ANZCTR search results

What is this study about? We are looking at the immune response to influenza vaccine and how this can be improved in patients during or after treatment for certain types of blood cancers. When you are vaccinated, your body makes antibodies against influenza virus, which protect you from influenza infection. We know that the body’s immune response to influenza vaccine is not as strong after treatment for blood cancer. Currently, having one dose is recommended to try to protect you against influenza. We would like to study if two adjuvant dose influenza vaccines or two standard vaccines will improve the immune response. An adjuvant vaccine is a vaccine that contains an ingredient which can stimulate a stronger immune response and is generally used in people 65 years and above. Who is it for? You may be eligible to participate in this study if you are aged 18 years or older, have been receiving treatment for blood cancer (myeloma, chronic lymphocytic leukaemia or non-Hodgkins lymphoma) or have received treatment for the listed blood cancers within the last 12 months, and have not yet received a flu vaccine for the current season of recruitment (i.e. 2022 influenza vaccine for 2022 recruitment, 2023 influenza vaccine for 2023 recruitment). Study details There will be two groups of participants and both groups will two doses of influenza vaccine, one month apart. One group (Group 1) will receive two doses of the adjuvant influenza vaccine 1 month apart and a second group (Group 2) standard dose influenza vaccine followed by the standard dose vaccine 1 month later. Blood samples will be collected at four time points: before the first vaccine, before the second vaccine, 21-28 days after the second vaccine, and 6 months after the first vaccine. Participants will also be asked to provide information on vaccination history, side effects and if an influenza-like illness (ILI) occurs. Participants will be contacted weekly to see if they have developed any influenza-like illness from first vaccination until 6 months later. If respiratory symptoms occur, the participant will be asked to give a nasal swab and get checked out by their regular treating or general practitioner. This study will help us understand if two doses of the adjuvant or standard dose vaccine should be used in patients.

This study aims to prospectively assess the impact of multidisciplinary multimodal supportive care intervention on cancer selected outcomes in people diagnosed with high grade glioma (HGG) brain cancer and their family and/or caregiver. Who is it for? Adults (18+ years) diagnosed with high-grade (III-IV) gliomas, and if applicable their family and/or caregiver. Study details: 30 participants will be randomly allocated into one of two groups. One group (n=15) will receive standard care currently available at their clinical site (oral/written information and the contact details of the specialist nurse for additional support, if required). The other group (n=15) will undergo (needs-based) multimodal supportive care, which involves informational materials, holistic needs assessment, self-management care plan and a tailored exercise programme. It is anticipated the results of this study will improve health outcomes for cancer patients in Canberra by driving changes in local health procedures and policy to ensure better integrated multimodal supportive care based on routine, holistic needs assessments. This project may also have implications that inform care models both domestically and internationally.

The SMuRFless CAD Registry is a study involving patients referred to an National Health & Medical Research Council (NHMRC) Centre for Research Excellence (CRE) for Coronary Artery Disease (CAD) clinic: a specialty clinic of patients with diagnosed or suspected atherosclerotic CAD. The SMuRFless CAD Registry seeks to measure and improve quality of care in SMuRFless CAD patients utilising traditional and applied data linkage methods for key longitudinal endpoints, to determine the clinical and cost effectiveness of the NHMRC CRE clinical pathway in identifying risk factors of CAD progression and to understand risk factors for outcomes and regional/centre differences.

Chronic kidney disease (CKD) is a complex health condition that has a profound impact on an individual’s general health and wellbeing and consumes enormous economic resources. The lifetime of living with CKD requires individuals to actively manage their own healthcare needs where possible. Health services in Australia have had limited success in encouraging self-management among people with CKD. To overcome these low levels of self-management, a new patient activation approach has been identified. Patient activation requires relevant healthcare knowledge, skills, and confidence in order to achieve optimal self-management. A growing body of research in chronic conditions has shown low activation is associated with higher symptom burden, higher hospital admissions rates and reduced health-related quality of life. However, a complete understanding of patient activation in the CKD population is limited, creating a challenge to develop the strategies required to address low patient activation and low self-management. This study aims to identify: (1) the current status of patient activation levels in people with advanced CKD (2) measure the association between patient activation and patient sociodemographic characteristics, clinical variables, treatment adherence and emergency visits/hospital admission rate. This study will result in a better understanding of patient activation and enable kidney care teams to target appropriate individuals and propose strategies to move towards a more active role for patients and their family in their own health care.

Women with a history of a hypertensive disorder of pregnancy (HDP) have significantly higher blood pressure in the early years of postpartum and in later life compared to normotensive women. As well as this increased risk of chronic hypertension, these women have also been shown to have an increased risk of recurrent HDP in futures pregnancies, premature cardiovascular disease (CVD) and death beginning within 10 years of the HDP pregnancy and continuing lifelong. The majority of women in the postpartum period do not remain hypertensive, and although they may remain at risk of HDP in a future pregnancy, pharmacological management such as Angiotensin-converting enzyme (ACE) inhibitors are contraindicated. However, prevention to reduce the risk of early onset CVD trajectory is lacking. This represents a need for evidence-based non-pharmacological therapies, including lifestyle interventions. The aim of this study is to explore the feasibility of conducting a yoga-based mind body intervention to reduce blood pressure for women 6 months postpartum. This will be achieved through a mixed methods model involving: (i) a non-randomised open label pre and post-test design to assess the feasibility of a yoga-based mind body intervention to manage blood pressure postpartum and improve quality of life; and (ii) in-depth interviews with women to examine their experience and views of acceptability of the intervention. Twenty women will be recruited to the study.

