ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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30846 results sorted by trial registration date.
  • Abdominal drains for ascites

    Chronic liver diseases, from any aetiology, progress over time to cirrhosis if untreated. Ascites-related readmissions are the predominant cause of hospitalisations in these patients, especially in the last few months of life. Large volume paracentesis is the only therapeutic option in those who cannot undergo LT. LVPs are typically performed every week or two in medical day-care units (MDU) as elective procedures, or as emergency hospital admissions. There are practical difficulties in organising LVPs due to bed limitations in the medical day-care unit, and this situation often leads to emergency room presentations and hospitalisations. Since ascites drainage in patients unsuitable for LT is a palliative procedure, it is best done in the comfort of their homes on a regular basis. This study explores the possibility of an alternative procedure via a catheter inserted in the abdomen and repeated small-quantity drainages (simply, long-term abdominal drains or LTADs).

  • The right to rehabilitation for people with dementia: Implementation and evaluation of the "INCLUDE" interventions

    There is evidence for rehabilitation interventions to reduce disability and improve wellbeing for people with dementia. However, experiences of people with dementia with rehabilitative treatments are almost non-existent. There are barriers and challenges at multiple levels: 1) Health professional stigma about the value of rehabilitation for people with dementia and their ability to engage in therapy, 2) Low levels of knowledge about the evidence for dementia rehabilitation exist, which is also likely to contribute to stigma, 3) People with dementia and their care partners find services hard to navigate and report needing information to empower them to ask for rehabilitation and support to access it, 4) No clear model or pathway in the system for providing rehabilitation for people with dementia. Given the evidence for rehabilitation interventions to reduce disability and improve wellbeing in people with dementia, there is much need in addressing stigma and low knowledge, to overcome challenges to promote rehabilitation access for people with dementia. Co-design workshops have been held to determine strategies to address stigma and challenges to rehabilitation access for people with dementia. A package of solutions “INCLUDE” has been decided on (A dementia rehabilitation e-module, a community of practice, and GP/GP practice nurse dementia training). We will test and evaluate their implementation in the South Eastern and Eastern Melbourne Primary Health Network areas. The specific aims are to determine: 1. The number, type, work setting, and proportion of health professionals (GPs, practice nurses, allied health professionals (AHPs) and other professionals) who agree to participate in the study and partake in any of the INCLUDE solutions 2. The effect of the INCLUDE solutions (e-module, GP training and Community of Practice) on change in stigma and knowledge about dementia rehabilitation 3. The effect of the e-module and community of practice on change in: a. social networks b. number of people seen with dementia by allied health professionals and c. number of advocacy actions and changes to practice by members in their workplace 4. Acceptability, satisfaction and perceived sustainability with each of the INCLUDE solutions

  • An elastic knee brace for patients with ongoing symptoms following anterior cruciate ligament reconstruction: a pilot study

    The primary aim of this pilot study is to determine the feasibility of wearing an elastic knee brace (Genutrain, Bauerfeind) for 6 weeks on clinical and biomechanical features of early knee osteoarthritis after ACL reconstruction. Together with a pilot cross-over study to estimate the immediate-effects of the brace (separate trial registration), this pilot study will inform a future full-scale RCT.

  • Optimising Transition to Residential Aged Care

    The problem: A staggering 50% of the 190,000 residents living in aged care in Australia have depressive symptoms, while 35% have a diagnosis of depression. Evidence-based interventions exist to (i) reduce depression in residents (ii) improve mental health outcomes in their family members, (iii) improve the quality of care provided by Residential Aged Care Staff. However, despite their existence, these interventions are not widely available or systematically implemented. The transition into living in aged care is recognised as a critical time point for the onset and exacerbation of depression. Despite this, there is currently no consistent approach to inform access to, and the provision of, mental health support when a person transitions from community living into a residential aged care facility. The solution: We will implement a sustainable, evidence-based, and innovative approach to prevent depression in aged care residents. We will achieve this by embedding processes to deliver a suite of interventions that will work synergistically to prevent and reduce depression, targeting all involved in the care triad: the resident, their family/carers, and the residential aged care facility (RACF)staff. Specifically, this will include embedding processes to deliver (i) the PEARL intervention for new residents adjusting to residential aged care, (ii) the adapted START intervention to support family/carers; and (iii) the Dignity of Choice training program to upskill RACF staff in person-centered mental health care provision. This will be a world-first approach, setting the foundations for a definitive cluster randomised controlled trial to assess the cost-effectiveness of this suite of programs, which if proven effective will transform the residential aged care living and working experience. The improvement of mental health in aged care residents, families/carers, and staff will be a major step forward in addressing the recommendations of the Commission, and extending healthy, active years of life for those living in RACFs.

