ANZCTR search results

This feasibility trial will evaluate the provision of pre-operative carbohydrate drinks in the acute hip fracture setting to inform feasible and clinically relevant reserach protocol to enable a larger efficacy study to answer the research question.

Bladder infections (urinary tract infections or UTI) are amongst the most common infections in women. It is estimated that almost 50% of women will experience at least one episode of UTI in their life time and almost 44% will experience a recurrence within 6 months. These infections can be very troublesome and cause issues like burning sensation when urinating or going very frequently to pass urine, lower abdominal pain, nausea and vomiting, tiredness, days lost from work and sometimes admission to hospitals. While treatments are available to treat these infections, some women will experience several UTI during a year. These women may benefit from preventive treatments. In this study, we are planning to use Methenamine Hippurate or Hiprex which breaks down to a specific chemical in the bladder which can stop the bacteria growing in the bladder; it is not an antibiotic. The rationale in using this medication is that to date there has been no bacterial resistance reported to Hiprex and generally it is a well-tolerated medication with a low side effect profile. In this study, we will compare Hiprex to nitrofurantoin, an antibiotic used for many years to treat and prevent UTI. While effective, nitrofurantoin has the same implications as other antibiotics when used long-term which are resistance and side effects.

This is a prospective observational study looking at bone health in transgender individuals. The purpose of this study is to investigate the changes that occur during cross sex hormone therapy for gender dysphoria, in particular changes to the architecture of bones but also to muscle mass, fat mass, cardiovascular risk factors and quality of life. We will recruit participants just about to start on hormone therapy (i.e. have not previously taken gender hormones in the past) . We plan to review participants 5 times over a 2 year period and will be using DXA/body composition scans as well as a specialised bone CT scan. We will also be performing blood tests and quality of life surveys.

Extremely premature infants do not tolerate enteral feeds well and are routinely tube fed. Our pilot trial suggests that regular smell and taste of milk with tube feeds may lead to better milk tolerance in very preterm infants, but interestingly may also increase weight z-scores at discharge, an outcome potentially relatedto better head growth and later neurodevelopmental outcomes.

The purpose of the proposed project is to examine the acceptability, efficacy and feasibility of a low-intensity CBT-based self-management program, the Wellbeing Neuro Course to support the emotional and cognitive health of adults with neurological conditions. The proposed trial employs a single-group open-trial design (n = 100) and participants will be given access to a modified version of an established self-management Course for managing depression, anxiety and disability associated with chronic conditions (the Chronic Conditions Course). The Course contains a 6-lesson 10-week internet delivered program. Participants will have brief weekly contact with a clinical psychologist as they work through the Course. A single-group open-trial feasibility design will be employed; all participants are provided full and immediate access to the Wellbeing Neuro Course and are asked to complete standardised questionnaires at 3 main time points: Pre-treatment, post-treatment and 3-month follow-up.

This research project is being conducted to look at the pharmacokinetics of both DUR-928 and Midazolam; this is done by measuring the amount of DUR-928 and Midazolam in the blood at different times throughout the dosing periods. Data from this study will allow us to evaluate how DUR-928 is handled by the body (for example how quickly it gets into the blood stream) and it will allow us to determine the impact of DUR-928 on how Midazolam is handled by the body.

A randomised controlled trial will be used to investigate the effectiveness of the iChooseWell program. The iChooseWell program will be offered through the My Digital Health platform. People visiting the website, in response to advertisements or through self-interest, will be informed of the availability of the iChooseWell program and invited to participate in the study. People who consent to take part in the study will be randomly allocated to either an immediate access to the program condition or a delayed access condition (8 week delay). The iChooseWell eHealth program consists of 41 biological, psychological, social, and wellness strategies, all designed to increase mind and body health (e.g., sleep hygiene, social connectedness, practising gratitude). Participants will be able to choose from the array of biopsychosocial strategies available within iChooseWell. Background information is also provided on health and wellbeing (e.g., the stress response, brain/neural plasticity) and useful resources are provided (e.g., self-monitoring, ‘On the Go’ mobile tools). Each individual wellness strategy is between 2-6 pages (taking between 5-20 minutes to read) and its user friendly and interactive components are designed to keep the user engaged. To consolidate learning, participants will be given activities (10 minutes per day on average) to complete offline to practise the principles of the chosen wellness strategies. Participants will also receive automated emails (e.g., remind them to log on, when to complete post/follow-up questionnaires). The iChooseWell program includes text, graphics, audio, video, interactive games, quizzes, and downloads. iChooseWell can be accessible via web, mobile or tablet devices. Participants randomised to the iChooseWell immediate access group will complete a pre-intervention assessment (Week 0), during intervention (Week 3) assessment, post-intervention assessment (Week 5) and a 1 and 3-month follow-up assessment (Week 9 and Week 17). Participants randomised to the delayed access group will complete the same assessment phases and will be given access to the iChooseWell digital health program following the 1 month follow-up assessment (Week 9). However, the delayed access group will be asked to complete the post intervention assessment after they have completed the iChooseWell program (Week 13) and a 1 month follow-up (post program) (Week 17). Access to iChooseWell will be provided for the entire trial period. Engagement will be measured by the number of strategies visited by post assessment (measured via passive analytics). It is expected that people who undertake iChooseWell immediately will show greater reductions in negative affect and increases in mental health and wellbeing and optimism and at post-intervention and the 1 month follow-up time point, as compared to the delayed access group.

