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Exploring attitudes towards emerging technologies in a paediatric cystic fibrosis clinic: airway gene therapy and XV LVAS imaging
Expand descriptionFor medical technology and advances to be utilised in clinical practice they need to be not only effective and safe but also acceptable to consumers. To achieve this, it is important to invite the users of health technologies, including patients, carers and clinicians to provide feedback on new and emerging technologies. To determine the opinions, motivations, barriers and potential uptake of new technologies for cystic fibrosis care we are inviting paediatric patients, their parents/carers and associated health care workers to provide their opinion on two emerging technologies: XV LVAS imaging and airway gene therapy. It is important to determine the opinions of paediatric patients as well as their care team as in cystic fibrosis lung health in the early years impacts lifelong health and wellbeing for these patients. Mitigation of barriers to existing and emerging health interventions in this group will have a lifelong impact on wellbeing, life expectancy and healthcare utilization. Subjects will be invited to participate in this study based on their experience in the XV Feasibility Study (Protocol No: WCH_XV_001, ACTRN12623000109606). During this study cystic fibrosis affected children were offered an XV LVAS scan which is compared to results of routine Lung Function testing to determine whether this technology is safe, effective and an appropriate addition to paediatric cystic fibrosis care. Those children and their care teams will be interviewed to determine their attitudes towards the new technology and also that of airway gene therapy which is under development. Subjects will be invited to participate in a one-hour semi-structured interview to discuss their lived or clinical experience of cystic fibrosis, XV LVAS scans and understanding of gene therapy. This will be complemented by limited demographic data collection and complimentary data extracted from the XV Feasibility Study (WCH_XV_001).
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Evaluation of Nurse Practitioner Program within Aged Care Facilities
Expand descriptionResidential aged care facilities (RACF) have difficulty accessing timely primary care for their residents. A solution within RACFs is to employ Nurse Practitioners (NPs) to supplement GP services. Evidence suggests that NP models within RACFs positively impact resident well-being. The current research evaluates impact, acceptability, and feasibility outcomes for 5 RACFs where an NP model of care is active. The impact of the NP program is evaluated by comparing resident health outcomes (e.g. hospitalisations, polypharmacy, falls) routinely collected for the 5 intervention RACFs against 5 matched control sites without an NP program, for 12 months prior to and during the intervention. A sample of staff, residents, NPs, and GPs will also participate in qualitative interviews assessing acceptability of the program. It is expected that resident outcomes will be improved for the NP sites during the program relative to prior and compared to control.
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Effect of blue light stimulation of the optic nerve head on choroidal thickness and axial length in children with myopia
Expand descriptionMelanopsin is expressed by axons of intrinsically photosensitive retinal ganglion cells (ipRGC) that pass through the optic nerve head, corresponding to the blind spot. Blue light stimulation of the blind spot has been demonstrated to activate melanopsin. The synaptic pathway between ipRGCs and dopaminergic amacrine cells in the retina has implicated these cells in the light-mediated mechanisms regulating eye growth. This human experimental study addresses the hypothesis that the biomarker choroidal thickness increases with repeated daily blue light stimulation of the blind spot over a seven-day period as compared to red light stimulation in myopic children and adolescents.
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A study to test the safety of MYNFLU001 Influenza Vaccine in Healthy Adults
Expand descriptionThe purpose of this study is to assess safety, reactogenicity (reactions that occur to the body soon after vaccination) and immunogenicity (the ability of a vaccine to provoke an immune reaction in the body) of an influenza vaccine, MYNFLU001. The MYNFLU001 vaccine will be administered twice via intramuscular injection, 21 days apart. This study will be conducted on healthy men or women, 18-59 years old. This study will compare MYNFLU001 with placebo. A placebo has no active drug in it. One group of participants will receive a low dose of the vaccine (12mcg), one group will receive the high dose (32mcg) and the other group will receive a placebo. The effects seen in participants receiving the study drug will be compared to the effects seen in participants who receive placebo. Each group will involve 15 participants, with 45 participants to be enrolled in total.
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Urinary sodium in the management of acute heart failure
Expand descriptionUrinary sodium (UNa) enables rapid assessment of the response to diuretic therapy. If inadequate, it allows for rapid escalation of the diuretic dose until adequate diuresis is achieved. Insufficient decongestive therapy in acute heart failure (AHF) is associated with poor outcomes. Hence, spot urinary sodium concentration (UNa) has been proposed as a tool to rapidly assess the response to decongestive therapy and to estimate future outcomes by the Heart Failure Association of the European Society of Cardiology in 2019 and incorporated in the 2021 European Society of Cardiology Guidelines for the diagnosis and treatment of AHF. This recommendation is entirely based on expert opinion, and the efficacy of this approach has not been tested in a randomised controlled trial (RCT). In this prospective RCT, we investigate the clinical utility of spot UNa measures in the treatment of patients with AHF, and its effect on the short-term and long-term clinical outcomes compared with the standard treatment. Primary Aim is to determine if titrating intravenous loop diuretic dosing based on serial spot UNa samples (intervention arm) compared with diuretic dose titration based on the evolution of clinical signs and symptoms (standard care arm) leads to a shorter length of stay in patients hospitalised with AHF. Secondary aims are to determine if Una-guided loop diuretic titration is associated with: (1) Greater weight loss and decongestion at 72 hours. (2) Less adverse effects during admission (3) Improved all-cause mortality and unplanned readmissions at 30 days, 6 months, 12 months, and 2 years (4) Better prediction of the risk of adverse events, death and readmissions compared with standard care.
