ANZCTR search results

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.

By the nature of their work, veterans and first-responders are vulnerable to developing difficulties with sleep (e.g. insomnia), and these problems can sometimes affect mental health and vice versa. The aim of this clinical trial is to investigate the effectiveness of a new treatment for sleep disorders called the Transdiagnostic Sleep and Circadian Intervention (Trans-C), and its efficacy when delivered using tele-health (via videoconferencing). In this trial, the Trans-C treatment is provided to veterans and first responders who meet the trial eligibility criteria. Eligible participants will be randomly allocated into one of two conditions: 1) an immediate treatment condition or 2) a wait-list delayed treatment condition (individuals who receive treatment after 12 weeks waiting period). Participation also involves completing a number of clinical interviews and self-report questionnaires over the duration of the trial. Additional daily assessments of sleep quality is also collected using a smartphone app, and objective sleep quality data is collected via a provided actigraph (i.e., watch) worn for the duration of treatment. Early studies using TranS-C intervention are showing that sleep can be improved, as well as benefits gained in mental health and overall well being, and this trial is examining whether similar benefits can be seen when treatment is delivered via telehealth, and if improvements can also be seen in high risk exposed populations such as veterans and first responders. We expect that participants who receive the TranS-C intervention, will demonstrate significant improvements in sleep, as well as other mental health symptoms (e.g., PTSD, depression, anxiety). In addition to this, we expect that participants will be satisfied with the TranS-C treatment, as well as the delivery of the treatment via tele-health.

The energy status of skeletal muscle is tightly coupled to the activity of proteins and genes within the network of molecular responses to exercise and the resulting health benefits of exercise. This research project will investigate how protein and gene responses to a single session of exercise are changed when skeletal muscle glycogen levels are altered in healthy adults. A total of 10 healthy, recreationally active males, 18-30 yr of age with a body mass index (BMI) of 18.5-27 kg/m2 will be recruited after providing written informed consent. In the fortnight before the experimental two-legged high intensity exercise session, all participants will complete preliminary testing including a 3-day food record, body composition scan (DXA), fitness testing (VO2 peak test), exercise session familiarisation and one-legged glycogen depletion exercise. This study will use a healthy human model whereby glycogen concentration in the right and left legs of the same individual are differentiated (low versus high glycogen) the evening prior to the experimental day. This experimental design allows us to distinguish between possible systemic and local effects because the systemic concentrations of circulating hormones and metabolites are the same for both legs, yet the local (muscle) glycogen availability is markedly different. On the experimental day, a total of 6 muscle biopsies (including 3 from each leg) and a total of 3 blood samples will be obtained from each participant. These samples will be utilised to determine how exercise-induced changes in protein post-translational modifications (i.e. phosphorylation), protein content and gene expression in skeletal muscle are influenced by glycogen availability. We hypothesise that a single session of exercise with low skeletal muscle glycogen availability will result in greater increases in exercise-stimulated muscle protein post-translational modifications (i.e. phosphorylation) and muscle gene expression (i.e. transcription), but comparable changes in muscle protein content, compared to high glycogen availability.

This study is one of nine projects being run as part of a program of endometriosis research recently funded by Medical Research Future Fund Infertility is associated with an increased rate of endometriosis. Surgically treating mild endometriosis has been demonstrated to improve fertility outcomes but studies assessing moderate and severe endometriosis are limited. Even the best studies, however, show that pregnancy rates via natural conception are substantially lower than those seen in fertile women. Laparoscopic surgery to remove endometriosis exposes women to surgical risks including infections, adhesion formation and damage to a major organ. Exposing women to this risk can only be justified if there is a real benefit, either in symptom reduction or with improved fertility. This study will explore the impact of surgical treatment of moderate to severe endometriosis on pregnancy and live birth rates from both natural conception and IVF. In addition, it will seek to clarify whether pre-emptive surgical treatment of endometriosis has an impact on future fertility.

This study evaluates a falls education intervention designed to empower patients to reduce falls by increasing their knowledge and risk awareness, and by supporting behaviour change. This study will also educate and train clinicians on how to deliver this intervention in hospital within an inter-professional context. This study also examines the views of the patients and clinicians on this falls education intervention.