ANZCTR search results

This study will follow-up drivers who have a diagnosis of dementia for a period of 2 years - which is the period after diagnosis in which many people with dementia stop driving. The primary objective is to identify the factors which are associated with participants deciding to give up driving and also to record how both the participant and the carers feel about the changes in the participants driving over the two year period following a diagnosis of dementia or Alzheimer’s disease.

Diaphragmatic dysfunction (DD) represents an important clinical problem after lung transplant and has a considerable influence on respiratory function and recovery. It frequently results in longer time on the ventilator; longer time in Intensive Care and longer time in hospital, which as a result may lead to further muscle weakness. The incidence of diaphragmatic dysfunction following lung transplant surgery has been estimated at more than 40 per cent. There is little documentation in the literature regarding the natural history and prognosis of diaphragmatic dysfunction in these patients. Ultrasound has been used to identify severe diaphragmatic dysfunction after heart surgery (Lerolle et al., 2009). Bedside ultrasound has been shown to be accurate for the assessment of diaphragmatic dysfunction in patients after heart surgery (Sanchez de Toledo et al., 2010). This assessment can be performed at the bedside and avoids the exposure to radiation. By documenting the incidence and extent of this problem, we hope to identify risk factors for diaphragm dysfunction and determine if any of these are preventable with future studies. Patients will be identified from the active lung transplant waiting list and approached for enrolment when they attend their routine heart-lung clinic appointments, or scheduled assessments. Protocolised diaphragm ultrasound assessments will occur whilst on active list, in Intensive Care on day 1 after transplant, in hospital in week 1, in hospital/heart-lung clinic at one month and three months post lung transplant. Measurements of diaphragm excursion (descent) and thickness will be taken at each assessment.

Acute post partum anaemia is a common complication of pregnancy. It is principally iron deficient and is largely predicted by blood loss >1000mL. Ten percent of women with post partum anaemia develop severe anaemia (haemoglobin Hb<8g/dL) and this is associated with significant lethargy, fatigue and poor concentration which impair women from being able to care for their newborn and place them at increased risk of post natal depression. Current management of hemodynamically stable women with acute post partum anaemia is highly variable. Most clinicians opt to administer multiple red blood cell (RBC) transfusions to correct symptoms and restore Hb. No guideline or consensus exists to inform clinicians exactly when to transfuse women and the inherent risks associated with RBC transfusion, including life threatening adverse reactions, infection and thromboembolism, warrant investigation into alternative therapies. Currently, intravenous iron has been proposed as one alternative therapy to RBC transfusion in selected women though the comparative clinical efficacy and safety of this method has not yet been evaluated. Our study aims to compare intravenous iron polymaltose with RBC transfusion in women who sustain peri-partum blood loss >1000mL with resultant Hb 5.5-8.9g/dL after stabilisation and are symptomatic for anaemia. The study will employ an open label randomised design and be carried out at Westmead Hospital. Primary outcomes will measure Hb, CRP and ferritin levels at Day 7. Secondary outcome will measure Hb ferritin and CRP levels at Day 14 & 28 as well as improvement in anaemia symptoms as measured by Health Related Quality of Life (HRQoL) questionnaires at the same time points.. Treatment safety will also be compared between the groups by looking at incidence and severity of adverse events including infection. All women with blood loss >1000mL will be identified by Obstetrix, the mandatory hospital record. Once stabilised, these women will be consented by the study researcher and baseline bloods (Hb, reticulocytes count and ferritin) and symptom data will be collected. Women with resultant Hb 5.5-8.9g/dL who remain clinically stable but symptomatic will then be randomised to receive either RBC or intravenous iron polymaltose All adverse reactions will be recorded during and immediately after treatment and again by telephone at Day 1 and 2. Participants will then be reviewed by a midwife or doctor on Day 7, Day 14 and Day 28 where they will have repeat bloods. repeat symptom scores and clinical assessment for infection. Outcomes between treatment groups will then be compared and statistically analysed.

This study was designed to conduct an equivalence experimental trial adopting a randomized control design. The participants will be individually randomized to three independent groups, email or postal or telephone. Number of respondents required in each group is 229 and total number required n=687. The study was designed with overall aim to conduct a effectiveness analysis of three different methods of data collection; email, postal and telephone. The primary outcome of interest will be effective successful follow up. Effective successful follow up is defined as providing a response to each of the 26 questions in the survey. A valid response might be that the patient declines to answer a question and secondary objectives are to: a. Estimate recurrent costs of data collection using telephone, postal services/mail and electronic mail (email) for PROMs data in PCOR-VIC b.Compare the cost-effectiveness of the three different methods of data collection. c. Develop a cost projection model to estimate the cost for nation-wide scale-up of administering the PROMs data collection tool in the most efficient setting for follow up of prostate cancer patients in Australia. To collect costing data ABC (Activity Based Costs) method will be adopted and data will be collected through structured questionnaire. Cost data will be collected from provider perspective. A model will be developed based on most cost-effectiveness approach to determine the cost for national scale up. The main outcome of interest will be effective successful follow up. Secondary outcome measures will also include time to complete an effective follow up and direct costing associated with an effective follow up. This study will provide an opportunity to identify the most cost-effective approach for completed follow up of prostate cancer patients by using EPIC-26 tool. This will be important for many registries which are currently collecting data from patients. Moreover, we expect that the findings of this study will help us to understand the cost for national scale up.

