ANZCTR search results

We think that we now have a better test for identifying clinically important alcohol use, by measuring an alcohol product, phosphatidiylethanol (PEth), in blood. We want to compare this test with the current standard blood test for alcohol (the blood alcohol level) by running both tests on every blood specimen sent from the emergency department (ED) for alcohol testing in the next 12 months. This is a non-interventional, observational study, consisting of patients whose alcohol consumption is being investigated as a causative factor in illness or injury. The study will involve the secondary use of routinely collected blood samples that have completed their clinical purposes and are in storage, awaiting disposal. The clinical study is a single time-point (snapshot) experiment, where patients will not be contacted, and their treatment will not be affected by the outcome of the research.

Chemotherapy induced nausea and vomiting is a well-recognised problem for patients undergoing cancer treatment. While significant progress has been made over the last few years, nausea remains a debilitating issue for some people and therefore newer treatment interventions are required. Among the non-drug interventions, music therapy intervention appears promising based on its previously demonstrated health benefits. Therefore, the aim of the study is to evaluate the feasibility and acceptability of a novel music therapy intervention for the prevention and treatment of chemotherapy induced nausea and vomiting. Who is it for? You may be eligible to join this study if you are aged 18 years or older, and are planned to undergo systemic chemotherapy for your cancer that is known to be associated with nausea and vomiting. Study details All participants will be provided with a music listening device with preloaded music that was recorded using music therapy principles designed to promote relaxation. The device will be given to participants at the beginning of their first and second chemotherapy cycles. Participants will be asked to listen to a minimum of 5-15 minutes of music through using the device during each day chemotherapy cycles. Before and after the first and second cycle, the participant will complete questionnaires using the device regarding chemotherapy induced symptoms, symptoms of nausea and vomiting, and sleep quality. It is hoped that this study will show that music therapy is feasible, acceptable, and effective for the prevention and treatment of chemotherapy induced nausea and vomiting in cancer patients undergoing chemotherapy.

This study aims to evaluate the effect of a 12-month eHealth exercise and diet program on the quality of life and wellbeing of women with metastatic breast cancer (MBC), compared to a current practice control Who is it for? This study is for women aged 18 years or older, who have been diagnosed with metastatic breast cancer in the previous 10 years, living in Queensland and are well enough to partake in an exercise program. Study details Participants who choose to enrol in this study will be randomly allocated (by chance, similar to flipping a coin) to one of two treatment groups. Participants who are allocated to the first group will be given access to an eHealth-delivered exercise and diet program for 12 months. These participants will be able to attend up to 10 one-on-one remote video sessions with an Accredited Exercise Physiologist and up to 10 sessions with an Accredited Practising Dietitian. During each session the health professionals will work with participants to create a tailored exercise and/or eating plan to optimise participants' health and wellbeing. Participants who are allocated to the second group will continue to receive their current treatment/s from their specialists and will be encouraged to access existing services and resources (e.g., Breast Cancer Network Australia’s online tool to receive information and resources in relation to exercise and nutrition). The My Journey online tool is available to all Australian women diagnosed with breast cancer (https://www.bcna.org.au/understanding-breast-cancer/bcna-resources/my-journey/). The online tool also informs women of other existing community-based or online support options, including accessing support to allied health services (e.g., dietitians and exercise physiologists if they wish to) through a General Practitioner (GP)-coordinated Chronic Disease Management (CDM) Plan. Data Collection All participants will be asked to complete a physical assessment (via video), a DXA scan at a local imaging facility, an online questionnaire, and a food/drink recall at the time of enrolment, and then at 6 and 12 months after enrolment. At 3 and 9 months, participants will only complete a brief online questionnaire. It is hoped this research will determine whether a tailored telehealth exercise and diet program has a positive impact on the health and wellbeing of women with metastatic breast cancer. If this program is found to be effective it may be expanded across Australia for access by a larger number of metastatic cancer patients.

