ANZCTR search results

The Synergy Online System collects data via multiple sources including online self-report, health professional and service surveys as well as third-party integrations (e.g. Fitbit) as a means to offer individual user’s personalised assessment and intervention options as well as continuous monitoring. This research employs a naturalistic prospective clinical trial design wherein all individuals presenting for care to a traditional face-to-face or online mental health service (participating in Project Synergy research studies) will be informed of the trial via a tiered consenting process including 'opt-out'. Upon consent, Synergy collects, stores and analyses personal and health information (data) in its database. By taking part in this clinical trial, participants give researchers permission to access their non-identified data, which will be used to scientifically, clinically and analytically validate "stage-based stepped-care" recommendations generated by the System.

Septic shock is a state of low blood pressure resulting from a physiological response to an infection. The low blood pressure commonly presents along with an elevated heart rate, which is in turn associated with poor outcomes in patients. Beta blockers have had favourable effects in the past, but its use in this clinical context may potentially lead to an exacerbation of the low blood pressure. Ivabradine causes selective heart rate reduction via an alternative pathway and is not known to have any other effects on the heart. It has previously been shown to have benefit in the treatment of chronic heart failure and stable cardiac disease, and previous studies have documented safety and tolerability. Furthermore, it has been used in acute medicine for the treat-ment of patients with low blood pressure due to acute heart failure and is currently being tested in critically ill patients with multi-organ failure. We propose to conduct a feasibility study to test whether Ivabradine can be used safely to reduce the heart rate in patients who are in septic shock with an elevated heart rate.

PTSD is the most common psychological disorder in veterans, and while evidence-based treatments exist, much can be done to improve outcomes. The study is a pilot randomised-controlled-trial comparing two interventions in veterans with a diagnosis of PTSD before and after they receive standard hospital treatment. This study will test the efficacy of two types of attention training to augment standard treatment for veterans with a diagnosis of PTSD. Attention training is delivered via computer and involves participants viewing words on a screen and then pressing a corresponding button on the keyboard. The first task, ‘Attention Control Training’ (ACT) works by re-balancing attention, whilst 'Attention Bias Modification; (ABM) aims to decrease over-responding to threat stimuli. We want to investigate whether receiving either one of these attention training programs significantly improves mental health outcomes after receiving standard treatment.

Traditionally, latent tuberculosis infection (LTBI) in Australia are treated with either six to nine months of daily isoniazid (6-9H). These regimens are hepatotoxic and long. Recent randomized trials have shown that two shorter regimens are equally effective, but substantially less toxic. Four months of daily rifampicin (4RIF) and three months of once weekly rifapentine and isoniazid (3HP). This study will address the following primary research question: What is the treatment completion rate for patients with LTBI treated with home-based 3HP plus SMS monitoring, compared to daily self-administered 4RIF?

The purpose of this study is to examine the feasibility of body-mind exercises (called ‘Qigong’) for cancer survivors. Who is it for? You may be eligible for this study if you are aged 18 or over, completed anticancer treatment at least 3 months ago and meet a criteria for insomnia. Study details All participants will partake in a three week group program, involving two face-to-face sessions and three online sessions. The program will involve slow-moving gentle exercise in a standing or sitting position. Participants will complete a diary and answer some questionnaires throughout the three week program and for a week after the program It is hoped this research will provide some evidence of the feasibility and potential benefits of Qigong for insomnia in this patient group.

Cardiac rehabilitation (CR) is an important secondary prevention strategy, yet women’s participation is low. It has been postulated that lower self-efficacy and social and psychological factors contribute to a low participation (Briffa et al 2009). Literature suggests that CR programs specifically designed for women, based on their expressed needs, are effective in improving the physical functioning and symptom status of participants. The aim of this project is to investigate the use of a gendered approach to healthcare through developing strategies to improve women’s heart health in Australia, including evaluating in a randomised controlled trial the benefit of a group-based program, tailored specifically to the needs of women, to increased self-efficacy and improve functional status. Key components of the intervention include information about heart disease, changing social roles, the impact of emotions on cardiovascular health, coping with stress, communication, and strategies to promote self-management. This project incorporates a gendered approach to health care, which is commonly lacking in cardiovascular science.

