ANZCTR search results

The MINI-MAP Trial is testing whether different blood pressure targets affect outcomes in critically ill patients who need medications called vasopressors to maintain their blood pressure. Patients will be randomly assigned to one of three minimum blood pressure targets (60, 65, or 70 mmHg) to determine which approach leads to better recovery and fewer complications. The study hypothesis is that using lower blood pressure targets will reduce the need for vasopressor medications and improve patient outcomes. This research aims to help doctors determine the safest and most effective blood pressure goals for patients in intensive care units.

Night-time muscle cramps affects about 1 in 3 adults. These cramps reduce quality of life and sleep, sometimes severely. A recent Cochrane review of non-drug therapies found some evidence of effectiveness of stretching in reducing the frequency of night-time calf cramps, though deficiencies in the stretching protocol and study designs reduce certainty of the evidence. Our previous research identifies a potential mechanism of benefit of stretching for muscle cramps, as well as other potentially effective, low cost and low risk educational interventions that align with the scientific understanding of cramp pathophysiology. We propose to undertake a randomised feasibility trial of lower limb stretching and cramps prevention education for night-time calf cramps. We will recruit 26 to 40 adults who experience night-time calf muscle cramp at least twice per week and who do not have known neurological disease. Approximately 13 to 20 people will be randomly assigned to a combination of calf and hamstring stretching plus receive cramps and cramps-prevention education. Approximately 13 to 20 people will be randomly assigned to sham stretching and cramps education (no cramps prevention education). Intervention duration will be 6 weeks. The primary outcome of the study is to determine the feasibility of conducting a full-scale RCT. The secondary outcome was to investigate limited efficacy testing of the effect of the intervention on cramp frequency and severity (as recorded in a cramp diary), quality of sleep, and quality of life.

The Women's Emotional Well-Being (WEB) Project aims to test via a randomised controlled trial, a primary care system model for women experiencing domestic and family violence (DFV) to improve women's mental health, safety, support and access to care. The project will recruit 24 general practice clinics (with at least 3 GPs/nurses) trained in delivering appropriate DFV first line responses. From these clinics, 864 women patients who are afraid of their partner, ex-partner and/or family member will be recruited before being randomised to an intervention or comparison group. Women in the intervention group will be offered a funded appointment to see the GP or nurse that includes an online safety assessment and planning, referrals to a peer support worker and DFV services. Women in the comparison group will receive usual care from their GP clinic. We hypothesise that the the intervention will decrease women's distress symptoms and increase helpful referrals, and their sense of empowerment, safety and support.

This study explores how daily physical activity affects sleep in people recovering from substance use disorders (SUD). Sleep problems are common during and after treatment for SUD and can make recovery harder. While physical activity is known to improve sleep in other populations, little is known about how it impacts sleep in people with SUD—especially over time and at different stages of recovery. We will follow people in three groups: those currently in residential treatment, those in ongoing recovery programs, and those in long-term recovery (over one year). Participants will wear activity and sleep monitoring devices and complete short daily surveys for one month. This will help us understand how day-to-day changes in physical activity relate to sleep and overall wellbeing. We will also compare two different sleep tracking devices to see how well they agree. The findings will provide a better understanding of how physical activity supports recovery, and may help tailor future treatments to each person’s unique needs.

Sleep Ninja® is a smartphone delivered program that targets poor sleep. It was previously evaluated in a randomized controlled trial which demonstrated an improvement in sleep and a reduction in depression symptoms relative to a control group. The app was made available to the public in Feb-2023 via the App Store and Google Play. This study sought a waiver of consent to access and examine data collected through the Sleep Ninja® app between Feb-2023 and July-2024. The aim of this study is to monitor whether the app, now released into a real-world setting, continued to generate the same positive benefits that were demonstrated in the randomized controlled trial. Specifically, the aim of this study is to: (1) Examine the characteristics (age, gender, location, sleep, mood, worry, quality of life) of individuals who use the Sleep Ninja® app. (2) Examine whether use of the Sleep Ninja® app is associated with improvements in sleep, depression, anxiety, and quality of life . (3) Examine the patterns of app use which are associated with the greatest clinical benefits.

This research aims to investigate the implementation of the evidence-based program, Tuning in to Kids (TIK) in rural early education services (TIK-REES). TIK has been adapted specifically for early childhood services, and provides professional training, resources, and supervision for early childhood educators to develop an understanding of emotion coaching skills, and how it can be practically applied to support children’s wellbeing and emotional development. The intervention also provides parents with an online parenting program that complements the early education intervention. TIK is a universal prevention program but is also especially useful where children have emotional or behavioural difficulties, including problems with separation anxiety. In particular, this study will seek to reduce separation anxiety for children in their experience of 4-year old kindergarten, reducing the risks that they will have school refusal during their first year at primary school. This study will be the first evaluation of TIK in Australian kindergartens, and focuses on an under-serviced, priority population in rural and remote areas of Victoria.

