ANZCTR search results

The research project is testing a new treatment for perianal fistula. The new treatment is called Fistula-tract Laser Closure (FiLaC), produced by Bio-litec ®. This treatment is approved by the Therapeutic Goods Administration for treatment of this condition. The aim of this study is to assess the efficacy of FiLaC in treating patients with perianal fistula disease. This includes success rate of the treatment, associated pain, and return to normal daily activities post-operation.

We are planning on performing a double-blinded randomised controlled trial (RCT), investigating the role of oral metronidazole in the management of Post Open Haemorrhoidectomy pain. Haemorrhoidal disease is a common benign condition, with conventional open haemorrhoidectomy remaining the gold standard for treatment. The main post-operative complaint is pain. Various methods have been used to optimise analgesia post-haemorrhoidectomy. The most widely used pharmacological agent is metronidazole, typically administered orally. However, the overall quality of previous studies investigating this have been few in number and generally of poor quality. It is common practice however, for the majority of surgeons both nationally and internationally to administer a prophylactic course of oral metronidazole to decrease post haemorrhoidectomy pain. We hope to run our own RCT, double blinded, to assess whether oral metronidazole really does decrease post-operative pain. Patient will be either randomised to a seven day course of oral metronidazole (400mg TDS) or placebo. Patients will be followed up for 6 weeks, with the use of a 10-point Visual Analogue Scale (VAS) to assess their pain at various time intervals post-operatively.

The purpose of this study is to evaluate if tetrahydrocannabinol (THC) can improve anorexia in people with cancer. Who is it for? You may be eligible for this study if you are aged 18 or over, have advanced cancer, and have experienced reduced appetite (anorexia) for at least 2 weeks Study details Participants will be randomised by chance into two groups. Both groups will take an increasing dose of sublingual wafers before meals for one week before sustaining the high dose for up to 3 weeks. In one group, the wafers will contain THC and in the other group the wafers will be the same except not contain any THC. All participants in this study will complete a series of questionnaires and complete a food diary. It is hoped this research will provide some evidence about the utility of THC for appetite improvement in this population

We have designed a simple intervention aimed at increasing physical activity in females aged 50+. Stage 1 of the Active Women over 50 project involved a pilot RCT (ACTRN12617000485336) to test the impact of a one hour face-to-face education session about physical activity, as well as access to follow-up support strategies (goal setting, email prompts) for promoting behaviour change. In the Active Women over 50 stage 1 pilot RCT (n=130) the education session was well-received among university and hospital employees, with 100% of attendees subsequently investigating the suggested physical activity resources further (e.g. physical activity websites, local facilities, Fitbit device) to increase activity. In order to broaden the reach of the program and to enable implementation to a more varied population of women from different geographical areas, we now plan to develop and evaluate the impact of an online resource in phase 2 of the Active Women over 50 project. Active ageing is at the core of this highly innovative project that targets women aged 50 years and older. To our knowledge there currently exists no other online resource that specifically targets physical activity information and resources in a way that is relevant to the needs of women aged 50+ years. Women in this age group have unique barriers to becoming more active and hence a targeted and supported approach to ensure behaviour change is sustainable is particularly important. Women aged 50+ years may struggle to increase physical activity participation due to factors such as lack of time, carer responsibilities, demands of work, chronic health conditions, chronic pain and disability. By taking a tailored and supported approach to the provision of physical activity information, our innovative project has the potential to substantially increase physical activity participation in people aged 50+. The use of video case studies of real women who have managed to become active in the face of many barriers is a particularly innovative aspect of our program since it provides relevance and familiarity to the target audience. This approach also allows for the targeting of key messages to a broad range of women 50+ from all geographical areas and socioeconomic backgrounds. This project aims to assess the feasibility and acceptability of an online physical activity behaviour change resource with follow-up support and to pilot test the proposed methods for a planned large RCT to assess the impact of the intervention on physical activity among women aged 50 years and over.

Partnering with Parents is a practice support system designed to embed evidence-based approaches to working in partnership with parents in an early childhood education and care (ECEC) service. The aim is to create an environment welcoming of and responsive to parents as well as strengthening educators’ skills and confidence to interact with parents in a way that is supportive of their parenting. With the support of the Department of Health and Human Services (DHHS), the Parenting Research Centre (PRC) propose to evaluate whether Partnering with Parents is effective in achieving its objectives via an experimental trial design - a Cluster Randomised Controlled Trial (cRCT). PRC plan to support the implementation of Partnering with Parents within 14 sites throughout 2019 and evaluate both process and outcomes via an experimental trial. Our research questions are: • To what extent do staff, including educators, educational leaders and Practice Coaches use components of the practice support system? That is, which components are used, by whom, and how often? • To what extent do staff, including educators, educational leaders and Practice Coaches find components of the practice support system useful? • Following intervention, and compared with wait list participants, to what extent are changes seen in educators’: measures of quality of parent-educator relationships, skills and confidence in communicating with parents, and referral activities? • Following intervention, and compared with wait list participants, to what extent are changes seen in parents’: measures of quality of parent-educator relationships, satisfaction with communication at the centre, perceptions of the relational environment at the centre, help-seeking after advice from educators at the centre, and parenting confidence? • What process or demographic factors mediate or moderate the results obtained? • To what extent do parents’ and educators’ responses correlate when they fill in common measures? We will collect data online from ECEC staff and parents at three time points: pre, post and three months following the intervention. We will collect feedback from Practice Coaches after they are trained to deliver Partnering with Parents.