Researchers at the Black Dog Institute have developed a new digital mental health tool for children aged 8 to 10 years who worry or experience low mood. The goal of the program is to help children to develop healthier thinking habits to help with their worry and low mood. In this study, we are conducting a clinical trial to evaluate whether the program is beneficial for children’s mental health. The current project will investigate the efficacy of a novel Cognitive Bias Modification of Interpretations (CBM-I) intervention for children with elevated symptoms of anxiety and/or depression. The CBM-I program has been developed in consultation with children, parents and mental health professionals to maximise engagement and relevance of content and features for children with anxiety and depressive concerns. Children aged 8-10 years who are reported to experience anxiety and/or depressive symptoms above a clinical cutoff will be randomly allocated to a CBM-I intervention or a waitlist control group. Children in the intervention group will undertake eight sessions online on a home device which trains them to interpret ambiguous information more positively or neutrally. Anxiety and depressive symptoms, and interpretation bias will be assessed before and after the intervention/waitlist period. Compared to the waitlist control group, we expect that the intervention group will report fewer symptoms and biases following the intervention/wait period and these gains will be maintained at one month follow up. We will also examine whether the intervention is enjoyable, useful, and easy to use among participants in the intervention group. This project is significant as it will evaluate the first CBM-I intervention which targets both anxiety and depressive symptoms in children and has been co-designed in consultation with children parents and clinicians. If the intervention is found to be effective and acceptable, it has potential to be used during a waitlist for standard care (e.g., Cognitive Behavioural Therapy (CBT)).

Surgical wound complications such as surgical site infection or surgical wound dehiscence are a considerable burden to the patient, carer and provider. They result in delays to wound healing, reduced patient wellbeing, readmissions to acute care and clinical management in the primary and community nursing setting. Early identification is key to prevention and the use of dressings that reduce the bacterial load of the incision site may reduce the occurrence of wound complications after surgery. A randomised control trial is proposed to determine the efficacy of bacterial binding dressings for the prevention of surgical site infection and surgical wound dehiscence in an adult population undergoing abdominal surgery. The interventional dressing contains a fatty acid coating bacterial binding agent dialkylcarbamoylchloride (DACC) associated with reducing bacterial burden in chronic wounds. Unlike other antimicrobial dressings that rely upon a chemically active agent to reduce bioburden, DACC dressings use a mechanical rather than a chemical mode of action to reduce bioburden. Two arms will be investigated, one with the DACC dressings and a control arm using no DACC dressings. Participants will have a 14 day wear time of the dressing and will be followed up for a period of 30 days after their surgery including standard wound review meetings as per usual care. This study aims to determine the comparative efficacy of DACC containing dressings for the prevention of surgical wound complications following abdominal surgery in an adult cohort.

Osteoarthritis (OA) is the 12th highest contributor to global disability. It typically involves the hip and knee causing joint pain that leads to impaired function and reduced quality of life. There is no cure for OA and treatment focuses on long-term self-management of pain with exercise and weight loss (if overweight). But, people with OA are dissatisfied with the quantity and quality of information provided to them about their condition and do not feel equipped to self-manage successfully. We are conducting a randomised controlled trial to evaluate whether a Massive Open Online course about OA and its management may be a scalable solution to improve people with hip and/or knee OA’s knowledge of the condition and their confidence to manage their joint pain, compared with OA education that is currently available online. The primary outcomes under investigation are OA knowledge and pain self-efficacy. Participants will be randomly allocated to one of two treatment groups; i) Consumer-focused Massive Open Online Course (Experimental intervention) ii) OA information pamphlet (Control intervention) Primary and secondary outcomes will be collected by web-based survey at baseline (if applicable), 5 weeks post randomisation (primary) and 13 weeks post randomisation (secondary).

Occupational therapists conduct home assessments to establish patient safety at home and provide rehabilitation to support hospital discharge and prevent readmissions. Assessment requires visual observation of the home environment. This requires significant engagement with the patient and often a carer. In 2021, over 6000 home assessments were completed across Sir Charles Gairdner Osborne Park Healthcare Group (SCGOPHCG), with staff spending over 1,650 days per year completing home assessments at a cost of over $700,000. Virtual care has been introduced to undertake home assessments and has great potential for providing a non-inferior and cost-effective service. Some small studies have demonstrated that home assessments delivered via virtual care are feasible at assessing the home environment for risks, providing rehabilitation and potentially reducing hospital length of stay. This study will implement an occupational therapy home visiting service using virtual care to reduce therapy time. It is hypothesised that this model will be non-inferior to the traditional face-to-face model of care in regard to adverse events and patient satisfaction.

