ANZCTR search results

Overall study hypothesis: That increasing levels of resilience for low socio-economic status (SES) smokers who are contemplating quitting will help them quit smoking cigarettes. This study is likely to have an impact on improving the poorer health of lower SES populations by reducing smoking and increasing resilience, mental wellbeing, confidence, self-esteem and self-efficacy. This will address the high smoking prevalence rates in lower SES areas and the limited number of studies that have addressed this health problem in this target population. The cost-effectiveness analysis of the interventions will also provide important information to policy-makers. This study will utilise a Randomised Controlled Trial (RCT) design with one control group and three intervention groups. Once consented, participants will be randomised to one of these four groups: 1.) Arm 1-Mindfulness-integrated CBT (MiCBT) plus peer-support; 2.) Arm 2-Mindfulness Training (MT) plus peer-support, 3.) Arm 3-Setting Realistic Goals (SRG) plus peer-support 4.) Control. This will enable the study to determine which of the interventions works best when compared to the control group and also when compared to each other.

Obstructive sleep apnoea (OSA) is associated with increased risk of cardiovascular disease including hypertension, and screening for this condition and treatment may help reduce those risks. Furthermore, undiagnosed OSA is also linked to increased risk of postoperative complications in patients undergoing major surgery. Opportunities to screen using simplified diagnostic devices may be an important approach to addressing this clinical burden. Conventionally, the diagnosis of OSA is conducted by laboratory polysomnography (PSG) . A number of simplified devices are emerging commercially including single use disposable single or dual channel home monitoring. Single use disposable devices may emerge as the most convenient method for screening for OSA, especially in the home setting, however formal validation against PSG has not been previosly performed. The NightOwl is a small dual channel device that acquires data from a single fingertip and is now TGA registered as a single-use device in addition to a previously validated reusable option. The purpose of this study is to validate the single-use NightOwl compared to its reusable counterpart and the gold standard laboratory PSG for the diagnosis of OSA. Findings of this study will inform models of care that may include screening for OSA. This may be important in the clinical assessment of operative risk in those suspected of OSA undergoing major surgery.

There are an increasing number of families attending the Diabetes Clinic at Perth Children’s Hospital (PCH) who are using low carbohydrate (CHO) diets in an attempt to control blood glucose levels. However, little is known about what these children are eating and their overall nutritional status. The use of these diets is often promoted for weight loss in adults; however, there is minimal evidence on the short and long-term impacts on the use in children. As such, they are not promoted in clinical guidelines or in the clinical setting and families are seeking advice elsewhere such as non-evidence based online forums. This study aims to determine if children with T1D on low CHO diets are at greater risk of poor nutritional status, cardiovascular disease, osteoporosis and poor psychosocial functioning, compared to those who meet the daily recommended CHO targets for children. The findings will directly inform future studies and clinical practice to benefit children with T1D. All children aged 10 years and younger with T1D for more than 1 year will be invited to participate in the study. A population–based sample of 100 children will attend PCH on one occasion to measure: non-fasting bloods (to assess biomarkers for malnutrition, cardiovascular disease, kidney and liver function); height; weight; blood pressure; bone density and body composition (using dual energy X-ray absorptiometry (DXA)) and; questionnaires to assess physical activity and psychosocial functioning. Participating families will complete a 4-day food diary to assess dietary intake, which will be entered into a nutrient analysis program. Statistical analyses will determine associations between proportion of energy from CHO, types of CHO-containing foods, nutritional status and risk factors for co-morbidities.

Breast cancer is a common cancer diagnosed among females in Australia. Studies have demonstrated there may be an increased risk of radiation exposure in certain occupations. The primary aim of this research is to determine if breast cancer prevalence differs among female orthopaedic surgeons from that of the general population in Australia. Who is it for? You may be eligible for this study if you are a female who is a Fellow of the Australian Orthopaedic Association. Study details All participants in this study will be invited to complete one 30-minute survey where they will complete questions regarding their occupational history and medical history. It is hoped that this study will help determine what the prevalence of breast cancer is within Australian female orthopaedic surgeons.

The aim of this study is to assess the effectiveness of a novel self-managed cognitive behavioural therapy program on concerns about falling with or without an additional graded balance program versus an online health education program with a focus on general health concerns relevant to older people. The primary outcome (concerns about falling) and secondary outcomes (balance confidence, depression, anxiety, activity avoidance, wellbeing, fall-related health literacy, physical activity, movement intensity, quality of life, exercise self-efficacy and falls) will be measured in the form of a randomised controlled trial. Ongoing exercise participation for both intervention groups beyond the 8-week program will be facilitated through the New South Wales Active and Healthy website to continue with a pandemic-safe exercise program.

