ANZCTR search results

The aim of this study is to test the impact of messages about COVID-19 vaccine booster doses in adults vaccinated against COVID-19 on intention to receive a COVID-19 vaccine booster dose. We will recruit adults vaccinated against COVID-19. Participants will receive 1 of 4 information conditions or a control. The 4 information conditions will focus on: the personal health impacts of vaccinating; family and community health impacts of vaccinating; non-health benefits of vaccinating; and personal choice and control associated with vaccinating. The control will be text about eligibility for a COVID-19 vaccine booster dose. Analysis will compare the primary outcome measure (intention to receive a COVID-19 vaccine booster dose) between intervention groups and the control (4 comparisons) using an ANOVA test. Secondary analyses will compare secondary outcome measures (beliefs about COVID-19 vaccines) between intervention groups and the control using an ANOVA test.

Less than one third of people with type 1 diabetes (T1D) achieve glycaemic targets known to reduce the risk of long-term complications. Automated insulin delivery (AID; also known as closed loop or artificial pancreas) is a new therapy that improves outcomes for people with T1D. AID combines an insulin pump and continuous glucose monitor (a small sensor worn under the skin) with a maths program, which tells the pump how much insulin to give based on the glucose levels. Current AID systems still require users to manually give insulin at mealtimes. We are investigating an open-source AID system developed within the diabetes community, to see if it can safely treat diabetes without any manual input. A key barrier that may prevent AID systems from maintaining good glucose control around meal times is speed. This is because it takes several minutes for the glucose sensor to detect a rise in blood glucose, and then several minutes for the insulin to act once it is delivered. We are investigating an ultra-fast acting preparation of insulin, called Fiasp, to see if this is more effective than a "standard" insulin (NovoRapid) in managing mealtime glucose levels. We will recruit 20 participants into this trial. They will have already completed a six-month trial (CLOSE IT), in which they will have used an automated insulin delivery system without mealtime boluses, using insulin NovoRapid. We will change NovoRapid to Fiasp and look to see if this has any effect on glucose levels over the course of four weeks. During the trial we'll closely monitor every participant to ensure their safety, and issue a report if any issues emerge.

Less than one third of people with type 1 diabetes (T1D) achieve glycaemic targets known to reduce the risk of long-term complications. Automated insulin delivery (AID; also known as closed loop or artificial pancreas) is a new therapy that improves outcomes for people with T1D. AID combines an insulin pump and continuous glucose monitor (a small sensor worn under the skin) with a maths program, which tells the pump how much insulin to give based on the glucose levels. Current AID systems still require users to manually give insulin at mealtimes. In this trial we will investigate an open-source AID system developed within the diabetes community, to see if it can safely treat diabetes without any manual input. We will recruit 75 people with diabetes across Australia and New Zealand to one of two study sites: the Baker Institute in Melbourne and the University of Otago in Christchurch. The duration of the study is six months. During the first three months everyone will start on an insulin pump and continuous glucose monitor. Participants will need to manually give a bolus whenever they have a meal, but the system will automate all other aspects of insulin deliver. We'll gradually adjust the settings to achieve the best possible control. During the second three months participants will be randomly divided into two groups. The first group will stop giving manual insulin boluses with meals. The second group will continue to give manual insulin boluses with meals. At the end of the trial we'll compare the glucose recording between the two groups, to see if stopping manual boluses made any difference to diabetes control. During the trial we'll closely monitor every participant to ensure their safety, and issue a report if any issues emerge. We'll also collect data relating to the experiences of participants using the AID system, including standardised questionnaires and an interview with 15 participants.

