ANZCTR search results

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

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32856 results sorted by trial registration date.
  • Can lifelike baby dolls provide a positive therapeutic response for people living with dementia?

    People with dementia often have complex health and social needs that do not always receive appropriate attention. This can result in the person exhibiting symptoms such as anxiety, agitation and aggression. These are referred to as behavioural and psychological symptoms of dementia (BPSD) and are often related to the person having a need that has not been fulfilled. Pharmacological treatments have been the preferred treatment to alleviate such symptoms. As a result of a greater understanding about the adverse side effects of pharmacological treatments, a number of psychosocial interventions have been trialled. One psychosocial intervention that is increasingly being used to comfort, occupy and care for people with dementia is Lifelike Baby Dolls even though there is limited evidence for their use. It is imperative that we understand if these dolls are beneficial, harmful or indeed worthless in helping to comfort people with dementia. This parallel-randomised controlled trial will compare a Lifelike Baby Doll intervention with Usual Care in reducing anxiety, agitation and aggression symptoms in people with dementia. Participants will be assessed pre-and post- intervention for BPSD using the Neuropsychiatric Inventory and video recordings. Post intervention interviews with staff and family will evaluate the impact and perceptions of the doll.

  • MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study

    Poor adherence to medication is a global concern, especially in chronic diseases, such as cardiovascular disease. In Australia, it is estimated that between 14 to 43% of patients with cardiovascular disease do not adhere to medications. The use of smartphone apps has been proposed as a potential solution for this problem. In recent years, the increasing popularity of apps is evident as there has been exponential growth in numbers of apps available in online stores. Despite the plethora of health apps, there is a lack of information on the quality of apps, how they differ, which are more effective and why, making it difficult for health professionals to recommend a useful app to patients. In our systematic search of app stores, we have identified around 300 medication adherence apps. About half of these apps identified had basic features involving simple reminders for patients to take medication at appropriate times. The other half included additional customisable and interactive features that could increase engagement with the app and motivate sustained usage. Through a quality assessment, we selected two high-quality apps to be tested in this study. In this trial, we aim to determine whether smartphone apps to remind patients to take their medication can improve medication adherence, blood pressure and cholesterol levels. We also aim to compare and contrast the features of the smartphone apps through a detailed qualitative evaluation that will provide evidence on which features consumers perceive to be most useful, enhance engagement and optimise effects.. Our results will inform future research about the role of apps in improving medication adherence.

  • Cognitive Remediation Therapy for Obesity

    Obesity is at epidemic proportions and current weight loss programs offer little respite. While many current interventions help individuals to reduce 5-10% of their body weight, most individuals regain the weight as soon as professional contact ends (Perri & Corsica, 2002). Treatment strategies that will aid with weight loss maintenance are urgently needed. Recently weight loss failure has been linked to cognitive difficulties, specifically problems with executive functioning. Executive functioning encompasses a range of processes that facilitate initiation, inhibition, planning, regulation, sequencing and achievement of complex goal-oriented behaviour. It is evident that executive functioning underlies many behaviours associated with successful weight management (Riggs, Spruitt-Metz, Chou & Pentz, 2012). Our review (Smith et al., 2011) found 22 out of 24 studies showed a negative association between obesity and executive function. Despite this, current treatments do not target executive function deficits. Manualised cognitive remediation therapy (CRT) is a face-to-face treatment approach with a focus on improving cognitive functioning. CRT consists of mental exercises aimed at improving cognitive strategies, thinking skills and information processing through practice (Tchanturia, 2014). There is evidence that CRT improves executive function and helps individuals regulate their eating. It has been shown to be effective at improving executive function in those with anorexia nervosa (Dingemans et al., 2014). Our recent pilot RCT on manualised CRT for obesity provides promising evidence for its efficacy (Raman, Hay & Smith, 2014). The results showed that those in the CRT group experienced a significant increase in executive function and a significant decrease in weight compared to controls and that changes in executive function predicted changes in weight. This study aims to determine the efficacy of CRT in reducing weight and improving executive function in obese patients. The following conditions will be compared; CRT plus behavioural weight loss (BWL) compared to BWL (standard care) alone. It is hypothesized that individuals who receive CRT will show greater weight-loss and improved executive functioning than those in the BWL alone, both at post-treatment and at 1-year follow-up (post-treatment). Treatment will continue for 5 months and be provided by two psychologists and a dietician. Participants aged 18 to 55, with a BMI of 30 or above will be randomly allocated to one of two conditions: 1) CRT group: Eight 50 minute weekly sessions of individual CRT plus twelve, 2hour, weekly sessions of group Behavioural Weight Loss (BWL) 2) BWL group: Eight 50 minute weekly sessions of individual BWL plus twelve, 2 hour, weekly sessions of group Behavioural Weight Loss (BWL)