Participants will access the website from a link provided in the SONA Participants pool for 1st year Psychology students at Macquarie University. Once accessing the study website interested participants provided informed consent (online) and will be taken directly to complete the online pre-survey. Immediately after completion of the survey, participants will be randomly assigned to either the online self-compassion writing condition or the online control objective writing condition. Each writing activity will take 25mins maximum. One week following the baseline questionnaire completion, researchers will email participants a follow-up questionnaire. After completing the follow-up questionnaire, participants will engage in a brief version of the previous writing exercise as per allocated condition. Approximately one-month post baseline assessment participants will be emailed a link to the final questionnaire to complete.

Autism Spectrum Disorder (ASD) is a lifelong developmental disorder that typically emerges over the earliest years of life. Social and communication therapies during early childhood are critical for promoting favourable longer-term outcomes in ASD. However, until very recently we have not had interventions tailored towards infants (<14 months of age) who show early signs of ASD. While there is emerging evidence for the effiicacy of these interventions, there remains several challenges in their broader community implementation. Amongst the most significant challenges is that the efficacy of many programs depends on considerable therapy time with trained clinicians. This time requirement, and associated substantial financial expense, means that a significant proportion of families are unable to access these programs. To enhance the translational potential of very early interventions into the public health system, we have developed a more cost-effective model of therapy that is delivered in groups. We aim to test the efficacy of this parent-mediated group therapy in a randomised controlled trial (RCT) as compared to current best practice (i.e., treatment as usual). Participants (n = 80) will be infants (aged between 7 months to 14 months, 31 days) showing early social communication delays. Consenting families will be randomised into receiving either the parent-mediated group therapy (n = 40) or treatment as usual (n = 40). Families in the 'experimental' group will receive between 7-9 sessions with a speech pathologist or psychologist (1 individual session pre-group, 5 weekly group sessions, 1 individual session post-group, plus the option of 2 additional individual booster sessions, if indicated). Families in the ‘treatment as usual’ group will receive current treatment protocol offered within the community, which may comprise a parent information seminar, the provision of reading materials on infant development, or any indicated services such as speech and language therapy, occupational therapy, or physiotherapy. Infants in both groups will be assessed at baseline (i.e., prior to being randomised to an intervention arm) and at immediate treatment endpoint (time-locked to six months after their baseline assessment).

This project addresses the highest cause of years lived with a disability in Australia: low back pain (LBP). The aim of this project is to conduct a feasibility and acceptability study of a personalised primary care program for acute LBP. The MBMP program is designed to be a low cost, high value primary care program for acute LBP. It is based on the following principles: (1) Clinicians and patients collaboratively develop a person-centered, individualised treatment plan that addresses identified biopsychosocial contributors to their LBP; (2) Three treatment streams will be available, based on psychosocial screening and clinician-identified factors; (3) All patients receive integrated multidisciplinary care with a GP and a physiotherapist, with psychological therapy added as indicated; (4) Patients will be taught skills to self-manage their LBP and prevent recurrences; (5) A novel patient booklet will facilitate integrated care. The results will inform review of how integration of health care and clinical pathways can optimise primary care for LBP. The project’s outcomes will be initially translated into clinical practice at MQ Health clinics for this phase 1 trial. Results from this feasibility trial will inform iterative review of the MBMP program, prior to multi-site testing in a fully-powered randomised controlled trial for which we will seek external funding.

One of the risks of having surgery is the formation of a blood clot in a vein in the body. These may form in the deep veins in the legs especially, this kind of clot is called a “thrombus” and if it moves to another part of the body it is then called an “embolus”. Developing a blood clot is a major complication of surgery and at its worst may be life-threatening, and at its best in some cases you may not even know you have a clot as there are no signs and symptoms. Part of the usual care of a person having a surgical procedure is to try and stop these clots forming by using 3 treatments or a combination of these 3 treatments: • Compression stockings (commonly known as TED stockings) • Intermittent pneumatic compression devices (IPCDs). These are disposable and inflatable “sleeves” and are applied to your legs at the time of operation by wrapping around your lower legs and are connected to a pump to inflate and deflate continuously to help move blood from your lower legs back to your heart. • Injection of an anti-blood clotting drug called Clexane® under the skin daily, up to 28 days from surgery (extended Clexane® injections is not for all patients). For this “pilot” the research team are wanting to know if they are able to get sufficient patients to a 30 day ultrasound of both legs.

The primary purpose of the study is to evaluate the efficacy of probiotic and egg oral immunotherapy compared to placebo in achieving sustained unresponsiveness in participants with egg allergy 8 weeks after end-of-treatment. The trial will include proven egg allergic people from 5 to 30 years of age. They will be randomised 1:1 into active and placebo groups. This study is expected to run for 4 years from the start of participant screening to the last participant finishing the study. The length of the treatment period for each participant is 18 months and the follow up period is 3 months. The discovery of a safe and tolerable treatment for food allergy will have great public health benefit.