ANZCTR search results

Concussion is the most common form of brain injury, making up 75-90% of all brain injuries. Concussions generally resolve within 7-10 days, however, up to 25% experience delayed recovery which may interfere with return to pre-injury activities (e.g. work) and cause significant stress for months and sometimes years after injury. Persisting concussion symptoms are thought to reflect a range of factors beyond the original injury to the brain including stress and anxiety and physical factors such as injury to the neck, visual and/or balance systems. Given that multiple factors may be contributing to the persistence of symptoms after concussion, an interdisciplinary approach to management is now recommended in clinical practice. Therefore, we aim to conduct a randomised controlled trial and evaluate an interdisciplinary intervention that incorporates expertise from psychology, physiotherapy, and medicine to target the primary factors thought to contribute to persisting concussion symptoms.

In settings of care for people who cannot breathe without support such as intensive care units (ICU), dyspnoea (the experience of difficulty breathing) is a frequent and terrifying problem. Recent reports indicate that dyspnoea in the ICU is just as commonly experienced as pain (47% report mod-severe dyspnoea vs 41% pain, n=138 ICU patients [Gentzler et al. 2019]), yet dyspnoea by comparison is poorly recognised, underassessed and under-treated. This results in increased length of ICU stay, poorer physical and long-term psychological outcomes; and occurs despite the availability of potentially suitable assessment tools and evidence-based effective interventions for dyspnoea in the ICU. Implementation of dyspnoea assessment and management in Australian ICUs is largely unexplored. This project aims to address explore this issue through two research questions: 1. What are the perceptions and beliefs of Australian ICU clinicians about dyspnoea assessment and management in patients in the ICU setting? 2. What is the experience of dyspnoea in people who have been cared for within an ICU environment? Methodology: The project will be conducted in two parts within an action research framework: 1. A cross-sectional national descriptive survey of medical, nursing and allied health clinicians working within Australian ICU’s, to explore attitudes and practices in dyspnoea assessment and management. 2. Semi-structured interviews with a purposive sample of ICU patients from a local facility, to explore the experience of breathlessness in people who have been cared for within the ICU environment. Significance: Internationally, addressing assessment and management of dyspnoea in ICU settings has been recognised as an ethical and moral imperative to lessen suffering, improve patient outcomes, and reduce health care costs associated with delayed time in the ICU and post-ICU morbidity. To date, there is no Australian data available on prevalence, assessment practices and management strategies on dyspnoea within the ICU setting. This study aims to gain an understanding of current Australian practice using a collaborative participatory action research approach to focus on patient and clinician-valued priorities and solutions. The findings from this study will provide a foundation for developing strategies to translate breathlessness science and evidence-based interventions into clinical practice in the ICU.

This trial will evaluate the efficacy of Growing with Gratitude as a preventative program, by specifically examining whether the program will: 1) increase gratitude and resilience, and 2) prevent and reduce anxiety and depression symptomology in children. Furthermore, the current trial will also aim to explore resilience, gratitude and emotion regulation as a potential mechanisms by which the program prevents negative affect such as anxiety and depression.

The aim of the current study is to compare the effects of the Nerva gut-directed hypnotherapy (GDH) program to psychoeducation (control) on gastrointestinal symptoms and psychological indices in patients with irritable bowel syndrome (IBS). It is hypothesised that participants randomised to the Nerva GDH program will see greater degrees of improvement in terms of overall and individual gastrointestinal symptoms and psychological indices compared to those who receive psychoeducation (control).

This project will explore the effectiveness of a cultural navigator or ‘Natural Helper’ mentoring intervention. The purpose is to understand if patients from culturally and linguistically diverse (CALD) backgrounds experience greater activation when they receive mentoring from a cultural mentor, compared to those who do not receive this mentoring. Who is it for? You may be eligible for this study if you are aged 18 or older, you are commencing active treatment with one of the participating clinics for a specified condition of interest, and you self-identify with a CALD community of interest for cultural mentoring by the clinic they are attending. People who are currently undergoing treatment for their cancer or who have recently completed cancer treatment may be eligible for this study. Study details Participants who choose to enrol in this study will be randomly allocated (by chance, similar to flipping a coin) to either immediate mentoring after enrolment, or delayed access to mentoring (approximately 9 months post-enrolment). This allocation will occur at the clinic level, so all participants who are attending the same clinic will either receive immediate mentoring or delayed mentoring depending upon their clinic's allocation. In the immediate mentoring clinics, participants will be paired up with a Natural Helper mentor who will have a lived-experience of the same chronic disease. Mentors will use a range of techniques associated with promoting behaviour change and chronic disease self-management. Advice provided by mentors will be grounded in their own experience with chronic disease self-management. Participants will be asked to attend a minimum of 3 sessions with their mentor over a 3 month period. If they wish to, participants can continue to meet with their mentor after this time. The delayed mentoring clinics will not have any natural helper mentors available for the first 9 months but participants attending these clinics will be able to access standard care services as provided by the clinics. After 9 months, these delayed clinics will then undertake the mentoring program as outlined above. It is hoped this research will determine whether having a mentor with similar life experiences a mentor can result in better outcomes for patient engagement with treatment, coping, self-efficacy and health-related quality of life.