The Enhanced Advance care planning and life Review Longitudinal Intervention (EARLI) aims to enable older adults to effectively engage with Advance Care Planning (ACP), in the home care setting. Advance care planning is the process by which older adults, or people who are experiencing chronic disease, terminal illness (including cancer) and/or are at risk of dementia and similar conditions can provide instructions to their carer/s about their main preferences and goals for future care, should they reach a stage where they may not be able to make these decisions on a day-to-day basis. Who is it for? You may be eligible for this study if you are aged 65 years or older (50 years or older for Aboriginal or Torres Strait Islander people), you have had a previous aged care assessment team (ACAT) assessment, you are living in a private residence (own or rented dwelling, including retirement village or other co-operative housing, but NOT a residential aged care facility) and you are receiving home care services from one of the participating aged care provider study sites (Home Care Package Level 1-4, or commensurate self-funded service). Participants who meet these criteria and have been diagnosed with cancer will also be eligible. Study details Participants who choose to enrol in this study will be allocated to one of two groups. The first group will receive the EARLI program which involves meeting with a member of the research team every fortnight for up to 10 weeks. Each meeting is expected to last up to 1 hour and these participants will be guided through the ACP process and given an opportunity to discuss their goals and preferences with members of their aged care and primary care (GP or other specialist) teams. The second group will be given one 30 minute session which provides a brief introduction to ACP and directs participants to available resources. The allocation into the first or second group is randomised (like flipping a coin) - each aged care provider study site will be randomly allocated to recruit for the first or second group for a defined period of time, before swapping over. Each participant will be invited to participate in just one of the groups, with the allocation depending on which stage of the process the aged care organisation is in at the time the participant is recruited to the study. The overall duration of participation in this study will be 3 months from the date of enrolment. It is hoped that this study will determine whether this program is effective in helping older adults in the home care setting to be clearer about their values, preferences and plans for the future, while strengthening relationships and improving wellbeing.

This is an 18 to 54 week study assessing the efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) on the severity of autism spectrum disorder in young people. The purpose of this study is to determine the effectiveness of NTI164 in patients with ASD when treated with 20mg/kg/day for 8 - 54 weeks. The study comprises of an 8-week double-blinded randomised controlled treatment period followed by an 8-week open-label maintenance period followed by a 2-week wash-out period. Participants who wish to continue receiving the study treatment beyond the 16 week period may do so for up to fifty-two weeks (Extension phase) Efficacy will be measured and monitored by performing participant- and psychologist- led questionnaires specific to measuring changes in the behaviour of patients with ASD. Safety will be measured and monitored by performing full blood examinations and liver and renal function tests throughout the study. Additional assessments include microbiome and inflammatory marker assessments.

Our previous work has established that social media presents a unique opportunity for suicide prevention initiatives, particularly with young people. However, only recently have we started exploring the impact of using social media for the purpose of delivering suicide prevention interventions. Further, while it is known that young people often turn to social media to discuss and share information about suicide, little is known about the types of social media content that young people find most helpful and informative when it comes to educating them about safe online communication about suicide, and what impact such information has on their communication behaviours. To extend this body of work and to develop a social media campaign that is safe, acceptable and helpful for young people, Orygen has received funding to conduct a randomised controlled trial (RCT) with young people across Australia. This project will not only further test the impact of the #chatsafe suicide prevention social media campaign in a controlled study, it will add to the body of knowledge relating to youth-friendly and effective suicide prevention initiatives that can be delivered to young people directly through social media.

We will implement an intervention to improve the quality of care for residents in aged care facilities. The intervention consists of an electronic dashboard on falls and quality of life. It is intended for use by aged care staff and predicts the risk of falls and poor well-being and presents information, action areas and clinical evidence-based recommendations that can be inputted by staff to minimize the resident risk of poor health outcomes. To evaluate the dashboard we will be conducting a cluster-randomised controlled trial where we will randomise 20 facilities into intervention and control groups (i.e. 10 in each group). The intervention will be introduced across all intervention sites at the same time in early 2023. A 1-month intervention wash-in period will be allowed to allow the integration of the dashboard into routine practice. Since the intervention is an add-on to an existing system, 1 month will be sufficient to allow users to familiarise themselves with the dashboard. The impacts of the dashboard will then be compared between the intervention and the control sites after 12 months (excluding the wash-in period data). We will include two additional sites for the pilot testing. The primary outcome we will look at is the rate of all falls (i.e., any falls regardless of whether an injury was involved, or hospitalisation was required). We hypothesise that the intervention will reduce the rate of falls in the intervention group in comparison to the facilities in the control group. The secondary outcomes include: injurious falls, falls requiring hospitalisation, client wellbeing, social service use (attendance at leisure and lifestyle activities), hospital service use, use of the Peninsula Health Falls Risk Assessment Tooland change in use of Falls-Risk Increasing Drug use.

