ANZCTR search results

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

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31193 results sorted by trial registration date.
  • Exercise training in older men and the effect on brain derived neurotrophic factor (BDNF).

    The purpose of this study was to examine the effect of training on BDNF levels and whether this change would be accompanied by enhanced pacing strategies in previously untrained older men. We hypothesised that chronic training would alter circulating BDNF values and accordingly there would be altered pacing strategies during a self-paced time trial performance.

  • Do fatigue and stress levels affect the quality of life among stroke survivors.

    The primary aims of this project are to investigate the effects of changes in the levels of perceived stress on the relationship between post-stroke fatigue and quality of life and to explore the relationship between perceived stress and post-stroke fatigue. The secondary aims of the project are to explore the relationship between post-stroke fatigue and cognitive function and profile the expression of circulating microRNAs in post-stroke fatigue. The objectives of the study are to measure the baseline and follow-up perceived stress, fatigue, cognitive function and quality of life among 65 recruited stroke survivors over a period of three months and investigate the effects of the change in the level of perceived stress on the relationship between post-stroke fatigue and quality of life. We will also explore the correlation of post-stroke fatigue and perceived stress and the correlation of post-stroke fatigue and cognitive function. From collected blood samples we will profile and identify circulating microRNAs in post-stroke fatigue. The hypothesis of this project is that: 1. The increase in the level of perceived stress significantly increases the detrimental effect of post-stroke fatigue on quality of life in stroke survivors; 2. The increase in the level of perceived stress significantly increases the level of fatigue over a period of three months.

  • Queensland new troponin evaluation for patients presenting to the emergency department with suspected acute coronary syndrome

    This project will evaluate the health services impacts of the recent introduction of the Seimen's Attellica high-sensitivity troponin assay across twenty Queensland Health Hospitals. The aim of the project is to compare the emergency department length of stay, hospital length of stay, the proportion of patients admitted and the proportion of patients undergoing cardiovascular testing in the pre- and post-implementation periods. The primary outcome is the proportion of patients who were discharged from the ED within four-hours of presentation for suspected acute myocardial infarction. Consecutive adult patients who presented to an emergency department with suspected acute myocardial infarction will be included. Six-months of pre- and six-months of post-implementation non-identifiable data will be sourced from several hospital databases including AUSLAB, the Emergency Data Collection minimum data set and the Queensland Hospital Admitted Patient Data Collection database. We anticipate approximately that 120,000 patients will be included in the pre- and post- implementation periods. We hypothesis that following the introduction of the Siemens Atellica high sensitivity troponin assay more patients will be discharged within four hours of ED presentation without an increase in the proportion of patients receiving cardiac angiography.

  • Feasibility and preliminary effectiveness of virtual reality as a patient education tool for people with cancer undergoing immunotherapy: a randomised controlled pilot study in a regional setting

    Patient education is a critical component of healthcare delivery. However, medical information and knowledge is complex and can be difficult for patients and families to comprehend when delivered verbally, via pamphlets and/or video. This study aims to assess whether using virtual reality (VR) as an education tool for people with cancer is effective and well received. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with a cancer of any stage (e.g., melanoma, kidney cancer, mesothelioma, lung cancer) that will be treated with immunotherapy and you are due to start only immunotherapy agents (i.e., patients may not receive any other treatment, such as chemotherapy or radiotherapy). Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups. Participants who are allocated to the first group will have a standard of care verbal education session with an education nurse, followed by a 5-7 minute 3D 360° virtual reality (VR) education experience during their first immunotherapy treatment session. Participants who are allocated to the second group will have a standard of care verbal education session with an education nurse, followed by a 5-7 minute 2D video education presentation during their first immunotherapy treatment session. Participants who are allocated to the third group will only receive a standard of care verbal education session with an education nurse during their first immunotherapy treatment session, and will receive educational pamphlets about immunotherapy treatment as well. Prior to their first treatment session, straight after the first treatment session and at two weeks after their first immunotherapy treatment session, all participants will be asked to complete a series of questionnaires regarding their understanding of the educational information provided to them. Participants will also be asked to complete a one-on-one 20 minute interview with a member of the research team to discuss how they found their education session and delivery method. It is hoped this research will determine whether it is feasible to provide patient education via VR and how this delivery impacts participants' understanding of their immunotherapy treatments. If this initial study is positive, the use of VR education may be expanded to a greater number of cancer patients undergoing immunotherapy treatment in the future.

