ANZCTR search results

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

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31201 results sorted by trial registration date.
  • Preliminary study of the SUicide IMagery REScripting (SUIMRES) treatment for adults experiencing mental images of suicide.

    When people contemplate suicide they can think using words (e.g., "I want to die") and/or mental imagery (e.g., visualising and mentally rehearsing suicide methods). Despite evidence that mental images of suicide are associated with greater risk of both having a detailed suicide plan and having previously enacted suicide behaviours, compared to verbal thoughts of suicide (Lawrence et al., 2022, 2023), no evidence-based treatment for suicide images has been published to date. We have developed a 3-4 session psychotherapy treatment for suicide imagery that is delivered as an addition to the usual-care that people experiencing suicidality receive in therapy. This project aims to evaluate feasibility, acceptability, and safety of this new treatment with a sample of people who receive the treatment. The project also aims to test the feasibility of evaluation procedures in preparation for a larger study of the efficacy of this intervention in future. We anticipate that the intervention will be safe and acceptable to participants, as well as feasible to deliver. We anticipate that the trial evaluation procedures will be suitable for use in a future larger evaluation of the efficacy of the intervention. We will recruit 40 people in therapy who experience mental imagery of suicide, and randomise half to receive the new treatment in addition to their regular care (the other half will continue their usual treatment without the new therapy). We will collect data about people’s experiences of the intervention, their suicidality and mood using online surveys and questionnaires. With participant consent, we will also ask for their regular therapists to complete surveys about their progress and what types of treatments they have received during the trial period.

  • A randomised, double-blind, clinical crossover study to assess novel hydration formulations in healthy adults

    The research project is looking at whether rehydration drinks can help improve hydration, sleep, and cognitive performance after exercise in hot conditions that cause dehydration. During the study, we will use a controlled method to reduce your body weight by 2% through dehydration. After that, you’ll be given one of four drinks: either a placebo (which contains no active ingredients) or one of three rehydration drinks. These drinks contain a mix of ingredients like electrolytes, vitamins, carbohydrates, proteins, amino acids, and sugar substitutes, all dissolved in water. Each participant will try all four drinks, with at least five days between each trial. We’ll assess how each drink affects your hydration that day, your sleep that night, and your cognitive performance both on the same day and the next day. Since dehydration can affect cognitive performance and sleep quality, we’re hoping these drinks may help with rehydration and recovery. By comparing the different drinks, we hope to discover which ones work best in supporting hydration, sleep, and cognitive performance after dehydration.

  • RESIST-HF: A randomised controlled trial of a comprehensive nurse-coordinated home-based Resistance ExerciSe program to Improve frailty and phySical funcTion in adults with Heart Failure

    This study aims to make people with heart failure feel stronger, improve their physical function, and keep them out of hospital. We hypothesise that a home-based nurse-coordinated program embedding resistance exercise and healthy eating advice will reduce hospital admission rates at 6 months and lead to improvements in frailty, physical functioning, and quality of life scores at 3 months in adults living with HF. Heart failure affects 1-2% of the Australian population, resulting in a significant number of hospital admissions and placing a huge burden on the NSW health system. Approximately half of those with heart failure will also develop frailty, a devastating syndrome of ‘accelerated ageing’, putting them at even greater risk of adverse events and hospitalisation. This project uses a randomised controlled trial study design to test whether a three-month comprehensive nurse-coordinated home-based exercise program can reduce hospital admissions for adults with heart failure and improve their frailty, physical function, and quality of life.

  • Evaluating the Effect of a Patient Worksheet on Communication In The Surgical Clinic

    Presenting to a surgical outpatient clinic can be a stressful experience for patients. Disparity in education levels, perceived power imbalances and other factors can result in the patient feeling unsatisfied or confused at the completion of the consultation. We propose a randomised controlled study; whereby, the participant is placed into either the intervention group and will receive a pre-designed form containing five prompts to ask their surgeon, or they are placed in the control group. The outpatient consultation will be audio-video recorded. Within 7 days of the consultation the participant will be contacted by telephone to discuss their experience. The purpose is to analyse the utility of a patient prompting document in improving patient understanding, increased patient empowerment and facilitating successful outpatient consultations.

  • A pilot study testing virtual care for patients with rib fractures at home

    This research project is evaluating a new approach to caring for patients with broken ribs using virtual care. In this new approach, a team of healthcare professionals will help patients to recover at home by conducting consultations over video conferencing and using devices that measure their heart rate and blood oxygen levels. The study aims to show if this new approach is a feasible and safe alternative to looking after patients with this condition in hospital, which is the current standard of care.