Deep brain stimulation (DBS) is an established treatment for people with Parkinson's disease and other movement disorders whose symptoms are resistant to drug therapy alone. DBS uses electrical pulses applied to target regions of the brain (e.g. the subthalamic nucleus) to reduce symptoms such as tremor, rigidity and reduced movement at will. Standard DBS treatment is performed in an ‘open-loop’ fashion, where stimulation is continuously applied regardless of presenting symptoms. This leads to periods of unnecessary or inappropriate stimulation that can cause side effects, for example slurring speech, and limit battery life of the generator of the stimulation (or "pacemaker") thus decreasing efficiency of the device and treatment. These issues may be overcome by using 'closed-loop' stimulation, in which stimulation is only applied when symptoms indicate it is necessary. This study aims to identify in the brain suitable markers or measurable characteristics that we can then use to optimise stimulation. In particular we wish to evaluate closed-loop stimulation in participants with temporarily 'externalised' electrode leads. Externalising electrode leads is an established clinical practice involving a delay (typically 5-6 days) between implantation of the deep brain electrodes and implantation of the pacemaker. During this time an external connection to the electrodes is available, which can be used for stimulation and recording using equipment that is more flexible than standard implantable pacemakers. An externalisation period is also possible during routine follow-up surgical procedures, such as implanted pacemaker battery replacement. It is intended that approximately 30 participants will be studied in Melbourne and Brisbane. Experimental sessions will be scheduled twice per day over the externalisation period, depending on each participant’s condition. Within each day, sessions will be conducted both off and on medications. During sessions, objective measures of participant symptoms will be recorded along with conventional clinical assessments (e.g. the Unified Parkinson's Disease Rating Scale). Additionally, brain electrical activity will be recorded for use in deriving suitable markers or measurable characteristics. Comparisons will be made between different pacemaker stimulation patterns within a participant. Experimental protocols standard for this type of study will be observed including blinding of assessments, randomizing the order of conditions, allowing ‘wash-out’/‘ wash-in’ periods and taking account of the possibility of an implantation ‘stun effect’ and variability in electrode positioning. Following the externalisation period, the participants prescribed DBS procedure (e.g. system implantation, battery replacement) will be completed and clinical management will proceed as usual..

Over the last several years we have been working hard to understand recovery from whiplash injuries to help develop more effective treatments. We now believe that recovery may be facilitated if we change how care is delivered soon after their whiplash injury. We now need to test this process. In this randomised trial, people with whiplash will be allocated to two different processes of care. In the first process, people with receive the treatment normally provided to individuals with a whiplash injury. In the second process, people will receive care based on a questionnaire that assesses their risk of recovery. Care will range from 1-3 sessions with their usual health care provider, to referral to a health care provider with specialist expertise in whiplash injury. This specialist provider will then undertake a more detailed assessment of physical and psychological measures. The specialist provider may either 1) continue providing people with treatment , 2) refer them back to their own health care provider with advice on their or 3) refer them to another practitioner for additional treatment. The outcomes will be assessed at the initial assessment and three follow-up assessments at: 3, 6 and 12 months after the first assessment. Health outcomes assessed will questionnaires relating to how neck pain affects daily activities and in what way neck pain affects people personally. This study will uncover the best process to help people with whiplash recover.

The primary purpose of this study is to develop and evaluate a new low literacy decision aid relating to fertility preservation for younger women with early stage breast cancer. Who is it for? You may be eligible to join this study if you are a pre-menopausal woman aged 18 to 40 years of age, who has been diagnosed with early stage breast cancer with no history of metastatic disease, and was interested in finding out more about fertility and/or fertility preservation at the time of diagnosis. Study details Participants in this study will be randomly selected (by chance) to receive either usual care or to access the decision aid website. The decision aid includes easy to understand information regarding the side effects of cancer treatments in terms of their effects on women's fertility, and options for preserving fertility to increase chances of having a baby at a later date. Participants will then be asked to fill out a questionnaire before seeing the decision aid website, and also a questionnaire regarding the choices made and the use of the decision aid after one month, 6 months and again after one year. It is hoped that the findings of this trial will provide information on how helpful fertility preservation information is to women with early stage breast cancer, and to improve access to this information by women as part of their medical care going forward.

This study will evaluate the efficacy of a psychological strength training program. The program will be designed to improve coping skills and resilience with a view to preventing Posttraumatic Stress Disorder (PTSD) in professions that are frequently exposed to trauma. The program will be delivered to fire and emergency recruits, who will then be tracked for up to 5 years to assess their exposure to potentially traumatic events, PTSD symptoms and other coping indicators.

Participants will do four weeks of 'usual' care involving daily breathing exercises (PEP) and walking, running or step ups. After 4 weeks, those who have adhered to these requirements will be randomly allocated to either continue this routine or to stop the PEP and to just continue with the walking, running or step ups for 3 months. Participants will be assessed before and after the four weeks of usual care and at the end of the three month intervention phase.

To evaluate whether the Keeping Active program is effective in achieving the key program outcomes of supporting people with intellectual disability to increase social contacts and independent participation in mainstream community activities and whether these outcomes can be achieved within available funding available through the NDIS.