ANZCTR search results

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.

This study will evaluate the effect of an exercise and education self-management program on physical function and functional recovery in people undergoing surgery for lung cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, plan to undergo surgical treatment for non-small cell lung cancer (NSCLC), and do not currently meet physical activity guidelines. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will continue to receive usual care throughout the study. Participants in the other group will receive an exercise and education self-management program in addition to usual care. The program consists of an appointment with a physiotherapist before hospital discharge post-operatively. Additionally, the patient will receive weekly phone calls up to 12 weeks after surgery to promote adherence to physical activity goals, discuss barriers/issues with their exercise and progress their exercise program. All participants will undergo a number of tests including measurement of physical function, quality of life and physical activity before surgery, at hospital discharge, and 3 and 6 months post-surgery. We will also follow up to look at quality of life, health care resource usage and the cost effectiveness of the intervention over 12 months from surgery, and survival up to 5 years post-surgery. This study will provide important information on the effects of an exercise based intervention for people with lung cancer.

Parents of children with autism experience greater parenting stress than those of typical children or children with other disabilities. While there is some evidence for efficacy of parent-mediated interventions, existing studies are limited in scope focusing on short-term child outcomes rather than potentially important longer-term outcomes for parents. This pragmatic RCT is achievable uniquely within the operations of the Victorian Autism Specific Early Learning and Care Centre (ASELCC), based in Melbourne Australia. We will determine whether a Parent Coaching approach to delivery of the Early Start Denver Model (P-ESDM) adds value to traditional therapist-delivered ESDM intervention, bringing benefits for parents and children with autism alike, over the short and medium term. Participants in this trial will be followed over 2 years. Initially, children will be recruited on the basis of enrolment (not at random) into one of three groups – ASELCC Playrooms and Autism Playmates (two different approaches to therapist-delivered ESDM), and community services Treatment as Usual controls. Following an eligibility assessment, enrolled participants will complete a baseline (BL) assessment including 1) standardised assessments with the child, 2) questionnaires and interviews completed by parents for self-reported mental health/wellbeing and parent-reported child functioning, 3) collection of naturalistic interaction samples for coding of parent and child behaviour, and 4) collection of parental saliva swabs for Cortisol Awakening Response and salivary Alpha Amylase Awakening Response assay. A mid-point assessment will be conducted 5 months later (5m MP) following which half of families will be randomly assigned to receive Parent Coaching or No Coaching (whilst continuing with their existing enrolment). An end-point assessment will occur 10 months post-BL (10m EP), following which all ASELCC-delivered ESDM-based therapy will cease (i.e., ASELCC Playrooms and Autism Playmates enrolment, and Parent Coaching), and families will transition to Treatment as Usual. A final follow-up assessment will occur 12 months later, 22 months post- BL (i.e., 22m FU). Analysis of the efficacy of Parent Coaching vs. No Coaching – as an adjunct to therapist-delivered intervention – will be conducted via intention to treat method on 10m EP data controlling for any 5m MP between-group differences. Planned preliminary analyses on baseline data will be conducted to 1) determine distribution of Clarke QRS scores in this sample to inform appropriate stratification on this measure, and 2) refine the coding framework for quantifying expressed emotion from five-minute speech samples. Further, to comply with reporting requirements of the funding body, planned interim analysis on BL and 5m MP data will be conducted to inform the short-term relative benefit of the two different therapist-delivered ESDM approaches (ASELCC Playrooms, Autism Playmates) vs. Treatment as Usual.

The aim of this study is to determine how effective the blood vessels (collateral vessels) are that develop around the area where the blockage (occlusion) occurred in patients who have had treatment for a branch retinal vein occlusion (BRVO) or a hemicentral retinal vein occlusion (Hemi-CRVO). The study visit will take place once the patient has been stable for 3 months requiring no anti-VEGF treatment for macula oedema. The duration and number of anti-VEGF treatments that participants have received during their treatment will be recorded. Fluorescein angiography (FA) and optical coherence tomography (OCT) images taken during the treatment will be used to determine how efficient the collateral circulation is that develops. We will also use a new imaging technique called optical coherence angiography (OCT-A) to examine the efficiency retinal circulation at the collateral sites. OCT-A is a non invasive imaging technique and takes about 45 minutes to complete.