ANZCTR search results

This study is the third phase follow up at 4 years of age of subjects who received neonatal acellular pertussis vaccination. This study looks at safety and immunogenicity of pertussis vaccination, and extends knowledge from the first phase (birth to 13 months) and the second phase (18-24 months).

The proposed study will investigate the efficacy of a tailored 10 week CBT program with minimal exercise intervention vs combined CBT and novel exercise intervention. Depression is a common mental illness, affecting up to 1 in 7 Australians in their lifetime with the third highest burden of all diseases in Australia (i.e. total impact of disease measured by financial cost, mortality, morbidity and other indicators) and the number one cause of non-fatal disablity in Australia. Research has shown that inidividuals who are overweight or obese have higher rates of depression than normal weight peers and that individuals who are depressed are more likely to be overweight or obese than non-depressed peers. The use of exercise has proven to be an effective intervention for depression although a limited number of studies have been performed using a RCT.

Aims This study aims to: 1) develop and examine the feasibility and effect of a psycho-education intervention delivered via mobile application for family caregivers of people with dementia on caregiver burden, coping strategies, depression, gain in caregiving, distress caused by BPSD, and frequency and severity of BPSD over a 3-month follow-up; and 2) examine family caregivers’ appraisal and perceived benefits of the intervention. Hypotheses Primary outcomes When compared with the routine care control group across two time points (immediately and 3-month post intervention), the intervention group will have significantly: lower level of caregiver burden, and higher level of coping strategies. Secondary outcomes When compared with the routine care control group across two time points (immediately and 3-month post intervention), the intervention group will have significantly: lower level of depression, higher level of gain in caregiving, lower level of distress caused by BPSD, and reduction in the frequency and severity of BPSD

Participants between the age of 18 – 35 yrs old that fulfill the inclusion criteria will be chosen to take part in the study. All participants will be randomly assigned to one of six groups 14 days prior to commencement of the study. All the participants will receive a dental clean and will be advised to stop the use of their regular mouthwash. When the experiment begins (day 0) participants will be advised to follow the experimental oral hygiene protocol. And they will be advised to use one of five mouthwashes (or water which is a negative control). Five different gum measurements will be measured and the soft tissue health will be noted at all four visits from the start of the experimental period. At the last visit participants will be requested to fill a questionnaire form as well. In addition they will also receive a dental clean to remove bacterial accumulation on their teeth and extrinsic tooth staining. There is significant evidence in the current literature that commercial alcohol containing mouthwashes such as Savacol (Registered Trademark) and Listerine (Registered Trademark) reduce bacterial accumulation and gum inflammation. However despite some progress, there is a huge gap in clinical evidence demonstrating the efficacy of commercially available non-alcohol containing mouthwashes such as Savacol (Registered Trademark), Listerine Zero (Registered Trademark) and a herbal mouthwash – Dr Organics Aloe Vera (Registered Trademark) mouthwash, in the prevention of bacterial accumulation and gum inflammation. This study is expected to give us more evidence about the benefits that these non-alcohol containing mouthwashes can provide to our patients.

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.