ANZCTR search results

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

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30848 results sorted by trial registration date.
  • Evaluating the effectiveness of scale up strategies tailored to local context on the adoption of a text message based lunchbox program to address poor dietary intake in primary school aged children

    The SWAP IT program is integrated within an app-based communication platform used by schools to communicate with parents and consists of text-messages sent to parents targeting barriers to packing healthier lunchboxes. SWAP IT has proven to be effective in improving child nutrition and weight outcomes, is acceptable to parents and principals, and is cost effective. Although SWAP IT has the potential to improve child health at a population-level, little evidence exists to guide efforts to encourage school adoption of these programs at scale. This research aims to maximise the impact of the SWAP IT program through a scale-up involving 1341 primary schools across 10 NSW local health districts. A modified platform trial design will be used to test the effectiveness of a series of scale-up strategies that have been tailored to context to maximise the adoption of an effective healthy lunchbox program within NSW primary schools located within 10 Local Health Districts of NSW. Adoption of the SWAP IT program will be the primary outcome of the trial. This research will result in new knowledge to inform how school-based nutrition programs can be successfully tailored to the local context and scaled-up at a population level.

  • Testing tools to support the A Better Choice Strategy Implementation: the CREATE study.

    The primary aim of this pilot study is to assess the feasibility and acceptability of conducting an RCT to evaluate the CREATE intervention in Queensland health services, and to inform the primary outcome measures and sample size for the full RCT. Our proposed intervention CREATE (Co-designed Retail Tools for healthier food Environments) directly addresses these factors through the provision of a Retailer Toolkit and Practitioner Training which have been co-designed with end-users to support the implementation of ‘A Better Choice’ healthy food retail targets. ‘A Better Choice’ Strategy aims to increase the provision of healthy food and drinks for staff, visitors, and patients within Queensland hospital and health services (HHS). The trial will determine the feasibility and acceptability of the implementation support tools, and that of the RCT study design, and will inform future full size RCTs.

  • Brain health effects in at risk populations with chilli extract supplementation

    Cognitive decline is the primary symptom of dementia and is preceded by reduced brain blood vessel (i.e. cerebrovascular) function. Cognitive decline and cerebrovascular dysfunction are made worse by obesity, which results from a poor diet and low physical activity levels. These are increasingly prevalent in regional Australia and contribute to the increase in dementia rates, reducing quality of life of older Australians. Current preventive treatments for dementia focus on reducing risk factors, including exercise and diet, but these are associated with low compliance. Capsaicin, the spicey molecule in chilli, reduces fat mass and blood pressure in humans. It also improves markers of cardiovascular disease and cognitive decline in animal models of disease by reducing inflammation and improving blood vessel function. However, capsaicin can cause oral and gastrointestinal irritation, limiting its potential for human use. Capsimax is a unique beadlet encapsulation of capsaicin that prolongs capsaicin release in the gut, and prevents irritation associated with capsaicin ingestion. Hence, Capsimax is a safe and tolerable supplement that can be used to examine the effects of capsaicin in humans. We will conduct a randomised control trial that will investigate the effects of Capsimax supplementation for 12 weeks on cognition and cerebrovascular function in middle-aged to older, overweight and obese adults who are at risk of cognitive decline and dementia. This pilot study will be the first human study to explore the use of a capsaicin supplement in improving cognition and cerebrovascular function, thus providing a foundation for future use as a preventive treatment for dementia.

  • The feasibility of REducing Cognitive decline and dementiA by Lowering bLood pressure Pilot (RECALL Pilot)

    RECALL-Pilot is a prospective, decentralised pilot trial to investigate the feasibility of using a blood pressure lowering ‘polypill’ including telmisartan 20mg, amlodipine 2.5mg, indapamide 1.25mg in a decentralised trial to prevent ‘significant cognitive impairment’ (MCI or dementia).

  • INtegrative approaches for Optimizing Recognition, Management and Education of concussion at the community sports level

    Telehealth is an emerging way of assessing and managing patients, particularly after the COVID-19 pandemic. The role of telehealth in concussion diagnosis and management is not fully researched yet, therefore in this trial, we are in the first instance testing the effectiveness of the diagnostic ability of a telehealth program. This trial is running for 2 years and is available to all players in VAFA and will enrol at least 500 head-injured patients with suspected concussion. If deemed eligible, participants will be randomly allocated to either one of the following two treatment options: a) attending an online virtual video-based telehealth consultation with a neuropsychologist/ neurologist or physiotherapist which will take about 45 minutes OR b) provided with the most current and available concussion/head injury advice. There will be no restrictions on participants in terms of lifestyle or regular medications or behaviours. Regardless of which option participants are randomised to, they will be contacted on day 7 and day 14 post head injury regarding their clinical symptoms. If they attend the telehealth consultation, they will also be contacted again on day 30 to assess their satisfaction and feedback regarding the telehealth program. The primary outcome for this study is the diagnosis rate, whilst secondary outcomes include symptom improvements, RTP adherence, access to clinical specialists, and user satisfaction with the telehealth program.