The aim is to demonstrate that targeting rising minimal residual disease (MRD) in patients with progressive acute myeloid leukemia (AML) may be an effective approach to maintaining patients in remission for longer. The trial will also determine if a range of novel treatments aimed at targeting MRD will result in improved treatment outcomes. You may be eligible to participate in this study if you are an adult with acute myeloid leukemia and are currently in your first or second morphologic remission with a known and trackable MRD marker. If you enter the trial your MRD marker(s) will be monitored as per standard practice until evidence of MRD progresssion and/or morphological relapse. When this occurs you will then be allocated to the best available treatment option for your MRD markers. This is determined by a set of clinical decision rules upon discussion with a MRD committee (a group of specialist doctors in AML), If there is no preference for a specific treatment for you, you may be randomly allocated to one. Once on treatment you will be continue to have your MRD monitored, if you do not respond to treatment or your disease worsens you may be removed from treatment and be reassessed for the next best treatment option for you to receive (either on or off trial). During treatment you will be assessed regularly which will include physical exams, blood tests, ECG (test on your heart), bone marrow biopsies, toxicities to the treatment, quality of life. If responding to the treatment you will continue on treatment for 12months. After treatment your disease will continue to be monitored and if you have MRD progression or morphological relapse you will be assessed for the next best treatment option for you. It is hoped that the results of this trial will help us understand the natural history of MRD markers in patients during the course of their disease through diagnosis, treatment and relapse as well as making new treatments available to patients with AML at a faster rate using the platform trial design (many treatments teste through one trial) than with current clinical trial practices

Temperature imbalance during surgery results in adverse outcomes for patients, however temperature is rarely monitored in accordance with guidelines. One key barrier to regular, consistent and documented temperature monitoring during surgery is a lack of a non-invasive, but accurate temperature monitoring device. This pilot study will assess feasibility of recruitment, protocol fidelity, sample size and process evaluation for a future cluster randomised study testing the impact of a non-invasive, continuous temperature monitoring device upon clinical practice and patient outcomes.

The proposed research seeks to answer the following research question: In older adults undergoing rehabilitation for a non-neurological condition, does the perception of one’s own walking ability relate to their executive function and future falls risk? A prospective cohort study conducted at a sub-acute rehabilitation facility will identify the relationship between perception and executive function. Perception will be assessed by determining the difference in the time to complete a mobility task (the timed-up-and Go) physically and in their imagination. Executive function will be assessed by The Trail Making test. This project will identify the relationship between real and imagined walking and executive function in 100 older adults undertaking in-patient rehabilitation. This project will also establish the relationship between imagined walking, executive function and falls. Participants will have their physical and cognitive abilities tested twice over a 12-month period. It is expected that older adults with poor accuracy of imagined walking will have poorer executive function and be more likely to fall than those with high accuracy of imagined walking. The results of this project will provide a platform for earlier cognitive and executive function testing in older adults leading to timely detection of mild cognitive impairment and dementia.

Treatment outcomes for existing eating disorder interventions are often inadequate, with around 60% of people continuing to have residual symptoms after treatment. It is possible that biased thinking styles contribute to dropout rates and reduce people with eating disorders’ ability to engage in benefit from existing interventions. Therefore, the present study aims to improve the effectiveness of 10-session cognitive behavioural therapy (CBT-T) for eating disorders by providing cognitive remediation therapy (CRT) to target biased thinking styles. Emerging research suggests that using the waitlist period to provide adjunct interventions may improve both treatment retention and outcomes. We will use this approach, and randomly allocate participants waiting for CBT-T to one of three different one-month waitlist conditions: (i) passive control, (ii) active control (psychoeducation), or (iii) CRT.

The Imminent Birth by Immersive Virtual Reality Project will build on the existing Imminent Birth Education Program. This program was developed in partnership with the Northern Maternity and Neonatal Clinical Network, Statewide Maternity and Neonatal Clinical Network and Statewide Rural and Remote Clinical Network. The Imminent Birth Program is offered throughout Queensland Health as a continuing professional development opportunity and as mandatory training for non-midwifery health professionals in rural and remote locations where birthing services are not offered (Queensland Health, 2019). This randomized control trial will recruit nursing students and aims to compare the existing Imminent Birth Program with the version of the program that includes Immersive Virtual Reality(IVR) simulation. The two versions of the program will be compared to assess knowledge retention and confidence in practice. The usability of the simulation in the training environment will also be examined. The outcomes of this pilot study will inform future research on the effectiveness, acceptability and usability of immersive VR technologies in the Imminent Birth program with potential for enhanced professional development of registered nurses for situations where they need to attend an unplanned birth in a non-birthing facility.