ANZCTR search results

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

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31356 results sorted by trial registration date.
  • Healthy Body Healthy Mind: Randomised controlled trial of an exercise intervention for the treatment of youth depression

    It is known that regular exercise has a positive effect on improving depressed mood in adults. At this stage it is not known if exercise offers the same benefits to young people. The purpose of this study is to evaluate the effectiveness of exercise on reducing symptoms of depression among adolescents and young adults.

  • Encouraging Activity to Stimulate Young Minds Program (E.A.S.Y Minds Program): Evaluation of a school-based program that integrates physical activity across the primary school curriculum

    To produce an evidenced based physical activity intervention for classroom teachers that will integrate PA across the primary school curriculum as highlighted in the Auditor General’s Report June 2012. The Easy Minds intervention has run a successful feasibility trial that demonstrated that integrating PA into other subjects can lead to: Increased moderate to vigorous physical activity (MVPA) within both the intervention session and the school day, reduce sitting time and improve classroom behaviour.

  • Feasibility of an Australianised Mediterranean diet in healthy volunteers aged 65 years and older - MedLey Trial

    This is a pilot study designed to test how easy it is to follow an Australianised Mediterranean Diet (AusMed diet) for 2 weeks. This includes an investigation into consumption of nutrients, BMI stability, palatibility, satiety and cost of the diet, and other lifestyle factors which might be affected by the diet. The information we collect will then be used to help refine and change the diet to make it easier to follow in the long term. We hypothesise that with some minor changes, it will be feasible to follow the AusMed diet for 2 weeks.

  • Home Monitoring of Chronic Disease for Aged Care

    This project will deploy, operate and evaluate a state of the art, NBN enabled telehealth system for the management of chronic disease in the community in five different states and six different clinical trial sites in partnership with a variety of public and private sector health care service providers, including Local Health Districts, Medicare Locals and not for profit health care service providers. New methods for the automated risk stratification of patients will be developed that will facilitate future large scale deployment of NBN enabled telehealth services. Each clinical trial site will operate as a statistically independent case matched control trial with 25 Test patients supplied with NBN enabled Telehealth services and 50 patients receiving normal care. The overall patient cohort of 150 test patients and 300 control patients provide sufficient statistical power to ensure reliable and reproducible results across the whole health care sector. This project will provide the clinical and health economic evidence on how NBN enabled telehealth services can be scaled up nationally to provide an alternative cost effective health service for the management of chronic disease in the community. As well as demonstrating effective deployment of NBN enabled healthcare services, a number of critical success factors will be analysed. These include; * Health care outcomes * Health economic benefits * Impact on clinical work force availability and deployment * Human factors (acceptability, usability by patients, carers, nurses, GPs and administrators, impact on workplace culture) * Organisational change management and business processes Large scale deployment will also require automated risk stratification of patients according to their health status to ensure that the best possible response is orchestrated at the right time to avoid unnecessary hospitalisation. In the first year of the trial, CSIRO and its partners will develop a range of sophisticated automated risk stratification algorithms based on sophisticated statistical analysis and advanced data analytics. These were intended to be deployed and tested in the second year and the outcomes with respect to a range of healthcare outcomes, and socio-economic variables analysed and reported. However with the trial period now effectively shortened to 16 months, we will now be able to deploy the new risk stratification and decision support algorithms and evaluate useability and clinical acceptance of the service, but there will be insufficient time to rigorously evaluate the impact of this new facility on health care or socio-economic outcomes. This would require an additional eight months as initially planned. The third major contribution that will be the development and testing of a data architecture and communication framework consistent with NeHTA National eHealth Architecture, capable of transferring telehealth data to and from the PCEHR. Since the PCEHR will ultimately synchronise with GP systems and receive data from multiple sources, this development will firmly embed telehealth data recorded by patients at home as an important adjunct to the patient electronic health record. In addition, this project will analyse and report comprehensive health care outcome, health economic, work force and organisational change management data to provide the evidence that Government and treasury need to develop the policy and funding framework to facilitate the development of a national public and private sector market for the provision of telehealth services.

