ANZCTR search results

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

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32107 results sorted by trial registration date.
  • CELPI: a randomised trial of a Carer End of Life Planning Intervention in people dying with dementia.

    Dementia is a leading cause of death in developed nations. Despite an often distressing and symptom laden end of life, there are systematic barriers to accessing palliative care in people dying of dementia. Evidence exists that 70% of people living with severe dementia attend an emergency department (ED) in their last year of life. This randomised controlled trial (RCT) will test a Carer End of Life Planning Intervention (CELPI) co-designed by clinicians, content specialists and consumers to improve access to end of life care for older people with severe dementia, using an ED visit as a catalyst for recognising unmet needs and specialist palliative care referral where indicated.

  • Recovery Training of Emotion and Cognition with Vortioxetine for Depression (RECOVER-D) Study

    The aim of the current study is to trial a new psychological treatment designed to improve psychosocial functioning in middle- to older-aged depressed individuals, together with an antidepressant medication. The psychological treatment will target three domains of psychosocial functioning, which when impaired, appear to underlie psychosocial dysfunction in depression. These domains include cognition (e.g. attention, memory), emotion processing (e.g. pessimism), and social cognition (e.g. interpreting social situations). Personalised training that considers the strengths and weaknesses of individuals in these domains is expected to be more beneficial than just standardised training. Therefore, this study will compare an intervention group undergoing a personalised version of the training program, to a control group undergoing a standardised version. The psychological treatment will be combined with option to commence the antidepressant medication, Vortioxetine. The use of antidepressants in the treatment of major depressive disorder is very common both internationally and in Australia (Malhi, Bassett et al. 2015). As the psychosocial training program can be rather intensive, the use of an antidepressant may help to alleviate depressive symptoms in individuals undergoing training. Vortioxetine has been shown to have beneficial effects on cognitive symptoms seen in depression and is the only antidepressant listed in the Royal Australian New Zealand of College Psychiatrists (RANZCP) guidelines to show this effect (Malhi, Bassett et al., 2015; McIntyre & Lee, 2016; Nierenberg, Loft, & Olsen, 2019). It is hypothesised that middle- to older-aged adults will be able to adhere to the study protocols of personalised and standardised cognitive, emotional and social cognitive treatment and that participation will result in improved psychosocial functioning at week 8 (i.e. end of study) relative to baseline.

  • The Impact of an Online Integrative Antenatal Education Programme on Labour and Birth Outcomes

    In Australia, antenatal education programs are mostly unregulated and educators do not require formal qualifications that ensure evidence-based teaching (Downer, Young et al. 2020). In a climate where birth interventions are increasing (AIHW 2018), antenatal education can play a role in helping women to make evidence-based decisions about labour and birth that may improve outcomes for themselves and their baby. Randomised control trials (RCTs) of antenatal education interventions are diverse, and largely weakened by low numbers and poor design. The strongest suggestion so far that antenatal education can improve birth outcomes was an RCT of 176 births in Sydney, Australia where women undergoing a an antenatal program based on the SheBirths® course, compared to controls, had 65% less epidural anaesthesia, 44% less caesarean sections and 50% less medical augmentation/induction (Levett, 2016). In order to make generalisations about the impact of this antenatal education course, the results need to be replicated in other populations. The proposed project will be an open-label, assessor-blind RCT of the online, self-administered adaptation of SheBirths® antenatal education program in Port Macquarie and Coffs Harbour Base Hospitals.

  • Exploring the impact of midwife-led group antenatal care on caesarean section rates and infant health: a multi-site randomised controlled trial

    Pregnancy and birth provide a critical window for intervening to improve short- and long-term health and wellbeing for women and their children, yet there is a lack of evidence to guide preventative interventions. At two sites in Victoria, Australia we will conduct a randomised controlled trial comparing midwife-led, group-based pregnancy care model with usual pregnancy care. We will implement and evaluate a midwife-led, group-based pregnancy care model aimed at influencing risk factors and behaviours that result in adverse outcomes in pregnancy and beyond. We aim to decrease the proportion of births by caesarean section, and the proportion of infants born premature or low birthweight. All three are associated with significant maternal and neonatal morbidity. This collaborative model combines continuity of midwife care, education and peer support to address women’s individual needs, support them to make informed decisions to achieve a healthy pregnancy, and improve clinical and psychosocial outcomes.

