ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32712 results sorted by trial registration date.
  • Total Ankle Arthroplasty Outcomes Study (TAAOS): Assessment of patient-reported measures and clinical outcomes following total ankle arthroplasty

    The aim of this study is to investigate clinical and patient reported outcomes following total ankle arthroplasty (TAA). The study will comprise a consecutive observational cohort with retrospective and prospective study design. Recruitment will include patients who have presented with ankle pathology to the principal investigators, Dr Andrew Wines and Dr Michael Symes, and elected to undergo TAA procedure. Patients will be presented with a Participant Information Sheet to inform them of the nature of the study and will be given an opportunity to provide informed consent for collection of their clinical data for research purposes via an opt-in approach. The data collection process will involve retrospective chart review and collection of patient demographic, treatment and clinical data as well as patient reported outcome scores collected routinely as part of the standard clinical pathway at the baseline presentation. Consenting patients will also be requested to complete a set of questionnaires (FAOS, satisfaction) to enable evaluation of patient reported outcomes as part of the post- treatment follow up. Aggregated pooled results will be deidentified, analysed and reported in the form of a manuscript for publication in a peer-review journal.

  • Variations in the level of blood ketones in patients commenced on a very low-calorie diet before and after having weight loss reduction (bariatric) surgery

    This study aims to assess the change in blood ketones seen in patients prescribed a very low carbohydrate diet (VLCD)before bariatric surgery. Patients on a VLCD have an increase in the blood levels of a chemical know as a"ketone' The level of measured ketones is different in each patient. Some diabetic medications can result in excessive levels of ketones in patients on VLCD. This study will help understand changes in blood ketones in patients undergoing bariatric surgery who are on VLCD who may or may not be on diabetic medications

  • Optimisation and validation of a nutritional intervention to enhance sleep quality and quantity

    The aim of this study was to investigate whether a nutritional intervention could enhance sleep by determining the effects on sleep quantity and quality as well as balance and cognitive function in healthy adults. Three trials were performed where different combinations of ingredients were provided and compared to a placebo in 18 healthy male participants.

  • Evaluation of a Brief Treatment Program of Cognitive Behavior Therapy for Insomnia in Older Adults

    The current study used a randomized controlled trial to investigate the effects of a brief, group-based CBT-I program in a large sample of older adults with chronic primary insomnia not currently taking hypnotic/sleep aid medications.

  • An observational study of discharge analgesia and analgesic outcomes after discharge following surgery in Southern Adelaide Local Health Network: A prospective pilot study

    Many patients experience pain after surgery, but this can vary significantly between individuals. With patients being discharged from hospital following surgery earlier than in previous generations, managing pain after discharge has become an important part caring for surgical patients. Frequently, this includes the prescription of opioid medications on discharge. While opioid medications are widely used to treat pain after surgery, there is now a large amount of evidence demonstrating that when prescribed on discharge opioids can contribute to a range of adverse outcomes for patients and the community more broadly. This presents a challenge to clinicians, who need to balance these risks while meeting the pain relief needs of patients. The purpose of this study is to capture accurate data on the nature of opioid prescribing and usage on discharge within Southern Adelaide Local Health Network, data which has previously never been captured or reported. We are aiming to assess if; 1. Opioid analgesia prescribed on discharge following surgery undertaken in SALHN is undertaken in accordance with current clinical guidelines. 2. Opioid analgesia prescribed on discharge following surgery undertaken in Southern Adelaide Local Health Network (SALHN) is adequate for patient analgesia requirements. 3. Opioid analgesia prescribed on discharge following surgery undertaken in SALHN results in unused prescription opioid in the community. 4. The volume of opioid prescribed on discharge could be reduced without increasing rates of patients needing to return to hospital as a consequence of pain OR patients experiencing pain limiting function when they are unable to access care.

  • NODE Study - Randomised Trial of Extended Pelvic Lymph Node Dissection In Patients Undergoing Robotic-Assisted Radical Prostatectomy For High-Risk Prostate Cancer

    The purpose of this pilot study is to determine whether it is possible to recruit sufficient participants in a trial investigating the role of extended pelvic lymph node dissection in addition to the removal of the prostate gland for the treatment of prostate cancer. Who is it for? You may be eligible for this study if you are an adult with prostate cancer who has already been scheduled for robotic assisted radical prostatectomy. Study details Participants in this study will receive one of two treatments: 1. Removal of the prostate gland, or 2. Removal of the prostate gland plus removal of pelvic lymph nodes Both surgeries will be completed using robotic assistance, as is the standard of care. The treatment the participant will receive will be decided randomly. All participants will be followed up for 12 months for recurrences of cancer, side effects and overall survival. Following the procedure, you would be required to undergo regular blood tests, and possibly radiological scans to monitor for cancer recurrence. It is hoped that this research will determine if a larger trial can be completed on extended lymph node dissection, and that the larger trial will help determine if extended lymph node dissection is beneficial over a radical prostatectomy.

