ANZCTR search results

A simple baseline controlled open trial methodology will be used to investigate the efficacy of the Strengths eHealth program, as well as the characteristics of participants and their usage of the program. The Strengths eHealth program is housed within the Federation eHealth Platform. The Strengths eHealth program consists of three sessions designed to help a person identify, develop and maximize the use of their personal strengths to enhance their health and wellbeing. The program uses evidence based positive psychology principles and established face-to-face protocols that were operationalised and transformed for self-administration via a fully automated website with feedback and reminder mechanisms. Participants will spend a week completing each session before moving onto the next session, so as to practise and to reinforce the session material learnt. Each session will last for approximately 15 minutes and its user friendly and interactive components are designed to keep the user engaged. To consolidate learning, participants will be given activities (approximately five minutes per day) to complete offline to practise the principles of identify and maximising strengths and asked to provide simple feedback on this practise at the next session. Participants will complete online questionnaires at pre-program, during-program, post-program, and at a one and three month follow-up stage.

A simple randomised controlled trial (RCT) design will be used to evaluate the effectiveness of a online Cognitive Behavioural Therapy (CBT) program for decreasing the symptoms of panic and anxiety (called Panic eHealth). The Panic eHealth program is placed within the Federation eHealth Platform, which is a platform containing multiple eHealth programs. People who visit the website, either directly or through seeing the program advertised, will be invited to take part in the Panic eHealth evaluation study. Those that consent will be randomly allocated to one of 3 groups: 1) Panic eHealth program (with immediate access to all of the program modules) group, 2) Panic eHealth program (with weekly, sequential release of the program modules) group or to 3) a wait control group (delayed access to the Panic eHealth program with weekly, sequential release of modules). The delayed access group will receive the intervention following a 10-week waiting period. Panic eHealth contains six modules, delivered over six weeks. It is designed to provide people with strategies to address their panic and anxiety. Each module will take approximately 20 minutes to complete. In addition, in order to reinforce the module-based information there are 20-30 minutes of offline activities each week. Participants will also receive automated emails (e.g., to remind them to log on, when to complete post/follow-up questionnaires) and will be asked several questions at the beginning of each week, to monitor their progress. Participants randomised to the Panic eHealth program groups will complete a pre-intervention assessment (Week 0), during intervention (Week 1-6) assessment, post-intervention assessment (Week 7) and a 1 and 3 month follow-up assessment (Week 11 & Week 19 respectively). Participants randomised to the delayed access program group will complete the same assessment phases, except for the 3 month follow-up assessment, as they will be given access to Panic eHealth program following the 1 month follow-up assessment (Week 11). However the delayed access group will be asked to complete the post intervention assessment after they complete the Panic eHealth program (Week 17).

A randomised controlled trial will be used to investigate the effectiveness of the Mindful eHealth program. The Mindful eHealth program is placed within the Federation eHealth Platform. People visiting the website, in response to advertisements or through self interest, will be informed of the availability of the Mindful eHealth program and invited to participate in the study. People taking part in the study will be randomly allocated to either an immediate access to the online program, or delayed assess (15 week delay). The Mindful eHealth program consists of three sessions designed to make an individual more mindful or being aware of moment-to-moment experiences (e.g., thoughts, feelings, images, sensations) and simply accepting what is there and not wanting it to change it in any way. Participants will spend a week on each session before moving onto the next session, so as to practise and to reinforce the session material learnt. Participants will complete online questionnaires at pre-program, during-program, post-program, and at one and three month follow-up stages of the study.

Participants with dual diagnoses of acute coronary syndrome and type 2 diabetes in both intervention and control groups will be evaluated on primary and secondary outcomes to determine whether aims of the study have achieved. Aims: 1)To evaluate the effect of the Cardiac/Diabetes TRANS-CARE on: 6-month re-admission rates, time to first readmission, unplanned emergency department presentations, general practitioner visits after discharge, self-reported health status, psychosocial well-being at 1, 3 and 6 months. 2) To evaluate the cost-effectiveness of this intervention from the perspective of the health system

It is known that 30-50% of inpatients are either malnourished or at risk of developing malnutrition, including those at our Eastern Health facilities. A range of strategies have been tried to reduce weight loss during admission, but few have proven effective. Protected mealtimes is a strategy that aims to protect mealtimes from unnecessary and avoidable interruptions, through providing a supportive environment for eating. It supports staff to provide patients with support and assistance with meals, and is therefore a systems approach to address the vast problem of in-hospital malnutrition. This study will compare the implementation of a protected mealtimes intervention with usual care in the subacute setting. The study aims to positively improve food intake at mealtimes, therefore treating and preventing malnutrition developing. A high quality study design will be used, with the intervention introduced incrementally across three subacute sites. Evaluation will focus mostly on energy and protein intake, with compliance with the implementation also evaluated. The observational studies of protected mealtimes to date have shown promising clinical outcomes effects, but these effects have been limited due to reports of barriers to implementation of the strategy. These will be addressed through the design and implementation of this translational study. The research is supported by an NHMRC Fellowship, enabling a high quality study to be undertaken.

