ANZCTR search results

The aim of this trial is to examine the impact of the drug semaglutide on metabolic risk factors and hunger/satiety in individuals with psychosis at risk of developing type 2 diabetes (T2D). This study will use an RCT design with an intervention group and treatment as usual (control) group. Metabolic risk will be measured using changes to weight, waist circumference, and blood glucose levels pre- and post-intervention and whether any changes were still present at a 12-month follow-up. Hunger/satiety will be assessed throughout the intervention by comparing the intervention and control group. Service utilisation, quality of life and general health will also be assessed pre- and post-intervention. Findings from this study will provide further information on the suitability of this drug in preventing T2D in this group and the feasibility of its use as part of routine care. A sub-study will include a small group of individuals from the intervention group who will complete additional measures of body composition and bone density. This will provide further information on the impact of antipsychotic medications on the body and whether the study drug affects their impact.

The assessment of Autism Spectrum Disorder (ASD) in children takes into account the perspectives of many professionals across the education, health and community sectors. Within Queensland Health, Allied Health Professionals (such as Psychologists, Speech Pathologists and Occupational Therapists) work with medical specialists for children (also known as Paediatricians) in the assessment of ASD. However, there is variability in the clinical care pathways available in the assessment of ASD. This includes the order and timing of allied health assessments in relation to Paediatrician appointments. At some facilities, children are seen by allied health professionals first before seeing a Paediatrician. While in other facilities, the opposite occurs where children are seen by a Paediatrician first, then are later seen by allied health professionals. Both clinical care pathways for the assessment of ASD are safe and appropriate. However, we do not know which clinical pathway results in more efficient and satisfying care for children and their families. Understanding which clinical care pathway is more efficient and satisfying for families will help inform which clinical care pathway is offered more consistently across Queensland. This will ensure children have access to early intervention as soon as possible and avoid any delays. In this study, we are aiming to determine whether first contact with a Paediatrician or Allied Health Professional results in more efficient and satisfying care for children and their families. We hypothesize that an allied health first-contact model of care reduces service healthcare costs and results in comparable patient quality of life and satisfaction with care, when compared to a traditional medical first-contact model of care for the assessment of ASD in children.

We are testing a different method of receiving the patient outcomes survey for our national stroke registry. The Australian Stroke Clinical Registry traditionally collects outcomes data between 90-180days after stroke using a paper-based survey that is mailed to the registrant. If registrant does not respond after two attempts by mail, we telephone them to complete the survey. Use of short-message-service (SMS) with an electronic link to the survey form that is sent to the registrant's mobile phone number may be a more feasible and cost-effective approach to receiving the outcome survey data from registrants. We hypothesise that, compared to our traditional methods, those receiving an SMS will have greater response rates and more timely completion of the outcomes survey with less missing data, and that this new method will reduce costs for collecting these data. A process evaluation to determine why some patients might choose to complete the follow-up questionnaire via the SMS method, while others do not, will also be undertaken. The outcome of this project is to provide evidence on whether the option of electronic collection of outcome data via SMS should be incorporated as part of our usual registry processes.

The overall project will evaluate an evidence-informed brief contact intervention comprising a series of text messages for people bereaved by suicide. This study is focused on finding out if this text message intervention is helpful and improves people's wellbeing. To test if it is helpful, half of all those who decide to take part will be sent a sequence of text messages over a 6-week period. The text messages comprise key messages and information that other people bereaved by suicide and international experts have identified as important. Everyone who takes part will be able to continue with their usual supports and after 6 weeks, we will see if receiving the text messages was helpful. Participation involves completing two online surveys (pre-test and post-test). These surveys will take about 30 minutes to complete and cover a range of questions, including questions about your mental health and wellbeing. Those people allocated to the intervention group will receive text messages over a 6-week period between the two survey assessment time-points. Allocation to the intervention group will be random. Anyone who didn't receive the text message intervention will be able to receive these texts messages at the end of their participation period. After the 6-week intervention period, participants will be requested to complete a post-test survey. A subset of people in the intervention group will also be invited to participate in a one-on-one (virtual or phone) interview to share their experiences of the intervention

This study is focused on preventing falls in people with stroke. Falls are common, particularly in the early stages following stroke and following the transition from hospital to home, with around half of people falling in the first 6 months after stroke. These falls can have serious consequences such as bone fracture, head injury, or death. There are a number of factors which can increase a person’s risk of falls, including poor balance, environmental hazards, sensory deficits, and medications. Evidence suggests effective falls prevention programs should include a tailored approach addressing individual risk factors, and include balance-specific exercises. This study will pilot an individualised, multifactorial telehealth-supported falls prevention program for people with stroke who are being discharged from hospital to home. The study will test the feasibility and potential benefit of this program in 16 individuals with stroke who are at risks of falls following discharge home from an inpatient setting. Participants will be recruited prior to discharge home and will undertake a 4-week program in addition to their usual care. The program will include a comprehensive falls risk assessment and tailored intervention based on identified risks and agreed goals, and using health behaviour change techniques (exploration of individual barriers and facilitators to recommended fall prevention behaviours). This will involve twice weekly physiotherapy sessions (in person or via videoconferencing or phone call) to review or supervise home exercises, review goals and discuss barriers and strategies for falls prevention. Environmental modifications and referral to other services will be undertaken as required. Participants will undergo in person home-based testing at baseline (within one week after discharge home) and at 4 weeks. Participants will also be interviewed within 3 weeks of completion, asking about their experience of the program. This project will inform the development of a randomised controlled trial and may help inform development of future falls prevention programs that can be delivered with greater efficiency.

