ANZCTR search results

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

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31383 results sorted by trial registration date.
  • Engaging residents and families about managing psychotropic medicines in aged care facilities

    This project aims to investigate resident and family engagement in communicating about psychotropic medicines by developing and testing creative strategies in aged care facilities. Psychotropic medicines affect the mind, emotions and behaviour of individuals. The project will involve the conduct of interviews and observations, which will help to inform the conduct of co-design panels. Strategies developed from co-design panels will be evaluated in a feasibility and acceptability trial. Knowledge dissemination of the results will occur with audio scenario interviews, development of infographics and workshops at the aged care sites.

  • ENgaginG older people Across transitions of care to improve medication manaGEment – Developing and Testing Co-designed Strategies

    The aim of the study is to develop and test tailored co-designed strategies that are agreed upon between hospitalised older people, their families and health professionals in managing medications as patients move across transitions of care. Strategies developed from feedback events and co-design group workshops, will be tested in a feasibility and acceptability trial. The work will inform the future development and testing of a randomised controlled trial of co-designed engagement strategies.

  • A Study to Investigate the Safety of SEP-786 101 Capsules Compared With Placebo Capsules in Healthy Volunteer Participants Aged 24 Through 55 Years

    The main aim of the study is to evaluate the safety, PK, and PD effects of SEP 786 in healthy participants. The results of this study will help inform the dosing and frequency of dosing in participants with hypoparathyroidism, which is the anticipated main therapeutic use for SEP-786.

  • Do relative motion flexion orthoses improve proximal interphalangeal joint extension following traumatic finger injury or surgery? A randomised controlled trial

    This project aims to evaluate the role of the relative motion flexion orthosis in recovery of proximal interphalangeal joint (PIPJ) extension following hand injury or surgery. Participants who have 20 degrees or more PIPJ extension deficit, and satisfy the other inclusion criteria, will be eligible to participate. They will be randomised into two groups; usual care, or usual care with the addition of the relative motion orthosis. Assessments will be completed at baseline and six weeks post commencement of intervention. We hypothesise that the intervention group will have greater PIPJ extension at six weeks, compared to the control group.

  • Fall prevention through education and coaching trial (PROTECT)

    Falls in hospital remain a common and costly problem but due to the complex intrinsic and extrinsic factors involved, no single approach or intervention has proved a panacea. This stepped wedge type I hybrid effectiveness-implementation trial will evaluate whether supported implementation (via quality improvement coaching and other tailored strategies) of tailored ward-based fall prevention interventions reduces patient falls in hospitals (primary objective). The impact of supported implementation of tailored ward-based fall prevention interventions on other fall related outcomes (e.g. falls injuries, unwitnessed falls), hospital acquired complications (e.g. pressure injuries and delirium), patient hospital length of stay, staff professional fulfilment and on a range of implementation outcomes and determinants will also be evaluated, as will the cost-effectiveness of the intervention. Routinely collected data from patient medical records and hospital databases will inform the primary outcome measure of rate of falls and some secondary effectiveness outcomes. Pre and post implementation patient and staff surveys, bedside audits and semi-structured interviews will inform secondary effectiveness and implementation outcomes. The primary hypothesis of this study is that supported implementation of tailored ward-based fall prevention interventions will reduce the rate of patient falls.

  • Ketamine-assisted psychotherapy for methamphetamine use disorder

    This study aims to determine the safety and feasibility of a combination of ketamine and cognitive behavioural therapy (ketamine-assisted therapy) for people with methamphetamine use disorder in an outpatient drug and alcohol treatment setting. There are currently no approved medications in Australia to help people manage, reduce, or stop their methamphetamine use; and psychotherapy is moderately effective. It is hoped that this study will help find out if ketamine-assisted psychotherapy (four sessions of cognitive behavioural therapy with three doses of ketamine, over a four-week period) is a safe and feasible treatment approach for methamphetamine use disorder.

  • Maximising Embedded pharmacists in aGed cAre Medication Advisory Committees (MEGA-MAC): implementing Australia’s new Guiding Principles for Medication Management in Residential Aged Care Facilities using a knowledge broker and national quality improvement collaborative intervention.

