ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32707 results sorted by trial registration date.
  • Thirsty? Choose Water! Behavioural Interventions and Water Stations in secondary schools

    Childhood overweight and obesity is a significant public health issue. A key contributing factor is sugar sweetened beverages (SSBs) consumption. Promoting increased water consumption and provision of chilled water stations can reduce SSBs consumption. Research question: Can a behavioural intervention and chilled water stations, alone or combined, increase water consumption and effect changes in students’ knowledge, attitudes or consumption of SSBs in year 7 secondary school students? Methods: A twobytwo factorial study design will be used to determine the effect of the Thirsty? Choose Water! behavioural intervention (TCWBI), and the installation of chilled water stations. Sixty secondary schools will be randomised to receive either: 1. TCWBI, 2. Chilled water stations, 3. TCWBI and chilled water stations, or 4. Neither intervention (control arm). Year 7 students in Arm 1 and 3 will receive TCWBI based on the Health Promoting Schools Framework in Terms 2 and 3, 2018. Chilled water stations will be installed in schools in Arm 2 and 3 during Term 2, 2018 with the remainder having water stations installed at the end of the project (if demonstrated to be effective). Baseline measures including student selfreport surveys, a school summary information and an environmental scan will be obtained in Term 1, 2018. Student surveys will be repeated in Term 4, 2018 and Term 1, 2019. Regular water meter readings from the chilled water stations will be recorded, as well as school canteen sales of all drink types, throughout the study period

  • The SToP Trial: See Treat Prevent skin sores and scabies A healthy skin programme in communities in the Kimberley.

    What is the problem? Skin infections (sores and scabies) are common in Aboriginal communities. At any one time, almost one out of every two children have skin sores, and one in five children may have scabies. If skin sores are not treated, they can lead to serious illness including severe infection (sepsis), bone disease, kidney disease and possibly rheumatic heart disease. Skin infections are potentially one of the most treatable causes of serious disease in Aboriginal communities. Why are so many children affected? There are many reasons for this. One of these may be that as skin sores are very common, they can become “normalised”, which might mean the child doesn’t complain, they don’t go to clinic, or the doctor or health worker doesn’t treat the sores because “everyone has them”. What we want to do - the SToP Trial Skin health has been identified as one of the health priorities by communities and health services in the Kimberley. A number of healthy skin activities are currently underway. The SToP trial study aims to strengthen and build on these existing practices to improve the awareness, detection, and treatment of skin infections in the Kimberley. The SToP trial study will implement several activities aimed at Seeing (S), Treating (T) and Preventing (P) skin infections: Seeing: Provide health worker training to improve detection and treatment of skin infections, and introduce a school-based screening program to check kids’ skin for skin infections, and refer them to their local clinic if they need treatment. Treating: At the local community clinic, provide streamlined treatment medications for skin infections that are safe, effective, less invasive and easier for people to manage. Specifically, Cotrimoxazole (oral syrup or pill medication that you swallow) will be used to treat skin sores rather than an injection of Benzathine Penicillin, which can be painful. Ivermectin (oral pill medication that you swallow) will be used to treat scabies rather than Permethrin medication (an oily cream that needs to be applied to the whole body, which can be messy and may come off). Preventing: We will work with local communities and health services to strengthen culturally appropriate health promotion activities about healthy skin and stopping skin infections. This will increase community awareness about what skin infections (sores and scabies) are, why they are important and why getting treatment is important. We will also work with communities and health services to strengthen the role of environmental health activities in helping to manage skin infections. This will increase community awareness about the importance of environmental health in relation to skin health, and to help ensure community members have access to environmental health services.

  • SpeechATAX: Intensive home based biofeedback driven speech treatment for hereditary ataxia

    We have designed a home-based, intensive four week speech exercise program designed to improve speech in patients with spinocerebellar ataxia or Friedreich ataxia. The treatment protocol is based on principles of motor learning and neuroplasticity with a focus on improving intelligibility and vocal control. Exercises and feedback were created to enhance self-monitoring and include computer based aural, visual and results feedback and self-management.

  • PAIVE - Preventing Atrophy in Immobile Vulnerable Elderly. Does high dose exercise or electrical muscle stimulation (compared to standard physiotherapy) improve strength and function in an elderly, immobile, cognitively intact, non-weight bearing, in patient population?