This study is seeking to validate a patient-reported symptom tool to identify pancreatic exocrine insufficiency in patients diagnosed with pancreatic cancer Who is it for? You may be eligible to join this study if you are aged 18 years or above with a clinical diagnosis of pancreatic cancer Study details All participants in this study will complete the new Exocrine Pancreatic Insufficiency/Pancreatic Exocrine Insufficiency- Symptom Score (EPI/PEI-SS) tool online with the help of the study research assistant. Participants will also complete the PAN-26 assessment tool online, which includes 9 overlapping symptom questions as well as other questions related to quality of life. Participants will also be asked to collect a faecal sample within the study period of 14 days which will then be used to diagnose PEI via faecal elastase testing. This research may improve the diagnosis of PEI for clinicians by providing a simple tool for use in a clinic or at the bedside.

This study aims to evaluate the uptake, engagement and short-term effects of an online parenting program 'Partners in Parenting Kids' (PiP Kids). The online program is designed for parents/caregivers of children aged between 5-11 years and is comprised of up to 12 online self guided educational modules empowering parents/caregivers to support their child to prevent or reduce symptoms of depression and anxiety. Before commencing the program, participants will be able to select between a ‘Tailored’ pathway to their program (i.e. program content is personalised based on responses to an initial self assessment) or a ‘Non-tailored’ pathway (i.e. program content is completely self selected with no self assessment completed) . The project aims to evaluate the PiP Kids program for its: (1) uptake and engagement via the Raising Children Network (RCN) website (2) effects on preventive parenting practices, parental self-efficacy and child internalising symptoms (3) parent/caregiver program satisfaction (4) ability to meet parent/caregiver initial pre-program goals We also aim to explore parent/caregivers’ qualitative feedback about their experiences of PiP Kids through qualitative feedback interviews conducted at the post-program timepoint. No hypotheses are specified for this aim. For Aims (1) to (4), it is hypothesised that from pre to post program (90 days later) users who complete the PiP Kids program will report: (1) improved (higher) scores on the The Parenting to Reduce Child Anxiety and Depression Scale (PaRCADS), indicating improvements in preventive parenting practices; (2) improved (higher) scores on the Parental Self-Efficacy Scale-Child (PSES-C), indicating increased parental self-efficacy in parenting domains associated with child depression and anxiety; (3) reduced scores on the parent-report version of the Paediatric Symptoms Checklist (PSC-17) internalising subscale, indicating reduced internalising symptoms in their child; (4) the program to be satisfactory and meeting their initial pre-program goals

More than half the people living in Australia do not exercise regularly, an issue even more acute for adults with physical disabilities (PwD). Physical disabilities can affects motor control, skill, and coordination. There is an association between the severity of a disability and the presence of additional health and psychosocial issues leading to greater complexity of the condition. PwD find it difficult achieving the recommended amounts of physical activity. PwD have often excluded from research, particularly studies relating to exercise. Most PwD research has focused on children and young adolescents with less complex disabilites and who live in metropolitan areas. It is often hard for people with disabilities to exercise because of difficulties accessing places where there are opportunities to be active. In addition, they might not have the right support. The All-Abilites program has been modelled on FitSkills, which was was created to address this issue. FitSkills matches people with disabilities and health students (Nursing, Occupational Therapy, Exercise Science) to exercise together in a gym environment. Studies have shown that FitSkills can engage youth with disabilities in community-based exercise, a finding further supported by a mixed-method case study recently completed (unpublished) carried out in a regional area. With additional support, including screening, risk assessment, and additional professional support for the peer-mentor health student, FitSkills can be tailored for young people with complex disabilities. Our project examines how well FitSkills, renamed All-Abilities, can be implemented in a real-world setting for PwD who live regionally. In this study, we want to see if we can implement an intervention that has the potential to help PwD living regionally to improve their health, well-being, and ability to participate in activities that are meaningful to them.

This prospective randomized controlled study of patients who are successfully resuscitated following cardiac arrest patients will receive either MeB or placebo, in addition to standard medical care. The study will assess the impact of MeB on overall survival, neurological outcomes, and hemodynamics. We hypothesise that MeB will be safe and effective in improving markers of neuronal injury, with a possible translation to improved mortality. The findings will inform future large-scale research aimed at improving outcomes in this currently highly morbid condition.