ANZCTR search results

This study is an open label single arm trial coordinated by the Investigators at the Princess Alexandra Hospital (PAH) in Woolloongabba (Queensland, Australia), the Australian Centre for Complex Integrated Surgical Solutions at the Translational Research Institute (Queensland, Australia) and the Centre for Regenerative Medicine at the Institute of Health and Biomedical Innovation in Kelvin Grove (Queensland, Australia). The primary purpose of this study is to assess the feasibility of surgical placement of a new protein scaffold in conjunction with free tissue transfer for bone reconstruction in patients who have an acquired skull defect secondary to trauma, malignancy or infection. Experimental data suggests augmented bone regeneration of this new protein scaffold when combined with autologous vascularised free tissue from the subject. It is hypothesised that this method of reconstruction will result in superior regeneration of skull bone with improved cosmesis at a reduced cost to hospital and patient. This will be assessed through pre-and post-operative CT imaging to quantify bone regeneration. This will be compared to previous types of skull reconstruction in terms of functionality (i.e. cosmesis and patient satisfaction) and financial implications (i.e. costs associated with operation(s) and complications). Patients will be followed up at 4weeks, 3, 6, 12 and 24 months to assess to adequate bony union (through CT and clinical exam) as well as completed surveys of their experience and physical, mental, emotional and social outcomes.

The diagnosis of anterior cruciate ligament (ACL) injury and reconstruction (ACLR) in skeletally immature patients is climbing at a rate significantly higher than adults. The increased incidence has been attributed to several factors including rise in competitive sport participation, decreased incidental activity, increased clinical awareness of a potential for ACL tear in this population, more comprehensive diagnosis and evaluation with Magnetic Resonance Imaging (MRI) and a shift in clinical practice to provide early intervention. The weight of available evidence now supports reconstruction over conservative management with minimal complications. Nonetheless, evidence regarding the ideal surgical technique for the skeletally immature patient is still lacking. Two commonly implemented surgical methods are reconstruction using single or double hamstring tendon autograft. The primary aim of this single blind randomized controlled trial is to determine whether a single or double hamstring tendon graft ACLR leads to superior clinical outcomes post-surgery in paediatric patients with ACL injury.

The use of multiple medicines (polypharmacy) is associated with poor clinical outcomes. It has been reported that more than a third (36.1%) of older Australians (aged 70 years or older) living in the community were affected by polypharmacy. There has been a move towards deprescribing (the process of withdrawing an inappropriate medication that is supervised by a health care professional with the goal of managing polypharmacy and improving outcomes). However, there are many barriers to deprescribing from the perspectives of both the patients and prescribers. The Team Approach to Polypharmacy Evaluation and Reduction (TAPER) medication review process has been developed to directly address these barriers. The focus is on maintaining essential drugs while supporting reduction in medicines with known associations with adverse effects, some of which could lead to emergency presentations and/or unplanned admissions to hospital, and those in which risks outweighs benefits. Participants attend sequential linked consultations with a pharmacist and their GP to collaboratively stop/reduce potentially inappropriate medications (in the context of their personal preferences and goals of care), using a structured ‘pause and monitor’ period. This randomised control trial will compare the TAPER intervention to usual care in older adults living in the community to determine the effect of TAPER in participants taking 5 or more medicines on the participants' medication use, wellbeing and health system utilisation including emergency presentations and/or unplanned admission to hospital. Addressing polypharmacy in older people may reduce adverse events and save money. There is evidence to suggest that there will be cost benefits by both reduced medicines costs, and reduced adverse events leading to reduced health service utilisation.

A randomised, single-blinded, controlled, non-inferiority clinical trial comparing a technology-based, remotely delivered ("Telehealth group") TKR rehabilitation program to usual, in-person care ("Clinic group"). 150 participants who are scheduled to undergo primary elective total knee replacement will be recruited over a period of 10 months with 75 participants randomly allocated to each arm of the study. Participants allocated to both arms of the study will complete 6 weeks of post-surgery exercise rehabilitation (twice per week for three weeks, then once per week for the next three weeks). Primary outcome measures are 'knee flexion range of motion' (ROM) and the 'Knee Injury and Osteoarthritis Outcome Score' (KOOS). Secondary patient reported outcomes include Visual Analogue Scale, Short Form Health Survey (Sf-36), Global Rating of Change, Patient Satisfaction and the Telehealth Digital Literacy Questionnaire. Secondary functional assessments include 40meter Fast Paced Walk Test, 30 Second Sit to Stand Test, Stair Climb Test (9 stairs) and the Timed Up and Go Test. Participants from both groups will have outcome measures collected in an in-person assessment: pre-surgery, 7 weeks post-surgery (+7 weeks), and at 12 months post-surgery (+12 months). Online questionnaires only will be send at 6 months post-surgery (+6 months). This study aims to: 1. Determine if short- and medium-term outcomes for TKR patients are similar following a 6-week rehabilitation delivered either via telehealth or within a clinic setting (in-person). 2. Assess the economic costs of rehabilitation delivered in each of these modes. 3. Determine whether knee joint range of motion (ROM) can be assessed both practically and accurately via telehealth.

