ANZCTR search results

Randomised Controlled Multi Centre Trial to research the effectiveness of a chronic disease management model to care for patients with decompensated liver disease.

We have developed a comprehensive LBP website in collaboration with Arthritis Australia, the peak national consumer organisation for individuals with musculoskeletal pain. The website integrates evidence-based LBP information, tailored guidance and explicitly considers the needs and preferences of people with LBP. We currently seek to evaluate the website in a randomised controlled trial to measure its effect on health literacy, treatment choices and clinical outcomes. This step is vital before dissemination of the website can occur.

The aim of this research is to determine the effectiveness of one dressing product over another on bacterial levels/counts and wound healing outcomes in a controlled clinical trial that includes the use of ultrasonic debridement therapy for adults with chronic wounds. Chronic wounds place an enormous burden on the individual and the health care system. it is well known that individuals with non-healing wounds suffer from a reduced quality of life, experience pain, anxiety, report a financial strain, and attend frequent medical appointments. They often require antibiotics and have an increased risk of infection and further complications. There are a wide variety of dressing products available these days, all of which aim to assist the healing process. One way to assess the effectiveness of one product over another is within a clinical trial. This type of investigation can provide information to help the researcher determine how wound products perform at a cellular level. This clinical trial will involve participants being randomly assigned to receive one of two different regimes to find out which one works best. Each participant will receive ultrasonic therapy weekly for six weeks, after that a particular dressing product will continue for a further six weeks, totaling 12 weeks or upon healing. It is hypothesised that the application of ultrasound therapy will assist with reducing the bacterial burden that is common in chronic wounds and furthermore the application of dressing products with antiseptics in combination with the ultrasound are thought to further assist with preventing bacterial burden reformation and promote wound healing. This study aims to assess this hypothesis.

Sensory-based intervention (SBI) aims to improve undesirable behaviours of children with autism spectrum disorder (ASD). Proprioceptive input is one type of SBI that is hypothesised to organise the central nervous system and aid sensory regulation. Proprioceptive input arises as a result of an individual’s own movement, specifically, active muscle contraction against resistance. However the research on SBI is inconclusive as it remains unclear how to effectively use proprioceptive input to improve behaviour of children with ASD. This study aims to understand how undesirable behaviours of children with ASD and co-occurring sensory over-responsiveness change following parent-facilitated proprioceptive input. The research uses an ABA single-case design (SCD) research over a 9 week period. Five children, aged 4-14 years, with ASD and co-occurring sensory over-responsiveness will participate in the study. Following training from the researcher (occupational therapist), their parents will facilitate responsive, proprioceptive input during play and tasks in the home environment. The parents will score their target behaviour prior to intervention (A1), during the proprioceptive intervention (B), and following the intervention period (A2) on a visual analogue scale. Visual analysis of the VAS data for each participant will be used to establish preliminary evidence of a causal relationship between parent-facilitated, responsive proprioceptive input and undesirable behaviours for children with ASD and co-occurring sensory over-responsiveness.

We aim to determine the incidence of post-operative residual curarisation (PORC) in Peri-anaesthesia care unit (PACU) after general anaesthesia requiring a muscle relaxant. We will also measure the incidence of adverse airway events in PACU and determine if there is an association with PORC. As this was deemed to be a low risk study, patient consent was not required prior to recruitment. Patients were followed up in PACU after transfer from the operating theatre. Once in PACU, a neuromuscular monitor was placed and the train-of-four ratio (TOFR) was measured. This measurement was performed at 1 minute intervals until TOFR reached 0.9. The time then for TOFR to reach 0.9 was measured.

Many patients with chronic low back pain are referred for surgical consultation without clear indications for surgical intervention. Patients often wait for extended periods for consultation during which their disability worsens and general health declines. Furthermore, a high percentage of these patients are overweight or obese and may benefit from conservative healthy lifestyle care. Unfortunately, this type of care is rarely offered to these patients. This study will test the effectiveness of a coordinated care program that includes: evidence based advice and education for low back pain, and telephone based lifestyle and weight management and smoking cessation counselling. We hypothesise that this intervention will confer a 3-point reduction in disability measured on the 0-24 point Roland Morris Disability Questionnaire, compared to usual care.

The purpose of this study is to investigate the efficacy of two strengths of oral medicinal cannabis oil in patients who have been diagnosed with recurrent glioblastoma multiforme (GBM). Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with a recurrent brain malignancy (GBM): MRI revealing recurrent tumour growth. Study details Participants will be randomised to receive one of two different CBD:THC strains for 12 weeks. Each participant will have a MRI at baseline and at 12 weeks. Blood work will be conducted at baseline, 4 weeks, 8 weeks and 12 weeks. How this study will contribute to research and/or Treatment This research will assist medical doctors and patients understanding if medicinal cannabis can assist their treatment in slowing glioma tumour re-growth or growth in conjunction with standard treatment and dosage of medicinal cannabis.