The primary aim of this study is to evaluate the feasibility and acceptability of conducting a randomised controlled study that includes pelvic floor muscle (PFM) exercise and mindfulness delivered in a hybrid mode (four face-to-face sessions and four remote sessions) for women with endometriosis associated pelvic pain. In addition, we will measure the changes in PFM dimensions before and after the eight weeks of the treatment protocol. We aim to recruit 56 participants with a confirmed diagnosis of endometriosis from health services or via social media. Participants will be asked to complete online questionnaires and undergo ultrasound assessments before and after eight weeks of PFM exercises and mindfulness. All participants will also be invited to participate in an interview after the completion of the eight weeks of the treatment protocol to talk about their experience and the acceptability of the pelvic floor exercises and mindfulness interventions. We will recruit a purposive sample of women for this interview.

Hypothesis of this study is application of anterior chest wall compression on mechanically ventilated patients will prevent ventral lung overdistention. We aim to examine changes in respiratory system compliance, oxygenation, ventilation and CT changes in lungs after applying anterior chest wall compression in mechanically ventilated patients We intend to enrol 10 patients in this single centre study. This trial will be conducted in the Southern Adelaide Local Health Network, Intensive and Critical Care Unit, Flinders Medical Centre. Screening and Recruitment Patients will be referred by treating ICU clinicians. Referral will be made as soon as possible after admission for patients who are intubated and ventilated Consent will be sought prior to enrolment Intervention Patient will have a 100 gm/kg weight placed on the anterior chest wall, while in supine position. The weight will be placed on the patients’ chest wall for 10 minutes and then removed. A number of measurements will be recorded before and after the procedure. Similar intervention repeated during CT chest. Device: weight on the anterior chest of the patient (soft and smooth weight (saline bags) placed and secure around each hemithorax) After enrolment, each patient will be treated as follows: Patients will be sedated and paralysed while mechanical ventilation settings will be kept unchanged over the course of the entire study. Initial baseline in the lying on the back ( Supine) position (T0) 10-minute period in supine position with 100 gm/kg soft and smooth weight (saline bags) placed and secure around each hemithorax (T1) In case of drop of oxygen level ( SPO2) , increase in delivered oxygen ( FiO2) will be allowed to achieve the previously described oxygen target. During the study, each patient will undergo standard ICU monitoring:

This is a randomised, open-label, multiple-dose, 2-period crossover study to evaluate the PK and bioavailability of Smartech (diclofenac sodium topical solution) 2% w/w compared to PENNSAID® (diclofenac sodium topical solution) 2% w/w, This trial is the first clinical study to evaluate Smartech (diclofenac sodium topical solution) 2% w/w. PENNSAID® (diclofenac sodium topical solution) 2% w/w is a marketed product. Smartech’s PK study is intended to confirm that the use of optimised Penetration Enhancer (PE) ingredient/s in the Smartech product will deliver a higher amount of drug through the skin and joint, and into the blood, such that the systemic exposure for the Smartech products would be higher than PENNSAID® (diclofenac sodium topical solution) 2% w/w. This study is a relative PK study planned to determine the PK parameters (Cmax and AUC) between a Smartech (diclofenac sodium topical solution) 2% w/w compared to PENNSAID® (diclofenac sodium topical solution) 2% w/w. Up to 32 healthy male and female participants will be screened within 28 days (Days -28 to -2) of the first treatment period. Smartech (diclofenac sodium topical solution) 2% w/w will be applied as a 40 mg dose to each knee. The dose will be dispensed as 2 pump actuations (20 mg [1mL] per actuation) from an airless container for each knee. PENNSAID® (diclofenac sodium topical solution) 2% w/w will be applied as a 40 mg dose (2 pump actuations, 20 mg [1mL] per actuation) to each knee, which is the recommended dose. For each product, the dose will be applied twice daily (in the morning and in the evening, 12 hours apart) from Days 1 to 7. On Day 8, a morning dose only will be applied. The doses should be applied at the same time each day. Assessment of the safety and tolerability of Smartech (diclofenac sodium topical solution) 2% w/w is a primary objective of this study. Safety and tolerability will be determined by physical examination findings, vital signs, ECGs, clinical laboratory parameters, and AEs. Safety and tolerability assessments may also be performed at various unscheduled time points or different assessments may be performed, if deemed necessary for participant safety by the PI.