ANZCTR search results

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

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31380 results sorted by trial registration date.
  • Pilot of a general practice-led intervention to optimise National Bowel Cancer Screening Program (NBCSP) participation.

    This study aims to pilot a general practice-led intervention to increase participation in the National Bowel Cancer Screening Program (NBCSP) within 100 general practices in two Australian states. Who is it for? You may be eligible for this study if you are an adult aged 45 years or older who is a patient at one of the participating general practice (GP) clinics and you are eligible for bowel cancer screening. Please note that the primary participants in this study are the GPs, however patients may be involved during the study whilst the screening initiatives are being trialled. Study details Participating GPs who agree to participate in this trial will be asked to continue their usual bowel cancer screening procedures for the first 5 months of this study. After 5 months, GP clinics will be randomly allocated by chance (similar to flipping a coin) to one of two groups. GPs who are allocated to the first group will be asked to incorporate a variety of strategies aimed at increasing the number of patients who take up bowel cancer screening opportunities. These strategies have been co-designed prior to the current trial and include the use of decision support tools, reminder prompts, additional education focusing on appropriate screening pathways and communication guides to address screening barriers in non-participant patients. Patients who attend one of the participating GP clinics may be exposed to one or more of these strategies during the trial period. GPs who are allocated to the second group will be asked to continue their usual bowel cancer screening procedures for the duration of the study and will not be given access to the new strategies and tools at this time. It is hoped this research will determine whether including new tools and educational materials into routine care for bowel cancer screening that occurs through GP clinics has a positive impact on the number of patients who undergo bowel cancer screening. If this trial shows that any of the strategies used are effective at increasing screening, they may be expanded to all GP clinics at a national level.

  • Brains, Babies & Bodies: A group psychological intervention for pregnant women living with bipolar disorder – a pilot feasibility and acceptability study

    The present study aims to assess the acceptability and feasibility of a recovery-orientated well-being group therapy program for people living with bipolar disorder that was developed to be specifically designed to be delivered via telehealth (Zoom platform) by clinicians using a randomised-controlled pilot design. It was hypothesised that by assessing weekly attendance, drop-out rates, homework compliance and qualitative interview data that the zoom-delivered program would be found to feasible and acceptable program for participants living with BD and that the telehealth platform would be viable as a form of delivery.

  • A randomised controlled trial of faecal microbiota transplantation versus placebo in patients who are non -responders to the low FODMAP diet.

    On average, only 50% of IBS patients respond to the first-line treatment of low FODMAP diet. The non-responders may have gut microbiome dysbiosis that requires targeted treatment. Recent RCTs have shown improvement in IBS symptoms using faecal microbiota transplantation (FMT) from healthy donors in IBS symptom scores up to 3 months, with the proposed mechanism being the correction of gut dysbiosis, However, there is a lack of studies into the impact of FMT in combined with low FODMAP therapy to optimise the improvement of IBS symptoms. This study aims to investigate whether the novel therapy of FMT improves IBS symptoms for IBS patients without significant symptom improvement after a low FODMAP diet. Methods: IBS patients with moderate to severe symptoms will be enrolled into a dietician-led 3 week low FODMAP treatment. The patients who do not have symptomatic improvement will be randomised into receiving FMT or placebo. Studies suggest that altering microbial composition via FMT might also lead to improvements in cognitive function. Therefore, we will investigate cognitive function at baseline compared to follow-up in a subsample of 20 enrolled participants. In contrast to participants of the overarching clinical trial, sub study participants will undergo additional cognitive testing, which takes around 50 minutes per visit, and will be asked to fill out additional mood and quality of life questionnaires, which will add another 10 minutes to study visits. This result in a total study visit time of 80 minutes for substudy participants, as opposed to 20 minutes for participants of the overarching trial, who will only fill out two questionnaires on IBS-symptom severity. Cognitive function will be assessed via Cambridge Automated Neuropsychological Test Battery (CANTAB), a validated, computer-based, neuropsychological test battery that allows testing for cognitive changes in different cognitive domains, including memory, processing speed, and executive function. To assess the impact of mood and stress on IBS symptom severity, mood will be assess via the Depression, Anxiety and Stress Scale (DASS) and quality of life via IBS-QoL.

  • A Novel Yoga-Mindfulness Intervention Targeting Anxiety Among Children with Autism Spectrum Disorder

    Extensive research has demonstrated that yoga is beneficial for general physical and mental health and well-being. However, only limited yoga-based interventions have been developed specifically for children living with Autism, with mixed results in reducing psychological distress and enhancing wellbeing. This study aims to understand the effects of a novel yoga intervention for reducing anxiety in children (aged 6 to 18) with Autism. This intervention is developed and co-designed with considerations of the special needs of children living with Autism, and it is primarily focusing on yoga postures, mindfulness awareness, breathing and relaxation training. The classes will run online, 1 hour per week for 8 weeks in a group setting.

  • How does tyrosine intake influence brain stimulation effects on working memory and planning?