Patients with a diagnosis of high grade glioma are at risk of extended hospital stays. The lack of access to timely services is an ongoing challenge for multidisciplinary teams when planning discharge for these patients. This study aims to assess the impact of early referral (at diagnosis) to allied health services on the quality of life and health outcomes for patients with high grade glioma (HGG) and their carers. Who is it for? You may be eligible for this study if you are aged 18 years or older and you have been diagnosed with high grade glioma within the past three months. Patients with and without carers will be eligible. Study details All participants who choose to enrol in this study will be given an early referral to the allied health service at Sir Charles Gairdner Hospital. Participants will be contacted by either a senior occupational therapist or a senior social worker within 6-8 weeks of their first oncology appointment, which may occur in person or over the phone. During the initial appointment, the occupational therapist or social worker will complete an assessment with the participant (and their carer, if applicable) to determine their needs. Follow-up appointments will be scheduled for each participant dependent on their needs. The initial and subsequent appointments will either be face to face or via virtual care (remotely delivered telehealth) and will vary in length from 30-90 minutes. Standard interventions that are provided by the occupational therapist and social worker in the oncology service include provision of equipment, assessment and referral for home services, National Disability Insurance Scheme (NDIS) application support, case coordination and patient and carer education. Participants and their carers will be asked to complete a series of questionnaires during the initial assessment and again at 6 months after the initial assessment. The study period is set at 6 months, but therapy treatment will continue after this time dependent on the participant’s needs. It is hoped this research will determine whether providing early referrals for high grade glioma patients to allied health services, including occupational therapists and social workers, leads to improved quality of life and fewer unplanned hospital admissions. If this model of care is found to be more beneficial than the current as needed referral system, it may be implemented more broadly to high grade glioma patients nationwide.

Individuals living with treatment resistant depression are faced with an especially challenging road to recovery. The factors that complicate treatment include, lack of a universal definition on what treatment resistant depression is, poor doctor-patient relationship, inadequate knowledge about treatment options, patient /caregiver fatigue, and high cost associated with co-morbidities. Due to the nature of treatment resistant depression, a need to emotionally self-regulate amidst stress commonly arises in adults. This stress may range from activities of daily living (like bathing, taking medication, grocery shopping) to medical management (attending doctor’s appointment, corresponding with insurance providers etc.) and/or social engagements. Continuous exposure to such stress keeps one’s sympathetic nervous system charged and activated often resulting in a heightened state of alarm which further exasperates depressive symptoms. In this way, repeated exposure to stress is part of the lived experience in adults with treatment resistant depression. This graduate researcher believes that moving towards stability begins with an increased understanding and awareness about one’s automatic stress responses. Such knowledge can help foster and create a path where individuals living with treatment resistant depression can comfortably identify manage their stress. Current tools in depression treatment do not document the experience of learning and practicing somatic based stress management techniques after participating in group dance therapy sessions. This tool may be potentially helpful for both, adults living with TRD and their health practitioners in tracking symptoms of TRD. Based on this background, this research project is designed as to help understand if group dance therapy sessions may be helpful in alleviating stress associated with a treatment resistant depression diagnosis by fostering somatic aptitude in participants and if dance therapy helps provide any symptomatic relief associated with treatment resistant depression.

To assess the efficacy of the NurofluxTM device to continuously monitor and detect significant neurological deterioration in patients with acute ischaemic stroke due to large-vessel occlusion (LVO) in anterior cerebral circulation against the gold standard of high-intensity nursing monitoring of vital signs and neurological function, and use of routine brain imaging. Study Design: This is an investigator-initiated and conducted, multicentre, open-label, single arm, clinical evaluation feasibility (proof-of-concept) trial. After an internal pilot phase (Phase 1; registered seperately) to rehearse the main study to identify key issues to consider in the next phase of the study, as well as to optimise the device parameters, this study phase (Phase 2) will be rolled out for full assessment of the sensitivity, specificity, and predictive value of monitoring of patients in acute phase across three major teaching hospitals in Sydney under the supervision of leading stroke clinician-scientists. Phase 2 – Main phase 260 consecutive patients with AIS with LVO in the anterior circulation will be recruited and monitored using the device and followed through the course of regular treatment and management. Device metrics (sensitivity, specificity, and positive/negative predictive values) will be determined against routine clinical and brain imaging (CT/MRI) to determine thresholds for detection of: AIS (severity and location), response to treatment (successful reperfusion) and neurological deterioration (from bleeding [haemorrhagic transformation], cerebral oedema [‘brain swelling’] and/or extension/recurrent stroke). Phase 2 Primary Outcome: 1. Performance of the device (sensitivity and specificity) on detection of neurological deterioration Secondary Outcomes: 1. Positive and negative predictive values of the device 2. Detection of acute ischaemic stroke (severity and location) 3. Correlation to initial and follow-up imaging parameters 4. Response to treatment (successful or unsuccessful reperfusion) 5. Detection of recurrent stroke 6. Detection of cerebral oedema, haemorrhagic transformation, and early seizure (after study enrolment) 7. Proportion of time spent wearing the device within the intended period