  • An investigation into the effects of Light Emitting Diode (LED) mediated photobiomodulation on root resorption and the rate of orthodontic tooth movement

    The hypothesis of this research project is that LED (Light emitting diode) light (photobiomodulation) will minimise orthodontic root resorption while allowing an accelerated rate of orthodontic tooth movement (acceleration of tooth movement is claimed by the manufacturer).

  • Test of a mobile app to aid mindfulness and improve wellbeing in young people

    There is now substantial evidence that mindfulness training improves wellbeing. Smartphones have become an integral part of young peoples’ daily life. Smartphone applications (apps) can potentially serve as an intervention medium to improve youth’s mental health. While there are many mobile phone apps on mindfulness, there is little evidence on the efficacy of these apps. The present study aims to evaluate the efficacy of a high qualtiy mindfulness app through a 6-week delayed treatment randomized controlled trial. A sample of 150 young people who experience at least mild level of distress (scoring between 17 and 50 in Kessler 10) will be recruited for the trial. The primary outcome variable is wellbeing, measured by the Mental Health Continuum – Short Form (MHC-SF) and the secondary outcome variables are distress, measured by Kessler-10 (K10), mindfulness, measured by Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) and happiness, measured by Oxford Happiness Questionnaire - Short form (OHQ-SF). Outcomes will be assessed at baseline, 6, 12 and 18 weeks follow up.

  • Prevention Across the Spectrum: A randomized-controlled trial of three programs to reduce risk factors for both eating disorders and obesity

    The Prevention Across the Spectrum (PAS) project builds on previous school-based eating disorder prevention research by Dr Simon Wilksch and Prof Tracey Wade as well as a considerable body of prevention work by Prof Susan Paxton (LaTrobe University) and work in the area of obesity by Dr Sue Byrne (University of Western Australia). In brief, the PAS project will compare the effect of three prevention programs on risk factors for both eating disorders and obesity, in a controlled trial with Grade 7 male and female students across South Australia, Victoria and Western Australia. Two of the interventions, Media Smart (MS: Wilksch & Wade, 2009) and Happy Being Me (HBM: Richardson & Paxton, in press), have been found to be promising eating disorder risk reduction programs. However, their effect on risk factors for obesity has not yet been evaluated and this is the key aim of the current project - to see if it is possible for individual programs to reduce the risk of both eating disorders and obesity developing. Happy Being Me is a 3-lesson program that was adapted into an 8-lesson program titled Helping, Encouraging, Listening and Protecting Peers (HELPP) for the current study (so that all 3 programs were of the same length to rule out dose-response as a reason for differences across the groups). These two interventions will be compared to a control group and a program developed for the purpose of this study, Life Smart (LS). While MS and HBM were originally developed to directly target eating disorder risk factors, LS is designed to focus more on obesity risk factors and is informed by aspects of previous successful school-based obesity prevention programs (e.g., Gortmaker et al., 1999).

  • Implementing best clinical practice for stroke patients across a private health service

    Stroke is the most common cause of complex disability for adults (Adamson, et al. 2004) and there is strong evidence that implementation of stroke clinical practice guidelines will improve the quality and effectiveness of the health care received by patients following a stroke (Donnellan, et al, 2013). Despite this, there is wide variation in the quality of stroke care provided by different health organisations (Lindsay, et al. 2011). Clinical practice guidelines are documents that integrate current evidence on how to most effectively structure and provide health services for a given condition (Weisz, et al. 2007). They can inform health care decision making for the patient, clinician and the health service. They can also inform an evaluation of the health care sevice (Gagliardi, et al. 2015). In March 2014, Cabrini appointed a stroke service steering committee with the aim of enhancing care to Cabrini stroke patients to a level that is consistent with the (Australian) National Stroke Foundation's (NSF) 'Clinical Guidelines for Stroke Management' (Bodice, et al. 2010.) The NSF's Acute Stroke Services Framework (2011) recommends all hospitals admitting 100 or more patients with stroke per year should be a primary stroke centre (PSC). Cabrini has patient numbers admitted that are consistent with this criterion and therefore has aimed to provide a PSC service for our patients. The NSF defines a PSC as having a dedicated sroke unit with clinicians who have stroke expertise; written stroke protocols for emergency services, acute care and rehabilitation; ability to offer thrombolytic therapy or protocols to transfer appropriate patients to a comprehensive stroke centre; timely neurovascular imaging and coordinated processes for patient transition to ongoing rehabilitation and secondary prevention services. It is the transition from the previous non-specific model of care for patients admitted to Cabrini following a stroke, to the current evidence-based practice, which is central to the current evaluation. This follows the implementation at Cabrini of the Clinical Guidelines for Stroke Management between September 2014 and July 2015. The broader project shall complete a comprehensive medical history audit to investigate how well Cabrini performs against the Clinical Guidelines for stroke Management, including patient clinical outcomes, before and after the implementation of the Clinical Guidelines for Stroke Management.