An automated (self-help) decision-support crisis and suicide prevention program (called iConsiderLife) will be evaluated. The iConsiderLife program is one of the My Digital Health platform programs. People visiting one of the My Digital health sites will be able to find a link to iConsiderLife within the ‘Crisis and General Support Services’ page. This page provides the general public with information and links to crisis and mental health service providers. In response to clicking the iConsiderLife link or hearing about the iConsiderLife site, people will be invited to participate in the study. People wishing to participate in the iConsiderLife evaluation study will be provided with immediate access to the program, following the provision of their informed consent to participate in the study and answering several brief demographic / personal questions. People who do not wish to participate in the evaluation study or are under 18 years of age will be provided with a list of alternative sources of support. iConsiderLife is designed to provide people who are currently distressed or experiencing a crisis with a simple, step-by-step, problem solving approach design, to assist in reducing this distress in real time. There are six key sections that participants are guided through one by one. If a person was to say ‘no’ to each question within the program, it would take them approximately 3 minutes to complete. People are asked their age, gender, what country they reside in, postcode if Australian, whether or not they are currently under the influence of alcohol and other drugs, and their current level of distress (from 0 – 100). Once people reach the end of iConsiderLife, or opt out early because they are no longer feeling as distressed, the person is asked to re-rate their distress level and they are then provided with some additional feedback / information. The flow (e.g., what sections people visit most) and their before and after distress ratings will be explored to examine the effectiveness of the program. It is expected that people who use the iConsiderLife program will feel less distressed once they have finished using it.

A cognitive behavioural and biopsychosocially-based program for decreasing symptoms of post-traumatic stress, as well as anxiety and depression (called LIFE FLeX 4 PTSD), will be evaluated. LIFE FLeX 4 PTSD is one of the digital health programs offered through the My Digital Health platform. People visiting the platform, in response to advertisements or through self-interest, will be informed of the availability of the LIFE FLeX 4 PTSD digital health program and invited to participate in the study. People taking part in the study will be provided with immediate access to the program, following completion of the pre-intervention schedule. LIFE FLeX 4 PTSD is designed to provide people with information and strategies to address their post-traumatic stress, anxiety and depressive symptoms and contains six ‘core’ modules, plus an Introduction module, delivered over 8 weeks. There will also be a short ‘Booster’ Module released in Week 11. Each module will take approximately 25 minutes to complete. In addition, in order to reinforce the module-based information, there are 30 minutes of offline activities each week. Participants will also receive automated emails (e.g., to remind them to log on, to complete their daily mood survey, when to complete post/follow-up questionnaires) and will be asked several questions at the beginning of each module to help evaluate the module they previously completed. Participants will complete a pre-intervention assessment (Week 0), during intervention (Week 1-8) assessments, post-intervention assessment (Week 9) and a 1 and 3 month follow-up assessment (Week 13 & Week 21 respectively). Participants will also be asked questions relating to their program engagement levels at post assessment. Program access will continue for another 8 weeks post the 3 month follow-up assessment (Week 29). It is expected that people who undertake LIFE FLeX 4 PTSD program will show reductions in post-traumatic stress, anxiety and / or depressive symptoms at post-intervention assessment and follow-up assessment time points, as well as increases in positive affect and emotional regulation.

A cognitive behavioural and biopsychosocially-based digital health program (called iSleepWell) for decreasing insomnia and stress symptoms will be evaluated.iSleepWell is one of the digital health programs offered through the My Digital Health platform. People visiting the iSleepWell site or the My Digital Health platform, in response to advertisements or through self interest, will be informed of the availability of the iSleepWell program and invited to participate in the study. Consenting participants will be provided with immediate access to the iSleepWell digital health program, following completion of the pre-intervention schedule. iSleepWell is a self-help digital health program designed to provide people with information and strategies to address their insomnia and stress symptoms. iSleepWell contains five core modules, delivered over 7 weeks. Each module will take approximately 25 minutes to complete. In addition, in order to reinforce the module-based information, there are 30 minutes of offline activities per week. Participants will also receive automated emails (e.g., to remind them to log on, to complete their daily mood survey, when to complete post/follow-up questionnaires) and will be asked several questions at the beginning of each module to help evaluate the program modules. Participants will complete a pre-intervention assessment (Week 0), during intervention (Week 2, 4, 6) assessments, post-intervention assessment (Week 8) and a 1 and 3 month follow-up assessment (Week 12 & Week 20 respectively). Participants will also be asked questions relating to their program engagement levels at post assessment. It is expected that people who undertake iSleepWell will show reductions in their insomnia symptoms at post-intervention and follow-up assessment time points, as well as decreases in stress, anxiety and or depressive symptoms.