ANZCTR search results

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

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31407 results sorted by trial registration date.
  • 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.

  • Connection and Kinship: Co-design of a Culturally Safe and Responsive Care for Aboriginal and Torres Strait Islander Children and Families in a Public Paediatric Service

    This study employs a single-site, multiphase, mixed-methods pre-post evaluation of a co-designed model of care for Aboriginal and/or Torres Strait Islander children and families accessing a public tertiary hospital outpatient paediatric service. The model of care implementation will be evaluated using the Ngaa-bi-nya Aboriginal and Torres Strait Islander program evaluation framework, as well as Implementation and Evaluation Outcomes to evaluate implementation, service, and consumer outcomes. A full service evaluation, including economic analysis using a cost-utility approach to determine the cost-effectiveness of the new model of care will be undertaken. By sharing learnings, processes, and outcomes from this study, this methodology can inform future co-design studies, empowering Aboriginal and Torres Strait Islander peoples and enhancing access to care.

  • Implementation of Personalised Risk Assessment in Oncogenetics

    This is a two-stage trial to: -develop, implement and evaluate polygenic scores (PGS) that describe the inherited risk of four common cancers: breast, prostate, bowel and ovarian. - investigate the efficacy and feasibility of a personalised risk assessment for cancer that includes PGS alongside current clinical genetic testing. Who is it for? Individuals aged between 18 and 74 years who have been referred to a participating clinical genetics service for testing of rare high- and moderate-risk cancer susceptibility genes. Study details: In the first phase existing genomic data from current cohort studies will be used to operationalise clinical PGS testing adapted to the Australian healthcare setting. At the same time a control arm of 1000 patients undergoing current standard genetic testing will be enrolled through specialist cancer genetics services. In the second phase an intervention arm of 1000 patients will be enrolled and offered a personalised risk assessment, that includes PGS based testing, for up to 3 common cancers. It is hoped that findings from this study will help inform researchers and clinicians of the impact of personalised risk assessments on cancer risk management behaviour in individuals.

  • CON-EXT Study: Examining the feasibility and acceptability of personalised treatment for childhood anxiety disorders based on children's cognitive-learning markers

    To determine the effectiveness and clinical utility of the fear conditioning and extinction task (CON-EXT) Predictive Marker Task and targeted Cognitive Behavioural Therapy (CBT) for children with anxiety disorders with 62 anxious children between 7-12 years. Additionally, to examine clinician and consumer feasibility and acceptability of the CON-EXT Predictive Marker Task. Following evidence-based multi-modal assessment, including delivery of the CON-EXT Predictive Marker Task, all children will receive standard CBT (10 weekly sessions) with the child and treating clinician remaining masked to CON-EXT Marker status. The post-treatment assessment and a one-month post-treatment follow-up assessment will be conducted by independent clinicians masked to children’s prior assessments and CON-EXT Marker status. The post-CBT assessment at primary end-point addresses the key question of whether CBT produces greater clinical benefits in Marker (+) than Marker (-) anxious children. The follow-up assessment addresses the question of whether greater clinical benefits of CBT for Marker (+) than Marker (-) anxious children persist after treatment. It is expected that participants who had a positive score in the CON-EXT task, will respond better to cognitive behavioural treatment than those participants who had a negative score in the CON-EXT task.

  • A clinical trial assessing medicinal cannabis for managing anxiety and evaluating quality of life in adults with autism.

    An open label trial evaluating the feasibility of a medicinal cannabis product for the symptoms associated with adult autism such as anxiety. The participants will complete a 3-week titration then stay on that dose for 12 weeks thereafter. There will be four weekly follow up visits in person and safety bloods will be taken. The trial is assessing if it is feasible to conduct a trial using medicinal cannabis in an adult Autism population. It is assumed that it will be feasible, and that medicinal cannabis will help reduce anxiety and improve quality of life.

  • Piloting single session interventions for the early intervention of eating disorders

    This pilot randomised controlled trial aims to assess the effectiveness, feasibility, and acceptability of nine single-session interventions (SSIs) compared to a waitlist control for the early intervention of eating disorders in young people aged 14–25. The findings will identify the most effective SSIs based on changes in disordered eating and secondary mental health outcomes, guiding their refinement and development. The top-performing SSIs will undergo further evaluation in a subsequent RCT. Ultimately, the final SSIs will be made freely and widely available to support early intervention efforts for eating disorders in young people. We anticipate that participants receive one of nine SSIs will have lower depression, anxiety and disordered eating scores at 1-month follow-up compared to participants in the waitlist condition.

  • Are the postural orthostatic tachycardia syndrome diagnostic criteria limiting? Defining and comparing patient reported outcomes of an Australian cohort with postural symptoms without tachycardia

    Postural orthostatic tachycardia syndrome (POTS) is a multisystem, autonomic disorder that culminates in extensive morbidity for those affected. POTS is currently diagnosed on the basis of strict heart rate response to a standing test in addition to the presence of orthostatic symptoms for greater than 3 months unexplained by another condition. However, the heart rate criterion is confounded by multiple factors and has not previously been well validated to correlate with symptoms. Additionally, little is known about whether individuals with postural symptoms without tachycardia (PSWT) have similar symptom burden and health related quality of life impairment to those with POTS. As such, we will explore the symptom burden of PSWT patients and compare this to a POTS cohort.

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