms among elderly persons in residential care. Facilities are randomised not individuals. This will be achieved through measuring changes in response to thirty (30) specific items on the Geriatric Depression Scale, GDS score from baseline to follow up. We will additionally compare scores between the three (3) groups (face to face delivery, digital delivery, and control) to identify the strength of DDDAA vs face to face DAA.

The purposes of this study is to 1. Determine if integrated health mobile text messages (unidirectional), including medical, diet, exercises, and psychological support follow-up people with Type 2 diabetes for 12 months, can improve their glycaemic control at 6 and 12 months. 2. Determine if participants’ lipid profiles, blood pressure, and weight status (BMI) can also be improved at 6 and 12 months We hypothesize that there will be improved HbA1c, lipid profiles, blood pressure, and weight status (BMI) in 6 months and a further improvement in 12 months; there will be a high acceptance rate or high satisfaction levels about this research from participants.

Alcoholic hepatitis is an acute deterioration in liver function in the context of excessive alcohol consumption. Those with severe Alcoholic Hepatitis (sAH) have a high short-term mortality. Prednisolone has a modest efficacy in reducing short-term mortality in sAH, but it cannot used in many patients because of contraindications, and if used, it is associated with increased risk of infections. The gut-liver axis modulation through healthy donor faecal microbiota transplantation (FMT) has been proposed as a therapeutic alternative in managing patients with sAH. FMT has been shown to alleviate gut dysbiosis and restore gut microbial diversity. The role of orally delivered FMT capsules in sAH is yet to be explored. We hypothesize that orally delivered FMT capsules is a safe and efficacious therapy in patients with sAH. Aims of this study are: (i) to assess the gut microbial signatures in those with sAH, followed by (ii) A pilot randomised controlled trial to assess the safety and efficacy (primary outcome: 28- day mortality) of FMT compared to prednisolone in patients with sAH.