  • A prospective audit of sentinel node biopsy for vulval carcinoma in Australia and New Zealand

    This study aims to prospectively collect clinical data following sentinel node biopsy for vulval carcinoma in Australia and New Zealand. You may be eligible to join this study if you are a female aged 18 years or above with histologically confirmed, unifocal invasive squamous cell carcinoma of vulva less than 4cm in greatest dimension. Women in Australia and New Zealand women with early vulval cancer will be offered sentinel node procedures in place of groin node dissection. On the day before or the morning of your operation, you will have a small injection of a radioactive marker into the skin next to the cancer. A local anaesthetic cream will be used to reduce any discomfort from this injection. Pictures will then be taken over the next 2 1/2 hours to see which glands the marker has spread to. The marker will also help us find the ‘sentinel nodes’ during your operation. Either on the afternoon after the injection or the next day you will have your operation as planned by your doctor. Whilst you are asleep we will inject some blue dye around the cancer which will also help us to identify the sentinel glands. During the 60 minute operation we will remove the cancer. We will identify and remove the sentinel lymph gland(s) from one or both groins. When sentinel nodes in one or two groins can not be identified a full removal of the groin nodes (lymphadenectomy) on either one or both sides will be performed. The gland(s) will be sent to the laboratory for detailed assessment by the pathologist. Follow up clinical data will be collected from your clinical records at 3, 12, and 24 months after surgery (and at, 36, 48, and 60 months where possible), from information obtained when you attend outpatients clinic. The majority of women with early vulval carcinoma do not have groin node metastasis and these women are unlikely to benefit from groin node dissection. The use of sentinel node dissection is safe and should be part of the standard treatment for women with early stage vulvar cancer.

  • Evaluating decision aids for acute respiratory infections on the use of antibiotics in general practice

    Antibiotic resistance is an international rapidly growing threat to health care. It is a direct result of antibiotic use and results in not just health resource waste, but significant and avoidable health burdens. Reducing antibiotic use is central to minimising resistance. Primary care is a priority target for reducing use as this is where antibiotics are used most (80% of all human consumption is in the community) AND with least effect, especially for acute respiratory infections (ARI). ARIs are the most common reason for an antibiotic prescription in primary care (>5 million per year in Australia) despite providing minimal benefits and some harms. We have identified that patients overestimate the benefits of antibiotics and underestimate their harms and patient expectations are a key driver of antibiotic prescriptions. Appropriately managing patient expectations in ARI consultations is crucial to reducing inappropriate prescribing. Shared decision making (SDM) provides a means of doing this, enabling the general practitioner (GP) and patient to discuss the benefits and harms of using and not using antibiotics and jointly decide on the most appropriate option. We have established that patients want more involvement in decision-making about ARI management and that SDM reduces antibiotic prescribing in primary care. However methods of implementing SDM are limited and it rarely occurs. We have systematically developed the first set of brief decision aids about antibiotic use for common ARIs and successfully piloted them. This project is a cluster randomised trial to determine whether these evidence-based decision aids (for acute otitis media, sore throat, bronchitis) and a brief training package reduces GPs’ antibiotic prescribing rate.

  • Comparison of the probability of live birth after elective freezing of all embryos versus standard fresh embryo transfer in patients undergoing in-vitro fertilisation (IVF)

    This study will test whether freezing all good or top quality day 5-6 embryos after IVF and subsequently thawing and transferring the best day 5-6 embryo into a natural or artificially prepared cycle leads to an increase in the probability of delivering a live baby from 35% to 50% as compared to the standard strategy of treatment which includes transferring the best quality day 5-6 embryo fresh and cryopreserving the remaining good or top quality embryos.

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