ANZCTR search results

The study aims to establish and evaluate Australia’s ‘Birthing on Country’ remote, demonstration site in Mparntwe, Alice Springs, Northern Territory. We will redesign the health service to increase continuity and quality of maternity care, and positively impact the health and wellbeing of First Nations women and babies in Central Australia. The clinical, cultural and cost effectiveness, and acceptability, of the new service will be systematically evaluated.

People with type 1 diabetes (T1D) need insulin for survival but hypoglycaemia (low blood glucose, also called ‘hypo’) is a common side effect. Untreated hypos can cause confusion, injury, coma, and sudden death. Living with the risk of hypo impairs mental health. For example 75% of people with T1D have mild fear of hypo and 25% have severe diabetes distress. Fear of hypo drives misguided coping strategies (e.g. skipping insulin or maintaining glucose above target), which increases risk for long-term health complications. HypoPAST (Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment), is the first Australian fully online self-guided psycho-education program. It aims to reduce fear of hypo through improved prevention and management of hypos. This study will evaluate the effectiveness, cost-effectiveness and acceptability of HypoPAST. We expect that HypoPAST will lead to lower fear of hypo and improvement in other psychosocial and clinical outcomes. We expect that HypoPAST will be acceptable to adults with T1D and cost effective.

This examiner-blinded, randomized controlled clinical trial will use a two-treatment, parallel design to assess the effects of the treatments on the severity of gingivitis, accumulation of supragingival plaque and changes in the microbial composition of supragingival plaque. Participants will be randomly assigned to one of two treatments with each treatment comprising 21 days. The two treatments will be as follows: A. Tooth brushing with GC MI Paste One Perio containing 10% CPP-ACP and stannous fluoride (1100 ppm F) three times a day (after breakfast, after dinner and before bed), with no other oral hygiene procedures over 21 days. B. Tooth brushing with Colgate Total SF containing stannous fluoride (1100 ppm F) three times a day (after breakfast, after dinner and before bed), with no other oral hygiene procedures over 21 days. During the treatment period, all participants will be requested not to brush with any other toothpaste and not to consume any antibiotics or antimicrobials including antimicrobial mints, lozenges, films and chewing gums.

This feasibility study will Virtual Reality (VR) delivered mindfulness as a treatment for chronic insomnia. The experimental treatment is VR-delivered mindfulness ("VRmind"). The investigators will demonstrate the feasibility of conducting a trial of at-home VRmind for people with chronic insomnia. Participants will be randomised to receiced 4 weeks of twice weekly mindfulness sessions delivered using a VR-headset (VRmind) or a or a computer-screen ("2Dmind"). At the end of treatment, participants will provide feedback by completing a satisfaction questionnaire. To complete the weekly at-home mindfulness sessions participants in the VRmind group will be provided with a VR-headset by the study and details to access the weekly mindfulness content. Participants in the 2Dmind group will be given online access to the same mindfulness content be using their own computer/phone. Participants randomized to 2Dmind will be the option to complete an additional 4 weeks of VRmind at the end of the study.

Sleep disturbances are common among people living with dementia, with consequences far reaching for the person, their carers and care systems. Sleep disturbances result in decreased quality of life for the person with dementia and cause significant stress for caregivers. Additionally, sleep disturbances are associated with increased admissions to care settings and healthcare costs. As such, sleep disturbances for people living with dementia are recognised as a major challenge that requires addressing. Nonpharmacological interventions are prioritised for the treatment of sleep disturbances; however, medication is frequently used, with a range of risks (including increased falls and confusion). Currently there is no gold standard sleep intervention for people with dementia. Use of weighted blankets is emerging as a safe sleep intervention option, although little is known about the effectiveness of use for people with dementia. A staged investigation will be conducted to 1) examine the effectiveness of weighted blankets as a sleep intervention for people with dementia; 2) understand the barriers and facilitators to use of weighted blankets; and 3) co-design a plan for future implementation across a range of settings. This trial reports on stage 1 of the project. During this stage we will recruit 14-18 participants living in a dementia-care unit to be randomly divided into either the intervention group or usual care group. The intervention group will use the weighted blanket overnight for two weeks, then the groups swap. A range of measurements, including sleep duration and quality, and medication use, to determine the blankets’ impact. We hypothesize that participants in the intervention group will have improved sleep outcomes and reduced behavioral and psychological symptoms of dementia. Research questions: 1. Are weighted blankets an effective and feasible sleep intervention for people with behavioural and psychological symptoms of dementia? 2. What are the implementation strategies for uptake of weighted blankets for people with behavioural and psychological symptoms of dementia in an inpatient setting? 3. What are the recommended implementation strategies for uptake of weighted blankets for people living with dementia across a range of settings?

Most chronic lung conditions cause variable changes in the movement of air within the lungs (known as regional lung ventilation), and therefore alter how the lungs function. These changes are difficult to detect early by conventional lung function tests, such as spirometry. The newly developed 'XVD lung scanner' intends to provide a quick, non-invasive and accurate assessment of regional lung ventilation, which may allow for earlier diagnosis and improved monitoring of patients with chronic lung conditions. This scanner is a medical imaging device which captures four images of the lungs during one breath, in the seated position. These are combined with recent lung CT scan images and using XV software, produce an XV scan report. We aim to scan the lungs of 60 adults with chronic respiratory conditions assess feasibility compared to other pulmonary function test measures used in standard clinical practice.