Initial treatment for Idiopathic childhood nephrotic syndrome is prednisolone. In Victoria our routine duration of prednisolone treatment has been 12 weeks, with a multi-step tapering dose used after 4 weeks of treatment. An alternative regime is used elsewhere in Australia, which has a two-step wean over 8 weeks. Prednisolone courses can rarely be complicated by a side effect called adrenal suppression, which is where natural adrenal gland steroid production is reduced. The Initial Prednisolone Weaning and Adrenal Suppression in Childhood Nephrotic Syndrome study is a clinical trial that will compare the two different courses of prednisolone, the multi-step wean over 12 weeks and the two-step wean over 8 weeks, in patients with their first presentation of idiopathic childhood nephrotic syndrome. The study will find out how frequently adrenal suppression occurs after different courses of prednisolone, and whether there is any association with nephrotic relapse.

The aim of this study is to assess the visual performance and wearability of prototype ophthalmic lenses compared to commercially available ophthalmic lenses

The primary aim of this pilot trial is to determine whether a larger definitive trial is worthwhile and feasible. Success will be defined by all of the following: (i) A patient/family member consent rate at least 40% (ii) Complete study drug administration at least 80% (iii) A reduction in the extent of NSTI at least 25% (within 95% CI of median total area) (iv) Serious study drug-related adverse events less than 5%. Study Hypotheses (i) Feasibility – A multicentre randomised trial evaluating tranexamic acid (TxA) in necrotising soft-tissue infections (NSTI) is feasible (ii) Clinical efficacy - TxA administration in patients admitted to hospital with a suspected diagnosis of NSTI reduces the spread of tissue infection when compared with placebo. Methods This multicentre, double-blind, parallel group, randomised trial will enrol 60 patients admitted to hospital with a diagnosis of NSTI. We will evaluate intravenous TxA, 1 gm, administered twice daily for 4 days.

Airways disease such as Chronic Obstructive Pulmonary Disease (COPD) are amongst the top 5 causes of global morbidity and mortality. In Australia, 1 in 10 people above the age of 45 years has COPD and amongst the top 5 most prevalent diseases in Australia. COPD is usually progressive resulting in terminal respiratory failure. Standard therapies include bronchodilators and inhaled corticosteroids. Bronchodilators cause smooth muscle relaxation and may reduce mucus formation. Inhaled corticosteroids reduce eosinophilic inflammation in a cohort of subjects with COPD. Taken together these treatments provide symptomatic relief but do not address the ongoing tissue damage and impaired repair by the disordered immune system. We have demonstrated for the first time in human subjects that intravenous infusions of human mesenchymal stromal cells (MSCs) reduced systemic inflammation by immune-modulating monocytes and increasing anti-inflammatory T regulatory cells. Furthermore, we have shown that the supernatant or conditioned media in which the MSCs are grown in (MSC-CM) have similar immunosuppressive properties. Notably we demonstrated that when the MSC-CM is nebulised, it retained the anti-inflammatory properties. We therefore propose to test the safety and potential efficacy of nebulised conditioned media from MSCs (Neb-MSC-CM) in moderate to severe cohorts of COPD patients and those with frequent exacerbations of COPD. We will assess the safety and efficacy by improvements in quality of life, exercise tolerance and lung function and systemic inflammatory markers. The successful completion of this safety study will then allow us to pursue randomised control trials and commercialisation of this product.

This study aims to collect clinical outcomes data, particularly quality of life and limb function outcomes, from patients who have undergone either a surgical procedure to remove/treat bone and soft tissue tumours (cancer patients) or patients who have undergone a complex hip reconstruction surgery (non-cancer patients) to determine how these outcomes relate to surgical factors. Who is it for? You may be eligible for this study if you are aged 16 or older, and you are attending for consultation with one of the participating surgeons for management (surgery with or without chemotherapy or radiotherapy) of bone and soft tissue (sarcoma) tumours, or for surgery to revise a failed or infected hip replacement (non-cancer patients). Study details All participants who choose to enrol in this study will be asked to complete a series of questionnaires around the time of their first consultation with the surgeon, and again at 3, 6, 12, 24 and 60 months (5 years) following definitive treatment (whether treatment is surgical or otherwise). Participants will be able to complete these questionnaires in their own time via an online link, or can complete them at their regular follow up clinic visits. It is anticipated that completing all of the questionnaires at each timepoint will take around 20 minutes. It is hoped this research will provide surgeons with information which will be used to improve the precision of patient counselling preoperatively, and to tailor treatment decisions and post-operative management in order to maximise patient quality of life. The data will also be analysed together and results shared with the scientific community, to help patients in the future.