ANZCTR search results

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.

Study objectives: 1.To investigate children and families perspective on their experience when a family member has a brain injury 2.To understand if children perceive their needs were met as a significant other in the journey of a person with a brain injury. 3. To gain information on children and families perceptions of the optimum support system that should be offered including what, how, when and where. The aim of this research is to involve consumers, with a lived experience of Acquired Brain Injury (ABI), in how sub-acute Services can best support and educate children about brain injury. Qualitative interviews with children and family members will be the first phase of research which will aim at eliciting information about their lived experience of brain injury, any perceived lack of support/information and how services could have best supported their children. The second phase of the research (not included in this stage of the trial– another application/grant will be sought) is expected to thereafter develop an age-appropriate children’s brain injury education program or ‘tool’ which will encapsulate the topics reported through the qualitative interview. The purpose of this research is to address the gaps in resources and tools that professionals can use when supporting and educating children after a parent or significant person in their lives has a brain injury. Children can be a ‘forgotten’ component in someone’s rehabilitation as practitioners are often unsure of how to age-appropriately educate them as there are minimal resources available. This research will compile the information direct from consumers as to how brain injury in the family has affected them, how their lives have changed, how they feel, how they coped, how their relationships have been affected and what would have helped them understand brain injury better through their loved ones recovery/rehabilitation. With this information, not only will consumers have felt heard, they would have contributed essential information that will form the basis of the second phase of research which will be developing an education program or ‘tool’ that can be used in any sub-acute brain injury rehabilitation setting across the world. To ensure rigour of this research, 1. Interviews will be audiotaped and transcribed. 2. It will be important to ensure truth value, credibility and dependability by taking care that all descriptions reported are accurate. Each participant will be provided with a summary of their interview summary to check before coding begins (Krefting 1991). 3. Any discrepancies following member checking by participants will be altered ready for analysis. 4. Field notes consisting of observations during the audiotaped interviews need to be developed (Patton 1990). The three researchers will meet regularly to undertake coding (open, followed by axial, followed by selective) until all agree that all possible hypotheses have been considered and consensus has been reached.

Type 2 diabetes increases the risk of heart failure by 50%. The risk of increased cardiac events in patients who are have diabetes and heart failure are high. Metformin has been shown to reduce all cause mortality in cardiovascular patients, especially reducing the risk of event such as myocardial infarction. To address this urgent health problem, we aim to investigate the safety of low dose metformin in these patients. This study will consist of a study into the safety and pharmacokinetics of metformin in this patient group. In the first arm patients (n=50) will receive 500 mg of metformin once per day for the first 3 days and then increased to 1000 mg (500mg twice daily) from day 4 up to 12 weeks. We hypothesis that low dose metformin can be safely given to heart failure patients.

The primary objective of this pilot study is to determine if 7 days of clindamycin in combination with standard therapy will lead to a faster resolution of systemic inflammation than standard therapy alone in adults and children with severe methicillin-susceptible S. aureus (MSSA) infection. We hypothesise that the addition of lincosamides (clindamycin) to standard therapy will lead to more rapid resolution of local and systemic inflammation due to blockade of exotoxin production by Staphylococcus aureus(SA). The results of this pilot study will be used to determine the feasibility and refine study design of a definitive randomised controlled trial assessing the effects of adjunctive lincosamide on patient-centred outcomes in children and adults with severe MSSA infection.

The health of penile tissue is dependent on adequate blood flow. In Peyronie’s disease, fibrous plaques develop in the muscular tissue of the penis as a result of reduced blood flow, caused by aging, diabetes or trauma such as surgery for prostate cancer.. The hardened plaques can be firm to feel,cause pain, prevent normal stretching and cause curvature of the penis, making sexual activity difficult or if severe enough, not possible. The negative impact on quality of life is significant and more than 70% men with PD experience depression or relationship difficulties as a result. Currently, Peyronie’s disease is treated with surgical intervention or penile implant surgery, which may cause further scar tissue development, penile shortening and erectile dysfunction. Therapeutic ultrasound is commonly used to treat soft tissue trauma in musculoskeletal injuries and has no know side effects. It reduces inflammation, minimizes tissue damage, improves blood flow and helps soften scar tissue. The purpose of this study is to assess if therapeutic ultrasound assists in the resolution of Peyronies Disease. Rationale: To date, treatment for Peyronie’s disease has been invasive or mostly ineffective. Surgical correction for example, shortens the penis and contributes to further fibrosis and scarring. Less invasive techniques such as injections have had mixed results and sometimes cause pain, inflammation and increased scarring. In a recent case, complete resolution of Peyronie’s disease occurred as a result of therapeutic ultrasound use, as analyzed under Doppler scan (Dr Kaard).In addition, Ms Milios has observed promising results in her clinical practice. There is also some evidence in the literature of older studies that ultrasound might be a useful therapy (Miller, HC, Ardizzone J. Urology 1983 22(6) 584-85, Frank IN, Scott WW. The ultrasonic treatment of Peyronie’s disease.1971 J o Urol 106 : 883) The pathophysiological mechanisms by which ultrasound might be effective are currently unknown ,but in theory relate to the piezoelectric force that bombards the fibrotic tissue via high intensity vibration and heating to a depth of up to 5cm (1 MHz soundhead). In summary, there are clinical case reports and some non-randomized and uncontrolled experimental evidence that ultrasound might be helpful in the treatment of Peyronie’s Disease.