  • Survey of discharge prescribing of analgesia after surgery and Emergency Department attendance

    Survey of discharge prescribing of analgesia after surgery and Emergency Department (ED) attendance is a study designed to target Resident Medical Officers (RMOs), Specialist Trainees and Consultants in Royal Brisbane and Women's Hospital (RBWH) and Townsville University Hospital (TUH). This study seeks to understand the attitudes behind prescribing analgesia by doctors in specific clinical settings, to allow policy makers make targeted interventions with regards to opioid-prescribing. We hypothesise that there may be varying levels of understanding and confidence with regards to analgesia prescribing after surgery and in ED. There may also be differences in teaching, guidance and supervision, provided for RMOs. The survey will be distributed electronically to doctors in RBWH and TUH working in Emergency Department or Surgical Departments (including General Surgery, Cardiothoracic Surgery, Vascular Surgery, Neurosurgery, Orthopaedics, Colorectal Surgery, Urology and Gynaecology) for participants to fill in anonymously. Survey results will be analysed by project members for publication in a peer reviewed journal, presented as a poster at scientific meetings and used by local clinical leads to inform the development of targeted interventions.

  • A Collaborative Maternity and Newborn Dashboard for the COVID-19 Pandemic

    The COVID-19 pandemic has resulted in a range of unprecedented changes to the way healthcare is delivered in all Australian public hospitals. In maternity hospitals across Victoria, these changes have resulted in an altered schedule of visits for antenatal care. The aim of this study is to monitor monthly trends in key perinatal services performance indicators and maternal and newborn outcomes at the largest VIC maternity health services before, during and after the COVID19 pandemic. This is a multi-centre retrospective cohort study that will gather routinely collected data on births from January 1 2018 to December 31 2024. The first half of the study period (from Jan 1 2018 to commencement of study following HREC and local governance approvals in mid-2020) will be retrospectively collected in order to provide baseline rates of all outcomes. Data will then be prospectively collected each calendar month from each of the participating sites, and this will be continuously updated to provide timely reports on maternity services. These seven health services, including 12 hospitals, collectively look after 100% of all public births in metropolitan Melbourne. The participating health services are: • Mercy Health (Mercy Hospital for Women, Werribee Mercy Hospital) • The Royal Women’s Hospital, The Women’s at Sandringham • Monash Health (Monash Medical Centre, Casey Hospital, Dandenong Hospital) • Northern Health (The Northern Hospital) • Western Health (Joan Kirner Women’s and Children’s Hospital) • Eastern Health (Box Hill Hospital and The Angliss Hospital) • Peninsula Health (Frankston Hospital) The approximate number of births captured during the study period is approximately 300,000. An estimated 44,000 women give birth in the participating hospitals each year.

  • Post-operative physiotherapy provided by Allied Health Assistants for Patients with Hip Fracture

    This randomised controlled trial will investigate the feasibility of an allied health assistant providing physiotherapy to people following hip fracture surgery. The allied health assistant will provide all therapy to people in hospital. All therapy will be prescribed by a physiotherapist and will include daily walking, and standing and seated exercises. We hypothesise that it is feasible for allied health assistants to provide physiotherapy to people after hip fracture surgery.

  • The Building Educators’ Skills in Adolescent Mental Health (BEAM) study: A cluster randomised-controlled trial of an adolescent mental health training program for secondary school Educators

    Although school staff are well positioned to identify possible changes in their students' mental health, many classroom teachers report they feel a lack the confidence and knowledge in knowing how to recognise and best respond to possible signs of mental health changes among students. While best practice guidelines recommend schools offer professional development to teachers that addresses reducing stigma towards those with mental health problems, there are very few programs available that are evidence-based and target the skills required beyond classroom teaching. In response to this training gap, the Black Dog Institute developed Building Educators’ Skills in Adolescent Mental Health (BEAM), an online training program designed to educate secondary school educators in leadership positions (such as Year Advisors, Heads of Wellbeing, and Deputy Principals) about adolescent mental health. BEAM is based on a theory of change which posits that an increase in educators’ mental health knowledge will improve their positive attitude and self-reported confidence in managing student mental health-related issues, and thereby increase the frequency of helping behaviours directed towards students. This unique, flexible, blended-model of training aims to bridge the gap between e-learning and face-to-face training, and allows for the program to be completed when users are available without taking leave from their school. In 2019, a pilot trial of BEAM assessed the acceptability, feasibility, and preliminary effectiveness among 70 Year Advisors across NSW. The pilot found the program to be both acceptable and feasible to deliver, with participants reporting moderate to high satisfaction with the program, most indicating they would use the program again, and all would recommend it to others. Furthermore, preliminary effectiveness of BEAM was demonstrated, with participants reporting decreases in their own levels of psychological distress at 6-weeks post-test, and higher levels of self-reported confidence in managing students’ mental health needs at post-test, with their confidence levels continuing to increase at 12-week follow-up. Additionally, at follow-up, participants reported an increase in the number of helping behaviours directed towards students. However, users reported that ‘lack of time’ was a significant barrier to program completion, along with forgetfulness, and not prioritising the program. The program is ready to be formally assessed for its effectiveness on increasing educators’ self-reported confidence in managing students’ mental health. Additionally, its effectiveness for improving educators’ mental health knowledge, increasing the occurrences of helping behaviours towards students, and reducing stigma and personal distress will also be evaluated.

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