  • Defining and characterising malnutrition and sarcopenia in patients undergoing oesophageal and gastric cancer surgery: a pilot observational study.

    This study will focus on patients who are planned for surgical resection of the oesophagus or stomach as part of curative treatment for oesophageal, oesophagogastric junction (OGJ) or gastric (stomach) cancer. Oesophagogastric (OG) cancer surgery is associated with significant morbidity with specific challenges related to consuming enough food and fluids, poor nutrition status, reduced physical performance and impaired health related quality of life (QOL). Malnutrition and low muscularity (or low muscle mass) is common in patients with gastrointestinal cancer regardless of body weight or body mass index (BMI). Routine diagnostic computed tomography (CT) images can be used to assess body composition and have shown that low muscularity prior to surgery can lead to increased hospital length of stay, postoperative complications, mortality and reduced overall survival after gastrointestinal cancer surgery. Sarcopenia, commonly used to describe age related loss of skeletal muscle mass with low muscle strength and/or low physical performance, is also associated with poor health related outcomes but is yet to be explored in the context of the surgical oncology population. This prospective observational pilot study aims understand the clinical, nutritional and functional differences between sarcopenic and non-sarcopenic patients undergoing surgical treatment for oesophagogastric carcinoma, thereby defining two distinct syndromes. In addition, we aim to assess changes in the specific components of sarcopenia after OG cancer surgery and the influence on postoperative recovery. As a pilot study we aim to identify areas of potential difference between these sarcopenic and non-sarcopenic groups that may account for differences in treatment outcomes and lead to future larger scale research endeavours that consider specific interventions to prevent or reduce the development of sarcopenia.

  • Optimising maternal breastmilk and breastfeeding in preterm and very low birthweight infants: a retrospective review of the impact of donor milk and an expressing box

    A retrospective casenote review of three cohorts following changes to clinical practice, to determine the impact on breastmilk and breastfeeding outcomes. Group A is the historical baseline cohort and covers 6 months 1/1/18-30/6/18. Group B is a 6-month period following the introduction of PDHM into the Neonatal Unit for eligible infants and the employment of an IBCLC in a dedicated role within the Neonatal unit. Group C is a 6-month period following the introduction of an expressing box designed by the IBCLC, containing basic expressing equipment and information (syringes, medicine straws, expressing kit, information booklet), designed to encourage the earlier initiation of expression by making it easier for staff to provide equipment and information simultaneously. Across all cohorts, data assessed included: time of first breastmilk expression, any use of PDHM (where applicable), receipt of the expressing box (where applicable), the timing of the first infant exposure to breastmilk, the timing (corrected gestational age) at the first breastfeed attempt, and feeding outcomes at discharge (exclusive breastfeeding, exclusive breastmilk feeding, mixed feeding (breastmilk and formula), standard formula feeding or specialist formula feeding.

  • The effect of pre-pregnancy dietary advice and regular exercise to promote health in women with BMI between 18.5 and 24.9kg/m2, on pregnancy outcomes: the Begin Better 2.0 randomised trial.