    To conduct a feasibility study across the Aged Care Wards at Western Health to establish whether a high dose exercise program or use of electrical stimulation is more effective in maintaining quadriceps strength and patient function compared to a low dose exercise program during the NWB period in an elderly, cognitively intact, inpatient population. At Western Health, the orthopaedic management of elderly patients admitted post fall and lower limb fracture can require a period of non weight bearing or touch weight bearing. Elderly people are often unable to function whilst safely adhering to these precautions which can result in an extended in-patient admission due to their high level care needs and requirement for rehabilitation once permitted to return to weight-bearing. These patients who are unable to mobilise whilst adhering to their weight bearing restrictions, receive a low dose physiotherapy exercise program to maintain strength, range of movement and prevent functional decline. However, we recently conducted a systematic review and no evidence exists to support this intervention. It is unclear whether this form of physiotherapy during a period of non weight bearing or touch weight bearing is of any benefit to patients or whether alternative forms of physiotherapy such as higher dosage exercise or neuromuscular electrical muscle stimulation may be superior in improving patient outcomes. Our three groups are as follows: 1) Control (Standard Physiotherapy Care) - Low Dose Physiotherapy 2) High Dose Physiotherapy 3) Neuromuscular Electrical Stimulation. This study will inform physiotherapy practice and potentially improve patient outcomes in this elderly population

  • Clinical study of Cannabidiol in children and adolescents with Developmental and Epileptic Encephalopathy

    A sequential, multi-stage, open-label, multi-national, multiple-center, multiple-dose study to assess the long-term safety and tolerability of ZYN002 (transdermal CBD gel) in child and adolescent epilepsy patients 3 to <18 years of age with seizures associated with developmental and epileptic encephalopathies (DEE) according to the International League Against Epilepsy (ILEA) classification. In Period A patients will undergo a baseline period of 4-weeks, followed by a 2-week titration period, and a 24-week maintenance period. Patients will be treated for a total of 26 weeks. For Patients not continuing to Period B, following Week 26 or Early Termination, study drug will be tapered over a 1 to 3-week period (depending on dose). After the final dose, patients will be followed weekly for 4 weeks by telephone. After the 4 weeks, the patient will be discharged from the study. Patients progressing to Period B will continue to receive ZYN002 for a further 24 weeks at the same maintenance dose received at Week 26 (e.g. end of Period A). Upon treatment termination, the patient will be required to complete the taper and follow-up period. After the final tapered dose, patients will be followed weekly for 4 weeks by telephone. After the 4 weeks of follow-up, the patient will be discharged from the study.

  • The effect of Physical Activity in Venous Leg Ulcer Patients: an observational cohort study.

    The Physical Activity in Venous Leg Ulcer Patients pilot observational cohort study is a prospective multicentre observational cohort study to examine the feasibility of recruitment, the feasibility and acceptability of wearing an accelerometer and data output from the accelerometer as a means of assessing physical activity and sleep in venous leg ulcer patients. Between 20-40 participants will be asked to wear the ActiSleep-BT accelerometer (ActiGraph, Pensacola, Florida) over a 7 day period between Baseline and Week 12 and complete a daily log to record wake and sleep times and actigraph removal greater than 15 minutes. A physical activity questionnaire (IPAQ) will be completed at Baseline and an acceptability survey will be completed at the end of the wear period. Participants will also be asked to complete a questionnaire at three time points (Baseline, Week 12 and Week 24) and their medical records will be accessed twice (Baseline and Week 24). The primary objective is to determine if wound healing within 12 weeks from the baseline is associated with physical activity (and sleep) and the secondary objectives are: to examine factors related to ulcer healing and recurrence within 24 weeks and to examine study feasibility and patient accelerometer wear acceptability.

  • The assessment of Time to Improve Your Memory (TtIYM): a brief memory training program for community dwelling older adults.

    The aim of this study is to examine a memory training program that not only integrates various strengths of previous training programs, but also provides training that is practical, feasible and transferable to real-world tasks. It is hypothesized that (1) The will be a significant improvement on the Name-Face Task from pre-test to post-test for the experimental group (2) The experimental group will perform significantly better than the control group on the Place-Learning Task, Text Learning Task, and the Name-Face Task at post-test and follow-up.