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Quitting Using Incentives Trial for a HEaLthy Pregnancy (QUIT-HELP)
Expand descriptionThis protocol describes a 2-arm randomised controlled trial to examine the efficacy and effectiveness of financial incentives to help pregnant women quit smoking. The proposed study will involve women who are confirmed smokers at the time of their first antenatal visit. Financial incentives will be offered at three time points during pregnancy conditional on abstinence, with the value of the incentive increasing as the pregnancy progresses. The primary outcome is sustained smoking cessation through pregnancy to 37 weeks gestation, with follow up to 6 months post-partum. A qualitative evaluation will occur in conjunction with the intervention, and involve women who participated as well as health service staff.
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The impact of physical activity promotion by health professionals on physical activity levels of adults & young people receiving outpatient care (PROMOTE-PA study)
Expand descriptionPhysical inactivity is a major public health issue globally leading to 5.3 million avoidable deaths each year. Half of all Australians are insufficiently active with no sign of improvement. People living with disability and older adults are particularly inactive and face additional barriers to accessing suitable physical activity opportunities. Utilising physiotherapists and other health professionals to promote physical activity as part of routine practice has enormous, untapped potential in the quest for population health benefits. In 2018, 92% of people with disability aged under 65 saw a general practitioner. Tapping into the vast network and community of health professionals can facilitate physical activity promotion at scale within existing systems. The PROMOTE-PA trial is a large-scale hybrid type I effectiveness-implementation cluster randomised trial to evaluate the impact of physical activity promotion by health professionals on the physical activity levels of people who receive outpatient health services while observing and gathering information on the impact of the implementation support to clinical teams. We will recruit 30 teams across NSW Health LHDs and community sites. We may also invite private physiotherapy outpatient practices and medical practices to participate. We will collect preliminary service-level measures and identify implementation support strategies & PA promotion interventions for each site during the Service Mapping process for all teams. Teams will then be randomised into one of two groups: Early Implementation Support or Delayed Implementation Support. Teams in the Early Implementation Support will receive a multi-faceted implementation strategy to support delivery of PA promotion. Teams in the delayed group will receive the implementation strategies after they have recruited their anticipated quota of patients into the trial. We hypothesise that patients being treated by health professionals in the Supported Implementation group will have higher self-reported moderate-vigorous physical activity compared with patients in the delayed group.
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Magnetic Resonance (MR) Linear Accelerator (linac) prostate radiotherapy trial
Expand descriptionThis study aims to assess where a type of radiotherapy technique called stereotactic body radiotherapy (SBRT) can be delivered using a machine called a linear accelerator which uses magnetic resonance (MR) images and is safe for patients. The machine is also known as an MR-linac, and is a newer type of linear accelerator which is available in Australia. Standard linear accelerators use Computed Tomography (CT) images to guide treatment. MR images create better quality images of the body and can therefore better guide radiotherapy treatment. The SBRT technique for delivering radiotherapy has been used on standard linear accelerators to treat both the prostate and pelvis, as well as on the MR-linac to treat the prostate. However this study is the first time that SBRT for both the prostate and pelvis will be tested on the MR-linac. Who is it for? You may be eligible for this study if you are an adult older than 18 years of age, you have been diagnosed with a localised intermediate or high risk prostate cancer and you are planned to undergo radiotherapy treatment for your cancer. If you are unable to have an MRI for any reason e.g. pacemaker, claustrophobia etc. then you will not be able to take part. Study details Participants who choose to enrol in this study will receive SBRT on the MR-linac to their prostate and pelvis. They will be randomly allocated to receive one of the two treatment protocols available in the study. They are: Arm 1: SBRT to the prostate given in two treatments, followed by the pelvis in five treatments. Treatments will be once per week. Arm 2: SBRT to the prostate given in one treatment, followed by the pelvis in five treatments and then one last treatment to the prostate. Participants will be followed up regularly for a total of 3 years after they complete the study radiotherapy. During this time, treatment related side effects and prostate specific antigen (PSA) outcomes will be tracked, as well as patient reported outcomes or quality of life. It is hoped this research will determine whether SBRT to both the prostate and pelvis delivered using the MR-linac is feasible and safe for patients. This will help to design better radiotherapy treatment options for prostate cancer patients in the future.
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ConnecTBack Trial – Creating Team-Based care for a new primary care model for low back pain
Expand descriptionOur hypothesis is that a team-based approach to care in a general medical practice setting will have better outcomes than usual general practitioner (GP) led care for people with low back pain. The overall aim is to determine whether, for people with low back pain, a team-based approach in general medical practice that includes a musculoskeletal (MSK) clinician is more effective than usual GP-led care. Specific aims are to: 1) Understand the impact on disability (primary outcome at 3 months), pain intensity, quality of life, global rating of change, patient satisfaction, and adverse events. 2) Understand the impact on health system and societal outcomes, including healthcare access, GP workload, emergency department visits, diagnostic imaging, opioid medications used, and missed work. 3) Determine the cost-effectiveness of the planned approach.
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Investigating if the use of an antiseptic wipe can prevent catheter-associated infections in the community.
Expand descriptionThis study is a randomised double-blind crossover study to determine if the use of an antiseptic wipe prior to self-catheterisation will reduce urinary tract infections in the community. The study will run for 12 months, where participants in the community will undergo 6 months using wipe A and 6 months using wipe B (wipes solution will be blinded to the participants). Participants will report any urinary tract infections throughout the study. At the conclusion of the study the incidence of urinary tract infections in the control and intervention periods will be compared and assessed to determine whether an antiseptic wipes helps reduce the risk of a UTI.