The purpose of this research project is to test the effectiveness of a drug, called nivolumab, and the combination of nivolumab together with ipilimumab for the treatment of melanoma that has spread to the brain (known as brain metastases. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with melanoma with brain metastases. Study details Both drugs are approved treatments for advanced melanoma in Australia and overseas, but there is limited information on the effectiveness of the combination of these drugs in treating melanoma that has spread to the brain. This is a Phase 2 study and will look to evaluate the effectiveness of nivolumab and nivolumab combined with ipilimumab in three patient groups: groups 1 and 3 are melanoma patients with brain metastases that have had no prior localised treatments and no neurological symptoms related to brain metastases, while group 2 are melanoma patients with brain metastases who have had a prior failed local therapy or have current neurological symptoms or have leptomeningeal disease. Groups 1 and 2 will receive intravenous infusion of nivolumab 3mg/kg every 2 weeks until disease progression, unacceptable toxicity or death. Group 3 will receive nivolumab 1mg/kg combined with ipilimumab 3mg/kg every 3 weeks for 12 weeks then nivolumab monotherapy (3mg/kg every 2 weeks) thereafter. Responses to treatment and progression will be regularly monitored until the last patient has been in survival follow-up for 5 years. Tumour and blood samples will also be taken to determine possible predictive markers.

A pilot randomised controlled trial to evaluate the effect of an online shyness information program on the help seeking intentions of adults with social anxiety. The primary aim of the study is to collect data that will demonstrate the feasibility of the recruitment procedures and inform the design of an appropriately powered trial.

Rivastigmine (RIV) is an acetylcholine esterase inhibitor which prevents neurotransmitter breakdown. As such it is currently approved for the treatment of neurological disorders such as Alzheimer's and Parkinson's disease. RIV is available in two forms, oral (capsule and liquid) and as a transdermal (through the skin) patch. The latter was developed as a consequence of the oral forms causing nausea, vomiting and diarrhoea predominantly caused by the low oral bioavailability of this drug. Although the transdermal patch overcomes a lot of these side effects, a high percentage of people suffer from skin irritation and possible sleeplessness. This study will investigate whether delivering RIV intranasally (into the nose), results in lower side effects, while maintaining the desired therapeutic effect. As such this study will compare the bioavailability of intranasal delivery to intravenous delivery of RIV at a level that is reported to be therapeutically beneficial. Each intervention will be as a single dose with thorough blood sampling over 24 hours to assess drug levels; each intervention will be separated by a 2 day washout period. This is an exploratory phase 1 trial in 8 healthy elderly males and females aged 55 to 85 years. While comparing the two delivery methods, this study will also investigate the safety and tolerability of intranasal Rivastigmine.

PULSAR stands for ‘Principles Unite Local Services Assisting Recovery’. The overall aim of the PULSAR project is to imbed recovery-oriented practice in primary care and specialist mental health services in the Monash Health catchment. Recovery-oriented practice involves supporting a process of change through which individuals improve their health and wellness, live a self-directed life, and strive to reach their full potential. A training package has been developed in the UK that promotes recovery-oriented practice in teams. We will adapt these materials to needs of the Australian and Victorian mental health care system, the local cultural and legal contexts. The PULSAR intervention involves training staff in recovery-oriented practice using these adapted materials. The current trial pertains to the evaluation of the PULSAR intervention within primary mental health care services; the evaluation of PULSAR in specialist care services is being evaluated in a separately registered trial with ANZCTR. In the primary care trial, we planned to deliver the PULSAR intervention to staff at up to 30 primary care sites (clusters) across the Monash Health catchment area and adjoining Medicare Local regions and evaluate the effect on adult mental health patients of these services. Half of the clusters would be randomised to receive the PULSAR intervention in year one, the other half in year two. Clusters will be separated into similar types of services before randomisation to ensure cluster types are balanced across treatment conditions. Our key hypotheses are that consumers in the PULSAR intervention clusters will experience significantly greater gains in personal recovery, health and wellbeing compared to consumers receiving care in control groups. Data will be collected cross-sectionally from a minimum of 126 consumers at baseline, 9 and 18 months. The total number of participants will be a minimum of 378 consumers. Consumers will be recruited into the study if they respond to an invitation letter by returning a signed consent form and the project questionnaires mailed by their current service on behalf of the researchers. The questionnaires can also be completed online. The above documents the study design as intended to be carried out. However, we did not achieve the intended recruitment targets therefore we adapted the analysis to a pre-post design. This adaptation and final analyses that flow from that are described in the final results paper (see "Study Results"). The significance of the work will be to develop, evaluate, and make readily available a set of training materials and organisational change tools that would facilitate participating mental health services working together to successfully delivery recovery-oriented practice. Embedded qualitative studies explored GP and patient perspectives of recovery-oriented practice and investigated the relevance of the QPR within culturally and linguistically diverse communities.

The aim of this study is to determine the enduring effects on survivorship of an exercise intervention administered in addition to usual care, compared to usual care alone, during first-line chemotherapy for epithelial ovarian, primary peritoneal and fallopian tube cancer. Woman aged 18 years or above, who have been newly diagnosed with epithelial ovarian, primary peritoneal or fallopian tube cancer of any histological type and are suitable for first-line chemotherapy are eligible to participate in this study. Participants are randomly allocated (by chance) to one of two groups. Participants in one group will receive a structured exercise program, in addition to usual care, whilst participants in the other group will receive usual care alone. The structured exercise program will likely include walking and resistance exercise. Participants will be asked to complete questionnaires regarding their physical well-being and quality of life. Participants will be followed for up to 5 years.