  • Swimming Study for Severe Otitis Media

    The primary purpose of this study was to see if regular daily swimming in a chlorinated pool could help resolve severe middle ear infections in Aboriginal children.

  • Does the consumption of marshmallows reduce the stoma output for patients with ileostomies?

    The aim of the trial is to find out whether eating marshmallows helps to reduce the stoma output in people with an ileostomy. Eating marshmallows to reduce stoma output is widely documented on online websites and blogs as well as in the recommendations given by stoma-care therapists. However, there is no evidence to support these recommendations. We will invite people that have had an ileostomy for at least 3 months, are medically stable, with no relevant dietary restrictions and over 18 years of age to take part in the trial. We will use a repeated measures design with random crossover between a 5 day study period and 5 day control period with a 2 day ‘wash out’ in between. Primary outcome: to determine the efficacy of marshmallow intake in reducing stoma output in patients with ileostomies. Hypotheses: a) Marshmallow in take will reduce daily stoma output volumes b) Marshmallow intake will reduce the frequency of daily stoma bag empties and changes

  • Lip muscle strength training, sleep apnea and sleep quality

    The study proposes that lip muscle strength training using the Lip Trainer, The Patakara 'Registered Trademark' (DENTAL YOUME , Tokyo Japan), will improve labial closure force through strengthening of the orbicularis oris (lip muscle), and will reduce snoring and sleep apnea resulting in improved sleep quality.

  • A prospective, multi-centre randomised comparative study of implant fit, clinical outcomes and satisfaction with the Stryker Accolade II Hip Stem compared to the Corail Hip Stem

    This study is a prospective, multi-centre, randomised clinical study comparing the preoperative radiographic plan to the intra-operative femoral stem sizing, and assessing post-operative fit, clinical and satisfaction outcomes. The study will be conducted in patients with Non-inflammatory Degenerative Joint Disease. In addition, a substudy is running in NZ to evaluate the differences in peri-prosthetic bone remodelling post hip replacement in 3 different femoral component implants. The Lunar iDXA (GE Healthcare, Madison, WI) densitometer is a Food and Drug Administration (FDA) - approved device for measuring BMD and body composition. The relationship between bone loss, patient functional outcome and implant survival across the 3 femoral stems will also be investigated.

  • An Australian study evaluating a specialised blood collection drape to improve midwives' estimation of blood loss during labour.

    This pilot study aims to determine the accuracy of midwives' third stage labour blood loss estimations and the feasibility of a using a calibrated blood collection drape to measure third stage blood loss in the Australian setting. Australian clinicians tend to estimate third stage blood loss using visual estimation, which underestimates blood loss. Third stage blood loss, postpartum haemorrhage (PPH) and associated anaemia significantly contributes to serious postnatal health complications and maternal mortality. In Australia, PPH occurs in 6.8-9.2% of all births, with variation between states. However, Australian and overseas data has shown a trend increase in PPH and associated morbidity which have triggered a call for further research and improved management of the third stage of labour. One area that needs further research is blood loss estimation accuracy, as visual estimation of third stage blood loss leads to an under-diagnosis of PPH and poor identification of women at risk of complications from anaemia. Overseas researchers have piloted blood collection drapes, which have been found to be accurate for measuring third stage blood loss when compared to visual methods. No studies of the acceptability of these drapes have been conducted and they are untested in Australia. Furthermore, accuracy of Australian clinicians’ visual estimations has not been tested in the clinical setting. This study will compare the mean difference between clinician's visual estimation of third stage blood loss to third stage blood loss measured in a calibrated blood collection drape. Clinican's attitudes towards visual blood estimation and the acceptability of the drape will be surveyed. A cost benefit analysis will also be conducted. The results from this pilot study will inform the design of a multi-centre study involving a larger number of participants.

  • Cocoa for cognitive function, mood and cardiovascular function: acute and cumulative effect in younger adults.

    Study aims to investigate the effects of acute and cumulative doses of high-flavanol cocoa on cognitive function, mood, and cardiovascular health in a group of healthy younger adults.

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