ANZCTR search results

The aim of this study is to examine whether oral antibiotics can be used instead of intravenous immunoglobulin (IVIg) to reduce the risk of infections in people with blood cancers. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have an acquired hypogammaglobulinaemia secondary to a haematological malignancy. Study details Participants will be randomised (allocated by chance) to one of two treatment groups in a 2:1 ratio meaning that you are twice as likely to receive intervention treatment. Participants in one group (intervention) will receive co-trimoxazole (Trimethoprim-sulfamethoxazole) 160mg/800mg orally once a day or doxycycline 100mg once daily for those hypersensitive to co-trimoxazole. Participants in the second group (control) will receive standard care treatment with intravenous or subcutaneous immunoglobulin (IVIg or SCIg) in accordance with national Criteria: Monthly (every 4 weeks +/- 1 week) dose of 0.4g/kg, modified to achieve an IgG trough level of at least lower limit of age specific serum IgG reference range. The duration of each treatment is for 12 months from study entry, or until the treating physician determines that the patient should come off the treatment. The following data will be collected: Patient demographics (age, gender, diagnosis, stage of disease), baseline investigations (including IgG levels), grade 3 or 4 infections and other clinically significant infections – at monthly intervals for 12 months. This project aims to improve how we use IVIg in Australia by asking: Are prophylactic (preventive) oral antibiotics equivalent to immunoglobulin

The recent availability of low cost wearable sensors provides the research community with a rich opportunity to expand knowledge about the movement and activity of both healthy people and those suffering from a range of chronic conditions. This area is of particular interest in the management of so-called lifestyle diseases where activity is encouraged as a key component of both prevention and treatment. This study is designed to further the understanding of specific physical movements and activity in people with non-specific low back pain. The study will assess 40 people with low back pain on 2 separate occasions to measure a range of bio-psycho-social factors that are typically impacted by this condition. The study will develop our understanding of the relationship between these factors, specifically comparing commonly-used (but subjective) outcome measures to the objective outcomes provided by portable sensors.

This study is generating Australian evidence of effective sustained nurse home visiting (SNHV) interventions that are implementable and sustainable in the context of the local service system to reduce the impact of social and environmental factors predisposing urban Aboriginal infants and children to ill health and reducing their life potential. This study is the first international study to examine the immediate and longer-term effectiveness of a comprehensive SNHV program commencing antenatally and continuing to child-age 2 years for families of Indigenous infants. The study uses a quasi-experimental design comparing three cohorts of families to explore the effectiveness of SNHV for Aboriginal families. Primary research question What are the differences in length of time breastfeeding, child development at 18 months, and child body mass index and developmental outcomes at 4 years of age between Aboriginal children of vulnerable mothers receiving SNHV (Group A) and: a. non-Aboriginal children of a matched contemporary cohort of vulnerable mothers receiving SNHV (Group B)? b. an historical cohort of Aboriginal children who did not receive SNHV intervention (Group C)? Hypotheses 1. There will be no significant differences in the primary outcomes between Aboriginal children of vulnerable mothers receiving SNHV (Group A) and non-Aboriginal children in a matched contemporary cohort receiving SNHV (Group B). 2. There will be a difference between Aboriginal children of vulnerable mothers receiving SNHV (Group A) and Aboriginal children in the historical cohort who did not receive SNHV (Group C) of more than: (i) 5 weeks of breast feeding, and (ii) 5 points in the Griffiths2 Quotient (GQ) measure of child development at 18 months. (iii) 15% difference in proportion of children overweight/obese at 4 years. (iv) 5 points difference in the Griffiths Quotient (GQ) at 4 years; and 0.5SD difference in child vocabulary development at 4 years. Secondary research questions 1. What are the differences in program implementation for, and the way the program is received by vulnerable mothers and families of Aboriginal and non-Aboriginal children receiving SNHV? 2. What are the patterns of health and illness for Aboriginal compared with non-Aboriginal children of vulnerable mothers receiving SNHV, and compared with Aboriginal children who do not receive intervention? 3. What are the patterns of maternal health and health knowledge and behaviours, family and environmental conditions and service usage for vulnerable mothers and families of Aboriginal compared with non-Aboriginal children receiving SNHV, and compared with Aboriginal children who do not receive intervention?

