ANZCTR search results

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

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31913 results sorted by trial registration date.
  • TAPentadol vs OxycodoNe on the incidence of persistent opioid use after hip or knee arthroplasty (TAP-ON Study)

    Many people are given opioid medications such as oxycodone after hip or knee replacement surgery to help manage pain. While these medications can be effective for short-term relief, they come with serious risks, particularly when use continues beyond the recovery period. Ongoing opioid use after surgery has been linked to falls, fractures, constipation, higher infection rates, and even the need for revision surgery. Yet, inappropriate persistent use of opioids after hip or knee arthroplasty remains common in Australia and around the world. Tapentadol is a newer opioid that may offer similar pain relief to oxycodone but with fewer side effects. Early research suggests that patients taking tapentadol may be less likely to continue using opioids long-term. However, these findings come from observational studies, and more rigorous evidence is needed to confirm whether this alternative truly reduces the risk of persistent opioid use. This pilot study will compare tapentadol and oxycodone in patients recovering from hip or knee replacement surgery. Participants will be randomly assigned to receive either tapentadol or oxycodone as needed for pain, while all other aspects of post-operative care including non-opioid medications and anaesthetic techniques will remain the same between groups. The study will take place across multiple hospitals in Australia and include both metropolitan and regional sites. The main goal of the study is to see whether it is feasible to run a larger trial by looking at how many eligible patients can be recruited, how many stay in the study, and how closely they follow their assigned treatment. The study will also explore whether patients taking tapentadol are less likely to continue using opioids 90 days after surgery, and whether they report less pain, and improved function. Safety outcomes, including opioid-related side effects during the hospital stay and after discharge, will also be closely monitored. By testing whether an alternative opioid can reduce the risk of long-term harms, this study has the potential to improve surgical recovery and reshape how post-operative pain is managed in Australia.

  • The Heart Health Literacy Toolkit: Targeted Cardiovascular Disease (CVD) risk screening with health literacy support by Short Message Service (SMS) in general practice

    This project aims to test the impact of providing online health literacy support within an established Heart Foundation model of targeted CVD risk screening invitations, delivered by SMS in general practice. We will recruit participants in the standard Heart Health Check invitation SMS, via a link to information about the study. Those who consent will be randomised to usual care or access to a health literacy support website (www.checkyourheart.com.au). Those who don't click on the study link in the invitation SMS, or do not consent after the click on the link, can attend a Heart Health Check as usual with no study data collected. Participants who consent will take part in two online surveys delivered by SMS, one at baseline and a second survey after 3 months. We will compare the control and intervention group on health literacy and CVD related knowledge outcomes, as well as determining the acceptability of and engagement with the SMS and website support model. No data will be extracted from from medical records for this study.

  • Implementation and evaluation of a dashboard of predictive analytics and decision support to drive care quality and person-centred outcomes in aged care

    We will implement an intervention to improve the quality of care for residents in aged care facilities. The intervention consists of an electronic dashboard on falls and quality of life. It is intended for use by aged care staff and predicts the risk of falls and poor wellbeing and presents information, action areas and clinical evidence-based recommendations that can be inputted by staff minimize resident risk of poor health outcomes. To evaluate the dashboard we will be conducting a cluster randomised controlled trail where we will randomise 20 facilities into intervention and control groups (i.e. 10 in each group). The intervention will be introduced across all intervention sites at the same time in early 2023. A 1-month intervention wash-in period will be allowed to allow the integration of the dashboard into routine practice. Since the intervention is an add-on to an existing system, 1 month will be sufficient to allow users to familiarise themselves with the dashboard. The impacts of the dashboard will then be compared between the intervention and the control sites after 12 months (excluding the wash-in period data). We will include two additional sites for the pilot testing. The primary outcome we will look at is rate of all falls (i.e., any falls regardless of whether an injury was involved, or hospitalisation was required). We hypothesise that the intervention will reduce the rate of falls in the intervention group in comparison to the facilities in the control group. The secondary outcomes include: injurious falls, falls requiring hospitalisation, client wellbeing, social service use (attendance at leisure and lifestyle activities), hospital service use, use of the Peninsula Health Falls Risk Assessment Tool and change in use of Falls-Risk Increasing Drug use.

  • The impact of time-restricted eating in adults with obstructive sleep apnoea

    This study will utilise a Time Restricted Eating (TRE) dietary regime as adjunctive weight loss therapy alongside CPAP treatment of OSA. TRE is an eating pattern which reduces or eliminates night-time eating and prolongs nightly fasting intervals to >12 hr prompting energy intake to earlier in the biological day without any complex dietary prescription. With high adherence, tolerance, and safety, TRE is a promising and novel dietary strategy to investigate for OSA management. Aim: To investigate the effect of a TRE dietary regime as adjunctive weight loss therapy, on sleep and cardio-metabolic health in OSA patients using CPAP.

  • Impact of premenopausal risk-reducing bilateral salpingo-oophorectomy on non-cancer outcomes in BRCA1/2: 10-year follow up of a multicentre prospective controlled study.

