ANZCTR search results

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

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31373 results sorted by trial registration date.
  • The FOOTPRINTS Project : Follow-on Outreach - Bereavement care after the unexpected death of a child in PICU - Phase One

    This study will ask families who have experienced the unexpected death of a child in PICU about their experience of and their thoughts about bereavement care. The aim of PICU care is to help children to survive serious illnesses and injuries, but unfortunately not all children survive. For those who die unexpectedly, the experience for their family can be very traumatic. These families may struggle to understand what happened in the last moments of their child’s life, and why the efforts of doctors and nurses to save them were not successful. This may make it harder for these families to process their grief in a healthy way and may contribute to conditions such as post-traumatic stress, complicated grief, and problems in the way the family functions. The best way to support families after the unexpected death of a child is currently not well understood, with most research and resources focusing on expected deaths such as cancer. In the case of expected deaths, there is usually time to plan and partner with families, and there are specialist services such as palliative care available to provide support. The experience of families who lose a child unexpectedly can be quite different, and so a different approach is needed. This study will use focus groups and family interviews to ask close relatives of children who have died an unexpected death in PICU about the bereavement care they received, the gaps in care, their perceived bereavement care needs, and their recommendations for PICU bereavement care. The results will be used to design an experimental PICU bereavement service to be implemented as the intervention in Phase Two of the FOOTPRINTS project.

  • Evaluation of the Stop Smoking, Start Living (S3L) project

    NSW Health smoking cessation policy is evidence-based, yet poorly implemented. We are funded to roll out a TRANSLATE (TRAining in evideNce-baSed ImpLementATion for hEalth) (TRANSLATE- cessation (Tc) implementation intervention in randomly selected hospital wards of three LHDs as part of a quality assurance activity. Random selection aims to distribute limited resources in a fair manner and provides an opportunity to examine the efficacy of the Stop Smoking Start Living (S3L) bundle in intervention (Tc + S3L) versus control wards. The qualitative experience of patients from high-risk populations (HRPs) in intervention wards will be examined. HRPs include women who smoke during pregnancy, people with mental illness, people with diagnoses of drug and alcohol abuse/dependence and Aboriginal and Torres Strait Islander people. Sub-studies include: 1. Effect of Tc on health care professional behaviour. 2. Effect of Tc and S3L on patient smoking behaviour. 3. Qualitative experience of HRPs with the S3L treatments.

  • Feasibility of FitSkills for Young Adults with cerebral palsy who use wheeled mobility.

    More than half the people living in Australia do not exercise regularly, an issue even more acute for adults with cerebral palsy (CP). CP is a condition that affects motor control, skill, and coordination. There is an association between the severity of CP and the presence of additional health and psychosocial issues leading to greater complexity of the condition. People with complex CP have more difficulty achieving the recommended amounts of physical activity. Adults with complex CP have rarely been included in research, particularly studies relating to exercise. Most CP research has focused on children and young adolescents with less complex CP (i.e., those who are ambulant). It is often hard for people with disabilities to exercise because of difficulties accessing places where there are opportunities to be active. In addition, they might not have the right support. The FitSkills program was created to address this issue. FitSkills matches people with disabilities and health students (Nursing, Occupational Therapy, Exercise Science) to exercise together in a gym environment. Studies have shown that FitSkills can engage youth with disabilities in community-based exercise. With additional support, including screening, risk assessment, and additional professional support for the peer-mentor health student, FitSkills can be tailored for young people with complex disabilities. Our project examines how well FitSkills can be implemented in a real-world setting for adults with CP who use wheeled mobility (i.e., wheelchair, frames). In this study, we want to see if we can implement an intervention that has the potential to help younger adults with CP improve their health, well-being, and ability to participate in activities that are meaningful to them. So far, our work has reviewed the findings of existing research and has explored the experiences of adults with CP to learn more about what they want and need to exercise in their communities. From the adult’s perspective, it is important they can access the community and be seen by the community. Our next step is to test the feasibility of FitSkills. We aim to ensure it can be implemented and is practical and acceptable for adults with CP who use wheelchairs using elements of an evidence-based feasibility framework.

  • A retrospective review of rib fracture management at inpatient facilities in Sydney Local Health District from January 2018 - December 2019

    A retrospective clinical audit of patients admitted with rib fractures will provide a district wide summary of inpatient rib fracture management. This audit will assess patterns and outcomes of patients admitted with fractured ribs, and patterns in any complications the patients experienced. The audit has the potential to contribute to the body of evidence in the management of patients with fractured ribs. Pain management is a common priority when it comes to the management of patients with fractured ribs. Trends and patterns of analgesic use will provide insight into the current trends of pain management provided to patients with fractured ribs. Foreshadowing future complications from patients with fracture ribs will help refine the current management, pathways, and guidelines for rib fracture management.

  • Assessing the Impact of Digital Cognitive Behavioural Therapy for Insomnia on Depression Symptoms and Processes in Young Adults.