This study aims to explore whether participating in exercise during adjuvant chemotherapy can improve treatment tolerance and more specifically chemotherapy completion rates. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with a stage I-III solid tumour and are scheduled to receive chemotherapy. Study details Participants will be offered twice-weekly supervised small group exercise sessions for the duration of their adjuvant chemotherapy, or for a maximum of 8 months. Exercise sessions will last approximately 60 minutes and involve a combination of aerobic, resistance, and balance exercises. Participants will also be encouraged to engage in additional aerobic exercises at home with the goal of reaching a total of at least 150 minutes of moderate to vigorous intensity aerobic exercise each week. Data on chemotherapy completion, physical and mental wellbeing will be collected before, during and after the intervention. It is hoped that information from this study will help determine whether participating in exercise during adjuvant chemotherapy has a beneficial effect on chemotherapy completion rates and physical and mental wellbeing in people diagnosed with cancer.

VIHSP is a state-wide universal newborn hearing screening program in Victoria, Australia. Approximately 0.8% of infants receive a positive (‘refer’) result on their hearing screen and are referred to one of approximately 13 Victorian diagnostic audiology clinics for further assessment of their hearing. As part of routine clinical care (usual care), parents of infants referred to diagnostic audiology are contacted by VIHSP Area Managers to discuss the referral and assist to organise the initial diagnostic audiology appointment. Parents are then contacted by a member of the VIHSP ESS team. The VIHSP ESS assign a dedicated case-facilitator who provides preparatory written/verbal information about the diagnostic audiology appointment. The ESS facilitator is available to support each family prior to the diagnostic audiology appointment right up to enrolment into early intervention (as required). ESS is available to be contacted by the family at any time in the diagnostic and intervention pathway. Parents also speak with, and may receive, written/verbal information about the diagnostic appointment from the audiology clinic they attend. As an additional resource, VIHSP have developed an information video to help prepare parents for their infant's diagnostic audiology appointment. The information video follows a mother and her infant as they attended the infant’s initial diagnostic audiology appointment. This information video is approximately six-minutes in length and provides the viewer with both visual and auditory information about the audiology equipment, the likely sequence of events, the purpose of each test, and how best to prepare their infant for the appointment. This is a single site randomised controlled trial, embedded in clinical care, with an active control group. One parent/caregiver per infant referred to diagnostic audiology during the recruitment period will be invited to participate. Participants will be randomly allocated to either a control (usual care) or intervention group (usual care + intervention) and asked to complete one online survey prior to their infant's audiology appointment. Those in the intervention group will also be asked to view the six-minute information video embedded within the online survey. This study aims to explore if, in addition to usual care, providing an information video prior to an infant's diagnostic audiology appointment has an impact on: • parent/caregiver knowledge and understanding about the diagnostic process • parent/caregiver anxiety • the number of infant diagnostic audiology appointments required to reach a diagnosis It is hypothesised that: •Parents/caregivers in the intervention group will have higher knowledge scores and lower anxiety scores compared to the control (usual care) group •Infants of parents/caregivers in the intervention group will require fewer diagnostic audiology appointments to achieve an audiology diagnosis compared to infants of parents in the control group

The results of the recent pragmatic RCT of the Interdisciplinary Home-bAsed Reablement Program (I-HARP) have shown that a structured, evidence based and person-centred rehabilitation program delivered in the community improved daily functioning of people with mild dementia, enabling them to live longer at home. This NHMRC partnership project, Optimising functional independence of older persons with dementia: Implementation and evaluation of the Interdisciplinary Care Home-bAsed Reablement Program (I-CHARP), builds on I-HARP in order to transfer the program logic of I-HARP to residential aged care settings. This protocol provides detailed steps as to how I-HARP is translated and evaluated in residential aged care using a model called I-CHARP. This project I-CHARP integrates evidence based strategies into a person centred interdisciplinary rehabilitation package. The aim of the trial is to evaluate a co-designed I-CHARP model in residential aged care homes by examining whether (and, if so, how) I-CHARP implementation produces its intended effects and how this program can be adapted, sustained and scaled up across aged care homes. The I-CHARP study uses a hybrid design involving testing of the implementation strategy (REACH network) while observing/gathering information on the clinical intervention (I-CHARP) and related outcomes. The evaluation takes place in three cycles over four years using a cluster quasi-experimental design and qualitative methods. During the initial phase of the project, the delivery model for I-CHARP is co-designed with the partnering residential aged care providers to ensure the study is feasible within their context and staffing arrangements. This I-HARP protocol details Phase II of the project, a cluster quasi-experimental design and qualitative methods. I-CHARP uses the same principles and procedures as I-HARP delivered by OTs and RNs that consists of 20 weeks of delivery over four months integrated into residential aged care services as a model of care.

This study aims to improve the scientific understanding of the effects of intramuscularly (IM) administered 5-MeO-DMT on human brain activity as well as other indexes of well-being as assessed through psychological, physiological, and biological markers. Finally, we aim to further our understanding of the tolerability and safety profile as well as dose-dependent effects of different doses of 5-MeO-DMT or placebo administered per intramuscular administration and to uncover its phenomenological characteristics.