  • Evaluating the Effects of a Different Protein Beverages on Protein Digestion and Absorption

    Previous research has shown that older adults (i.e., 60 years and above) may require higher protein intake to preserve muscle mass, strength, and function. However, increasing protein intake can be difficult for multiple reasons such as reduced appetite, reduced protein digestion and absorption compared to younger adults, price/ cost, logistics, and that protein, naturally, is highly satiating (i.e.: it makes you feel full). In addition to consuming whole-food protein sources, protein-enriched supplements such as protein powders are convenient and high-quality protein sources that have been shown to help increase and maintain muscle mass. Of the many different protein supplements available on the commercial market, whey protein, which is derived from milk during the cheese-making process, is one of the most popular forms. Whey protein can be purchased in three primary forms: (1) Whey protein concentrate which is the least processed form of whey protein (70-80% protein by weight) that subsequently retains more of the naturally occurring fats, carbohydrates, and lactose found in whey; (2) Whey protein isolate, as its name suggests, isolates more protein (typically around 90% or more protein by weight) such that most of the fat, lactose, and other non-protein components are removed; (3) Whey protein hydrolysate, which is also typically around 90% or more protein by weight, undergoes a specialised processing technique called enzymatic hydrolysis which breaks down protein molecules into segments. As such, this form of whey protein is often considered the most easily digestible and rapidly absorbed. The purpose of this study is to gain insight into whether a whey protein hydrolysate and concentrate blend can be digested as effectively as a straight whey protein hydrolysate while still containing many of the beneficial naturally occuring fats and carbohydrates which can be important for immune and body health.

  • Cluster randomized controlled trial of silver fluoride for oral health and wellbeing in aged care residents

    This multi-disciplinary project aims to improve oral health access, assessment, and treatment for older adults in rural and regional Residential Aged Care Facilities (RACFs) through three key activities: 1. Pre-trial training/upskilling of non-dental staff at a network of regional and rural RACFs to assess residents' oral health using a modified oral health assessment tool (M-OHAT) and treatment referral system, currently under development via co-design. 2. A cluster randomised controlled trial to test the effectiveness of an intervention (application of silver fluoride to specific dental lesions) in improving oral health and wellbeing in approximately 1000 eligible residents at participating RACFs. 3.An economic evaluation of the cost effectiveness and potential scalability of the silver fluoride intervention. The primary project outcomes are residents’ oral health (reduction in caries development, arrest of dental caries, and reduction in tooth pain and sensitivity), while secondary outcomes include residents’ oral health-related quality of life, general quality of life, and mental health and wellbeing. The project also aims to explore if M-OHAT training improves RACF staff knowledge and perception of oral health.

  • Treatment goals and outcomes in patients greater than 90 years admitted to the intensive care unit

    This retrospective, observational cohort study will include nonagenarians admitted to the ICU between 2010 and 2023 across Australia and New Zealand. The study will utilise data from the Australian and New Zealand Intensive Care Society (ANZICS) Adult Patient Database. Who is it for? You are eligible if you are greater than 90 years old and admitted to ICI. Patients will be categorized into two groups: full treatment and treatment limitations. Study details This study will evaluate the short-term effects of treatment goals on ICU and hospital mortality, length of stay, and mortality-associated factors. We hope these findings will emphasise the importance of shared decision-making that respects patient autonomy and considers clinical, cultural, and systemic factors.

  • The effect of upper cervical musculoskeletal management on migraine headache in adults

    Neck pain is an important issue in primary headache. It contributes to costs and disability and is associated with poorer treatment outcomes and migraine chronicity. Current knowledge suggests pain sensitisation mechanisms and/or cervical musculoskeletal dysfunction account for the presence of neck pain in migraine and other primary headaches. Recent research suggests up to 40% of patients demonstrate signs of cervical musculoskeletal dysfunction. Better understanding of the nature of neck pain and function in primary headache is needed as this has important implications for management. This research will explore targeted management of the upper cervical spine to identify potential responders and non-responders. The study hypothesis is that a sub-group of migraine sufferers will report reduced migraine frequency and impact following the physiotherapy intervention.

  • The Intergenerational Wellbeing and Brain-Healthy Lifestyles Intervention (GenWell-BRAVE): A Feasibility Pilot

    GenWell-BRAVE is a SWAT (“Study Within a Trial”) of a large-scale NHMRC funded Clinical Trial, “The INTEGRITY Trial.” The INTEGRITY Trial aims to deliver an Intergenerational Practice Program (IPP) to 44 community pre-schools across Greater Sydney and evaluate the impact of the intervention on reducing frailty in community-dwelling older adults and improving the developmental skills of pre-school aged children. This preventative interventional approach, underscored by masses of public interest, may similarly be applied as a lifestyle approach for dementia risk reduction. There has recently been a growing awareness of the pivotal role psychological states play in health behaviours, and combating lifestyle-driven disease risk. It is additionally increasingly becoming recognised that positive psychological states (i.e., "Positive Mental Health') have a distinct protective effect on cognition, brain-health behaviours, and dementia incidence. As such, it is viable that targeting Positive Mental Health in lifestyle interventions to reduce dementia risk may be a vital ingredient for effectiveness. Leveraging several waitlist-control clusters of The INTEGRITY Trial, the present pilot addresses this rising evidence by exploring the impact of delivering an IPP with activities informed by positive psychological intervention (PPI), compared to a standard practice IPP. The GenWell-BRAVE pilot will explore whether this pro/prescription of PPI activities, results in any deviations in feasibility and/or on changing the dementia risk profile (i.e., cognitive trajectories and risk factor engagement) of adult participants.

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