    Depression and insomnia are important and related public health problems for young people. The recommended treatment for insomnia is Cognitive Behavioural Therapy for insomnia (CBTI). CBTI programs are known to effectively reduce symptoms of depression without directly targeting non-sleep symptoms. However, the mechanisms which underlie the association between insomnia and depression are not well understood. Many candidate mechanisms have been proposed (e.g., cognitive biases), yet, there is a lack of research which investigates these possible mechanisms, and data from treatment studies is greatly needed to investigate the causal role of these mechanisms in the association between insomnia and depression. This randomised controlled trial aims to investigate what psychological mechanisms explain how digital cognitive behavioural therapy for insomnia improves depression in young people. It is hypothesised that the group who receive the brief CBTI program will display greater improvement in symptoms of depression and insomnia, and a greater change in mechanisms thought to underlie the association between depression and insomnia symptoms, compared to the group that receive education (waitlist control).

  • A Phase 2, Open-label, Single-arm Study to Evaluate the Tolerability, Safety, and Pharmacodynamic Effects of KER-012 in Participants with Chronic Heart Failure.

    This study is designed to evaluate the tolerability, safety, and pharmacodynamics of KER-012 in combination with current background therapy at a stable dose in participants with heart failure. Background therapy will be defined by the investigator as appropriate. HF background therapy treatments will be provided by the treating physician based on local treatment guidelines and must remain stable throughout the study. If a participant is observed to show disease progression requiring additional therapy, the participant should receive standard HF treatment following locally relevant guidelines. This study will enroll a total of 12-16 heart failure patients with either preserved or reduced ejection fractions for subcutaneous injections with KER-012 every 4 weeks. Heart Failure is associated with increased activin receptor type II signalling. KER-012 is designed to bind to activins and thereby, potentially reduce activin receptor type II signalling. Therefore, it is anticipated that KER-012 could potentially improve the underlying pathology of heart failure.

  • Determining the feasibility of the use of the Crohn’s Disease Exclusion Diet (CDED) in adults with Crohn’s disease: A Pilot Study

    The purpose of this study is to investigate the feasibility and effectiveness of the CDED in adult patients with Crohn’s disease on outcomes including compliance of the diet, changes in nutrition impact symptoms and quality of life; in comparison to their baseline diet. It is hypothesized that if patients are compliant with the CDED and the CDED is completed appropriately and in its entirety, it will be a feasible treatment strategy and effective in inducing remission for adult patients with Crohn’s Disease.

  • Use of hearing protective devices in the clinical dental setting

    The effect of noise in the dental clinical setting has been shown to exceed safe levels, and the potential effects of this on the hearing of dental practitioners well-established. Occupational noise-induced hearing loss (ONIHL) is an irreversible condition that can affect dental practitioners as they are subjected to long-term, frequent exposure to high-frequency noise from equipment and instruments. Prolonged exposure may reduce hearing sensitivity and acuity and is associated with various comorbidities such as tinnitus; it may affect quality of life. Within the last decade ONIHL in dentistry has been well-researched, yet there remains limited discussion regarding use of hearing protection devices e.g., custom-made earplugs, in the clinical setting. Although such devices are a well-established means of preventing ONIHL in noise-prone professions there is little evidence regarding their use in dentistry. This study aims to investigate dental practitioners’ perceptions of the use of hearing protective devices and create a tool for future larger scale investigations. By raising awareness and implementing appropriate hearing protection measures, it may be possible to safeguard the hearing health and overall well-being of dental professionals.

  • Befriending with GENIE: Social intervention to address loneliness and social support for people with dementia and caregivers from Culturally and Linguistically Diverse (CaLD) communities.

    The BEFRIENDING with GENIE project aims to improve the quality of life of people living with dementia and their caregivers from CaLD backgrounds by reducing loneliness, increasing social support networks and improving access to and knowledge about appropriate services. BEFRIENDING is a program in which trained facilitators provide 8 regular (e.g. weekly) visits interacting with the participants to share informal conversations. GENIE is an online tool that supports participants to expand their social support networks and engagement with existing services based on their interests and intrinsic motivations. GENIE comprises a database of existing services and activities tailored to participants' interests/needs and a network mapping tool that measures their social supports over time. We have successfully implemented BEFRIENDING and GENIE interventions in our previous research, but this is the first project where we bring them together. We will deliver the BEFRIENDING with GENIE program to 100 participants and caregivers from four main language groups of older Australians: Italian, Chinese, Vietnamese and South Asian. The program will use trained facilitators with appropriate language and cultural knowledge. We will work with Partner Organisations (with whom we have a track record of successful research collaboration) who support community-dwelling people living with dementia and their caregivers in four states, WA, SA, Victoria and NSW, thereby providing a strong test of the generalisability of the intervention across Australia. The project methodology utilises a hybrid effectiveness-implementation design including a randomized clinical effectiveness trial combined with a mixed method multi-stakeholder process evaluation. The research is led by a multi-disciplinary team comprising anthropology, sociology, geriatric medicine, public health, social work, nursing, occupational therapy, and implementation science with expertise in CaLD populations and dementia.

  • Ultrasound measurement of stable and unstable shoulders

    This is the first component of a masters project that is investigating humeral head position and translation in unstable shoulders. In this observational study, we aim to measure the differences in humeral head position and/or translation between unstable and stable shoulders. We hypothesise that there will be detectable differences between stable and unstable shoulders as measured by ultrasound. This may then inform treatment strategies that aim to address the pathological humeral head position / translation.

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