ANZCTR search results

The PROMPT-RC study will assess whether the use of the AusTAPER App/Pathway by pharmacists improves medication management for residents in aged care facilities compared to usual care. This intervention helps pharmacists identify and reduce potentially inappropriate medicines (PIMs) to optimise medication regimens. The study hypothesises that the AusTAPER tool will lead to safer and simpler medication use, resulting in optimised medications and improved quality of life over 12 months.

Healthy eating advice is recommended by guidelines as a mainstay therapy for women at high risk or those who have developed gestational diabetes mellitus (GDM), prior to pharmacotherapy. GDM is a condition characterised by higher-than-normal blood sugar levels during pregnancy with immediate and long-term health consequences. 'Food is Medicine' programs aim to integrate nutrition interventions into the health care system to help improve the clinical population's diets and complement pharmacologic treatment of diseases. 'Produce prescription' is one such approach whereby clinicians and other health professionals prescribe free or subsidised healthy foods to people who experience food insecurity as part of their treatment. We will assess the effect of produce prescription on gestational weight gain for women with food insecurity and at high risk of GDM compared to usual care. We will conduct a randomised control trial of a produce prescription intervention in pregnancy women at high risk of GDM, who have difficulty buying or eating nutritious food. Intervention participants will be prescribed produce boxes from 14-18 weeks gestation to 34-38 weeks gestation. In addition, intervention participants will also receive three consultations with a dietitian. Predefined, composite secondary maternal (GDM, pregnancy related hypertension, excess gestational weight gain, caesarean section) and neonatal (large for gestational age, preterm birth, mortality) outcomes will be assessed. Diet quality, cardiometabolic outcomes, food and nutrition security, patient-reported outcome measures, and the feasibility and acceptability of the produce prescription program will also be assessed. Finally, a sub-sample of participants will be interviewed to explore how the program worked (or did not work) for them, and ways the program can be improved and scaled up. We hypothesise that the intervention group will have improved diet quality and reduced gestational weight gain during pregnancy which will prevent a range of pregnancy complications. We anticipate that the program will be highly acceptable to pregnant women and suitable for scale up as part of healthcare.

Breathing and coughing difficulties are extremely distressing for people living with MND and therapies that improve breathing capacity and related symptoms are needed. Our research team has previously shown that breathing exercises using a hand-held device to help people take a bigger breath (lung volume recruitment) can produce important changes in lung capacity. Separately, our collaborators in the United States have found that exercises using a different hand-held device (expiratory muscle strength training) can improve expiratory muscle strength in people with MND. This research project will evaluate whether combining these two therapies together has added benefit. We will test whether five weeks of combined respiratory training is feasible and acceptable to people living with MND and their carers, and whether it improves breathing and cough strength, symptoms and quality of life in people affected by MND.

Dysregulated fear memory processing as well as disrupted sleep (particularly rapid eye movement [REM] sleep) are important factors in the development of posttraumatic stress disorder (PTSD). Sleep is one of the few modifiable variables in the aftermath of a traumatic event, which might be utilized to prevent PTSD onset. Therefore, the aim of this project is to examine the effect of the insomnia drug lemborexant, that increases rapid eye movement (REM) sleep in primary insomnia, on fear extinction learning and extinction recall, as well as emotional memory consolidation compared to placebo in individuals with PTSD. We recently completed a similar pilot study in healthy controls using suvorexant (same mechanism of action like lemborexant but lower clinical effect, and safe in PTSD) and found increased REM sleep was associated with better extinction recall (ACTRN12619001694101). This study will provide evidence for the potential of enhancing REM sleep as a therapeutic target for improving PTSD onset.

The purpose of this study is to understand the prevalence, type and frequency of gastrointestinal symptoms in women with and without endometriosis, and to understand the role of psychological distress and stool and vaginal microbiota in influencing these symptoms. It is hypothesised that gastrointestinal symptoms will be more severe in women with endometriosis than those without.

