ANZCTR search results

The purpose of this study is to investigate the effect that the McKenzie method or lower abdominal exercises have on the thickness of the lower abdominal muscles in patients who have chronic low back pain when measured from images taken from real time ultrasound scans. We believe that patients who receive specific lower abdominal exercises will show an increase in thickness of these muscles while those who receive the McKenzie method will not show any thickening of these muscles, while pain and disability will improve similarly in both groups.

Childhood mental health problems are highly prevalent, experienced by one in five children living in low socioeconomic families. Although childcare settings, including family day care are ideal to promote children’s social and emotional wellbeing at a population level in a sustainable way, family day care educators receive limited training in promoting children’s mental health. This study is an exploratory wait-list control cluster randomised controlled trial to test the appropriateness, acceptability, cost, and effectiveness of “Thrive,” an intervention program to build the capacity of Family Day Care educators to promote children’s social and emotional wellbeing. Thrive aims to increase educators’ knowledge, confidence and skills in promoting children’s social and emotional wellbeing. A capacity building intervention in child mental health promotion for Family Day Care is an essential contribution to research, policy and practice. This initiative is the first internationally, and essential in building an evidence base of interventions in this extremely policy-timely setting.

A prospective, randomised, open-label, blinded endpoint phase II trial to test the hypothesis that anterior circulation ischaemic stroke patients, selected with “dual target” vessel occlusion and CT or MRI mismatch within 4.5 hours of onset will have improved reperfusion and early neurological improvement when treated with intra-arterial clot retrieval (Solitaire device) after intravenous tPA, compared to intravenous tPA alone. Planned recruitment of 100 patients, randomised 50:50 at approximately 12 centres in Australia and New Zealand.

This randomised controlled trial (RCT) will assess the effectiveness of an SMS reminder and home-based self-collected samples (home group) to increase the proportion of patients re-tested after a chlamydia infection, compared to an SMS reminder and clinic testing (clinic group). Approximately 600 patients diagnosed with chlamydia across two sexual health clinics will be randomised to the home group or the clinic group. In the home group, patients will receive a ‘collection kit’ containing the collection device, instructions, request form and pre-paid envelope. Three months after the intial diagnosis the clinic will send an SMS reminder to encourage the patient to collect a sample using the collection kit and mail it to the lab or return to the clinic for re-testing if they prefer. Patients randomised to the clinic group will receive an SMS reminder at three months following diagnosis to encourage the patient to return to the clinic for re-testing. At 4 and 5 months after the initial diagnosis, patients will be requested by SMS to complete an online questionnaire to assess the acceptability of home testing, re-testing elsewhere, re-testing barriers and sexual behaviour. Women will also be asked about symptoms of PID. If participants record in the questionnaire that they had a chlamydia test at another clinic since their positive test, or if women report attending another clinic with symptoms of PID, then the researchers will seek their permission for the researchers to contact this clinic to obtain the results of this test/ relevant medical records. The study will require 12 months to complete: 6 months for recruitment and 6 months to allow time for patients to re-test and complete the online questionnaire. The primary outcome is re-testing rate within three months of chlamydia treatment.

The study is a prospective follow-up of major cardiac events in patients presenting with confirmed CHF with LVEF of 45% or less and in whom NYHA classification rest in the II or III category. Patients will follow standard management plans informed by their HF classification, LVEF and global mIBG quantitation. The proposed project would allow prospective data to be collected with follow-up to 2 years, and provide an initial validation of our proposed novel 3-D tomographic SPECT based regional quantitation of myocardial uptake and washout of 123I-mIBG against the traditional more established global approaches using planar 2-D imaging. Our assertion is that regional quantitation should provide more accurate risk stratification than the existing global approaches. This information requires up to 24 months follow-up of cardiac events in patients presenting with heart failure. A follow-up to 5 years will be undertaken. Hypothesis: 123I-mIBG SPECT provides stratification of CHF patients most likely to benefit from aggressive management, independently of LVEF. Primary Aims: 1. Determine whether 123I-mIBG is independently predictive of SCD or ICD discharge in CHF patients with LVEF less than or equal to 35%. 2. Determine whether 123I-mIBG is independently predictive of SCD in CHF patients with LVEF greater than 35%.