  • Stimulating social cognition in first-episode psychosis

    Transcranial direct current stimulation is a cheap, portable device that may have application as a clinical tool for cognitive remediation. In the current study we will assess the effectiveness of high-definition transcranial direct current stimulation (HD-tDCS) to the dorsomedial prefrontal cortex (dmPFC) and right temporoparietal junction (rTPJ) to affect social cognition in patients with first-episode psychosis. We hypothesize that the patient group will show impairments at integrating and distinguishing between self and other processes across perspective taking and episodic memory tasks. They will also be impaired on an affective theory of mind (ToM) task. We hypothesize that dmPFC anodal stimulation will increase the integration of other into self across perspective taking and episodic memory tasks and improve affective ToM performance. Anodal stimulation to the rTPJ will improve the ability to inhibit the self-perspective in a perspective taking task that relies on mental rotation.

  • Spray on skin for diabetic foot ulcers: an open label randomised controlled trial

    One Australian loses a limb every 3 hours as a result of diabetic foot ulcers (DFU) with infection. This common condition accounts for substantial morbidity and mortality for affected individuals and heavy economic costs for WA Health and the community. There is an urgent need to test interventions that improve wound healing time, prevent amputations and recurrent ulceration in patients presenting with DFU whilst improving quality of life and reducing health care costs. A novel intervention towards achieving these goals is the use of spray-on skin for patients with DFU. The application of ‘spray-on’ autologous skin grafting aids epithelial regeneration and wound healing and has been used successfully for the treatment of burns to improve healing. In this research project we will compare spray-on skin with standard care in an open label randomised controlled trial in patients presenting to hospital with DFU. We hypothesise that spray-on skin will shorten the time for the ulcer to heal completely. In doing so, this approach can be expected to prevent amputations and recurrent ulceration whilst improving quality of life. Outpatient costs for dressings, home nursing visits and outpatient appointments are key cost drivers for DFU. If spray-on skin is effective, large cost savings to WA Health will be realised immediately through a shortened time to healing, and through a higher proportion of patients achieving complete healing. Any economic benefits are likely to be amplified across Australia and other similar demographic settings where aging populations with increased diabetes rates are considered major future challenges.

  • Measuring the clinical effectiveness and healthcare experiences for women undergoing a balloon induction of labour, where the balloon is used for 6 hours compared to 12 hours.

    Induction of labour (IOL) is one of the most frequently performed obstetric interventions. In high-income countries nearly one-third of all pregnant women undergo IOL. The process of IOL commonly involves cervical ripening, using mechanical or pharmacological methods; however, the optimum protocol of IOL remains undetermined. For almost 50 years, balloon catheters have been used to mechanically ripen the cervix. Balloon catheters apply direct pressure on the internal os of the cervix, stretching the lower uterine segment and indirectly increasing release of endogenous prostaglandins. In recent years, there has been a shift in clinical practice favouring mechanical methods in response to growing evidence of both efficacy and safety. In randomised controlled trials and meta-analyses mechanical methods appear comparable to pharmacological methods for successful IOL without the complication of uterine hyper-stimulation. Trends toward a reduction in instrumental births, fetal acidaemia and post-partum haemorrhage have also been observed with balloon IOL. IOL using a single or double balloon catheter typically involves removal of the catheter approximately 12 hours after insertion, followed by an artificial rupture of membranes (ARM) and commencement of an oxytocin infusion. Whilst there is good data supporting its efficacy in ripening the cervix, there is limited information to guide exactly how long a balloon catheter should remain in situ. The product recommendation states “up to 12 hours”. There are just two abstracts reporting on small clinical trials comparing a 6-hour versus 12-hour insertion. The methods do not describe how the IOL was managed following removal of the balloon. These data are under-powered but nevertheless reassuring that an earlier removal of the balloon catheter is likely associated with a shorter duration of labour and is unlikely to be associated with a difference in mode of birth. There is evidence to support that a longer duration of induced labour is associated with both a poorer healthcare experience and increased costs. Hence earlier removal of the balloon catheter shows promise as a method to reduce cost, and improve the healthcare experience for women without altering clinical outcomes. This study therefore aims to explore the clinical effectiveness and healthcare experience of women undergoing an IOL using a balloon catheter where the balloon is left in-situ for a shorter versus longer duration of time.

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