  • OCEANiC: A Phase II, Open-label, Multi-centre Clinical Trial of Osimertinib With or Without Adjuvant Chemotherapy Guided by Tumour NGS Co-mutation Status and ctDNA Detection in Patients With Stage IIA-IIIA EGFR-Mutant Non Small Cell Lung Cancer Following Complete Surgical Resection

    The purpose of this study is to investigate whether we can use co-mutation NGS profiling (looks for gene changes in your cancer tissue) and circulating tumour (ct) DNA (looks for fragments of the tumour moving through the blood stream. These fragments are known as circulating tumour DNA (ctDNA) and carry genetic information) to determine which patients with EGFR mutant non small-cell lung cancer can safely avoid chemotherapy. Who is it for? You may be eligible for this study if you are an adult with non small-cell lung cancer, with a mutation in epidermal growth factor receptor (referred to as EGFR mutation) that has had their tumour completely resected by surgery. Study details: During screening NGS profiling and ctDNA testing will be performed. The NGS and ctDNA results will be used to determine if your cancer is at higher or lower risk of returning. Participants with a higher risk of their cancer returning will have up to 4 cycles (over 12 weeks) of chemotherapy followed by up to 3 years of daily osimertinib. Participants with a lower risk of their cancer returning will have osimertinib daily for up to 3 years. The following assessments will be conducted throughout the trial: physical exam, CT scans, MRI, blood tests, pregnancy test, ECG and questionnaires. It is hoped that this study will help determine if osimertinib alone may provide similar benefits with less toxicity, improved quality of life and reduced health care costs, to chemotherapy and osimertinib.

  • Evaluation of the scope and efficacy of a digitised, innovative psychosocial recovery program for individuals post- Motor Vehicle Accident (MVA)

    LeapForward is a digitised 6-week clinician supported program harnessing psycho-education, technology and coaching to support people in a return to health, life and work after (compensable) injury or illness. LeapForward aims to address the psychosocial barriers that can most significantly impact recovery – by empowering individuals with the will-and-skill to move forward in their recovery with confidence-and-control. Whilst LeapForward has been developed based on leading evidence-based principles, a rigorous evaluation is required to determine the program’s ability to engage and retain users, to induce change in users’ health and wellbeing, and ultimately – to causatively impact on (personal injury) claim costs on a macro-scale within an MVA-scheme environment, through impacting weekly benefits and/ or total treatment costs. IAG and NRMA are evaluating whether providing their customers with a web-based health program called LeapForward can help claimants as part of their recovery after a motor vehicle accident. We aim to conduct an independent evaluation of this program.

  • Strengthening Care for Rural Children (SC4RC): the impact on quality of care for childhood conditions in rural Victoria and New South Wales.

    Across NSW and Victoria, 860,000 children, 30% of the States’ population, live in rural areas. Although 19% of these children live with a chronic illness, there are fewer GPs per capita and paediatric specialty care is often lacking. Strengthening Care for Rural Children (SC4RC), a model where paediatrician and GP’s work together in GP practices, aims to deliver and rigorously evaluate a primary health care system strengthening programme that can bridge the gaps in access to health services and health outcomes between children living in rural Australia and their urban peers. It aims to improve the health of children by increasing the capacity of the existing rural GP workforce to assess and effectively manage paediatric conditions.

  • An evaluation into the national scale-up of an effective text message based healthy lunchbox program aimed at improving child nutrition

    The SWAP IT program is integrated within an app-based communication platform used by schools to communicate with parents and consists of text-messages sent to parents targeting barriers to packing healthier lunchboxes. SWAP IT has proven to be effective in improving child nutrition and weight outcomes, is acceptable to parents and principals, and is cost effective (Sutherland 2019, Sutherland 2021 (ACTRN12618001731280)). Although SWAP IT has the potential to improve child health at a population-level, little evidence exists to guide efforts to encourage school adoption of these programs at scale. This research aims to maximise the impact of the SWAP IT program through a scale-up involving 450 primary schools across three states (VIC, QLD, SA). A randomised trial will be undertaken with schools allocated to receive either a 9-month multi-component scale-up strategy or to a control group. The scale-up strategy is theory-based and was developed in consultation with researchers and stakeholders from health, education and industry. Key outcome measures include: a) SWAP IT program adoption; b) Population level impacts on child nutrition and obesity; c) Sustainment; d) Economic evaluation; and e) Mechanisms of action. This research will result in new knowledge to inform how school-based nutrition programs can be successfully scaled-up at a population level.

  • Digital-powered healthcare: Optimising communication, engagement and treatment compliance in patients with implant-related infections

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