ANZCTR search results

Description of the study: This project entitled ‘Group psychological intervention for people with depression and overweight/obesity’ is a trial of a newly developed group intervention program for people with both depression and overweight concerns. Purpose of the study: The project aims to evaluate the effectiveness of a new group protocol which has been developed specifically to target overweight concerns in people who are experiencing depression. The majority of current approaches for weight loss and weight management focus primarily on dieting and exercise, and while programs for depression often touch on these issues they are generally not the primary focus. Thus the newly developed program targets both problems simultaneously. The main aims are to find out if this will: - Reduce depression - Increase exercise and healthy eating habits - Decrease unhealthy eating habits (such as emotional eating) - Improve stress management - Improve body image and self-confidence - Result in healthy weight loss To be clear, weight loss is not the sole or primary aim of this group program (but is likely to be a secondary outcome). What will I be asked to do? We invite you to participate in a trial of this new program. Participation involves attending ten weekly two-hour group sessions. Participation is voluntary and you may withdraw at any time. Groups will include between eight and twelve participants (ten being optimal), and will be facilitated by two mental health professionals. Sessions have been designed to be highly interactive – they will involve some teaching style presentations, but will mostly be made up of discussions, group exercises, and skills practice. In addition to work conducted in session, participants are expected to practice skills out of session also, to assist with learning and development (for example, monitoring thoughts and emotions, practising relaxation, setting and carrying out goals). Participation in this trial also involves attending several appointments with one of the researchers outside of the program itself for the purpose of assessment and evaluation. The initial appointment held before starting the program will involve a brief face-to-face interview and completion of a number of questionnaires – this appointment is expected to take between 1 and 1.5 hours. The interview component focusses on your level of current depression; the written questionnaires assess other relevant information such as your current activity and eating habits, health beliefs, sleep, self-esteem and body image. This appointment will be repeated at the end of the program, as well as well as at three and twelve months post-program, to help us determine if the new protocol is helpful. We understand that participation in this program involves considerable time commitment on your part. What benefit will I gain from being involved in this study? Our expectation is that by completing this program you are likely to learn new skills and strategies to improve

A large proportion of ED presentations and hospital admissions are preventable as they result from poor self-management skills and subsequently poor judgement of the severity of the manifesting symptoms. Furthermore, some admissions are due to other non-COPD related factors such as loneliness or misattribution of symptoms belonging to other diseases (e.g. anxiety or depression). A pre-triage conducted by trained health professionals who are experienced in detecting the severity of COPD exacerbations has the potential to reduce the number of unnecessary ED presentations. Current best practice management of an exacerbation or flare-up of COPD symptoms is with the use of a written COPD Action Plan and Emergency Pack of medications for early recognition and treatment of symptoms, however evidence demonstrates a minimal reduction in healthcare utilisation or health-related quality of life (Walters, Turnock et al. 2010). An action plan with ongoing support by a case-manager may decrease the impact of exacerbations in health status (Trappenburg, Monninkhof et al. 2011). Therefore this will be a randomised controlled feasibilty trial with the proposed intervention being the addition of 24-hour exacerbation support using existing specialised RNS during business hours and after-hours with SAAS ECP’s. Trained health professionals will assess the patient’s disease status to determine if the patient could be managed at home or requires presentation to a hospital emergency department. Outcomes will review the feasibilty of the study design, hospital utilisation, cost-effectiveness and outcomes of patient self-assessment questionnaires and a semi-structured interview.

