ANZCTR search results

Impact Diabetes Bump2Baby is a study to test whether women at high risk of developing diabetes can reduce that risk through a healthy eating and physical activity smartphone app and tele-health coaching. Women presenting to the maternity service for the first time will be assessed, using a validated set of questions, to determine the likelihood that they will develop gestational diabetes during their pregnancy. Women identified as at high risk will be invited to take part in a study study, to see if a personalised tele-health coaching service can help women with the self-management of modifiable lifestyle risk factors compared to women who will receive usual care. The tele-health coaching is provided through a smartphone application (app) called “Bump2Baby & Me”. This will guide a woman through the journey from pregnancy to birth and the end of the baby’s first year. Trained health coaches will optimise engagement with the app and help to personalise the behaviour change experience. The app is supported by a developed and tested commercial platform, that uses a health coach dashboard to coordinate and tailor engagement for each woman. The platform will integrate seamlessly with a woman’s smartphone and each site will have their own dedicated health coach. Our study will involve a woman during pregnancy and after birth will include her baby. During the first antenatal visit, all women will be screened for their risk of developing gestational diabetes using standard information collected at this visit such as age, body mass index, family history of diabetes. Women scoring 3 or higher will be eligible to take part. At the start, we will take blood samples, measure weight and height and ask the woman to fill out some questionnaires. Women in the intervention group will have access to the Bump2Baby & Me app and tele-health coach during pregnancy and for the first 12 months after their baby is born. At 12 months we will ask women to come in for a follow-up visit where we will repeat the blood samples, body measurements and questionnaires. We will ask a random sub-sample to take part in a short exit interview.

Dose administration aids (DAAs) facilitate ease of administration by packaging multiple tablets together by date and time, thereby reducing unintentional non-adherence and medication errors. Use of reminder packaging has been shown to improve adherence by 11% measured by pill count. However, barriers to DAA use remain including cost, limited GP involvement in the initiation process, lack of patient understanding and lack of randomised controlled trials of DAAs in Australia. The PAX Pilot study will determine if a coordinated strategy of delivering cardiovascular drug therapy via dose administration aids can effectively increase prescription possession ratio compared to usual care. The study will test the hypothesis that the use of dose administration aids will increase adherence and therefore, increase prescription possession ratio, among people with greater than equal to 5 medications compared to usual care.

Almost half of women who become pregnant have overweight or obesity. As well as increasing the mother’s health risks, their babies have a higher risk of stillbirth, preterm birth, delivery complications due to larger size plus are more likely to develop childhood and adult obesity. Whilst trials to limit weight gain during pregnancy have had very limited success, there is increasing recognition that targeting obesity prior to pregnancy has greater potential to break the obesity cycle. Yet a recent Cochrane review of targeted pre-conception interventions in women with overweight or obesity found no eligible trials. If pre-conception weight loss in women with overweight or obesity were to be effective and translatable at scale, it would have enormous potential to improve the wellbeing of mothers as well as their babies in both the short and longer term. Aim: To evaluate the effectiveness of a translatable meal replacement diet program for women with overweight or obesity planning pregnancy on the incidence of significant perinatal outcomes compared with recommended advice. Design: A superiority, unblinded, multicenter RCT with two parallel groups and primary endpoint of combined perinatal adverse outcome. Population: Women (18-40 years) with overweight or obesity (BMI greater than 25kg/m2) planning a pregnancy within 6-12 months and intending to deliver at a recruiting centre. Methods: A pragmatic randomised controlled trial conducted across public maternity hospitals in New South Wales. We will recruit 1927 women with a BMI greater than 25 kg/m2. They will be randomised to: a) Nutritionally complete meal replacement diet program or b) recommended preconception advice on weight management, for a 10- week period with a 12 month follow up schedule. Outcomes Primary: gestational diabetes mellitus; pre-eclampsia; first Caesarean section, perinatal death; LGA (birth weight greater than 90th centile); admission to a neonatal unit. Secondary: Separate components of the composite outcome plus the following: Perinatal: Stillbirth (infant loss greater than 20 weeks of gestation), neonatal death, need for resuscitation at delivery, shoulder dystocia, nerve palsy, fracture, birthweight, breastfeeding at discharge Obstetric and Maternal: Gestational hypertension, assisted vaginal birth, spontaneous vaginal birth, post-partum haemorrhage, 3rd and 4th degree tears, length of stay in hospital,

