ANZCTR search results

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

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31330 results sorted by trial registration date.
  • Occupational and symptom outcomes of combining vocational rehabilitation and cognitive remediation in people with schizophrenia

    Despite improvements in treatments and psychosocial interventions, workforce participation by people with psychotic illness remains low. In Australia, nearly 90% of people with psychotic illnesses receive income through government benefits and less than one third participate in paid employment. Unemployment rates for people with psychotic illness are five times greater than those in the general population. Work is highly valued and has many beneficial effects for people with schizophrenia. Some studies suggest that stability of work may reduce psychiatric hospitalisation. Increased productivity and reduction in hospitalisation has potential to reduce healthcare costs associated with these conditions. Individual Placement and Support programmes have been shown to improve job placement, hours worked and job retention for people with severe mental illnesses, however a significant proportion of those accessing this intervention still do not achieve employment. IPS services were established at various South and North Metropolitan Health sites though partnerships with DES providers since 2013. Cognitive and functional deficits are prevalent among people with psychotic illness such as schizophrenia and robust links between cognitive deficits (CD) and poor community functioning have been consistently demonstrated. Recently, neuroplasticity based cognitive training (CT) has shown promising results in people with schizophrenia. However, the effectiveness of CT to improve employment outcomes among these people has not been well researched. It is unclear whether CT would lead to improved occupational functioning and employment outcomes when offered as adjunctive therapy to IPS participation. We plan to evaluate whether delivering IPS and CT programmes in an integrated manner will further improve cognition, work and other functional outcomes over a one year period in people with schizophrenia. Further, we will ascertain whether these improvements translate into reduced need for psychiatric hospitalisation. We aim to recruit 80 adult patients with schizophrenia who are involved with the IPS programmes at 4 metropolitan sites for the study: Bentley Health Service; Peel and Rockingham Kwinana Mental Health Service; Osborne Community Mental Health Service and Swan Community Mental Health Service. Participants will be randomly allocated to 2 groups; one group will receive IPS service without CT and the second group will receive IPS and 40 hours of computer based CT using BrainHQ software. Socio-demographic data, clinical and work history, symptoms (psychotic, negative, depressive and anxiety), cognition and community functioning will be evaluated at baseline, after CT (or 8-10 weeks for the non-CT group) and 12 months after interventions in both groups. Similarly, occupational outcomes such as number of competitive jobs obtained, days worked and pay rates and healthcare expenses such as number and days of psychiatric hospitalisation in the 12 month period will be assessed in both groups. Between groups differences for continuously distributed variables will be assessed using independent samples t-test or analysis of covariance. Ordinal and nominal data will be treated using non-parametric procedures. The health economist involved with this study will calculate governmental cost savings by calculating expenses and savings through reduced psychiatric hospitalisation and extrapolating these figures to patients with schizophrenia cared for by WA Health. Productivity gains will also be calculated separately. If we find that integrating CT and IPS have promising benefits, we plan to embark on a study with larger sample size and longer follow up periods accessing national funding sources and advocate for the implementation of these programmes into evidence based clinical practice for people with schizophrenia.

  • A pilot study of a novel Sternal Protection Device to evaluate its safety in 12 patients requiring a cardiothoracic surgery

    The purpose of this first in-man, non-comparative study, is to evaluate the safety of the novel Sternal Protection Device developed by Protego Medical Pty Ltd during cardiac surgeries that require median sternotomy. The device has two identical components, each one will be placed over a hemi-sternal section after the median sternotomy incision but prior to insertion of the Internal Mammary Artery or sternal retractor. The device will kept in situ during the procedure and removed immediately prior to sternal closure. This will be conducted at the Alfred Hospital in just 12 patients. The other objectives of the study are evaluation of ability of this device to protect the sternum from trauma and bleeding, and its ease of use during the surgery.