    The Commonwealth of Australia (Department of Health and Aged Care) published updated Guiding Principles for Medication Management in Residential Aged Care Facilities (Guiding Principles) that set out recommendations for medication management to support aged care provider organisations, residential aged care facilities (RACFs) and aged care staff to improve medication safety. The intervention will involve a multifaceted implementation strategy including knowledge brokers, supported by a national quality improvement collaborative called the MEGA-MAC collaborative. The knowledge brokers will work in pairs at each RACF to form a ‘knowledge broker dyad’. The knowledge broker dyad (a pharmacist and a Medication Advisory Committee [MAC] chair/member) will develop, evaluate and monitor quality improvement strategies to implement the Guiding Principles into practice at their RACF. The MEGA-MAC collaborative will support the knowledge broker dyads to deliver the intervention. It is hypothesised that knowledge broker dyads supported by the MEGA-MAC collaborative will lead to improvements in Guiding Principles concordance in RACFs post-intervention compared to pre-intervention.

  • Therapeutic intervention for intimate partner violence survivors with PTSD

    In 2014, Australia declared intimate partner violence (IPV) a national emergency reported to affect one in six women. Unfortunately, the prevalence, severity, and frequency of IPV have been exacerbated since the outbreak of COVID-19, with more recent estimates of IPV reported to affect up to 1 in 4 Australian women and is the leading cause of preventable death, disability, and illness among women aged 15-44. Of the many challenges faced by IPV survivors, post-traumatic stress disorder (PTSD) is notable, with an estimated prevalence of up to almost 64% of survivors, irrespective of the type of IPV experienced. Also, 60-92% of women facing physical IPV experience facial/head injuries, including mild traumatic brain injury or non-fatal strangulation events, which can lead to persistent post-concussion symptoms (PPCS). The primary aim of this study is to determine whether aerobic exercise intervention can improve outcomes in IPV survivors with post-traumatic stress disorder (PTSD). Secondary to this is whether this intervention is effective in women who have experienced intimate partner violence brain injury (IPV-BI) experiencing persistent post-concussion symptoms (PPCS). In addition, we hope to identify objective markers in the blood to supplement our knowledge of improvement. Exercise intervention holds promise as a readily available, easy-to-apply, non-pharmacological treatment for PTSD and PPCS and offers a highly accessible option for healthcare providers. This project hopes to address the urgent need for an effective intervention in this underserved population.

  • Therapeutic intervention for intimate partner violence survivors with PPCS

    In 2014, Australia declared intimate partner violence (IPV) a national emergency reported to affect one in six women. Unfortunately, the prevalence, severity, and frequency of IPV have been exacerbated since the outbreak of COVID-19, with more recent estimates of IPV reported to affect up to 1 in 4 Australian women and is the leading cause of preventable death, disability, and illness among women aged 15-44. Shockingly, 60-92% of women facing physical IPV experience facial/head injuries, including mild traumatic brain injury or non-fatal strangulation events, which can lead to persistent post-concussion symptoms (PPCS). The primary aim of this study is to determine whether aerobic exercise intervention can improve outcomes in IPV survivors with persistent post-concussion symptoms (PPCS). In addition, we hope to identify objective markers in the blood to supplement our knowledge of improvement. Exercise intervention holds promise as a readily available, easy-to-apply, non-pharmacological treatment for PPCS and offers a highly accessible option for healthcare providers. This project hopes to address the urgent need for an effective intervention in this underserved population.

  • A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Dose Escalation (with optional food effect) Study of Orally Administered TRX-100 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of TRX-100 in Healthy Volunteers

    This is a double-blind, placebo-controlled study to assess the safety of TRX-100 and how this drug acts in the body in healthy volunteers. TRX-100 may be indicated for use in patients with influenza, but a trial of the drug in healthy volunteers is needed before trials in influenza patients can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 64 years and are in good general health without a clinically significant medical history. Study details All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive a single dose of TRX-100 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. It is hoped this research will determine the maximum dose of TRX-100 that can be administered safely without causing severe reactions. Once the dose of TRX-100 has been determined in healthy volunteers, a trial investigating the efficacy of TRX-100 as a treatment for patients with TRX-100 may proceed.

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