PD catheter ESI is a major predisposing factor to PD peritonitis and resultant catheter and modality failure. The two most frequent causative organisms of ESI are Staphylococcus aureus (SA) and Pseudomonas aeruginosa. Daily topical application of an antibiotic cream such as mupirocin is the standard of care, however this agent is not anti-pseudomonal and may promote antibiotic resistance. Acetic acid at low concentrations is non=toxic to humans and non-irritant, but has broad antimicrobial activity including against Pseudomonas aeruginosa and may therefore offer a cheap and effective alternative. It has a long history in chronic wound care for this purpose. In this trial we will investigate the feasibility of the use of daily acetic acid dressings to reduce exit site infection, in comparison to the use of standard mupirocin treatment.

Previous research has shown that poor adherence to cardiovascular medications is associated with a 10-40% greater risk of related hospitalisations and a 50-80% greater risk of death. The World Health Organization has suggested that increasing medication adherence may actually have a far greater impact than any specific medical treatment. Tools for promoting medication adherence might improve the benefits of prescribed medications and management of chronic diseases. Meanwhile, medication adherence is difficult not only to measure precisely but also to improve with a tool that patients would like to engage and operate. The TEXTCARE program, recently initiative by The George Institute for Global Health, found that SMS reminders doubled the odds of patients with chronic illnesses taking their medications correctly. A lot of smartphone applications for increasing medication adherence have been developed, however, most of their functions were limited to reminding patients of their medication schedule and never tested properly in randomized clinical trials. This study will investigate ‘Perx’, a newly developed iPhone application designed to encourage users to take their medications. Participants will be randomised to the Perx group or standard care group, who will receive education on medication compliance. Participants in the Perx group will be asked to download the app and will enter their personal and medication details under the supervision of their physician or research nurse. Once this is completed, users will receive regular reminders when their medication is due, and if they verify they have consumed their medication at the scheduled time they will be eligible to receive an opportunity to win an intermittent reward through a gamified interaction. The verification process can be useful to measure precise medication adherence rate and the instantaneous rewarding can help motivate and reinforce patients to adhere their medication. Participants in the Perx group will be encouraged to use the app for the 12 months duration of the study. We aim to determine the efficacy of Perx on medication adherence. We hypothesise that the Perx app will increase medication compliance among those suffering chronic disease/s and will improve clinical outcomes and hospitalisation rates.

The first part of the study aims to investigate whether an innovative allied health expanded scope Treatment Access Pathway (TAP) improves health outcomes compared to a waitlist control. The second part of the study (crossover) will investigate the clinical effectiveness of TAP following 6 months waiting for treatment. Measures of health outcomes will be objective measures of function and patient self-reports of physical function, pain, mood, acceptance, self-efficacy and health related quality of life. A secondary aim of the project is to investigate the cost-effectiveness of TAP utilising a cost-utility ratio, based on delivery cost/quality adjusted life years. We anticipate 196 participants referred to the Gold Coast Interdisciplinary Persistent Pain Centre (IPPC) will be recruited into the study. Participants will be included if they are over 18 years of age, have non-cancer pain of greater than 3 months duration, and able to read and write adequate English to complete questionnaires. Data will be collected from participants from two cohorts: 1) those receiving standard treatment through TAP (treatment) and 2) those on the waitlist (control). As part of routine practice, all IPPC patients receiving treatment complete objective measures and a battery of self-report questionnaires about their health-related quality of life at regular time points. Both the waitlist and treatment groups will complete the questionnaires following referral to the service (time 1) and at 6 months post referral (time 2). Additionally, the waitlist group (who will crossover into the “TAP with wait” treatment group at 6 months post referral) will complete the questionnaires at 12 months post referral (time 3). Study 1 Primary Hypothesis: Treatment Access Pathway (TAP) patients at six months will have clinically important changes in objective physical function and self-report outcome measures (pain, mood, acceptance, self-efficacy, catastrophising and HRQOL) compared with waitlist patients. Secondary Hypothesis: The TAP delivery cost/quality adjusted life year gained will be less than $73,000/QALY 21,23. Study 2 Primary Hypothesis: There is no significant difference in clinical outcomes (changes in pain, objective physical function, mood, acceptance, self-efficacy, and HRQOL) between patients that wait (6 months) and do not wait for TAP. Secondary Hypothesis: There is no significant difference in cost-effectiveness (TAP delivery cost/quality adjusted life year gained) between patients that wait (6 months) and do not wait for TAP.