Physical activity is recognised as an essential component of maintenance of respiratory health in cystic fibrosis (CF), and delivery of exercise education is a critical component of physiotherapy care. Reduced exercise capacity is associated with a decline in respiratory function and survival in people with CF. In both short and long-term studies, regular exercise has been demonstrated to decrease the annual decline in lung function in people with CF. Continued innovative approaches to prompt both exercise and activity participation and adherence at home for adults with cystic fibrosis is required. Group based exercise training is established as the gold standard in people with COPD resulting in reduced symptoms, improved quality of life outcomes, increased exercise capacity, reduced exacerbations and the prevention of hospital exacerbations. The current COVID-19 pandemic has already prompted a shift to ‘virtual’ models of care delivery within CF centres. People with CF are currently, and for the foreseeable future, receiving decreased routine face to face outpatient appointments at hospitals. This current change to care delivery minimises opportunities to offer exercise training for this cohort of patients. Home based tele-rehabilitation group exercise programs have been shown to improve exercise capacity in patients with COPD and other chronic diseases. A systematic review of telehealth in cystic fibrosis highlighted the potential to provide both physical activity and exercise programmes. Exercise sessions of 30 minutes, three times a week over six weeks offered via a virtual platform to children with CF demonstrated participation rates of 85%. The program was found to be a convenient and accessible method of encouraging physical activity and participants reported positive feedback regarding joining a group supervised class. Tomlenson et al ( 2019) examined the feasibility and acceptability of online exercise sessions using telehealth in nine adults with CF to engage patients in individualised exercise programs 2 -3 times a week 20. The participants successfully participated in the classes, rating satisfaction with the virtual training at 9/10, while compliance with sessions was 68%. Whilst these studies suggest that online training is feasible, questions remain regarding the applicability of the outcomes to the cohort of patients provided with care by TPCH Adult Cystic Fibrosis centre (ACFC). The large number of patients receiving care by this centre (over 300) is prohibitive to offering all patients individualised exercise classes. Delivery of 1-on-1 exercise training is labour intensive and expensive. Rapid improvements in survival of people with CF is expected to result in increased demand on physiotherapy services, which will outstrip service capacity. Consequently, alternate, scalable models of delivering exercise training are required.

The primary objective of this study is to investigate whether an ASMR intervention produces a measurable difference on pre-operative anxiety and primary vital signs using a randomised placebo controlled research study. Validated tools, the Amsterdam Preoperative Anxiety and Information Scale (APAIS), State-Trait Anxiety Inventory (STAI) questionnaire and Visual Analogue Scale (VAS) will be used to assess the pre-operative anxiety. Measuring the blood pressure and respiratory rate will assess the pre-operative primary vital signs. We hypothesise that for responders to ASMR, the intervention will improve anxiety scores and improve vital signs.

This is a pilot study to test the skin care effects of growth factors derived from stem cells isolated from either fast tissue – CKC-E1 or from dental pulp tissue – CKC-E2. Both of these are incorporated into two CKC creams for topical human application. Benefits include reduction/removal of fine lines and wrinkles – crows’ feet and improvement in overall skin elasticity and skin hydration. CKC topical creams in the dosages under study are likely to be well tolerated; therefore, the risk/benefit appears satisfactory based on anecdotal evidence.