The study design is a comparative effectiveness clinical trial with participants acting as their own controls. The research question is to establish if massage therapy in addition to standard care for chronic low back pain improves clinical and cost effectiveness outcomes compared to standard care alone. Standard care is defined as whatever the participant did for their low back pain over the month preceding recruitment and their first massage treatment for the low back pain and will be assessed retrospectively. Clinical and cost effectiveness will be assessed using validated patient reported outcome measures (PROMs) and case reports to be completed at recruitment and again after each month of treatment for the prospective two month treatment phase plus one month of follow-up (three months total study duration per participant). In addition, participant diaries for recording symptoms, medication and any adverse events experienced over each month will be distributed at recruitment and collected at each subsequent data collection point. Massage treatment will be determined by the participating massage therapists who will be recruited through the Practitioner Research and Collaboration Initiative (PRACI) and registered with an appropriate professional body. Participating therapists will screen potential clients for inclusion and obtain consent. The primary research objective will be to substantiate the clinical and cost effectiveness of massage plus standard care for the treatment of chronic low back pain compared to standard care. If this study shows clinical and cost benefits from adjunctive massage therapy it has the potential to enhance clinical management and improve health outcomes for patients with chronic low back pain in Australia and internationally.

Extracorporeal shockwave lithotripsy (SWL) is a non-invasive method of treating kidney and ureteric stones <2cm in size. SWL uses high frequency sound waves to break stones into small fragments, to allow it to pass through the urinary tract. Tamsulosin is a selective alpha-1-adrenoceptor antagonist that may lead to ureteral relaxation, reduce pain associated with stone passage and enhance the passage of stone fragments. It has been reportedly used for this purpose for more than a decade. A recent scientific study (meta-analysis by Chen and co-authors) combining the result of multiple randomised controlled trials looking at the effect of tamsulosin in assisting stone passage has been published in 2015. The study of 2093 patients found tamsulosin to be effective in improving the passage of stones and reducing the pain associated with stone passage following SWL. When looking only at the subgroup of 442 patients with stone size of 4-10mm, the study did not find tamsulosin to be useful in assisting stone passage. This is consistent with a recent study by Pickard in The Lancet journal, which found tamsulosin to be not useful in assisting stone passage or reducing pain in patients with stones in the ureter. In Australian practice, SWL are generally used for stones less than 1cm in size. Therefore, at the moment there are still conflicting data on the usefulness of tamsulosin in the cohort of stone patients we treat in Australia with SWL. We aim to answer this question in our randomised trial. The meta-analysis by Chen in 2015 also recommended further study looking into the ability of tamsulosin to reduce repeated SWL and the economic benefits of tamsulosin in this setting. Therefore, we also aim to answer the question of whether tamsulosin use after SWL leads to any economic benefit, which can come from the reduced cost of medical service delivery, and reduced economic burden on the society.

Foot ulcers are a frequent problem in people with diabetes. These wounds can be serious, and may result in amputation or even death, if left untreated. A frequent cause of these wounds is high pressure under the foot. Prevention of such wounds is of great importance. This is especially the case in people who cannot feel touch or pressure on their foot, which is called peripheral neuropathy, or an insensate foot. Reduced foot sensation can prevent people from noticing when high pressure develops. Early detection of high pressure in people with an insensate foot can be beneficial in avoiding these wounds. When high pressure is detected earlier, treatment can start earlier, to avoid ulcers forming. For this, pressure needs to be monitored on a daily basis. The long term goal of this project is to develop an insole for people with diabetes to measure pressure on the soles of the feet during daily activities. The current study will test how well the insoles measure pressure during a series of everyday activities. We will compare this to laboratory pressure measurement systems in the QUT Health Clinic. Participants will visit the QUT Health Clinic once. The results obtained from the new insoles will be compared to results from a laboratory insole testing system and a force plate, which are considered to be “gold standard” for some of the measurements. Fifteen participants with diabetes mellitus type 1 or 2 and peripheral neuropathy will be included in the study. People with vascular disease, a foot wound, or severe foot deformities will be excluded from the study. When the study is finished, we know if the new insoles give similar results as “gold standard” measurement system. We also know if insoles give similar results at similar steps. This will tell us if the insoles have potential to be used in daily life.