    Women of reproductive age have been identified by the WHO as an important target group as they prepare for parenthood, as the time around conception and pregnancy often represents a significant turning point in a woman’s cardiovascular and health trajectory, inducing metabolic changes which contribute to weight gain and poor health. Australian data indicate that 3 in 4 pregnancies are planned, and for women planning pregnancy, ~86% will initiate changes in health behaviours before conception. More than 50% of women attending their general practitioner for pre-conception advice, including information about healthy lifestyle and nutrition. Accessing up-to-date, evidence-based health information in a contemporarily acceptable format during reproductive years presents an unmet opportunity in Australia, to improve the health and well-being of potential parents. Our aim is to conduct a randomised trial of a dietary & lifestyle intervention prior to conception • To improve maternal nutrition, physical activity and healthy behaviours and • To evaluate the impact on maternal, newborn and child health outcomes. Our hypotheses are that this innovative public health approach will • Improve health outcomes for women, and their babies and children, • Reduce health care costs and • Provide an evidence-based tool that can be readily scaled up for implementation in the community.

  • Is the “Cogito” smartphone app a feasible and effective “assistant” to metacognitive training for people with psychosis?

    We seek to investigate the feasibility of integrating a therapy-homework smartphone app, “Cogito”, into an evidence-based psychological intervention for people with a diagnosis of psychosis. The intervention, individualized metacognitive training (MCT+), is an effective psychological treatment for reducing delusional symptoms in people with psychosis. The app, "Cogito", provides participants with brief once daily reminders of the lessons they learned in therapy sessions. Therapy homework is a core component of psychological therapies, allowing participants to keep practicing the lessons learnt and exercises/experiments covered in sessions outside of therapy session. Compliance with homework has been shown to improve treatment outcomes from therapy. MCT/MCT+ has traditionally used conventional homework sheets. While MCT/MCT+ has been shown to be effective, it has been noted that many patients with psychosis do not complete the homework exercises due to several factors, including forgetfulness and lack of motivation. Delivering therapy ‘homework’ via a smartphone app has the potential to increase engagement and compliance, and ultimately, may further improve the efficacy of interventions such as MCT. The “Cogito” smartphone app was developed to complement MCT/MCT+, with a goal of increasing homework adherence and thus maintaining and increasing the gains from therapy. We hypothesize that participants will find the app useful and will be more likely to complete homework activities using the Cogito app than they would using traditional paper worksheet style homework.

  • Investigating the effect of a new agent on heart disease and kidney function in people who have recovered from acute kidney injury

    BACKGROUND:- Acute kidney injury (AKI) is a potentially life-threatening condition caused by unsafe levels of fluid and waste products accumulating in the body due to kidneys not working correctly. AKI can occur in when a person is already unwell with another health condition, and so is more common in people who are in hospital. AKI can increase the risk of heart events, further kidney disease and death. Dapagliflozin is a medication that is used to treat people with diabetes, heart disease and kideny disease. Recent studies have shown dapagliflozin to slow the progression of chronic kidney disease, but it has not been investigated in people who have recently recovered from AKI. AIM:- To determine if giving dapagliflozin (10mg in one capsule per day) compared to placebo (a capsule that looks and smells identical but has no active ingredients) reduces kidney injury in people who have sufficiently recovered from AKI. This is a feasibility trial to show whether this trial will be successful before expanding to a larger trial. DESIGN:- The trial will enrol 60 participants from 3 hospitals with in NSW. Participants will be randomised (randomly assigned; like tossing a coin) by a computer to receive either dapagliflozin or placebo for a maximum of 84 days (12 weeks) and followed up for a total of 112 days (16 weeks). This trial is 'double-blinded' which means the doctor and treating team, nor the participant will know which treatment that are receiving.

  • IDEA: Improved Discharge Experience for All Project. Investigating the effect of a bundle of educational, process change and cultural interventions to optimise the paediatric hospital discharge summary processes.

    This was a (non-randomized) parallel cohort study with intervention and control arms looking at improvement of discharge processes. The study involved an intervention cohort and control cohort (approximately 1:3 ratio). The intervention cohort received a suite of educational, process change and culture change strategies that aimed at improving the discharge summary processes. Study Hypothesis Statement FOR General PUBLIC: Improved hospital processes will lead to tImely discharge summaries with better patient satisfaction.

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