ANZCTR search results

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

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33634 results sorted by trial registration date.
  • BETTER MAN: A healthy relationship tool to encourage help seeking for men who use violence in their intimate relationships

    Domestic or intimate partner violence is defined as any behaviour within an intimate relationship that causes physical, psychological or sexual harm to those in the relationship. It is predominantly perpetrated by men against women, but it also occurs in same-sex relationships. In Australia, current responses to men’s use of domestic violence focus on men whose behaviour has became so severe that they enter the justice system. This project uses a novel approach to reducing domestic violence by engaging men in the community at an earlier stage in their use of domestic violence to seek help. This project builds on previous projects where we developed and successfully piloted BETTER MAN, an online healthy relationship tool. The aim of this project is to evaluate BETTER MAN, by randomly assigning 360 participants recruited online to either BETTER MAN or a website that gives information on healthy relationships. Specific objectives are to test whether BETTER MAN increases men’s help-seeking activities for use of domestic violence, increases men's identification of their behaviour as domestic violence and men's readiness to change regarding their abusive behaviours. Finally, we will explore whether BETTER MAN is cost-effective compared with the comparison website of resources.

  • Is telephone delivery of the Strength 2 Strength (S2S) group program a feasible way to build resilience among family members supporting relatives with Acquired Brain Injury (ABI)?

    Strength 2 Strength is a group program developed and published in 2012. The program was designed to enhance the resilience of family members supporting a person who has acquired a brain injury. The group program provides family members with the chance to speak with others in a similar situation and share experiences. It also provides information on the ways of managing the changes and challenges after a family member sustains a brain injury and gives information about services and supports available in the community. People who participated in the face to face group have found it very useful and effective when run in a number of settings in metropolitan areas of NSW. It can be difficult to run the face to face group program in rural areas where people living with acquired brain injuries and the family members who assist them, are scattered over a wide area and struggle to consistently meet once a week for five weeks. As a result, a shortened version of the group program was developed in 2012 but its effectiveness was not established. The shortened program is facilitated by two people and the guidelines suggest that no more than 4 family participants be involved in each group if telephone conferencing is used. This study is designed to investigate the effectiveness of this shortened program which runs for about an hour once a w eek using discussion tools that have been sent to participants before each session. A number of questionnaires (administered pre- post and follow-up) will be used to investigate the outcomes (primary, secondary) for the participant family members.

  • Understanding real-world health, wellbeing and dietary outcomes after metabolic and obesity surgery

    AIM Metabolic and obesity surgery (MOS) is currently the most effective, durable strategy for weight management. Comprehensive outcome data following metabolic and obesity surgery is missing from the Australian bariatric population. This prospective long term cohort study aims to document and evaluate medical, psychosocial and behavioural factors linked to outcome measures. METHODS Recruitment will commence from April 2021 and continue until November 2023 or until 250 participants are recruited. The study will observe participants for 2 years with data collection commencing 1-2 months pre-MOS and at timepoints 3,6,12 and 24 months post-surgery. Participants include those undergoing surgery over 16 years of age, able to read and write English and give consent. All participants will receive usual care during the study period. Data collection will include demographics and family traits; medical history, mental health via the Depression, Anxiety and Stress Scale (DASS); Quality of Life via the Assessment of Quality of Life (AQoL-8D); dietary intake (via a dietitian assessment survey and a participant-completed food frequency questionnaire); dietary behaviour via the Eating Disorder Examination questionnaire (EDE-Q); social factors; weight stigma using the Weight Bias Stigmatisation Scale (WBIS); use of social support networks and beliefs using patient-completed surveys; and attendance at clinical appointments. The primary outcome of weight change will be reported in kilogram (kg) weight change, BMI (kg/m2) and percentage weight loss (%WL), secondary outcome measures will include health and psychosocial variables evaluated in the study. STATISTICAL ANALYSIS Descriptive statistics will be used to profile the baseline characteristics of the participants. Linear and generalised linear mixed models and survival models will be used for the longitudinal data analysis. The investigators plan to present and publish the findings of this study at scientific meetings, both nationally and internationally and in peer reviewed journals. Participants will be unidentifiable with results being anonymised. SUMMARY Obesity effects a third of Australians and MOS in Australia has become a popular tool for obesity management. This surgery is mainly performed in the private setting with minimal data available reporting on outcomes including that of health, psychosocial wellbeing, and dietary changes. This prospective observational study will add to the limited literature from the Australian setting, important real-world data on the long-term comprehensive outcomes following MOS. Results may assist clinicians in providing best practice individualised care.