The aim of this study is to assess the feasibility, efficacy, and safety of a new type of cancer imaging called gallium-68 fibroblast activation protein inhibitor (68Ga-FAPI) positron emission tomography/computed tomography (PET/CT), compared to the standard of care cancer imaging called 18F-fluorodeoxyglucose (18F-FDG) PET/CT, for the staging/restaging (i.e. determining how much cancer is in the body and where it is) of pancreatic cancer. Who is it for? You may be eligible to participate in this study if you are aged 18 years or older, have histologically or cytologically confirmed pancreatic cancer, and are under consideration for surgical resection by a Wesley hepatopancreaticobiliary (HPB) surgeon. Study details All participants will undergo a FDG PET/CT scan at I-MED Radiology, The Wesley Hospital, as part of standard care. This will involve the injection of 2.5MBq/kg + 75MBq FDG tracer intravenously, followed by the PET/CT scan 60 minutes post tracer administration +/- 10minutes, and will take approximately 30 minutes to complete. Within 1-7 days of the FDG PET/CT scan, a FAPI PET/CT scan will be performed at I-MED Radiology, The Wesley Hospital. This will involve the injection of 2.5MBq/kg FAPI tracer intravenously, followed by the PET/CT scan 60 minutes +/- 10 minutes later, and will take approximately 30 minutes to complete. The two scans will be compared for their ability to detect pancreatic cancer lesions and the effect of this on staging or restaging of the disease. Participants will also be monitored for side effects following injection of both tracers to determine the safety of each technique. In conducting this study, we hope to provide proof-of-principle that FAPI PET/CT provides a clinically useful imaging modality for the staging/restaging of pancreatic cancer at The Wesley Hospital.

BeNEFIT is a 4-week, international, randomised controlled trial designed to test whether adherence to a Mediterranean diet mHealth program is efficacious and cost-effective for improving depressive symptoms, compared with an m-Health control nutrition program. Community-dwelling adults (age 18-65), from Australia, New Zealand the United States and United Kingdom, with at least mild depression severity and who currently do not follow a Mediterranean diet or have conditions that prohibit the use of nutrition supplements will be recruited online. The Intervention consists of a Mediterranean diet education program, delivered via a mobile application. The program consists of modules containing video content and weekly goal setting activities. The control group will receive a control nutrition education program, also delivered via a mobile application. The program consists of modules containing video content and weekly quiz activities. We anticipate that the mHealth Mediterranean diet intervention will be effective compared to a mHealth control nutrition education program in improving self-reported depressive symptoms at 4 weeks.

Acute hospitalisation can result in significant decline in functional ability, termed hospital associated deconditioning (HAD). Older adults are most vulnerable with increased falls, increased disability with resultant institutionalisation. It is known that bed rest and immobility results in acute muscle atrophy and decrease muscle strength. Aim of the study: The aim of this “stay fit in hospital” exercise program is to introduce a very early exercise program of sufficient intensity starting within 48 hours of admission to hospital with a tailored exercise program for hospital associated deconditioning. We anticipate this program will prevent hospital associated deconditioning and significantly shorten their length of stay in hospital to enable them to return to the community safely, maintaining their functional level. We hypothesise that if we commence the rehabilitation program targeting strengthening of the muscles before the changes of deconditioning sets in, we can maintain the level of functioning during hospital stay to enable early safe discharge back to community. Specific Objectives 1. To determine the effectiveness of the “Stay Fit in Hospital” exercise intervention in preventing hospital associated deconditioning. 2. To determine the feasibility and cost-effectiveness of such a program in its implementation. 3. To determine its longer-term effects in maintaining functioning.

This randomised controlled trial is attempting to better understand the effectiveness of education material provided to patients considering a surgical opinion for their knee osteoarthritis. The primary aim of this study is to determine whether a co-designed decision aid for people with knee osteoarthritis considering surgery in addition to standard care (intervention) increases the proportion of people who make a high quality decisions compared to standard care alone (control). Patients will be recruited from a public clinic or private rooms of surgeons in NSW. They will be screened for inclusion and randomised to receive the intervention or control. Education material will be provided to participants prior to attending an initial consultation with their surgeon. After attending their initial consultation, participants will be followed up 2 weeks, 6 months and 1 year later regarding if they made a high quality decision, the impact of educational material on their decision, consideration for surgery, satisfaction with treatment decision, decisional conflict, decision regret, function and quality of life. We hypothesise that the use of this co-designed decision aid will lead to greater rates of high quality decision-making reported by patients compared to those receiving standard care. Further, we hypothesise the use of this co-designed decision aid will lead to decreased decisional conflict, decision regret and rate of change from original decision compared to those receiving standard care. We also hypothesise that overall satisfaction and impact of education materials on treatment option chosen will be increased, and function and quality of life will be unchanged compared to those receiving standard care. Based on the fulfilment of these hypotheses, we expect patients to choose surgery less often when receiving the co-designed decision aid.

The present study aims to explore the efficacy of an online intervention program designed to facilitate a sense of meaning in young people’s lives (aged 18-30 years), the possible wellbeing benefits associated with this facilitation, and the differing effects a focus on pursuing ‘eudaimonic’ meaning versus ‘hedonistic’ meaning may have on these outcomes. Carried out over the course of 2 online sessions, completed over the course of 14 days, participants will be invited to participate in a program advertised as the ‘Facilitating wellbeing behaviours workshop’. Participants will be randomized to one of three groups, including a group who will be provided with 2 lots of reading exercises (received 7 days apart) and activities that promote a focus on hedonic meaning; a group who will be required to complete reading and activities that promote a focus on eudaimonic meaning; and a no-treatment control group. It is expected that participants who complete activities focused on eudaimonic meaning will report higher wellbeing compared to those who complete activities around hedonistic meaning.