    This is a follow up study evaluating the impact of risk-reducing bilateral salpingo-oophorectomy (RRBSO) on sexual function, menopause symptoms and quality of life issues, bone health, cardiovascular health, sleep quality, depression/anxiety symptoms and cognitive function in high-risk, pre-menopausal women who participated in the WHAM study 10 years ago. Who is it for? You may be eligible if you participated in the WHAM study 10 years ago. Study details Participants will be assessed for non-cancer outcomes including sexual function, menopause symptoms and quality of life issues, bone health, cardiovascular health, sleep quality, depression/anxiety symptoms and cognitive function will be assessed at the 10 year follow up using the following: Blood tests, Bone mineral density scanning, Completion of questionnaires, cognitive function (online and face-to-face) testing Total time commitment no greater than 6hours. It is hoped that the result from this study will contribute to understanding the long-term effects of RRBSO to better inform future management.

  • Testing the feasibility, acceptability and impact of an online delivered stress management program for Australian with breast and colorectal cancer

    The primary objective of this pilot randomised controlled trial is to assess the feasibility and acceptability of a new, 5-week, group-based online-delivered stress management program for Australian with breast and colorectal cancer. Who is it for? You may be eligible for this study if you are an adult diagnosed with breast or colorectal cancer (Stage I, II, or III) and are currently undergoing cancer treatment (e.g., surgery, chemotherapy, radiotherapy, hormone therapy). Study details Participants will be randomly assigned to either the intervention group or the control group. Participants in the intervention group will attend 5 weekly, 100-minute sessions delivered online through Zoom. They will also have access to a study website, which will contain summaries of the sessions and guidance on relaxation techniques. Participants in the control group will receive information on support networks they can access, and following completion of the study period, will receive access to the study website. It is hoped that the findings from this study will help researchers evaluate the feasibility and acceptability of an online stress management program for cancer patients and guide the design of future larger trials.

  • The effect of personalised 3D printed metamaterial insoles on plantar pressures in healthy adults.

    Diabetes-related foot ulceration is a debilitating condition that arises in part due to high mechanical pressures acting on the underside of the foot. Preventative offloading treatments including medical grade footwear and personalised insoles are often used to reduce these pressures in an effort to prevent ulceration in people who are determined to be high risk. The research team have developed an approach to 3D print accessible and low-cost personalised metamaterial insoles with functionally graded stiffness that varies across the device. These insoles could potentially be used to enhance the effectiveness of pressure redistribution and prevention of diabetes related foot ulceration. This within-subjects repeated-measures crossover study in healthy participants will compare the immediate effects on plantar pressures in medical grade footwear with personalised 3D printed metamaterial offloading insoles produced using automated design algorithms compared to medical grade footwear with the current standard of care personalised foam insoles. The results of this study will provide insight to the most suitable design algorithms for functionally graded insoles as part of preventative treatment. The findings of this study on healthy participants will inform later studies with participants with Diabetes-related foot ulceration.

  • Assessment of Quantity and Utility of water for ICU-Acquired hypernatraemia. A Pilot, Six-Centre, Open-Label, Safety and Physiological Efficacy Randomised Controlled Trial

    The AQUA Pilot Trial is testing whether giving hypotonic fluids (such as 5% glucose or enteral free water) helps critically ill patients with ICU-acquired hypernatraemia (high sodium levels) recover faster compared to usual care. Patients will be randomly assigned to receive either a structured hypotonic fluid protocol or standard treatment to determine which approach leads to quicker sodium normalisation. The study hypothesis is that the protocolised administration of hypotonic fluid will result in a shorter time to normal serum sodium levels (equal or less than 145 mmol/L) compared to usual care. This research aims to help doctors develop better treatment strategies for managing hypernatraemia in intensive care patients, potentially improving outcomes and reducing complications. The trial will also assess safety by monitoring glucose levels, electrolyte balance, and other important clinical measures.

  • Helping New Parents Feel Good and Function Well After Childbirth: A Study Testing Text Messages to Support Mental Wellbeing

    This study will evaluate a new module of text messages designed to support postnatal mental wellbeing, embedded within the Healthy Beginnings for HNEKids (HB4HNEKids) mobile health program. Mental wellbeing in the perinatal period, including positive affect, emotional regulation, social connection, and purpose, is critical for both parents and children but is often overlooked in favour of treating mental illness alone. This two-arm, parallel-group randomised controlled trial will compare the HB4HNEKids program with and without the additional wellbeing module. Participants will be birthing parents, randomly allocated after birth. The primary outcome is parental mental wellbeing at six months postpartum, measured through validated self-report tools.

  • Safety and tolerability of plasma-activated water wound rinse for foot ulcers

    For this study, participants will have full wound standard-of-care provided by an experienced clinical trial wound nurse, with a wound rinse performed with one of two agents: saline control, or plasma-activated water (PAW). This novel solution has the potential to be a rapid-acting wound cleaning agent that will kill bacteria in biofilm without engendering antibiotic-resistant organisms. As a first-in-human study of a product with a favourable safety profile, we expect this trial to place CALHN researchers and patients at the forefront of new infection control technologies.

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