The purpose of this pilot study is to evaluate digitally supported skin self-examination compared to usual care in people treated for localised melanoma. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been treated for stage 0/I/II melanoma who are attending regular melanoma follow-ups at the Melanoma Institute Australia (MIA), Royal Prince Alfred Hospital (RPAH) and the Newcastle Skin Check . Study details People who are found to be eligible and who consent to participate will be randomised (allocated by chance) to the intervention or usual care in a 1:1 ration. Usual care group will receive an educational booklet on early melanoma and the usual number of routine clinic visits. In addition to usual care, participants allocated to intervention group will download the MoleScope app on to a smartphone and a mobile dermatoscope which they will use to perform total self-examinations every 2 months for 12 months in total along with a web-based ASICA app survey. Email and SMS reminders will also be sent every two months to participants in the intervention group. We will document how well participants are able to perform self-examination, their levels of melanoma-related anxiety, the number of skin lesions biopsied or removed, and the costs of follow-up to the participant and to the healthcare system. Frequent follow-up of localised melanoma is time and resource intensive, and has not shown improved outcomes. This pilot study will provide evidence on which model is best for follow-up care after treatment for localised melanoma

Wrist fractures are amongst the most common fractures suffered by elderly patients. There is limited data regarding grip strength of elderly patients who have suffered a distal radius fracture at the 2 and 6 week mark post injury. We performed a pilot study in the last year investigating grip strength in patients with distal radius fractures at 2 and 6 weeks post injury to determine whether they could drive. One major finding was that patients over the age of 60 who suffered a distal radius fracture had around 0-5kg of grip strength when measured at 2 and 6 weeks post injury. We also found that most patients were given a physiotherapy handout of range of motion exercises which they could perform. There was no strict guideline or recommendation of how often to perform the exercises and there were no grip strength exercises recommended. Grip strength in elderly patients has been noted to be a good indicator of function. Maintenance of function in the elderly patient is of great importance to a patient’s independence in mobility and activities of daily living. We hypothesize that a grip strength focused exercise program given to elderly patients with distal radius fractures will significantly improve patients’ grip strength and therefore function. This study would be of clinical significance to the elderly patient who suffers a wrist fracture. If we can improve a person’s grip strength and function, we may also improve their quality of life. Aim/Objective: To determine whether an exercise program will improve grip strength in elderly patients with distal radius fractures treated nonoperatively. Secondary objective 1. Determine whether an exercise program will improve pain in elderly patients with distal radius fractures 2. To determine whether an exercise program will improve function and reduce complex regional pain syndrome Hypothesis We hypothesize that adherence to a grip strength focused exercise program for a month between 2 weeks and 6 weeks post injury will improve grip strength in elderly patients who suffer a distal radius fracture.

After the age of approximately 40 years there is a progressive decline in physical function as well as bone, muscle and general health. Recent evidence indicates that some of these changes might be slowed or reversed with appropriate intake of nutrients such as proteins, calcium and vitamin D. However, whilst the effects of these nutrients have been quantified in older individuals (e.g. >65 years of age), no research has determined whether effects are present in younger (e.g. 40 - 60 years of age) individuals. Dairy foods such as milk contain these essential nutrients, and the processing of milk allows for the development of nutritional supplements with higher levels of them. Our hypothesis is that a dairy-derived supplement (fortified milk product, FMP) that is high in protein, calcium and vitamin D will improve physical function as well as bone, muscle and general health in 40 - 60 year-old women. Because the combination of dietary supplements with exercise, which normally forms part of a healthy lifestyle, has been shown to improve health outcomes after supplementation, we will compare the effects of the FMP supplement to a placebo powder (PLA) when taken twice daily during a 12-week period while completing prescribed exercise sessions four times a week. Additionally, because periods of physical inactivity are common in this age group (e.g. due to work and family commitments or short-term illness), we will first impose a 2-week period of reduced physical activity before introducing the exercise (i.e. healthy lifestyle) program and supplementation or placebo.

This study will help us answer the question: should children with chronic cough be given inhaled corticosteroids to promote faster recovery and improve ability for children to return to their normal daily routines? This study will also evaluate whether fractional exhaled nitric oxide levels can predict short term response to inhaled corticosteroids in children with chronic cough. We hypothesise that a short (two week) course of inhaled corticosteroids will reduce cough severity in children with chronic cough, and that FeNO measurements can be used to predict this response.