ANZCTR search results

This 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.

Physical 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.

This 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.

Our 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.

This 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.

Hypovolemic shock due to blood loss, known as haemorrhagic shock, is the most common cause of preventable death after injury. Principles of managing haemorrhagic shock include haemorrhage control and replacing the lost circulating blood volume. This requires venous access, which is a fundamental aspect of trauma resuscitation. In shocked trauma patients, obtaining venous access can be difficult and there are limitations to current methods of obtaining peripheral and central venous access. This project will investigate the use of the brachiocephalic veins for venous access in the resuscitation of shocked adult trauma patients. The origin of the brachiocephalic veins is currently used for venous access in adult and paediatric populations, there is no published literature on what happens to the brachiocephalic veins in shock and the use of the brachiocephalic veins for access in shocked adult trauma patients. The Right Brachiocephalic Vein has been found to be preferable for access in adult patients may stabilised by the surrounding anatomical structure which could prevent vascular collapse collapse in severe shock. If Right Brachiocephalic Vein origin access is found to be feasible in shocked trauma patients, it will provide a new access route for use during trauma resuscitation. This may improve venous access in patients with peripheral circulatory collapse, allowing for earlier replacement of lost blood volume using fluids and blood products. Additionally, vasoactive drugs can be given, and coagulopathies can be corrected earlier in resuscitation. This is vital in managing haemorrhagic shock and may improve patient outcomes. Hence, venous access using the origin of the Right Brachiocephalic Vein may improve resuscitation and decrease preventable deaths after injury due to haemorrhage. The aim of this prospective randomised control trial is to prospectively evaluate the RBCVO central venous access technique in adult trauma patients to determine if the technique is appropriate for access in the trauma resuscitation setting., by comparing it to SCV access. This will include analysis of complications, success rates, efficacy and accuracy. The research question of this study is: How successful is RBCV origin access for the resuscitation of adult trauma patients? The objectives of this study are to: 1. Determine the efficacy of RBCVO access in adult trauma resuscitation 2. Determine the safety of and complications associated with RBCVO access compared to SCV access. 3. Determine how appropriate RBCVO access is for the trauma resuscitation setting. We hypothesize that vascular access using the origin of the RBCVO will be greater than 90% successful in adult major trauma patients.

There is clear evidence from the recent Royal Commission in Aged Care Quality and Safety that (a) older people living in residential aged care and in the community need allied health services to optimise their health and well-being, (b) older people living in residential aged care and in the community are not getting the services they need, and (c) the ways in which allied health services are accessed in the aged care system is not working. The proposed intervention draws on a strong evidence base that reablement principles can improve outcomes for older people in living at home and in residential aged care. Reablement “involves time-limited interventions that are targeted towards a person’s specific goal or desired outcome to adapt to some functional loss or regain confidence and capacity to resume activities”. Some key points about programs that use reablement are they: • Focus on the skills, abilities and social situation a person has to help themselves, rather than doing things for the person; • Are focused, time-limited and goal focused; • Can focus on modifying tasks or the environment to address a loss of function and/or training a new skill and using existing social supports. There is evidence that allied health using reablement principles improve outcomes for older people including physical function, falls prevention, communication, nutrition, personal care and social function. However, the translation of this evidence into practice has not been systematically applied and reported in Australia. To address some of the issues around frailty, falls and social isolation identified in residential aged care and in the community, we will implement and evaluate a multidisciplinary allied health service consisting of physiotherapy, exercise physiology, occupational therapy and speech pathology. Importantly, this service will be based on evidence-based, reablement principles.

This semi-randomised control trial aims to investigate the effectiveness of the Wim Hof breathing method and cold immersion (compared to an active control condition) for promoting stress reduction, resilience, recovery, cognitive functioning, and overall mental health and well-being. The present research combines 24/7 physiological biometric capture, daily experience sampling, and survey measurements across the study period (including a 2-week baseline, 4-week intervention period, and 3-month follow-up period). By measuring physiological, cognitive, and subjective measures, and continuing to monitor participants post-intervention, we aim to contribute to the growing body of knowledge concerning the potential benefits of the Wim Hof Method. In particular, assessing whether it is a suitable and effective strategy for stress reduction, performance optimisation, and mental health enhancement. Hypothesis 1: Onboarding/Exit Measures (Pre/post the 4-week study intervention) We hypothesize that there will be an improvement in post-intervention scores compared to pre-intervention baseline scores across all three conditions. We expect Condition 1 to show greater improvements than Conditions 2 and 3, and Condition 2 to show greater improvement than Condition 3 in the post-intervention outcome measures. Hypothesis 2: Daily Momentary Measures (Pre/post daily intervention) We hypothesise that there will be an improvement in post-daily intervention scores compared to pre-intervention daily scores across all three conditions. We anticipate the improvement to be greater in Conditions 1 and 2, relative to Condition 3, for the momentary outcome measures. Hypothesis 3: Daily Measures (Post daily intervention) We predict better Stroop task scores (lower Stroop interference effect, faster reaction times, and greater accuracy) and N-back task scores (greater accuracy and faster reaction times) in the daily post-intervention cognitive tasks in Conditions 1 and 2, relative to Condition 3. Hypothesis 4: Daily Physiological Recovery (Nightly post-intervention) We predict improved average nightly physiological recovery (greater sleep: quantity (duration) and quality (slow wave sleep and rapid eye movement sleep), and cardiovascular functioning: higher heart rate variability, and lower resting heart rate and respiratory rate) in Condition 1 compared to Condition 2 and 3, and greater recovery in Condition 2 than condition 3.

Stress is a ubiquitous concern for people however it may be more prevalent in firefighters who routinely face arduous working conditions. Chronic stress has been shown to have detrimental effects on mental health and the ability to self-regulate mood and behaviour. Neurofeedback (NFB) is a brain-computer interface biofeedback intervention. The objective was to investigate whether NFB could substantially alter self-regulation capacity positively to improve self reported symptoms of stress. There were three hypotheses proposed including, H1: firefighters in the experimental group would show improved scores on self-report measures pre and post intervention. H2: firefighters in the experimental group would maintain these changes at long term follow up. H3: firefighters in the control group would show no change from baseline to follow up. Neurofeedback training involves watching a computer display to use mental activity to control brain waves of interest. The display and sound changes, in real time, as changes in participants’ brainwaves occurs. The feedback allows for the participants learn to regulate their mental activity. If the mental activity successfully changes the brainwaves in the desired direction to reduce stress and produce calming, participants are rewarded with points. With practice, consistent with how learning occurs participants can improve their response to stress.

We will conduct a clinical case series to investigate the acceptability and feasibility of Resilience Triple P for mainstream primary school students in Australia who have been diagnosed with ASD and are bullied by their peers. We will recruit 20 to 25 families and they will complete Resilience Triple P immediately. Children, parents, and teachers (if applicable) will complete assessments. It is expected families of autistic children will be satisfied with Resilience Triple P as an intervention for decreasing bullying victimisation and they will provide important insights into improving the delivery. Autistic children who participate in Resilience Triple P are expected to experience reductions in bullying victimisation, mental health problems, and school refusal. It is expected each family of an autistic child will use a different combination of strategies from Resilience Triple P depending on what their specific goals are.