ANZCTR search results

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

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31432 results sorted by trial registration date.
  • Getting it right from the start (GIRFTS): Effect of an early years’ school intervention on student oral language and reading outcomes.

    Oral language development in the early years of school is a developmental measure that is strongly linked to a broad range of outcomes including literacy, social skills, friendships, prosocial problem solving and conflict resolution skills, self-esteem, school attachment and subsequently mental health. In addition, students who do not master the basics of literacy in the early years of school struggle academically and may face a range of behavioural, social, vocational, and social-emotional difficulties into adolescence and adulthood. Focused efforts to improve oral language skills in the early years of school should lead to gains in literacy skills, social and emotional wellbeing, and academic trajectories. The single most important ’in-school’ factor impacting on student outcomes is the quality of teaching. Therefore, to improve oral language skills for children and confer the benefits for child social development and mental health, there needs to a paralleled improved quality of teaching. Response to intervention (RTI) is a model that can provide universal access to high quality classroom instruction in language and reading for all students, while providing intensive intervention for those students identified as at-risk (i.e. the intensity is proportional to the needs of individual students). The aim of this study is to use a RTI approach to improve oral language and reading instruction targeted to the early years of school, with a focus on: - Tier 1, addressing the whole of class, universal provision of quality instruction; and - Tier 2 interventions, addressing the needs of students most at-risk regarding their language and reading progress. This study is not designed to test the effectiveness of each component of the intervention separately. Rather, we propose testing the processes and impact of implementation of an intervention system in the ‘real world’ and how that can improve oral language competency. The mixed methods research design will innovatively combine: (1) a staged roll-out to determine impact, (2) a detailed implementation methodology to ensure that the interventions are implemented and sustained within a school system over time, and (3) qualitative data to investigate the barriers and facilitators to success.

  • Driving functional recovery after spinal cord injury using transcutaneous electrical spinal cord neuromodulation (TESCoN)

    This project addresses a significant unmet need: recovery of arm and hand function in people with tetraplegia (loss of use of the arms and legs). This issue is ranked by survivors as being of the highest importance, more important than the ability to walk. A novel non-invasive method of spinal cord stimulation (transcutaneous spinal cord neuromodulation – TESCoN) will be trialled for the first time in Australia, and in both subacute and chronic tetraplegia. Electrodes on the skin at the back of the neck will deliver a unique form of stimulation to the spinal cord without causing discomfort. This will modulate (alter the activity of) spared but non-functional pathways as well as the spinal circuitry below the injury level. When combined with intensive rehabilitation of the arm and hand, TESCoN leads to altered connections within the spinal cord, resulting in improved function. TESCoN enhances the effect of intensive rehabilitation and is not a replacement for it. This study will be an open-label trial using an adaptive design, with a combined efficacy and safety endpoint and clear rules for stopping the trial if the intervention is shown to be ineffective and/or unsafe. TESCoN is expected to lead to improvements in function that are superior to those obtained with current best practice rehabilitation. Such recovery of function may have a substantial impact on independence, potential for employment, and quality of life..

  • The Dementia, Sleep and Wellbeing Study: targeting sleep and mood in people living with dementia and their care partners.

    This pilot study aims to test the feasibility of a non-pharmacological intervention to improve sleep and mood in care partners and people living with dementia. The developed intervention is multimodal and encompasses cognitive behavioural therapy for insomnia (first line of treatment for insomnia), mindfulness-based and fatigue management strategies to holistically target sleep and wellbeing in dyads. 24 dyads of people with dementia and carer partners (n=48) will engage in weekly sessions with a psychologist over six weeks. It is hypothesised that the sleep intervention will demonstrate appropriate: a) acceptability, implementation, and b) preliminary efficacy in reducing symptoms of sleep disturbance, insomnia, daytime impairment and mood disturbance (symptoms of depression and anxiety) and improving quality of life in people living with dementia and their carers from pre- to post-intervention.

  • Venesection in iron overload and concurrent non-alcoholic fatty liver disease

    This study is assessing the utility of regular venesection (blood removal) for treatment of patients with non-alcoholic fatty liver disease and concurrent iron-overload on liver biopsy. Patients involved in this study will undergo 4-weekly venesection for up to 10-months, with a liver biopsy prior to and after the venesection schedule to assess the impact on non-alcoholic fatty liver disease and liver iron overload. We hypothesise that regular venesection will be a tolerable therapy that improves iron overload on liver biopsy and reduces severity of non-alcoholic fatty liver disease on liver biopsy.