  • Improving translation of intensity and quality of upper limb rehabilitation provided by occupational therapists to children with cerebral palsy

    Congenital hemiplegia occurs in over 1 million children under 21 years of age in the industrialized world and is the most common type of cerebral palsy. Children with unilateral cerebral palsy (CP) usually present with greater upper limb (UL) than lower limb impairment, which impacts on daily independence, societal participation and vocational aspirations. Contemporary rehabilitation approaches for which there is strong evidence (e.g. constraint induced movement therapy (CIMT), intensive bimanual training, task-oriented training) have been developed based on motor learning theory and neuroscientific research which has increased our understanding of the mechanisms of use dependent neuroplasticity. Essential elements of contemporary approaches include therapy that uses; (1) intensive structured task repetition; (2) progressive incremental challenges of increasing difficulty; (3) goal-directed framework that is self-motivating. All these components are crucial, as intensity of intervention alone, without being goal directed and structured is not efficacious. Recent surveys of paediatric therapists indicate that: (1) traditional neurodevelopmental treatment approaches remain commonly used as standard clinical practice, despite a lack of evidence of efficacy; (ii) collaborative goal setting does not often occur with patients; (iii) contemporary motor learning approaches are not often used; and (iv) objective measurement of treatment outcomes is infrequent. A tailored multi-faceted implementation strategy (using file audit and feedback, barrier identification and interactive training targeting barriers) was piloted with 9 occupational therapists from three paediatric teams and found promising changes in clinical practice behaviour including: (i) greater measurement of goals before (+17%) and after 15 (+22%) therapy; use of constraint therapy (+38%), bimanual therapy (+26%), home programs 16 (+14%); measurement of UL outcomes before (+29%) and after (+23%) therapy. Children receiving the target dose of therapy increased from 0 to 10%. A cluster randomised trial will now be conducted to compare this tailored multi-faceted implementation strategy to a single faceted strategy alone (audit and feedback). Geographical regions (n=4 regions; 36 therapists) will be randomised to receive either the multi-faceted or single faceted implementation strategy. We aim to recruit 40 children with unilateral cerebral palsy seen by participating therapists. The outcomes of the study will be assessed at the level of the therapist against 5 key evidence criteria: (1) were goals set collaboratively with patients/families; (2) were goals measured objectively before and after an episode of care; (3) was a contemporary motor learning approach used; (4) was a target dose of therapy provided (min 30 hours); (5) were upper limb outcomes measured objectively before and after a therapy episode of care. Patient outcomes include goal attainment and change in upper limb function.

  • Impact of obstructive sleep apnea treatment in patients with atrial fibrillation having ablation: a randomised controlled trial.

    There are multiple small observational studies suggesting that treatment of sleep apnoea has beneficial anti-arrhythmic effects on arrhythmia recurrence in patients with atrial fibrillation. In this study we want to evaluate the impact of obstructive sleep apnoea treatment with continuous positive airway pressure on AF ablation outcomes. We hypothesise that treatment of OSA will improve ablation outcomes.

  • Paediatric-to-adult transition and medication adherence in patients with inflammatory bowel disease

    Psychological factors are important in medication adherence. Interventions geared towards education may help facilitate adherence. Two questionnaires were administered to screen IBD patients. The Medication Adherence Rating Scale (MARS) questionnaire screened for non-adherence and consisted of four questions on a Likert-type scale he Beliefs about Medications Questionnaire (BMQ) addressed necessity and concerns. The BMQ consisted of ten questions on a 5-point Likert scale The first five questions addressed patient necessity towards medications and the last five questions addressed patient concerns regarding medications totalling a maximum of 25 points per domain. High necessity and concerns was determined with a score of >15/25 in each corresponding domain. Patients with MARS scores below 17 were classified as non-adherers and were offered a structured personalised counselling session with an IBD pharmacist addressing misperceptions, concerns, risk and other queries. Adherers were recruited as controls. All patients were followed up with the MARS and BMQ questionnaire at 6 months after baseline questionnaires. The primary outcome was adherence measured by the MARS score. Secondary outcomes were medication necessity and concerns

  • Comparison of upper airway properties during dexmedetomidine and propofol sedation