    Several studies have shown that the efficacy of non-invasive brain stimulation techniques such as tDCS and tRNS on cognitive function is partially modulated by individual characteristics. One of these characteristics is the amount of the neurotransmitter dopamine (DA) that a person has. Because some of the DA that is available in the human body is derived from our diet, one way of estimating DA availability is by using a food questionnaire which can tell us about someone’s tyrosine intake. Tyrosine is an amino acid that can be found in a variety of foods, and that through a chain of metabolizing steps eventually gets converted to DA. Thus, we hope to able to predict the effectiveness of tDCS/tRNS on planning and memory performance by an individual dietary consumption of tyrosine

  • Music Attuned Technology for Care via eHealth – MATCH (Study 3.2)

    An eHealth solution – Music Attuned Technology for Care via eHealth (MATCH) – was developed to support family carers of people living with dementia to use music intentionally to support care. To create scalable solutions for the growing number of people living with dementia, we developed a minimal viable product (the MATCH app) for the HOME setting, which will be adapted for the RAC setting in study 3. MATCH represents a paradigm shift in music and dementia technology because it will: a) embed training programs that guide FCs and professional care staff in the strategic use of music; b) use sensor technology to capture behavioural markers to interpret agitation levels and auto-suggest music using algorithms that learn preferences of the person living with dementia and then suggest music they may like (recommender system); c) be able to continuously adapt the music to match and attune to arousal levels and reduce agitation; and d) be accessible to culturally and linguistically diverse groups (training videos will be available in multiple languages). Stage 2 of this study aims to explore digital markers, using wearable sensor devices, as best indicators of agitation and other symptoms to inform the development of an AI system that can detect changes in agitation in response to music and refine music recommendations to reduce agitation symptoms in residents living with dementia. We expect that data from the sensor devices will be able to support the detection and better management of agitation symptoms in people living with dementia.

  • Wound healing and scarring assessment following application of bioengineered skin in burn patients

    The purpose of the study is to assess a new type of closure for deep burn injury. It will evaluate the safety and efficacy of bioengineered human skin equivalent (HSE) for the closure of full thickness wounds in burn patients requiring excision and skin grafting, and will compare the outcomes with areas treated with standard split skin grafting. HSE is skin which is constructed in a laboratory, using skin cells, which have been extracted from a participant’s skin sample. This project involves using and comparing two variations of the HSE, as well as using standard burns treatment, and assessing the outcomes. The participant may receive one or both variations of the HSE, and will also receive split skin grafting to some of their burns. The three different possible treatments for the participant's burn wounds are: • HSE using platelet hydrogel, which is made with platelets supplied by Australian Red Cross Lifeblood. Platelets are a component of blood, which are involved in the clotting process. These are combined with a hydrogel, which is a water soluble sheet used to grow the skin cells. • HSE using Novosorb® polyurethane polymer, which is a biodegradable foam, widely used in the treatment of burns. • The remaining burn areas will be treated with split skin grafts. The participant will have skin grafts applied to some of their burn injuries. The treated areas are subsequently assessed and photographed at 7-10 days post HSE application, 4 weeks post HSE application, 6 months post HSE application, and 12 months post HSE application.

  • Co-delivery of tele trial Behavioural Activation in people with negative symptoms of schizophrenia: a feasibility Randomised Controlled Trial

    Negative symptoms are frequently experienced by people with schizophrenia. People with negative symptoms often have impaired social functioning and reduced quality of life. There is some evidence that Cognitive Behavioural Therapy (CBT) results in a modest reduction in negative symptoms. It is unclear if similar effects can be achieved using Behavioural Activation (BA). This study will examine the feasibility and acceptability of implementing a BA tele-trial delivered collaboratively with three rural mental health services (Flinders and Upper North Local Health Network, Riverland and Coorong Local Health Network, and Limestone Coast Local Health network) that provide mental health services for people with Serious Mental Illness. Methods We aim to recruit 60 consumers aged 18 years or above with negative symptoms of schizophrenia as indicated by mild to moderate negative symptoms [greater than 3 on at least two negative symptom items from the Positive and Negative Syndrome Scale (PANSS). In addition, we aim to recruit eight mental health workers from three rural mental health services in South Australia and prepare them to deliver BA to consumers of their service. Consumers will be randomised to receive BA plus usual mental health care service or usual mental health care service alone. The BA plus usual mental health care service component will involve 12 sessions of up to one hour in duration which will be delivered over 12 weeks. Our team of experts will support the mental health workers to deliver BA via telehealth supervision and structure. This also helps to ensure fidelity to the intervention. Specific BA techniques that will be applied include the identification of depressed behaviours; analysis of the triggers and consequences of depressed behaviours; monitoring of activities; development of alternative goal-orientated behaviours; scheduling of activities; and the development of alternative behavioural responses to rumination. Changes in negative symptoms of schizophrenia (primary outcome) and depression (secondary outcome) will be assessed at three-time points: (a) at baseline, at 6 weeks, and 3-month follow-ups. Changes in health-related quality of life (secondary outcome) will be assessed at two-time points: (a) at baseline and (b) immediately at postintervention after six weeks. We will use the PHQ 9 and the SF36 scales to assess changes in mood and health-related quality of life, respectively. Descriptive statistics and thematic analysis will be used to assess feasibility and acceptability.

  • The potential benefit of air purifiers in the rooms of residents in Australian Aged Care Facilities

    .It is now widely accepted that respiratory viruses are transmitted via aerosols. This study will use air purifiers with HEPA filters in the rooms of residents of RACFs. It intends to examine the effect of air purification through filtration on the incidence of acute respiratory infections in RACFs. It will help to identify whether air purifiers could be used to decrease the burden of acute respiratory infections in residential aged care settings.

  • Co-delivery of tele trial Behavioural Activation in people in custody with depression: a feasibility Randomised Controlled Trial

    People in custody are at high risk of developing depression. Accessing psychological treatments such as Cognitive Behavioural Therapy (CBT) in a prison setting is a particular challenge in part due to difficulties in accessing specialist mental health workers. An alternative treatment, Behavioural Activation (BA), is just as effective as CBT for depression in adults who are not in prison settings. The application of Behavioural Activation may increase access to an effective treatment for people in custody with depression. However, we lack trial data concerning its acceptability and feasibility. This study will establish the feasibility and acceptability of preparing custodial health nurses to deliver BA to improve depression symptoms in people in custody. Findings from the study may provide opportunities for scaling up BA to support people in custody living with depression.

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