This will be a multicentre multisurgeon prospective doubleblinded randomized and controlled trial looking at the effectiveness of single dose intravenous administration of Tranexamic Acid (TXA) in patients undergoing shoulder arthroscopy and rotator cuff repair. The aim of this study is to extend Level I category evidence of the known benefits of TXA to shoulder arthroscopy and rotator cuff repair. The primary objective of this study is to test the hypothesis that systemic use of tranexamic acid decreases postoperative pain and stiffness. All consecutive patients presenting to an elective orthopaedic consultation indicated for shoulder arthroscopy and rotator cuff repair will be considered eligible for this study. After having been screened for inclusion and exclusion criteria, read the information sheet and signed the consent form, patients will be blindly randomized to one of 2 groups: Systemic TXA or Control. Patients’ general demographic characteristics such as age, sex, dominance, diagnosis and other relevant comorbidities will be collected in a deidentified database locked on a password-protected computer. During the surgery, patients will be administered either 2000mg of intravenous TXA or a placebo equivalent (saline solution). Analysed outcome variables will include: occurrence of postoperative haematoma, postoperative pain Visual Analog Scale (pVAS), range of motion at 8 weeks and 24 weeks.

This study aims to determine if a tailored multi-component non-pharmacological delirium prevention intervention is feasible and acceptable for people with advanced cancer in hospital. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have a diagnosis of advanced cancer, and are an inpatient at a participating Australian oncology or palliative care unit. Study details All participants in this study will undergo routine delirium screening and diagnostic assessment. In addition, patients being treated at sites allocated to the intervention will receive a multi-component delirium prevention intervention that includes six domains: preserve natural sleep, maintain optimal vision and hearing, optimise hydration, promote communication, orientation and cognition, optimise mobility and function, and family partnership. Intervention delivery will be tailored to the site, and strategies will be tailored to patient need. Patient, family caregivers, staff and volunteer perspectives about the feasibility and acceptability of the intervention will be obtained using interviews and surveys. The primary outcome is adherence to the intervention, defined as the proportion of patients who achieve at least four completed domains for least five of the first seven days of admission, measured by medical record audit. Secondary outcomes relate to fidelity and feasibility, acceptability and sustainability of the study intervention, processes and measures in this patient population, using quantitative and qualitative measures. The study will inform whether a multi-component non-pharmacological delirium prevention intervention in people with advanced cancer is feasible for testing in a subsequent phase 3 trial.

We intend to undertake this research project on ROTEM®, which is a rapid and specific blood clotting test which has been recently introduced to analyse clotting. This is a rapid test in that results can be obtained within 10 minutes, compared with 30 to 60 minutes for the current standard clotting test. It is specific in that it further defines parameters to assist in deciding what blood products need to be given in the event of bleeding. We will also analyse platelet function using a test called Multiplate®. The purpose of this study is to better understand the type and extent of clotting issues that are potentially seen with the pregnancy-related condition known as pre-eclampsia. You will not receive any direct benefit from participating in this study, but the knowledge gained from this research will help us to improve the management of major bleeding in pregnant patients. If a patient develops pre-eclampsia (uncommon condition) throughout the course of their pregnancy and if they agree to participate, then we will obtain a 7.5mL blood sample either through their IV drip or cannula when it is placed, or when they have blood tests done. This blood sample will be used to process for Multiplate® results, ROTEM® clotting test and the standard clotting test. If the patient has further routine blood tests performed, we will perform matched samples until the pre-eclampsia resolves. If a patient's pregnancy is uncomplicated and if they do not require an IV drip or any blood tests during their labour, then they will not be included in the study. As a substudy, we intend to recruit 20 women undergoing an elective Caesarean, who have experienced uncomplicated pregnancies and have no history of coagulation disorders, to establish a normal range against which the results of our main study cohort will be compared.