Exclusive enteral nutrition (EEN) is a nutrition-based treatment for Crohn’s Disease (CD) with numerous advantages compared to current conventional therapies. While its efficacy has been demonstrated in adult CD patients, EEN remains an underutilised therapy due to a number of factors including uncertainties around the optimal regimen, monitoring and treatment targets. While frameworks have been established to aid decision-making and prescription, evidence to support these recommendations is limited. This multi-centre single arm pilot clinical study aims to meet this clinical need through prospectively evaluating the efficacy and feasibility of a protocolised approach to delivering exclusive enteral nutrition in adult patients with active Crohn's Disease. Participants who meet inclusion criteria and provide consent will receive a 6 week course of exclusive enteral nutrition under the guidance of an experienced dietitian with regular follow up. This study's primary outcome is the clinical response or remission and/or objective response or remission as demonstrated by normalisation of inflammatory biomarkers or resolution of intestinal inflammation on gastrointestinal ultrasound. Our study will also assess the impact of EEN on disease activity utilising clinical, biochemical, radiological, patient reported outcome measures. Adherence to the therapy and protocol as well as tolerability to EEN will also be assessed. Protocol feasbility and fidelity will be analysed along with health economic data to evaluate the cost-effectiveness of the protocol. Changes in colonic microbial composition, diversity and function post EEN therapy.

For every minute that passes without defibrillation, survival from cardiac arrest falls by approximately 10%. Defibrillation by bystanders and GoodSAM responders using an automated external defibrillator (AED) halves the time to first defibrillation and can help double or triple rates of survival. Although the GoodSAM app aims to increase the visibility and access to AEDs in the community, the proportion of GoodSAM responders providing defibrillation remains low. This multicentre cluster randomised controlled trial will examine whether equipping high-frequency smartphone-activated (GoodSAM) first responders with an ultraportable defibrillator (CellAED®) can increase survival to 30 days in OHCA compared with the current strategy of retrieving the closest available AED.

Calcific aortic stenosis is a condition in which build-up of calcium on the aortic valve, located at the outflow of the heart, progressively blocks blood flow to the organs and can cause debilitating symptoms and very poor survival. Timely replacement of the valve can be lifesaving but comes with significant risks and at high cost. The incidence is increasing in Australia. Until now there have been no treatments that can prevent the progressive obstruction of the aortic valve. Our pilot study showed that supplementation of Vitamin-K, 10mg per day is safe and can prevent all early types of calcification in the arteries. The double-blind, randomised, placebo-controlled PASSPORT trial will test whether Vitamin-K can slow or prevent the calcium build-up and obstruction of the aortic valve. 108 subjects with mild or moderate aortic stenosis on echocardiography will be randomised to Vitamin K1 10mg per day or matching placebo for a median duration of 16 months (range 12-21 months). All subjects will receive an echocardiogram and non-contrast CT-calcium score at baseline and at the end of the trial. The primary end point will be progression in aortic valve calcium score on CT scans and secondary outcomes will be progression of flow obstruction parameters as assessed by echocardiography.

The objective of the research is to examine the difference in blood glucose control and length of stay in people that manage their own insulin and blood sugar levels in hospital versus people whose insulin and blood glucose cares are performed by a clinician (usual care) in an acute care setting. Blood glucose control will be measured by a continuous glucose monitor that will measure the percentage of time the blood glucose is within range. Participants will be screened for participation in the study and will require informed consent. Eligibility is people over the age of 18 who have been managing their insulin independently at home prior to admission. Participants will be randomly allocated to either the intervention or control group. The intervention group will measure their blood glucose levels via finger prick and inject their own insulin as they do at home. The control group will be managed by the nurses and doctors as is current practice. Continuous Glucose Monitoring will be performed on all participants. Out study will investigate if independent patient diabetes management in the acute setting will lead to improved glucose control, reduced length of stay, improved patient satisfaction, improved clinician satisfaction and reduced readmissions within 30 days.

Buprenorphine and methadone are medications used in the treatment of opioid dependence. Buprenorphine is a partial opioid agonist, meaning it has a ceiling effect, and thus transferring from a full opioid agonist such as methadone can be challenging because of the risk of causing precipitated opioid withdrawal for the patient. Current standard practice is to reduce Methadone doses to lowest dose possible , wait until the patient is in moderate withdrawal, then commence buprenorphine. This can be a time-consuming process, often requiring hospital admission for a week, or even longer in some cases, putting additional strain on public health systems. Micro-dosing is a novel approach to transitioning patients on full-agonist opioids (heroin, methadone, oxycodone, morphine) to buprenorphine using very small doses of buprenorphine concurrently with a full opioid agonist. The aim of this prospective dual arm, clinical trial is to establish a safe micro-dosing regimen for completing transfers from methadone to buprenorphine, and compare outcomes in patients that undergo micro-dose transfers from methadone to buprenorphine to those completing a standard of care transfer. Our hypothesis is that micro-dosing is a safe method for transitioning patients from methadone to buprenorphine in the community.