ANZCTR search results

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

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31379 results sorted by trial registration date.
  • Evaluation of Northern Patient Watch, a comprehensive care program to keep people well in the community

    Introduction: People in higher income countries are living longer, with higher burden of chronic disease, disability and psychosocial distress. People affected by this are more likely to present to hospital, where they may receive inefficient and fragmented care. Northern Patient Watch (NPW)was implemented with the aim of better meeting the needs of these patients. This program utilizes trained lay telecare guides, who monitor the patient and health coaches who aid the patient with self-management of their conditions, guided by a rules-based algorithm called the Patient Journey Record. This evaluation will determine whether NPW is effective in reducing acute hospital usage, its effects on participant quality of life, and the quality of the participant’s experience. Methods and Analysis: Emergency department and hospital length of stay will be determined for NPW participants, and compared with these metrics in propensity-matched patients who were eligible for but declined the program. Participant reported outcomes will be measured using EQol-5D-5L, and their experience of the program will be measured using a visual analogue scale and net promoter score. NPW participants and Northern Health staff will be offered the opportunity to participate in interviews and focus groups, to obtain qualitative data regarding the program. Ethics and Dissemination: Patient Watch, and the accompanying collection of hospital usage and patient reported outcome and experience measures, is established as standard care, hence audit-level ethics approval has been obtained. Low-risk ethics approval was obtained for patient/staff interviews and focus groups - see public note below.

  • A Phase I/II study to assess the safety and efficacy of full-spectrum medicinal cannabis plant extract 0.08% THC (NTI164) in the treatment of Rett syndrome (RTT)

    This is an 18-week open-label study to evaluate the efficacy of Full-Spectum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) on the severity of Rett syndrome (RTT) in children and young people. The purpose of this study is to determine how effective NTI64 is in patients with RTT when treated for 16 weeks. Participants will commence treatment with a daily dose of 5mg/kg of NTI164. This will gradually be increased over a four-week period until the maximum tolerated daily dose or 20mg/kg per day is achieved (Up-titration phase). Participants will continue to receive their respective maximum dose for eight weeks (Treatment phase). At the end of the Treatment phase, participants will be gradually decreased by 5mg/kg for a period of 4 weeks until the end of their participation (Down-titration phase). Efficacy will be measured and monitored by appropriate and releant questionnaires specific to measuring changes in patients. Full blood examinations will be conducted at various points of the study.

  • Evaluation of Body Surface Gastric Mapping in a Multidisciplinary Integrated Care Pathway for Chronic Gastrointestinal Symptoms

    The aim of this research is to evaluate the potential role of Body Surface Gastric Mapping (Alimetry Ltd., New Zealand) in a multidisciplinary integrated care pathway for functional gastroduodenal disorders, to determine whether Body Surface Gastric Mapping test biomarkers are predictive of therapeutic response to a 12 week structured program of care. Hypotheses: Patients with neuromuscular disorders identified by BSGM will demonstrate reduced clinical response to an integrated care program incorporating psychological and behavioural interventions. Conversely, patients with normal BSGM tests will be more likely to respond to the integrated care program. They will also be more likely to also register reduced anxiety and depression scores.

  • Preventing infusate injuries throughout a child’s hospitalisation

    Many babies and infants admitted to hospital need fluids or medicines delivered directly into their veins using an intravenous (IV) catheter. Over time, IV's can dislodge from the veins and some cases, the medicine or fluid can leak into the child's tissue around the vein, causing damage to the skin, tissue and the vein itself. This is called an extravasation injury. An early sign of extravasation injury is pain, however babies and infants cannot always communicate that the IV site is painful making early detection painful. The IV biosensor is a new device that may help detect extravasation injury sooner. A biosensor is a special light similar to an oxygen saturation probe that is placed on the child's skin above the IV site. It uses near infra-red light to scan the tissues to detect extravasation injury and alerts clinicians so the infusion can be stopped to limit damage caused to the surrounding tissue. This trial will examine whether the IV biosensor helps to detect extravasation injury in babies and infants earlier than compared to standard care. It will also assess whether it is safe and easy to use, and whether it decreases the severity of extravasation injuries.

  • Personal Spirometer and Electrical Impedance Tomography: agreement with clinic attendance tests (SpiroEIT)

    New home spirometer devices (the SpiroHome device) have not yet been tested for accuracy compared to hospital-standard devices. We are assessing the accuracy of new home spirometers, and whether they are easy to use in the community. Participants also have the option to trial new technology called "EIT" which looks at ventilation across the lung using sensors placed on the skin.

  • 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.

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