ANZCTR search results

Heart disease is the number one killer worldwide, with over one million cardiac operations performed each year. Patients undergoing cardiac surgery are typically elderly with multiple health conditions. Whilst cerebral (brain) complications such as stroke are infrequent (3%), a decline in cognitive (brain) function is more prevalent following surgery with reports that concentration, focus, cognitive processing speed and short-term memory is impaired in 15–40% of patients at 3 months or longer after surgery (Ahlgren et al., 1998; Roach et al., 1996; Newman et al., 2001; Royse A et al., 2000). This permanent loss of cognitive function is even higher in elderly patients (Moller et al., 1998; Benvenuti et al., 2014; Royse C et al., 2011), and results in disability and loss of independence. It may also accelerate the incidence of dementia, as high as 30% in patients 7.5 years after cardiac surgery (Evered et al., 2016). Dementia occurs in approximately 9% of the general population over the age of 65 years, causing substantial personal and family suffering, and a high cost to the health care system. Within the next 20 years, 100 million people are predicted to have dementia, which will pose a serious challenge for the health care system (Andrieu et al., 2009). Furthermore evidence of mild cognitive impairment (MCI), considered a precursor to dementia, is evident in 30-50% of patients prior to undergoing cardiac surgery (Royse C et al., 2017). Preventing further deterioration of cognitive function after surgery is therefore critical in reducing dementia in this vulnerable cohort. Previous studies have shown that exercise preserves or even improves cognitive function (Vaynman et al., 2004), as well as reducing long term cognitive decline (Liu-Ambrose et al., 2010; Hamer et al., 2009). This study will look at the effect of early weight training exercise, requiring an increased effort and heart rate, following open heart surgery. We aim to determine if there is an optimal dose (type, intensity and duration of exercise) to maximize cognitive and physical health benefits. Participants will be randomly assigned (like tossing a coin) to either a 12-week moderate intensity weight training program or to a 6-week low-intensity exercise program (usual care). Participants in both groups will attend twice weekly exercise rehabilitation, lasting for approximately 60 minutes per session (12-24 sessions). All exercise sessions will be supervised by an accredited exercise physiologist or physiotherapist to ensure patient safety. We predict that the weight training intervention will prevent further cognitive decline, and result in significantly greater improvements in patient-reported recovery, exercise ability and muscular strength up to 6 months after surgery. We anticipate that the participants will return to pre-disease levels of health and function or better.

Cardiac rehabilitation (CR) is a secondary prevention program for cardiovascular disease. Physical activity (PA) is considered a core component of cardiac rehabilitation programs. Despite this, studies have found that PA levels are low in CR participants and sitting time is high. The aim of this study is evaluate the feasibility of a behavioural smartphone application (ToDo-CR) to decrease sedentary behaviour (SB) in CR participants. A secondary objective will be to determine whether the smartphone application increases MVPA in CR. Studies have identified that CR patients are interested in support via the internet and mobile phones. Yet, few studies have investigated the efficacy of smartphone applications in CR. To our knowledge this will be the first study to investigate the use of a smartphone application in CR and its effect on SB.

A self-monitoring digital health program (MonitorMe), offered to adult clients from a large local regional healthcare service provider, will be evaluated using a quasi-experimental trial design. People taking part in the study will receive immediate access to the MonitorMe program following completion of the pre-program survey. MonitorMe is self-help digital health program designed to enable people to self-monitor their mood and daily lifestyle events with minimal effort, and provide them with decision supports to help them interpret their self-monitoring scores and stayed engaged. These decision support tools also provide the person with relevant feedback and timely ‘life skills’ strategy information and practice tools that either work at maintaining their current healthy behaviours or assist them to get back on track when things are not going so well (depending on what their actual scores indicate. Participants will be asked to complete the self-monitoring survey that should take approximately 1 minute each day. Then once every week, participants will be asked to use the ‘Monitoring Graph’ decision support tool that will walk them through their self-monitoring scores from the past 7 days. Using the decision support tool will require 2 to 20 minutes per week (depending on their individual scores). Participants will be asked to complete a pre-program survey assessment (Week 0), followed by 1 ‘during’ assessments (Week 5), and a post-program (Week 9) and 3-month follow-up (Week 21) survey assessment. Participants will also be asked questions relating to their program engagement levels at post-program assessment. Participant engagement with the program will be obtained through by passive analytic data (e.g., what pages / strategies they visited / used and when), as well as reviewing the completion of daily mood and lifestyle event survey data and the scheduled intervention assessments. Program access will continue for 4 weeks following the 3-month follow-up assessment. It is expected that people who undertake MonitorMe program will show reductions in their stress, anxiety and depressive symptoms at post-intervention and follow-up assessment time points, as well as increases in mental wellbeing.