  • Co-development and end-user testing of a Mobile App to support dementia carers.

    The current project seeks to work with end-users, people caring for a family member or friend with dementia, and a small number of representatives from dementia and carer organisations) to undertake real world testing and co-development of an App, called Carers’ CARE, to assist dementia carers. The project will use participants’ feedback provided in the App and from a small number of interviews, to assess the App’s a) patterns of usage, and end-user feedback about App features, content, user friendliness and acceptability b) dementia and carer related services providers' perceptions of the implementation potential of the App with extant services The study will also examine preliminary information about the App’s potential helpfulness for carers’ coping and psychological well-being.

  • Australian Cerebral Palsy Musculoskeletal Health Network: Bone Quality in Children with Cerebral Palsy

    In children and adolescents with CP, MSK complications are severe and progressive, with life-long impact. Hip displacement, scoliosis and skeletal fragility are often not detected until orthopaedic surgery is required or the child has sustained a pathological fracture. We will collect trans-iliac bone biopsy samples from 30 children with cerebral palsy to evaluate the bone quality and histomorphometry. Having a detailed understanding of the bone phenotype will help us plan targeted therapies to improve bone health.

  • Investigation of community participation outcomes for adults with acquired brain injury after discharge from post-acute rehabilitation: A mixed-methods study

    The primary purpose of this research project is to investigate community participation outcomes for adults with acquired brain injury (ABI) after discharge from post-acute rehabilitation. Community participation refers to the meaningful participation and engagement of an individual in life roles, occupations and activities conducted outside the home environment as well as actively being involved with society. The Brightwater 'Oats Street' Facility is a community-based residential acquired brain injury rehabilitation facility where clients live on-site to receive rehabilitation and support from a multidisciplinary team of health professionals. Rehabilitation at this facility is considered 'post-acute' rehabilitation. Community participation outcomes of Oats Street clients will be measured at discharge and then at 4, 8 and 12 months after discharge. Data from these outcomes will be analysed Phase 3 will then involve data analysis to analyse the changes in community participation outcomes.

  • Comparing Home-Based Digital Treatments for Insomnia.

    The research project is testing two new home-based insomnia treatments. One treatment is a sleep wearable device called THIM, which has been developed to administer a treatment called Intensive Sleep Retraining. The other treatment is an online program called SHUTi (Sleep Health Using The Internet) that administers a brief version of cognitive behavioural therapy for insomnia. Patients who meet diagnostic criteria for insomnia and have sleep onset difficulties will be randomly allocated to one of the four groups: THIM by itself, SHUTi by itself, THIM and SHUTi combined, waitlist control group. The study aims are to investigate: 1) the efficacy of THIM versus a waitlist control group for treating insomnia. 2) the efficacy of the combination versus all other treatments for treating insomnia. 3) the cost-benefits of remote therapies.

  • A randomised placebo-controlled trial examining the efficacy and safety of an adjunct herbal medicine formulation in patients with major depressive disorder and poor response to anti-depressant therapy