There is strong evidence that parents and the home learning environment are the most influential forces in shaping children’s early learning. The literature has shown family focused interventions can improve the quality of home learning environments for young children. In addition, interventions that support families to facilitate their children’s learning also enable parents to be more knowledgeable and confident in their own abilities to meet their parenting responsibilities. The purpose of this study is to develop and evaluate an evidence-based parenting program to support parents to provide an enriched home learning environment for their very young children that enhances children’s development in the first three years of life. This will be achieved through the development of a parenting program this is embedded into existing service platforms – supported playgroups and maternal and child health parent groups. The smalltalk program aims to build on existing parenting strengths and targets specific parenting skills that are known to promote child language and learning, such as quality interactions, reading at home, and play, in addition to strategies to promote parental self-care. The program will be delivered across two levels of intensity (intervention): lower intensity - a supported playgroup or parenting group that includes smalltalk parenting strategies and higher intensity - a supported playgroup or parenting group that includes smalltalk parenting strategies plus individual coaching of families in their home. The comparator group is a usual care supported playgroup or parent group that does not include any smalltalk parenting content. All families will be assessed at three time points: T1 = Baseline (before group commencement), T2 = Post (after the last group session) and T3 = Follow up (5 months after group). Each assessment will involve both a telephone interview and an in-home observation.

Older people who have just been discharged from hospital are high risk of falls and injuries such as hip fracture and are also at risk of medical complications and unplanned readmissions to hospital. Health workers have identified that better health care is urgently required for these patients. We recently conducted a large trial that identified that providing patient education reduced falls in hospital by over half in older patients with normal cognition. Therefore the aim of this research is to examine whether providing a similar patient education program for older people just before they are discharged from hospital can also reduce falls at home. This study will test the design of the discharge education. If the education successfully improves older peoples’ ability to engage in falls prevention behaviours after discharge, the researchers plan to test the education in a larger trial to directly examine its effect on falls and falls injuries. The research aims are: Evaluate the effect of providing a tailored multimedia falls prevention education program delivered by a health professional in hospital prior to discharge and in addition to usual care, on older patients’ levels of engagement in falls prevention strategies in the first month after hospital discharge.

A large part of the clinical responsibilities within the Department of Andrology involves the collection and laboratory analysis of semen samples for a wide range of clinical indications. Men usually attend the department and provide a semen sample through masturbation, which takes place in one of two designated collection rooms. The provision of erotic material (EM) in the form of soft core pornography magazines (sold freely in the community to adults) is routinely provided in each room. The practice of providing EM is universal among semen laboratories on the basis that it presumed to aid semen collection through the provision of imaginative stimulation for masturbation, which has to be performed in an unfamiliar environment unconducive to usual sexual activity. However, there is no established standard for such provision among semen laboratories; the WHO Semen Manual (5th Edition) provides guidelines for semen collection in the clinical setting but remains silent on the supply of EM as an aid to semen collection. Recent departmental discussions questioned the practice of routinely providing EM, both on aesthetic grounds as well as the legal issues of supplying prohibited material to minors attending for semen collection (for elective cryostorage prior to cancer treatment). There is also some cost incurred by the department for the replacement (EM is regularly stolen) and updating of EM. Despite the provision of EM some men remain unable to provide a semen sample for a variety of reasons. We therefore undertook a QI analysis of whether supplying EM was required for semen collection. As supplying EM is neither a proven requirement nor a regulated component of the fitout of a semen collection facility, we designed a QI study that randomised supply of such material according to the week in which men attended the laboratory i.e. collection rooms had EM insitu on alternate weeks only. As a variation of the nonstandardised physical facilities provided in the collection rooms, this did not require the individual consent of the men attending the laboratory. This QI study is well advanced, but not yet completed. We are now proposing to extend that QI analysis into a formal RCT to evaluate the impact of the requirement for written, informed consent on the outcomes of the original study question: does the requirement for fully informed, written consent influence the findings of such a study? This could be through refusing to participate, or to requesting crossover (ie requesting magazines when allocated to “nomagazine”) or more complex reasons. We are therefore now planning an extension to the original QI study but with the added requirement for informed, written consent. This extension study would address the original questions (how frequently do men fail to provide a semen sample with or without magazines available?) in a different framework as well as allowing the rare opportunity to determine whether the requirement for informed consent procedures, in themselves, influence the outcome of a study.

This study is a randomised clinical trial designed to evaluate the clinical benefits of two child-focused feeding intervention programs for children with feeding difficulties and restricted range of dietary intake. Baseline assessments will include parent-completed questionnaires, on-site assessment, and feeding and growth evaluations. After assessment, participants will be randomised into one of two intervention arms. Arm One is an individual operant conditioning program. Arm Two involves systematic desensitisation therapy. Although dose of intervention will be the same (10 sessions), intervention will either be provided in a weekly (once/ week for 10 weeks), or intensive format (all 10 sessions within a week). Parents will be able to choose between weekly or intensive therapy. Some outcome measures will be reviewed immediately post-treatment, and the participants will return for a full evaluation at 3-months post treatment.

This study aims to identify whether there is a difference in the micromotion of the Accolade II(R) cementless femoral stem between 6 months post-surgery and 2 years post-surgery, providing an indication of long-term fixation. Functional outcomes, pain and quality of life will also be assessed. This study is a prospective observational case series being performed at a single study centre. One Principle Investigator will perform all surgery for this study.