ANZCTR search results

We hypothesise that people who receive a short treatment encouraging people to set and achieve goals after a diagnosis of mild cognitive impairment or dementia will result in improved quality of life. The ‘Take Charge’ intervention is a short (2 session) therapeutic intervention which encourages people with chronic health conditions to consider their values and what is important to them and how they will maximise their quality of life in the coming months. The ‘Take Charge’ intervention was tested in two randomised controlled trials in New Zealand and was shown to be effective in improving health related quality of life when used with people after stroke. We are proposing to adapt the ‘Take Charge’ intervention with minor modifications and test the intervention with people with mild cognitive impairment and dementia. We are proposing to conduct a pilot study which will test feasibility and inform a larger trial of efficacy. Within the pilot we will be able to determine the feasibility of recruitment to the trial, randomising to the treatment arms, delivering the intervention in this population, and applying the outcome measures. We will also be able to explore whether people who received the intervention found it to be beneficial through both the quantitative data and interviews with people who received the intervention.

Angiotensin II is an endogenous peptide that causes potent vasoconstriction and promotes the release of aldosterone from the zona granulosa of the adrenal gland. The ATHOS-3 study demonstrated that continuous infusion of angiotensin II could effectively augment mean arterial pressure compared to placebo in patients with catecholamine refractory shock. Secondary analyses suggested that angiotensin II may be of particular benefit in patients with acute kidney injury, especially in those with a high ratio of angiotensin I to II. This prospective study will examine the renal outcomes of critically ill patients with distributive shock who receive angiotensin II compared to noradrenaline. Patients who meet all of the inclusion criteria and none of the exclusion criteria will receive a continuous intravenous infusion of angiotensin II until resolution of their distributive shock. The renal outcomes and survival of patients receiving angiotensin II will be compared to those of control patients who received noradrenaline in the preceding period.

The macronutrient fat is almost never consumed on its own but together with other macronutrients. The presence of fat in the digestive tract stimulates the release of the digestive peptide cholecystokinin (CCK) which in turn mediates feelings of fullness, eventually resulting in satiation (meal termination). There is evidence that CCK and stomach distension may work in combination to greater enhance such feedback. The presence of fat and high energy dense carbohydrates in the modern diet may result in a higher than optimal energy intake taking place prior to satiation, leading to weight gain and obesity. The purpose of this study is to determine whether the satiating properties of fat may be more effectively realised by combining fat with low energy dense carbohydrate in the diet.

This study involves the evaluation of an online CBT-based intervention (Reframe IT) delivered to secondary school students in North-West Melbourne. This study forms part of a larger study (the MAPSS project) which also involves delivery of educational workshops to school students. The educational workshops will be evaluated using a pre-test post-test study design. Participants in the current trial will be students who have experienced suicidal ideation in the past four-weeks, identified via their responses to the baseline questionnaire for the MAPSS project. Eligible participants will be invited to participate, and those who consent will be randomised to either Reframe IT or TAU conditions. The intervention period occurs between 2- and 12-weeks post-baseline assessment. The primary outcome is change in suicidal ideation; secondary outcomes are change in depression, hopelessness, and problem-solving skills.

The aim of this project is to investigate whether or not using the right internal mammary artery (rather than the ascending aorta) as a source of blood inflow for coronary artery bypass graft surgery (CABG) results in superior long term graft patency. CABG has been shown to be the most durable method of myocardial revascularisation. Efforts to further extend the long-term benefits of CABG have mainly focussed primarily on improving graft patency rates by using arterial grafts. Less attention has been paid to graft haemodynamics, particularly the source of graft inflow, and the role that this may play in prolonging graft patency. We know that high wall sheer stress leads to graft failure and we believe that gentler mammary artery inflow may encourage improved graft harm-dynamics and therefore patency. We plan to randomise patients undergoing CABG to standard practice (which involves using the ascending aorta as inflow) or to a composite graft group (using the right internal mammary artery as inflow) in order to assess whether or not graft inflow affects patency.

