ANZCTR search results

The study aims to prevent the development of child externalizing behaviour problems (eg aggression, oppositional defiance) by offering parents anticipatory guidance on how to effectively manage toddler behaviour. Up to 20% of Australian children aged 4 to 16 years experience significant behaviour problems and only ¼ of these receive professional help. Treating established problems is time and cost intensive and so a prevention approach is required. This community-based study will assess the effectiveness of a parenting program designed to promote warm and appropriate parenting, and to offer alternatives to harsh, punitive parenting (known to contribute to externalising problems). MCH nurses deliver the program. It is the first study of its kind in the world to offer a universal, primary health care preventive program for externalising behaviour problems.

The purpose of this study is to test the feasibility and safety of intravenous erythropoietin (EPO) injections in patients with recent acute myocardial infarction to improve cardiac remodelling and cardiac function

This research proposes to pilot the methods for a planned randomised controlled trial (RCT) which will test the hypothesis that in-patients aged 65 years and over who are randomly allocated to be screened for nutritional status and to receive appropriate nutritional support will have fewer negative health outcomes, compared to those who receive usual practice. The pilot study will test the feasibility of a multi-disciplinary nutritional support intervention for the population of older people who are at high risk of malnutrition and associated adverse health outcomes, while optimising the activities of a range of existing health services and patient support approaches. This study will implement a simple and efficient form of nutrition screening for men and women aged 65 years and over, who are admitted to the John Hunter Hospital in Newcastle, NSW. Consenting patients will be screened for under-nutrition using the Malnutrition Screening Tool by a Research Assistant who will remain blind to patient study status. Patients will then be randomly allocated, by a data manager, to either the control group, who will receive usual care for their presenting problem, or to the intervention. Patients within the intervention component of the study will be reviewed by a dedicated Nutrition Support Person employed by the study. “Best practice” nutritional care for these patients will be based on the recent Clinical Standards for Food, Fluid and Nutritional Care in Hospitals from Scotland. It is expected that patients will not know which condition they are randomized to, as the intervention is designed to fit seamlessly within normal hospital practice and routines. Follow-up data collection will occur at 6 months post-discharge, and will be conducted by the same Research Assistant as conducted baseline data collection, who will remain blind to patient study status. The main outcomes measures for the pilot will be a change in nutrition status from recruitment to follow-up using the Patient Generated SGA (PG-SGA), and Lean Body Mass. The findings from this study will provide a test of the feasibility of the RCT, which it is hoped will provide a much needed basis for targeting nutritional assessment and services in a growing population of older people, and would be expected to have a major impact on enhancing recovery and quality of life, and reducing length of stay and readmission for those people involved in the intervention component.

To assess if dipyridamole reduces the frequency of angina in patient with CSFP. Study pharmacist was the only person unblinded to study treatment. Blinding was achieved by using pre numbered study drug containers and by fax randomisation to study pharmacist who would then allocate the study drug to the patient who is also blinded

The purpose of this project is to investigate the effectiveness of physiotherapy treatment interventions aimed at improving ability to walk safely outdoors following stroke. This project is a pilot study that will compare the effectiveness of two physiotherapy interventions for regaining the ability to walk outdoors. The structured task practice is an evidence based approach focusing on repeated practice of the different tasks involved in walking outdoors, such as walking on slopes and crossing gutters. The alternative interventions are based on the Bobath Concept, a treatment approach that focuses on the development of postural stability to improve balance and walking function. Participants for the pilot study will be sought from patients who are currently undergoing rehabilitation (either inpatient or outpatient) following stroke and who have recently achieved the ability to walk with supervision indoors. Thirty participants will be recruited for the pilot study. Participants will have baseline assessments including the adapted six minute walk test, their walking velocity (over the central 6 metres of a 10 metre track), the time taken to ascend and descend a flight of stairs and scores on the Berg Balance Scale (an ordinal scale assessing ability to perform 14 balance tasks) by a blind assessor. Participants will be randomised to either of the two interventions. Patients are blinded to which group they have been randomised. Both interventions will require the participant to attend six one hour physiotherapy sessions over a two week period. In the structured task practice intervention, participants will practice activities such as walking on slopes, going up and down a single step, and walking on uneven ground. In the Bobath Concept intervention, the postural stability of the participant will be assessed and individualised treatment programs established, aimed at improving postural stability. These sessions will include activities in standing and walking to enhance standing balance, patterns of muscle activation and postural responses. The sessions will incorporate some task practice to a maximum of 1/6 of the treatment time. The baseline assessments will be repeated following the intervention stage.Analysis of the pilot data will enable accurate power calculations for a larger multi centre trial.