  • Effectiveness of the 'LeapForward' program on return-to-work and injury-related outcomes: a pragmatic randomised controlled trial

  • Schizophrenia, Nutrition and Choices in Kilojoules (Cadence SNaCK)

    This study will be a randomised, 12-week cross-over controlled design, the objective is to establish the feasibility, acceptability, and preliminary effectiveness of two dietary interventions (prepared meals and meal kits) vs a control condition (Coles/Myer vouchers) in community-based people living with schizophrenia who are overweight or obese. We hypothesise that both dietary interventions will be acceptable to participants (i.e., greater than or equal to 75% of participants will use prepared meals and meal kits for greater than or equal to 50% of the trial days), and that both dietary interventions will improve metabolic and other health-related outcomes from baseline to each 4-week follow-up. We also anticipate that prepared meals, given they require the least cognitive effort to use, will be the most acceptable option out of the three study arms, and Coles/Myer vouchers the least feasible and acceptable as participants in this arm receive neither specific foods, recipes nor prepared meals.

  • Acceptability of a Community Mental Health Integrated Disaster Preparedness Intervention in Response to the 2019-2020 Black Summer Bushfires: The Phoenix Study

    This is a project that aims to help communities who were impacted by the 2019-2020 Black Summer Bushfires. The focus is on recovery after the bushfires and increasing resilience to natural disasters within the community, which may help with recovery efforts for possible bushfires or other events in the future. We are looking at working with the local communities to help with recovery and community wellbeing after the bushfires and also to build preparedness for any future bushfires (should they occur again). It is our aim to obtain information from local residents who have experienced bushfires and utilise their experiences and input to produce a programme that will also help future communities in Australia to recover from bushfires.

  • Shop-to-Stop Hypertension: A public screening campaign to detect and manage raised blood pressure in Australian adults

    Aim: The study is testing a novel way to improve awareness and detection of raised blood pressure in Australia by screening customers and/or the workforce of Bunnings Warehouse for raised blood pressure and related health markers on SiSU Health Stations. The aim is to to identify, refer and follow adults in need of hypertension care, whilst raising population-wide awareness. In a randomised control trial, we will determine in participants with detected high BP at a SiSU health station in Bunnings, whether text message-based nudges encouraging repeat BP checks at the SiSU health station and to visit their GP, compared to those not receiving text messages, will result in a greater proportion of participants to recheck their BP at a SiSU health station over the course of 12 months. Secondary outcomes include identifying change in BP, weight, body mass index, body fat percentage, and use of BP medications in people who visit SiSU health stations more than once. Hypothesis: text message-based nudges will be superior to control in terms of promoting repeat BP checks in adults detected with high BP at SiSU health stations at Bunnings warehouses.

  • Which Way? Quit Pack- Mailout smoking cessation support for Aboriginal and Torres Strait Islander people who smoke

    Commercial tobacco use among Aboriginal and Torres Strait Islander people is intrinsically linked with colonisation, dispossession, and racism. Today, 43% of Aboriginal people are daily smokers and tobacco remained the largest single risk behaviour for the adverse health conditions of Aboriginal and Torres Strait Islander people, contributing 17% of total burden. Research has consistently shown that Aboriginal and Torres Strait Islander people want to quit smoking. This study is built upon a pilot trial conducted in 2022/23 (ACTRN12622000654752). This study is built upon a pilot trial conducted in 2022/23. The pilot trial showed the acceptability and feasibility of the mailout smoking cessation intervention for Aboriginal and Torres Strait Islander people. This study will provide flexible, and potentially low-cost access to evidence-based smoking cessation support for Aboriginal and Torres Strait Islander people. This study will evaluate the effectiveness of the mailout smoking cessation program using a self-reported 7-day point-prevalence and continuous abstinence at 3 months and 6 months follow-up.

  • MEDITATion for thE management of psycho-existential distress and anxiety in people with advanced cancer who are receiving Palliative Care (MEDITATEPallCare)

    One in four people who are admitted to palliative care experience psycho-existential distress, which can be highly debilitating and reduce people’s quality of life, particularly in the last year of life. This study is investigating whether a meditation program using a combination of face-to-face and at home guided meditation is feasible and acceptable to people with advanced cancer who have been admitted to palliative care. Who is it for? You may be eligible for this study if you are aged 18 years or older, you are currently undergoing palliative care for advanced cancer and you are currently experiencing distress. Study details All participants who choose to enroll in this study will be invited to attend up to five face-to-face meditation sessions over a 3 week period. These face-to-face sessions will be guided by a trained meditation instructor. Each meditation session will last up to 20 minutes and will involve techniques including focused attention to the breath, guided relaxation of major muscle groups, and silence with gentle ambient music. These techniques will be audio-recorded so people can continue to practice meditation in between the facilitated sessions. Participants will also be asked to continue practicing meditation between 1 and 3 times per week for the 3 weeks of the study. Throughout the 3 weeks of the study, participants will be asked to nominate how often they are practicing the meditation techniques and whether they are feeling less distressed before and after a meditation session. At the end of the study, participants will also have the opportunity to participate in a once-off interview with a member of the research team to discuss their experience with the meditation program. It is hoped this research will determine whether patients in palliative care find the meditation sessions useful, if they are happy with the number of sessions they undertook, and whether they would suggest any changes to the program. If this study finds that the meditation program is acceptable to patients, it may be expanded to a larger number of patients who are in palliative care.

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