Problem anger after experiencing trauma is a common mental health issue. Shift is a new cognitive-behavioral based just-in-time-adaptive intervention (JITAI), co-designed with users and experts, that works by prompting users to report their current anger state, and delivering personalised support to manage anger accordingly. A micro-randomised trial will be implemented with 65 adults with problem anger and a history of trauma exposure. For 30 days, four times a day, each participant will be prompted to self-report their current anger state, and will be randomised to be shown intervention components tailored to their anger state, or not. Post intervention surveys, and app use and engagement indices will be analysed to evaluate the acceptability of the intervention. The aim of the study is to test whether the intervention components designed within Shift actually reduce anger intensity. To test this, we are using a novel type of method, called a micro-randomised trial, where every participant will recieve both the intervention and the control at different times. This will be the first digital trial using micro-randomisation to optimise a JITAI for problem anger in a population who have experienced trauma, and one of the few micro-randomised trials to optimise digital mental health tools to manage dysregulated mood.

The aim of this study is to determine the impact of a online intervention (Recapture Life) to teach adaptive cognitive-behavioural coping skills to promote resilience in early survivorship. Who is it for? You may be eligible for this study if you are a young cancer survivor who have finished treatment, male or female, aged between 13 -39 years old. Also, fluent in English, able to provide consent and have access to internet and a suitable computer. Study details Participants who choose to participate in Recapture Life received six weekly 90 minute sessions delivered online. Each group consisted of a facilitator plus 3-6 AYAs with mixed childhood cancer diagnoses and genders. Sessions were delivered through a secure, password-protected video conferencing software. Each 90-minute module included both psychological skills and cancer related content, applying CBT techniques to the key domains of concern identified by previous studies, including fear of cancer recurrence and changes to activity levels The study design involves simple pre- and post-intervention measures. AYA participants completed questionnaires at intake (T1), and six-months later, after the completion of the intervention and the booster session (T2). These were completed online through a secure questionnaire portal. Questionnaires obtained participant demographic data, assessed Quality of Life (the primary outcome variable), psychological distress, and peer support. It is hoped that findings from this study will provide skills-based support for adolescents and young adult cancer survivors.

This study is a retrospective, observational study comparing 4 different implantable loop recorders in terms of their accuracy in detecting different arrhythmia episode types. We hypothesized that there is no significant difference in accuracy between the different devices and episode types.

A Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study in healthy, overweight and obese participants to investigate safety, tolerability and pharmacokinetics of KAI-9531 subcutaneous injection.This is a randomized, double-blind, placebo-controlled single ascending dose study evaluating the safety, tolerability and pharmacokinetics (PK) of a single subcutaneous (SC) administration of KAI-9531 at increasing dose levels from 1 mg to 6 mg.The purpose of the study is to examine the safety, tolerability and PK of KAI-9531 in a non-Asian and Asian population.

The purpose of this study is to improve the outcome of breast cancer patients who develop brain metastases. This will investigate the benefits of early detection of brain metastases using brain imaging. In patients diagnosed and currently being treated for advanced or metastatic breast cancer, current guidelines do not recommend routine brain imaging. Who is it for? You may be eligible to participate in this study if you are a female age 18 or over with diagnosed with metastatic breast cancer, ER-positive disease after second-line therapy and CDK4/6 inhibitors, plus more than two sites of bone metastasis or visceral metastasis as well as triple negative (TNBC) and human epidermal growth factor-2 positive (HER-2) patients. Study details Study participants will be screened for brain metastases using Computerised Tomography (CT scans) and patients will have 3 monthly CT scans of the brain for 2 years and then 6 monthly for 2 years. This will be organised by the oncology team and will last around 20 minutes for the procedure and will be undertaken by the radiographers in imaging units in collaboration with the radiologists, Throughout the study’s period, participant’s medical records and CT scan results will be reviewed and compared to historical data. It is hoped that the result from this study will help to determine whether routine brain imaging should be offered to patients with breast cancer.