In recent years new prenatal tests have been developed and these are available earlier in pregnancy. There has also been a dramatic increase in the uptake of screening tests for women in all age groups. Peak obstetric and genetic bodies in Britain, Canada and Australia now recommend that: 1. all women pregnant be informed of, and offered screening tests for fetal abnormality and 2. women who are at an increased risk of chromosomal abnormality on the basis of their age or previously affected pregnancy should be informed of, and offerred the choice of screening or diagnostic tests. This means that an ever-increasing number of women are confronted with information that is complex and women are required to make decisions that are often difficult and confusing. To date, technological developments have not resulted in commensurate improvements in the resources available to support women faced with important decisions regarding prenatal testing. Studies from a variety of health settings such as cancer treatments and hormone replacement therapy, have demonstrated that decision support strategies such as decision aids have facilitated an increase in the capacity of individuals to make an informed choice and have decreased levels of uncertainty and conflict. However, the role of decision aids in prenatal testing is not established. This trial aims to evaluate a decision aid for prenatal testing of fetal abnormalities in the Victorian primary health cre setting using a cluster randomised controlled trial. Fifty GPs will be randomly allocated to either the intervention or the control arm of the trial. GPs will recruit 10 consecutive women using pre-specified selection criteria. The primary outcomes will be the difference in the rate of informed choice and decisional conflict between the two groups assessed at 14 weeks gestation

This project will provide valuable information in relation to the feasibility of integrating supervised versus unsupervised exercise interventions into clinical practice. It will also enable a better understanding of the physical and psychosocial benefits attained and sustained through participation in the interventions in comparison to current care. The exercise physiologist will not be aware during the data collection testing phases which intervention arm the participants have been allocated to.

To assess if the early use of verapamil and Glyceryl trinitrate improves TIMI 3 flow(term used to state that blood flow through coronary artery is back to normal)Only the study pharmacist was unblinded to treatment allocation. Study drug was sealed in a box and allocated a number in lots of 10. Study staff would allocate the sealed box to the patient by number sequence. All study personel and persons involved in the clinical management of the patient were also blinded to treatment allocation.Emergency unblinding was available if required.

This study is measuring blood levels of the medication melphalan to improve the way to adjust the dose for people with myeloma. Who is it for? You can join the this study if you have myeloma (a cancer which affects plasma cells in the bone marrow) and are undergoing a bone marrow transplant. Trial details Participants will receive the drug melphalan and will be tested to see how their body breaks down and gets rid of the medication. This study does not replace other studies, but simply investigates key medication widely used in the treatment of myeloma. Participants will be followed for several years after the study to monitor their health. This study will help to define the best way to adjust doses of the drug melphalan, a key medication in helping to control myeloma. Too much causes toxicity and too little risks the disease being more likely to return.

Contracture after stroke is a condition that causes pain and disability in adults with hemiplegia after stroke. It is commonly treated by using hand splints. This trial aimed to evaluate the effect of two types of hand splints used clinically during rehabilitation to prevent contracture: a hand splint that positions the wrist in neutral and a hand splint that positions the wrist in extension. The trial’s primary hypotheses were (i) do commonly prescribed hand splints prevent contracture in people with hemiplegia after stroke, and (ii) do commonly prescribed hand splints improve function, and reduce pain and/or spasticity in people with hemiplegia following stroke. The trial assessed changes in outcomes at four weeks (following removal of splints) and at six weeks (follow-up). All outcomes were measured by a research assistant blind to treatment group allocation.