PTG-200 is an experimental drug being developed by Protagonist Therapeutics as a treatment for moderate to severely active Crohn’s Disease (CD) which is an inflammatory bowel disease (IBD). CD causes gastrointestinal signs and symptoms such as diarrhoea, abdominal pain, weight loss and passing blood or mucous. Current treatments for this highly complex disease have unacceptable side effects or cannot be used long term as they suppress the immune system and may increase the risk of serious infection or cancer. PTG-200 is believed to reduce the swelling that contributes to CD by blocking a specific part of your immune response pathway. There are a number of new treatments for CD which have been approved for use in other countries . PTG-200 is thought to be a better treatment for CD compared to these other medications as PTG-200 is restricted to the gut and very unlikely to spread to other parts of the body, meaning it would have fewer side effects and remain in the gut. The primary purpose of the study is to evaluate the safety and tolerability of the study drug referred to as PTG-200 in healthy individuals using single or multiple dose over number of days. The study will also evaluate how the PTG-200 is absorbed, spread in the body, and the body’s response to the drug.

A self-monitoring digital health program (MonitorMe), offered through the My Digital Health platform for adults in the general community, will be evaluated using a quasi-experimental trial design. People taking part in the study will receive immediate access to the MonitorMe program following completion of the pre-program survey. MonitorMe is self-help digital health program designed to enable people to self-monitor their mood and daily lifestyle events with minimal effort, and provide them with decision supports to help them interpret their self-monitoring scores and stayed engaged. These decision support tools also provide the person with relevant feedback and timely ‘life skills’ strategy information and practice tools that either work at maintaining their current healthy behaviours or assist them to get back on track when things are not going so well (depending on what their actual scores indicate). Participants will be asked to complete the self-monitoring survey that should take approximately 1 minute each day. Then once every week, participants will be asked to use the ‘Monitoring Graph’ decision support tool that walk them through their self-monitoring scores from the past 7 days. Using the decision support tool will require 2 to 20 minutes per week (depending on their individual scores). In addition, participants will be asked to complete a pre-program survey assessment (Week 0), followed by 5 additional ‘during’ assessments (one every 4 weeks), and a post-program (Week 25) and 6-month follow-up (Week 49) survey assessment. It is expected that people who undertake MonitorMe program will show reductions in their stress, anxiety and depressive symptoms at post-intervention and follow-up assessment time points, as well as increases in mental wellbeing.

The EPIC trial will examine whether extended peripherally-inserted catheters may offer an appropriate alternative to traditional intravenous cannulae in children. There is currently no published study that has explored this premise.

Opioid pain medication (e.g. codeine, morphine, etc.) can be very effective in controlling pain. It has been used more and more across the world over the last 20 years. It is mostly used for patients with pain caused by chronic disease (e.g. cancer). Unfortunately, taking opioid medication can lead to detrimental side effects. These side effects can include increased sensitisation to pain (hyperalgesia) and the body becoming more used to opioid medication (tolerance), and therefore requiring higher doses to get any effect. There is mounting evidence that when taken before joint replacements, opioids can lead to poor outcomes after surgery. This study aims to investigate whether patients can minimise their dose of opioid medication before surgery, and if they can, if minimising the dose leads to an improvement in their condition after surgery.