Caesarean section (CS) is one of the most common surgeries in Australia. Women who undergo a CS are at risk of surgical site infections (SSI), and post-CS SSI is associated with substantial maternal morbidity and healthcare costs, and can lead to significant physical and emotional burden for mothers. Despite this burden, no standardised CS SSI surveillance mechanism or mandatory reporting system exists, and CS SSI may therefore be undetected. This project will address the gap in surveillance through trialling an electronic wound healing questionnaire via an app called, HealthTracker. Acceptability of the survey will be evaluated through the response rate of the women, and a feedback questionnaire. Data from HealthTracker will enable post-CS SSI rates to be monitored post discharge from hospital in order to identify true infection rates and to inform decision making related to preventative strategies.

This study will determine whether conducting a comprehensive health assessment in older people with non-small cell lung cancer can assist in setting health-related goals and personalised treatment plans to achieve these goals. Who is it for? You may be eligible for this study if you are aged 65 years and older, you have been diagnosed with metastatic (spread to other body systems) non-small cell lung cancer, and you meet certain objective 'frailty' criteria. Study details Participants who are enrolled in the first 6 months of this study will receive standard care from their Oncologist. Participants who are enrolled in the second 6 months of this study will undergo a Comprehensive Geriatric Assessment, which involves seeing a Geriatrician for a 1-hour face-to-face assessment. The Geriatrician will ask participants a number of questions relating to their physical, mental and social health, identify any issues, and subsequently write a report with their recommendations and refer the patient to specialists who can help them further. All participants will be asked to complete a goal setting exercise after they have agreed to participate in the study, and will be asked to complete two questionnaires about their health as well. Participants in both phases of the study will be asked to attend two follow-up visits at 3 and 6 months after study enrolment. It is hoped this research may be used to improve health outcomes for older patients with non-small cell lung cancer by identifying health outcomes that are important to them and designing their treatment in a personalised manner to achieve these outcomes.

The purpose of this study is to determine if a targeted therapy (a drug called trametinib) has an effect on tumour response in children, teenagers and young adults with neurofibromatosis type 1 (NF1) associated Plexiform Neurofibromas and Optic Pathway Gliomas. Who is it for? You may be eligible for the treatment arm of this study if you are between 3 months and 25 years old and have NF1 associated plexiform neurofibromas or progressive optic pathway gliomas. You may be eligible for the control arm of the substudy if you are between 3 months and 25 years old with NF1. Study details All participants in the main part of this study will receive the targeted therapy (trametinib) and are expected to take this drug daily for two years. The medication will be provided as either an oral tablet or an oral solution. Participants taking trametinib will be expected to complete some assessments at enrolment and attend monthly hospital visits for general health reviews. Additionally, every three months for two years, assessments will include MRI scans, and cardiac and vision testing. These assessments will measure whether trametinib is effectively treating the tumour and will also monitor any side effects. There is also a sub-study occurring within this study to find out if trametinib can improve learning, behaviour and well-being for those with NF1. For this part of the study, an untreated control group will be enrolled to compare to the trametinib-treated group described above. The untreated control group will be children, teenagers and young adults with NF1 who do not have a tumour that requires trametinib treatment. All participants in the trametinib-treated and the control groups will attend four Neuropsychology Clinic Visits over a two-year period. During these visits they will complete a number of questionnaires and tests to measure their cognitive function (thinking skills), behaviour and quality of life. It is hoped this research will help determine if trametinib has an effect on tumours and if there are any additional impacts to cognitive function, behaviour and quality of life.

The purpose of this study is to determine the possibility of adding a one-time PIPAC procedure (spraying chemotherapy drug into the abdomen) to the standard treatment of gastric cancer Who is it for? You may be eligible for this study if you are aged 18 years or older, with diagnosis of gastric adenocarcinoma and undergoing or being recommended for the standard treatment. Study details Participants in this study will undergo a procedure with a camera is inserted into the abdomen to check for metastatic disease. During this procedure, chemotherapy drug will be sprayed into the abdominal cavity. The patient will spend one night in hospital for observation and be discharged home in the morning. Participants will be expected to complete some assessments. Assessments will include clinic visits and quality of life questionnaires. It is hoped that this research will help to determine whether patients will be able to tolerate the additional the standard of care regime without increased toxicity or a need to spend more than one extra day of time in hospital.