Insomnia is a highly prevalent chronic illness with approximately 30% of Australian adults classified as having insomnia or insomnia symptoms. The societal costs are significant with an estimated $10.9 billion in direct and indirect costs in Australia. Insomnia patients have poor health related quality-of-life, increased risk of depression, increased workplace disability and costs, impaired driving performance and increased risk of death from motor and unintentional fatal injuries. The majority of people with insomnia who are treated by primary care physicians will be prescribed hypnotic medications. This is despite substantial evidence that hypnotics are only marginally more effective than placebo and are not effective for long-term management. Hypnotics also come with significant risk for a range of side-effects (falls, car crashes, accidents and potentially increased overall mortality). Cognitive Behaviour Therapy for Insomnia (CBTi) has shown to be more effective long-term solution for people with insomnia. However, CBTi has major drawbacks as it requires specifically trained therapists, and is a complex time-consuming composite therapy that may include therapeutically redundant components. Sleep Consolidation Therapy is a behavioural component of CBTi that has been specifically tested in isolation and found to be as effective as multi-component interventions. The therapy ‘consolidates’ sleep-wake schedules by maximising sleep time through restricting bed time. This is achieved by anchoring bed times so that individuals are mildly sleep restricted which promotes sleep onset and decreases wake time in bed. The clinical delivery of the therapy can be relatively short (typically 1 hour delivery + weekly 10 minute telephone calls), but requires clinician input regularly. Sleep Consolidation Therapy has the potential to be delivered more widely as it has been shown to be feasible in primary care settings. We have recently developed a proof-of-concept mobile application following participatory design, user experience focus groups and a pilot study testing the engagement of the application. The mobile application can deliver population-based therapy for insomnia patients thereby improving scalability and treatment options. We now want to test the effectiveness of the mobile application to deliver Sleep Consolidation Therapy in participants with insomnia symptoms.

This study will evaluate the safety and efficacy of External Beam Radiation Therapy (EBRT) in combination with 177 Lu-prostate-specific membrane antigen (Lu-PSMA) theranostic against EBRT alone in patients with recurrent prostate cancer. Who is it for? You may be eligible to join this study if you are a male aged 45 years or above and have a confirmed diagnosis of recurrent prostate cancer following previous radical prostatectomy (RP) with curative intent. Study details Participants will be randomly allocated (by chance) to one of two groups. Participants in one group will undergo external beam radiation therapy (EBRT) in combination with 177Lu-PSMA theranostic treatment. EBRT will be administered daily (on weekdays) over 6.5-7 weeks. 177Lu-PSMA will be administered intravenously in three treatment cycles of once every 8 weeks. Participants in the other group will receive EBRT alone. All participants will be asked to attend 3-monthly follow up visits from the end of treatment for a total period of 24 months, in order to assess treatment response, safety, and health-related quality of life. It is hoped that EBRT delivered together with 177Lu-PSMA will enable the delivery of higher radiation doses to the tumour, resulting in a greater treatment response and improved survival.

This project aims to establish a shared registry between Australia and New Zealand in which all patient outcomes and patterns of care are measured for anyone undergoing Nephrectomy surgery. Who is it for? You may be eligible to join this study if you are aged 18 years or above and are scheduled to undergo nephrectomy or nephroureterectomy surgery in Australia or New Zealand. Study details All participants in this study will have the details of their nephrectomy or nephroureterectomy surgery recorded in a Registry, including diagnosis by procedure type, technique by procedure type (e.g. laparoscopic/ robotic/ open), average patient risk factors, complication rate (risk adjusted), transfusion rate (risk adjusted), mortality rate, and length of stay. By collecting this information we hope to identify trends and improve the quality of patient care as well as guide future surgical training.

The purpose of this study is to determine whether omega-3 supplementation attenuates aggressive behaviours in adult male prisoners who have previously demonstrated aggression within the prison. Prisoners will be randomly assigned to an active or placebo supplementation condition. Measures of institutional aggression and hypothesised associated mental health condition (ADHD) will be collected to assess the impact of omega-3 supplementation. It is hypothesised that prisoners receiving the active (omega-3) supplements will demonstrate reduced aggressive behaviour and reduced ADHD symptoms, compared to prisoners receiving a placebo supplement.