During the COVID-19 Pandemic a number of medical and allied health consultations has been changed from face-to-face to telehealth, using either telephone or video. This study would like to understand the level of satisfaction melanoma patients and their clinicians had with telehealth. Learning about the satisfaction may lead to improvement of this service in the future, as telehealth may be able to bridge geographical gaps many patients experience who do not live in large urban areas. Who is this study for? Patients: This study may be suitable for you if you are: at least 18 years of age, able to read and understand English and respond to survey questions, are able to provide informed consent, you have been diagnosed with melanoma, you have had at least one consultation via telehealth since March 2020, you are receiving services from healthcare professionals at Melanoma Institute Australia, or Melanoma and Surgical Oncology at Royal Prince Alfred Hospital Clinicians: This study may be suitable for you if you are: a healthcare professional (e.g. doctor, nurse, allied health) involved in providing care, support, and management of patients with melanoma, providing services at Melanoma Institute Australia and Royal Prince Alfred Hospital, you have provided at least one telehealth consultation in relation to melanoma management since March 2020. Study details: Participants enrolled in this study will be asked to complete ONE survey. Melanoma patients will be able to complete this survey online or in paper form. This survey will take about 20 minutes to complete and will contain questions about general demographic and melanoma information, satisfaction with telehealth, emotional and physical functioning, Clinicians will, be asked to complete a 10 minute survey containing questions about their general demographic information, their career stage, opinion about adequacy of Medicare items for telehealth as well as their own perception of telehealth they provided. Clinician survey will be available online. It is hoped that this study will highlight the benefits of telehealth, as well as some areas where improvements may be needed. This may lead to implementation of the strategies to address areas of low satisfaction in both clinical practice as well as research.

This study will be a placebo-controlled, double-blind, randomised Phase 2b/3 study in participants with established cardiovascular disease to evaluate the impact of statin therapy on changes in plaque burden and composition in participants with different polygenic risk scores using CT coronary angiogram. The study will take place at ten sites in Australia.

The purpose of this project is to examine the effectiveness of a self-help manual intervention compared to treatment as usual for reducing emotional distress, increasing effective coping and improving quality of life in patients undergoing a stem cell or bone marrow transplant. Previous experience has shown that this type of transplant is an intensive procedure that is physically and emotionally challenging, and many people undergoing a transplant experience significant emotional distress (ie. anxiety or depression). This can make it more difficult to cope with the treatment, and return to normal activities after treatment which may affect work, social and recreational interests. Providing people with education about emotional distress and strategies to better manage it, has been shown to improve the ability to cope with physical and emotional distress. It was hypothesised that a self-help manual intervention in addition to TAU will lead to reduced psychological distress and improved QoL at 2-3 weeks and 3-months post-HSCT compared with TAU alone.

In young people (<40 years), arthritis commonly occurs following knee reconstruction, forcing them to live with old knees and reducing their quality of life. In the SUPER KNEE trial we aim to evaluate whether supervised exercise and education can improve knee symptoms, function and quality of life and prevent joint deterioration compared to usual care in 184 young adults with knee reconstruction. We hypothesis that individuals in the supervised exercise and education intervention will have significantly less pain, greater quality of life and less early arthritis after 4 and 12 months compared to the usual care control group.

This project seeks to improve health and return to work outcomes for injured workers with work-related mental health conditions (MHCs) by improving the care provided by their general practitioner (GP). Workers with MHCs take three times longer to return to work and receive approximately three times more in compensation, compared to workers with musculoskeletal injuries. In Australia, GPs see 97% of injured workers and thus play a pivotal role in directing the recovery and return to work journey for these patients. However, current practice is hampered by clinical uncertainties and system difficulties that GPs encounter in practice. A national evidence-based clinical guideline on diagnosing and managing work-related MHCs in general practice is currently in development anticipating NHMRC approval, RACGP endorsement, and publication in early 2019. However, unless the guideline is actively implemented, it risks being underutilised. Our study aims to improve the health outcomes of people with work-related MHCs by implementing an intervention designed to increase the delivery of evidence-based care by Australian GPs. We will utilise a parallel cluster randomised controlled trial design to trial a complex intervention in general practice. Intervention components will consist of proven methods such as academic detailing, resource provision, and support through a community of practice. Our key objectives are to increase the delivery of evidence-based care for patients with work-related MHCs in general practice and to assess the cost-effectiveness of our intervention. The partnership team has unparalleled expertise with the proposed methods and is uniquely placed to conduct a high quality, pragmatic implementation trial that will be applicable across compensation jurisdictions in Australia. This trial is likely to produce both policy and practice changes that improve health outcomes of patients in the general practice setting.

Continuous Glucose Monitoring (CGM) systems have been commercially available for several years and have been of benefit in patients with Diabetes. A key goal for next generation Continuous Glucose Monitoring products is to have a sensor use life greater than the currently approved 7 days. The purpose of this study is to collect performance data on the Medtronic Extended Life Glucose Sensor System, which aims to provide accurate glucose sensor data for 16 days. The hypothesis is that the Medtronic Extended Life Glucose Sensor will provide glucose sensor data up to 16 days that compares in accuracy to currently commercially available sensors that only provide data for 7 days. The investigational device is similar in form and function to currently commerically available CGM devices, but also includes low doses of the anti-inflammatory drug dexamethasone to help improve device longevity. In this study participants will have 1 or 2 investigational sensors inserted into the arm, abdomen or arm and abdomen, as well as a control sensor without dexamethasone into the arm or abdomen. The investigational sensors will not provide glucose information to participants, and so decisions regarding their diabetes treatment will be made as usual and participants may continue to wear their own glucose sensor if they wish to do so.