A tailored, transdiagnostic cognitive behavioural and biopsychosocially-based digital health program for lesbian, gay, bisexual or queer adults to decrease symptoms of anxiety and depression (called LIFE FLeX - LGBQ) will be evaluated. LIFE FLeX - LGBQ digital health is one of the digital health programs offered through the My Digital Health platform. People who consent will be given access to the LIFE FLeX - LGBQ program immediately but are randomly allocated to one of two groups: 1) LIFE FLeX - LGBQ digital health program A (immediate access to all of the program modules) and; 2) LIFE FLeX - LGBQ program B (weekly, sequential release of the program modules). The LIFE FLeX program is designed to provide people with information and strategies to address their anxiety and depressive symptoms and contains six ‘core’ modules, plus an Introduction module delivered over 7 weeks. There will also be a short ‘Booster’ Module released in Week 10. This tailored version of the LIFE FLeX program has been updated to better reflect LGBQ adults and their lived experience. Each module will take approximately 25 minutes to complete. In addition, in order to reinforce the module-based information, there are 20-30 minutes of offline activities each week. Participants will also receive automated emails (e.g., to remind them to log on, when to complete post/follow-up questionnaires) and will be asked to self-monitor their mood and daily lifestyle events (e.g., sleep) and asked several questions at the beginning of each module, to monitor their progress. Participants will complete a pre-intervention assessment (Week 0), during intervention (Week 1-7) assessments, post-intervention assessment (Week 8) and a 1 and 3-month follow-up assessment (Week 12 & Week 20 respectively). It is expected that people who undertake LIFE FLeX - LGBQ will show reductions in anxiety and / or depressive symptoms at post-intervention assessment and follow-up assessment time points, as well as increases in positive affect and emotional regulation.

We are testing the hypothesis that Adductor Canal Catheters (ACC) have better quadriceps muscle sparing than Femoral Triangle Catheters (FTC), when used for post-operative analgesia in primary, unilateral total knee replacement surgery. Mobilisation is a key functional outcome after TKR. Ability to participate in physical therapy exercise is an important component of post-operative rehabilitation. This study will investigate if the anatomical location of the catheter used for analgesia impacts on mobilisation and analgesia, as this has recently been raised as a potential point of difference. If the study shows that mobilisation is superior or unchanged for a true adductor canal catheter placement, and analgesia is improved, it casts doubt on the applicability of previous studies. The clinical significance would be that anaesthetists should change the anatomical location for performance of this technique. If the study shows that mobilisation is not different, but analgesia is inferior for the adductor canal catheters, the significance is that while these compartments may be distinct on an anatomical basis, it is not clinically relevant. Anaesthetists can perform the current technique without concern about the theoretical differences raised between the anatomy of the ACC and FTC block.

Vision related problems, commonly associated with increasing age and chronic disease burden, amount to $16 billion annual costs in Australia and challenge the provision of cost-effective, accessible, and timely care for patients with chronic disorders. Visual impairment and blindness as a consequence of diabetes have increased by 64% and 27% respectively worldwide between 1990 and 2010. In Australia, diabetes is the leading cause of blindness in working-age people. Referral refinement schemes and shared-care models have recently been implemented internationally to manage patients with glaucoma, and alternative care pathways for other conditions have been investigated. These models integrate optometrists in the care of patients with chronic stable conditions, or in need of long-term at-risk disease monitoring, thus effectively focusing specialist and hospital care for patients with urgent or complicated conditions. TSH provides care to a large cohort of patients with diabetes, typically under the care of an endocrinologist, many currently do not receive appropriate levels of eye care. Patients also have access to an integrated care unit (HealthOne), which provides diabetes education, health and legal advice. In collaboration with CFEH, TSH recently established a hospital-based ophthalmology-optometry collaborative care clinic in Australia as part of this multidisciplinary team to make eye health care available to all patients with diabetes and support the development of integrated patient management between general practitioners, specialists and allied health professionals. This study will investigate a novel hospital-based ophthalmology-optometry collaborative care model to prevent vision related complications in patients suffering from diabetes. Successful implementation of this model would not only reduce the incidence of sight-threatening diabetic retinopathy in Australia, but provide a foundation for the provision of sustainable, accessible, and efficient eye health care for patients with diabetes. To investigate the potential of this model within the current setting as well as its potential for implementation in other hospitals, we will assess: • suitability of patients for shared care; • clinical status and demographic characteristics of patient cohorts; • patient satisfaction and quality of life; • cost analysis of the new model.