Xerostomia or dry mouth is a major problem that many people experience, especially those who have received radiotherapy for the treatment of head and neck cancer and it accompanies other diseases such as Sjögren syndrome. Saliva plays many vital roles in our daily life and people with reduced saliva production can experience a variety of health problems. Pilocarpine is a medication that stimulates the nerves supplying the salivary glands. This stimulates the production of your own saliva. The effect lasts for about three hours, and so it is usually taken three times daily. Pilocarpine is usually taken before a meal to produce more saliva in time for eating. Pilocarpine is only available as eye drops to treat glaucoma in Australia, but tablets are available for treating dry mouth in many countries around the world. This trial investigates pilocarpine orally dissolving tablets (ODTs), which are little tablets that dissolve rapidly in the mouth and can be compounded in pharmacies. This trial will provide information about whether pilocarpine ODTs are effective in treating dry mouth, and this information will help to improve management of dry mouth in Australia. A series of single patient (N-of-1) trials of 5 mg pilocarpine ODTs (intervention) vs placebo ODTs (control) will be run, in people suffering with xerostomia, with a population estimate of the benefit following the combination of multiple SPTs. Participants will complete 18 days of treatment, consisting of 3 cycles. Each cycle contains two periods: 3 days treatment, 3 days placebo. The first day of each period is considered to be the washout and data collected will not be included in analysis. The order of treatment and placebo will be randomly allocated for each cycle. Treatment allocation will be blinded to the participant and the Primary Investigator.

The objective of this study is to evaluate the efficacy and safety of donepezil transdermal patch comparing to donepezil oral tablet (Aricept) in patients with mild to moderate Alzheimer’s disease.

This study aims to assess feasibility of conducting a randomised efficacy trial to compare two different methods of anaesthesia in patients undergoing major cancer surgery. Who is it for? You may be eligible to join this study if you are aged 18 years and over and are scheduled to undergo major cancer surgery expecting to last two or more hours. Study details Study participants will be allocated by chance to one of the two groups. Group 1 - Inhaled anaesthesia, Group 2 - Anaesthesia administered via a cannula into a vein in the arm. This study will inform conduct of a large efficacy trial which will aim to provide insight into the mechanisms by which anaesthetics potentially drive cancer progression with the ultimate goal of developing novel biomarkers and strategies to limit the impact of anaesthetics on cancer progression.

Complex medication regimens are prevalent in residential aged care facilities (RACFs), can be burdensome for residents and are costly in terms of nursing time. The aim of this study is to investigate application of a structured process to simplify medication administration for residents of aged care facilities. We hypothesise this may reduce the total number of medication administration times and decrease time spent administering medications, and may improve clinical outcomes for residents. SImplification of Medications Prescribed to Long tErm care Residents (SIMPLER) is a non-blinded, matched-pair, cluster randomised controlled trial of a single multidisciplinary intervention to simplify medication regimens in RACFs. Research nurses will recruit English-speaking, permanent residents from 8 South Australian RACFs. Medications taken by residents in the intervention arm will be assessed once using a structured tool to identify opportunities to reduce medication regimen complexity (e.g. by administering all medications at the same time, or through the use of longer-acting or combination formulations). Residents in the comparison group will receive routine care. Participants will be followed for up to 3 years after study entry. The primary outcome will be the total number of charted medication administration times at four months after study entry. Secondary outcomes will include time spent administering medications, medication incidents, resident satisfaction, quality of life, falls, hospitalisation and mortality. Individual-level analyses that account for clustering will be undertaken to determine the impact of the intervention on the study outcomes. Study results will be disseminated via conference presentations and manuscripts submitted to peer reviewed journals.

This study aims to evaluate the effects of Nivolumab in Combination with Ipilimumab on biochemical and physiologic functions in Subjects with Advanced or Metastatic Solid Tumors. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a histologically or cytologically confirmed, metastatic or locally advanced solid tumor for which no standard therapy exists or standard therapy has failed. Study details Approximately 21 eligible patients with advanced or metastatic solid tumors will be enrolled into two cohorts. In the first cohort, nine (9) subjects will receive 1mg/kg of ipilimumab every 6 weeks and Nivolumab 3mg/kg every 2 weeks until disease progression or discontinuation due to toxicity or a maximum of 12 weeks. The second cohort of twelve (12) subjects will receive 0.3mg/kg of ipilimumab every 6 weeks and Nivolumab 3mg/kg dosed every 2 weeks until disease progression or discontinuation due to toxicity or a maximum of 12 weeks. The investigators seek to identify/confirm circulating pharmacodynamic biomarkers that correlate with immune activation.