  • Social Groups for Pain - A randomised controlled trial of group social education, and group facilitation of meaningful social interaction in people with chronic pain.

    The primary aim of this study is to find out whether a 5-6 session, small group, education and engagement course on social interaction and meaningful activity has an effect on pain, function and social networking. There will also be a qualitative part of the study that looks at enjoyment, engagement and efficacy of the course and aims use this feedback to progressively improve the course over time. Outcome measures for the main part of the study are quantitative, based on pain and function questionnaires and there is a control group who are waitlisted for twelve weeks prior to commencement of the study. We hypothesise that there will be an increase in social connection, function and pain self-efficacy in the treatment group when compared to the control group, and that these increases will be seen at the end of the course and at 6 and 12-week follow up.

  • TEXT TO DETECT: Heart Health Check Recall Program in Australian general practice

    This study will explore the impact of general practice-initiated SMS recall messages (with and without an additional nudge message) on increasing attendance at GP clinics and increasing CVD risk assessment. The trial design will be a three-armed randomised control trial. The level of analysis will be general practice clinics. Practices in the two active arms will be provided with an information package (constituting a recall SMS with an embedded link to health promotion resources) to be sent to appropriate patients Active arm 2 will be provided with an additional nudge message (with embedded link to health promotion material) to be sent two weeks after the recall message is sent. The control arm practices will be asked to maintain care as usual for a three-month follow up period. Following the 3 month observation period, the practices in the control arm will be provided with all materials and support provided to the active arm allowing them to provide identical information to their patients. The practices will be randomised using a pseudo random number generator (RNG) to assign participating practices to one of three groups.

  • Is sensory weighting under threat spatially precise?

    This study will investigate whether the expectation of threat influences sensitivity to temperature in healthy people. All participants will have their warmth detection and heat-pain thresholds on the back of their hand, forearm and upper arm measured. Participants will then be randomised into two groups: one will be told their hand will be immersed (only as far as the wrist) in green coloured, neutral temperature water (control group). The other group will be told their hand will be placed in a bucket of painfully cold water (intervention). Pressure pain-threshold will be re-measured post randomisation. We hypothesise that the cold water group will demonstrate reduced heat-pain threshold and increased warmth detection thresholds, suggesting an increase in sensitivity to noxious stimulation and reduced sensitivity to non-noxious stimulation, after being told they are going to have their arm immersed in cold water compared to those who are randomised into the neutral temperature water. We also hypothesise that the difference will be greatest at the hand as that is the rest of the arm is not expected to be immersed.

  • Does threat affect how we feel heat?

    This study will investigate whether the expectation of threat influences sensitivity to temperature in healthy people. All participants will have their warmth detection and heat-pain thresholds on the back of their forearm measured. Participants will then be randomised into two groups: one will be told their arm will be immersed in green coloured, neutral temperature water (control group). The other group will be told their hand will be placed in a bucket of painfully cold water (intervention). Pressure pain-threshold will be re-measured post randomisation. We hypothesise that the cold water group will demonstrate reduced heat-pain threshold and increased warmth detection thresholds, suggesting an increase in sensitivity to noxious stimulation and reduced sensitivity to non-noxious stimulation, after being told they are going to have their arm immersed in cold water compared to those who are randomised into the neutral temperature water.

  • Does threat change how we feel pressure?

    This study will investigate whether the expectation of threat influences sensitivity to pressure in healthy people. All participants will have their pressure-pain threshold on the back of their forearm measured using an algometer. Participants will then be randomised into two groups: one will be told their arm will be immersed in green coloured, neutral temperature water (control group). The other group will be told their hand will be placed in a bucket of painfully cold water (intervention). Pressure pain-threshold will be re-measured post randomisation. We hypothesise that the cold water group will demonstrate reduced pressure pain thresholds, suggesting an increase in sensitivity, after being told they are going to have their arm immersed in cold water compared to those who are randomised into the neutral temperature water.

  • An observational study of penicillin concentrations in an Aboriginal paediatric cohort receiving secondary prophylaxis for rheumatic heart disease in the Northern Territory.

    This six month observational study was undertaken to better understand the differences in the pharmacokinetics (if any) of children who receive secondary prophylaxis with benzathine penicillin G in Aboriginal individuals aged 5-21, for acute rheumatic fever and/or rheumatic heart disease. It is well established that plasma concentrations of penicillin vary greatly. To date no studies have been undertaken in an Australian Aboriginal cohort living in the Northern Territory. Other aspects such as breakthrough infections and inflammatory response will be assessed through repeated throat or skin swabs and measurements of anti streptolysin O titres throughout the study.

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