    Dexmedetomidine is increasingly used for procedural and intensive care unit sedation. This growing popularity is based on the belief that it has relatively little impact on both ventilatory drive and upper airway collapsibility, in contrast to benzodiazepines and propofol, which are known to depress ventilation and predispose to upper airway obstruction. However, we have preliminary data demonstrating that, at similar levels of sedation, the degree of upper airway collapsibility observed with dexmedetomidine is similar to that with propofol. Formal evaluation is now required. This study will compare the effects of dexmedetomidine and propofol on upper airway function in healthy people. Information gained from this study will improve our understanding of the effects of dexmedetomidine and its safe use for procedural and intensive care unit sedation Aim: To compare the degree of upper airway collapsibility and mechanisms underlying it during light and deep levels of dexmedetomidine and propofol sedation in healthy individuals Hypothesis: Upper airway collapsibility will increase with increasing depth of sedation but will be similar at comparable depths of dexmedetomidine and propofol sedation.

  • A study comparing the blood levels of two trastuzumab formulations given as a single dose in healthy adult males.

    The primary purpose of this study is to compare two formulations of trastuzumab to determine whether a new formulation produces similar blood levels to the current product. Who is it for? You may be eligible to participate in this study if you are a healthy male, aged 18 to 55, with a BMI of 18-30 and body weight of 50-100kg. Study details Participants enrolled in this trial will be randomly allocated (by chance) to receive a single dose of either the existing formulation of trastuzumab (known as Herceptin), or the new formulation of trastuzumab. After the single dose has been administered, blood samples will be taken [at the end of infusion and at 0.5, 1 6, 24, 48, 72, 96 and 168 hours and at Days 15, 22, 29, 36, 50, 64 and 78], to check the concentration of the drug in the blood over time. Researchers will also monitor participants for side effects e.g. by physical examination etc, until Day 78. It is hoped that the findings of this study will provide information on whether the new formulation of trastuzumab is equivalent to the existing formulation in the manner in which it is moved through and absorbed by the body.

  • Allostasis and Sedation Practices in the Critically Ill

    The survival of an organism in the face of internal and external events requires a measured and appropriate stress response. Recent strands of evidence suggest that an abnormal stress response is linked to the likelihood of the development and severity of critical illness and multi-organ failure. The stress response is coordinated by primitive brain structures in response to sensory inputs and comprises a broad range of effects. We hypothesise that the use of sedating medications confuses the normal generation of a stress response. If this is confirmed, this may be a fundamental underlying cause for the abnormal physiology, metabolic disturbances and organ dysfunction observed in critical illness. The current large multi-centre randomised-controlled Sedation Practices in Intensive Care Evaluation III (SPICE-III) study, in offers the opportunity to study two similar groups of patients who may have differing levels of physiological stress as a result of an Early Goal-Directed Sedation (EGDS) strategy as compared to standard care. The proposed observational study, to be conducted at Nambour Hospital, aims to provide the investigators with pilot data to determine the optimum timing of sampling for a stress panel and to conduct a statistical plan for a randomised–controlled sub-study of the larger SPICE-III study.

  • Travel for trials: Examining cancer patients’ willingness to travel to participate in a clinical trial

    This study aims to determine, using a discrete choice experiment survey, the willingness of cancer patients to participate in a clinical trial, including travel, change in provider and type of clinical trial. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have a diagnosis of cancer for which you are attending a cancer clinic. Study details All participants in this study will be asked to complete a brief survey either online or using paper and pen, at the oncology clinic or at home at a later time. It will take approximately 10 minutes to complete. It asks questions about demographics, cancer diagnosis, treatment, and about preferences when considering a clinical trial. This will take the form of a discrete choice experiment, with ten scenarios per questionnaire. Participants will be asked to state whether they would join a clinical trial or continue with standard care, given the scenario presented. This study will provide useful information on how willing cancer patients are to travel, or to be referred to a different centre to participate in a clinical trial.

  • Don’t let alcohol be in control! Can we teach adolescents to gain control over alcohol-related impulses and thoughts?

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