Volunteer hospital staff shall be asked to participate in three phases. The order of the phases shall be randomised. Each shall last for 4 hours. One phase is wearing a standard surgical trilayer mask. Another phase is wearing a fit tested N95 mask, And another is wearing no mask. We shall ask you to complete some baseline questionnaires, a summary of your past medical history, a list of medications, a list of past operations, a psychological assessment tool assessing depression and anxiety, and how short of breath you are feeling. We will also measure your blood pressure, heart rate and oxygen level. Every half an hour, a study investigator will come to you, and using a portable monitor shall measure your oxygen level and ask how short of breath you are feeling, using a scale from 0 to 10 and some simple questions relating dyspnoea to activity,. We shall not show you what your oxygen levels are, a process we call "blinding".

The research project aims to conduct a multicentre trial with 204 caregivers (34 in each of the six study sites) in a 9 month period to evaluate the effectiveness and cost-effectiveness of the Chinese version of WHO iSupport program. The hypotheses tested in the study are described in the following: 1. The generic web-based Chinese iSupport version Carers receiving the iSupport program will report improved quality of life; improved self-efficacy and report improved social support compared to the usual care group at a 6-month follow-up. 2. Compared to those allocated to the usual care group, carers receiving the iSupport program will report reduced dementia related symptoms of the person they care for; report improved quality of life of the person they care for via proxy rating and report fewer unplanned hospital admissions, less emergency department use and less use of permanent residential aged care by the person they care for. 3. The iSupport program will be more cost-effective than the usual care support.

Fathers' perinatal mental health is a major public health issue, but few fathers seek or are offered mental health support. Emerging evidence suggests that fathers prefer informal, digital methods of perinatal support, but currently few tools exist for them to access. This research project aims to evaluate an app-based mindfulness-CBT intervention for fathers mental health using an RCT design. A secondary, exploratory aim is to investigate the usefulness of social media data for identifying fathers in-need of support. The hypothesis is: Participants allocated to the smartphone intervention will experience significantly greater reductions in mental health symptoms, parenting self-efficacy, and infant bonding at post-test (4 weeks from baseline) relative to participants allocated to the wait-list control.

Impaired hand function is a common cause of everyday disability for people with Parkinson’s disease (PD) and can contribute to difficulties in work and leisure activities and daily tasks such as personal care and dressing. Changes in dexterity are also closely associated with reduced quality of life. Despite this, there is little evidence to guide physiotherapy or occupational therapy management of this problem. The primary aim of this pilot randomised controlled trial is to investigate the whether this novel home-based training program, targeted to improving hand function in people with PD, is feasible and acceptable to participants. Participants will be randomly allocated into a training group or a usual care group. The training group will undertake a home-based hand training program and the control group will continue with their usual care. Participants in the training group will be provided with home exercise instructions using an online exercise prescription application with uploaded exercises and will be asked to complete the training for 30 minutes, three times a week for four weeks, The training program will be monitored remotely once a week via telerelerehabilitation. Following the 4-week program there will be two further 30-minute telerehabilitation coaching sessions at 8 and 12 weeks. Main outcome measures relate to feasibility and include recruitment and retention, participant adherence and satisfaction with the program, and adverse events. Secondary outcomes are associated with the effectiveness of the program and include assessment of fine hand skills and self-reported hand function. Participants will be assessed before randomisation (baseline), post-training (4 weeks), and at 12 weeks and 24 weeks. We hypothesise that the study will show good feasibility with strong retention, adherence and high satisfaction with the program.

The ADELE clinical trial seeks to improve outcomes for people with high-risk endometrial cancer, who have a significant risk of relapse after standard post-operative treatment with chemotherapy & radiotherapy. Who is it for? You may be eligible for this study if you are aged 18 or older, have been diagnosed with high-risk endometrial cancer, have completed prior surgical treatment with total hysterectomy, have not received any prior chemotherapy or pelvic radiotherapy, and are planned for adjuvant chemoradiation. Study details Participants will be randomly (by chance) assigned to one of two groups. One group will receive a sequential adjuvant treatment of pelvic chemoradiation, followed by 4 cycles of the new combination therapy with Tislelizumab and carboplatin plus paclitaxel chemotherapy, followed by Tislelizumab for another 8 cycles. The other group will receive the same treatment (standard treatment) without the addition of Tislelizumab. Participants will be followed up for 12 months to assess for relapse of endometrial cancer and symptoms of treatment. It is hoped that this study may improve relapse rates in high-risk endometrial cancer by adding Tislelizumab immunotherapy to standard treatment.