    Anti-depressants are a commonly used medication in Australia, with over 15 million prescriptions dispensed in 2018-2019 (Australian Institute of Health and Welfare 2019). However, the response to anti-depressants is varied, and some patients experience flatline emotion, ongoing depression, decreased cognition, changes in sexual function/desire, insomnia, and other symptoms. Selective serotonin reuptake inhibitors (SSRIs) are the most commonly prescribed first-line treatment for major depression, however, the rate of treatment response from baseline symptoms following first-line treatment with SSRIs is moderate, varying from 40-60% and lower in subsequent treatment attempts. There is evidence that inflammatory cytokines contribute to the development of depression in both medically ill and medically healthy individuals (Felger and Lotrich 2013), and research supporting anti-inflammatory approaches to depression management has been shown to increase effectiveness of some anti-depressants in clinical trials (Muller, Schwarz et al. 2006, Akhondzadeh, Jafari et al. 2009, Hang, Zhang et al. 2021). Given the large proportion of patients who do not respond adequately to first-line therapy, or experience negative side-effects, incorporating adjunct treatments may need to be considered. Certain herbal medicines may be able to assist treatment response by decreasing inflammation and reducing side effects. It is hypothesised that specific anti-inflammatory and anti-depressant herbs may effect a clinically meaningful improvement when added as an adjunct to existing anti-depressants in patients with poor response to anti-depressant therapy.

  • Feasibility and efficacy of using lung measurements to predict complications during surgery for young children with and without respiratory symptoms.

    Perioperative respiratory adverse events (PRAE) pose a significant risk in paediatric anaesthesia, with the incidence of PRAE being reported between 15 and 50 %. Accurate detection of those at risk for developing PRAE is vital to enable tailoring of their perioperative management. Traditionally, risk of PRAE is assessed using the patient’s past medical history, family medical history and physical examination. However, given the multifactorial nature of the risk of PRAE and children with complex medical backgrounds such as chronic lung disease, obstructive sleep apnoea or obesity, patients may benefit from additional objective preoperative pulmonary function tests. Recently our group published an educational review identifying the clinical utility of preoperative pulmonary function testing in paediatrics which identified that there is little evidence to support the routine use of lung function in preoperative assessment. However, we noted that the measurement of Peak Cough Flow (PCF) is predictive of the need for respiratory support or cough support following surgery suggesting that a higher PCF may reduce the incidence of PRAE; thus far there is no evidence in the role of PCF in preoperative assessment, however this simple, non-invasive and portable test may help identify high-risk subjects. We propose a prospective cross-sectional interventional study to assess if Peak Cough Flow and spirometry in children with and without respiratory symptoms aged 5-10 years is clinically associated with an increased risk of developing PRAE. Monitoring and recording of PRAE (laryngospasm – closure of the vocal cords, bronchospasm – narrowing of the airways, severe and persistent coughing, airway obstruction, oxygen desaturation (<95%) and postoperative stridor-squeaky noises when breathing) will occur throughout the procedure and in the post anaesthesia care unit (PACU). We hypothesise that children with a higher percent of predicted PCF will be at a reduced risk for developing PRAE.

  • The use of MRI guided focused ultrasound for the management of focal hand dystonia

    Current treatments are primarily aimed at short term symptomatic control using oral medications or chemodenervation, with botulinum toxin, to provide relief of the involuntary movements. Physical therapies and rehabilitation, including constraint training and motor training with or without neuromodulation and sensory discriminative training, has shown some improvement but these findings are not definitive. Recently, the use of surgical stereotactic thalamotomy has been shown to provide significant efficacy in the treatment of patients with focal hand dystonia. This is an invasive treatment requiring burr hole and stereotactic probes being passed into the brain with a risk of intracerebral haemorrhage of 1-4%. Advances in minimally invasive surgical techniques using gamma-knife thalamotomy have been shown to be effective in refractory musician’s dystonia. The option of a less invasive neurosurgical technique, using MRI guided focussed ultrasound (MRgFUS), has provided a novel treatment approach for patients with focal dystonia. MRgFUS thalamotomy is a safe and effective treatment modality for essential tremor and other tremor disorders. A recent pilot study of non-invasive thalamotomy using MRgFUS showed promising results with marked improvement in symptoms related to focal hand dystonia with no adverse effects. It is the objective of this research project to establish the efficacy and safety of MRgFUS in an Australian population with focal hand dystonia and establish a database for ongoing research in the use of non-invasive neurosurgical techniques in the treatment of a wide range of movement disorders.

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