  • Uptake and impact of Government recommendations about COVID-19 (coronavirus)-Stage 3, Trial 1, vulnerable subgroup populations

    The COVID-19 (coronavirus) pandemic has led to a large amount of information being made available to the community through a range of mediums. How this information is presented can have a different effect on different people in terms of how much the accept it, and how much it may influence their future behaviours. This research seeks to compare the effectiveness of different approaches that can be used to convey COVID-19 health messages. This will better inform government strategies as to how they might share COVID-19 information as well as information relevant to other future health issues in our community. Specifically this study aims to assess: a) the use of animation versus 'talking head' visual stimulus approaches b) the use of a general practitioner to deliver the COVID-19 relevant information versus a community representative (specific to each subgroup population).

  • Uptake and impact of Government recommendations about COVID-19 (coronavirus)-Stage 3, Trial 2, community group

    The COVID-19 (coronavirus) pandemic has led to a large amount of information being made available to the community through a range of mediums. How this information is presented can have a different effect on different people in terms of how much the accept it, and how much it may influence their future behaviours. This research seeks to compare the effectiveness of different approaches that can be used to convey COVID-19 health messages. This will better inform government strategies as to how they might share COVID-19 information as well as information relevant to other future health issues in our community. Specifically this study aims to assess: a) use of animation versus 'talking head' visual stimulus approaches b) the use of a general practitioner to deliver COVID-19 relevant information (in a pre-recorded video) versus a politician to deliver other types of COVID-19 relevant information (in a pre-recorded video), versus written education (no video).

  • An investigation of 2 different methods of pain relieving injections around a nerve in the low back .

    We aim to see if there is a difference between 2 injection types to treat a nerve impingement that can cause low back and buttock pain. We wish to see if a newer technique is more efficacious and has a longer lasting effect than the usual technique

  • Photobiomodulation for Fatigue, Depression and Pain in Youth with Inflammatory Bowel Disease

    Inflammatory Bowel Disease (IBD) is a chronic, immune-mediated disease of the gastrointestinal tract with frequent extraintestinal involvement and high levels of fatigue, depression and abdominal and musculoskeletal pain. There are currently limited treatment options for fatigue in IBD, despite its significant impact on quality of life and disease burden. Similarly, although depression associated with IBD can be treated with antidepressant medication and psychological therapy, there is a paucity of alternative treatments for those who are unable or unwilling to take antidepressants or engage in psychological therapy. There are also limited treatments available for pain in IBD and many pain medications are contraindicated or poorly tolerated by individuals with IBD due to their impact on gastrointestinal tract. Peak age of IBD onset is during young adulthood and youth with IBD are particularly vulnerable to the effects of fatigue, depression and pain as they are individuating and developing a sense of self, and negotiating relationships. Photobiomodulation (PBM) is a novel treatment involving the use of laser-generated low-powered light therapy which has shown emerging evidence for improving fatigue, depression and pain in both healthy populations and those with chronic illness. Objectives The study aims to assess feasibility, acceptability and preliminary efficacy of photobiomodulation in treatment of fatigue in youth with IBD. It will also assess change in in depression and pain, quality of life, inflammatory markers and microbiome profile, physical activity and physical functioning in response to photobiomodulation. Stdy hypothesis is that PBMt will be feasible and effective in reducing fatigue, depression, pain and inflammatory burden in youth with IBD.

  • Implementing a clinical decision support system (CDSS) for chronic swelling in NSW public clinics

    To address inefficiencies and improve data collection, analysis and display, a bespoke clinical decision support system (CDSS) was developed - www.lymbase.com. This CDSS is now ready for implementation in the NSW public health system and this study will evaluate the implementation process. The anticipated outcome of the study will see refinement of the CDSS and processes to support implementation of Lymbase® for public health sector use.

  • Testing the effectiveness and implementation at scale of TransformUs program on physical activity and sitting time in Australian Secondary Schools.

    TransformUs is a behavioural school-based intervention targeting reducing sedentary behaviour and increasing physical activity that will be rolled out across Australian secondary schools. This is an adaption of a previously registered successful trial: Scalability of the Transform-Us! program to promote children’s physical activity and reduce prolonged sitting in Victorian primary schools (ACTRN12617000204347) for the Australian secondary school setting. To determine real world effectiveness and maintenance (at the individual level), a stepped wedge waitlist control design with follow up will be used. A sub-sample of 10 schools from different socioeconomic urban and rural areas of Victoria and Tasmania will be selected. Our findings will determine the effectiveness of the program in Australian Secondary Schools so that it can be rolled out nationally and become part of routine best practice.

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