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Water-based exercise training in people with stable coronary heart disease- Study B
Expand descriptionAims: The aim of this project is to assess the effects of water-based exercise training in people with stable heart disease. This study is being conducted in conjunction with an acute study assessing the physiological effects of a single submerged session compared to a single session of matched intensity land-based exercise. Justification: Exercise is an important component of rehabilitation and preventing recurrent heart problems in people with heart disease. However, exercise participation is sub-optimal in this population and increasing the range of exercise options for people with heart disease may increase exercise participation. For example, water-based exercise may be more appealing to people with heart disease who have other health issues, such as arthritis or obesity, which may make land-based exercise difficult or painful. Furthermore, preliminary research suggests that water-based exercise may have additional vascular and brain benefits due to the effects of water immersion on blood flow. However, this has not previously been investigated in people with heart disease. Participants: Patients who have had a heart attack or bypass surgery at least six months prior to enrolment, or documented blockages in the arteries of their heart based on the results of an angiogram (a scan of the heart) will be recruited to the study. Participants must be medically stable prior to participation and not be undertaking a formal exercise program. Design and methods: 60 participants will be randomised into one of three groups for the duration of a 12 week program: *12 weeks of land-based exercise * 12 weeks of water-based exercise * A control group who will maintain their usual activities for 12 weeks. Strength, fitness, vascular function, brain blood flow, body composition, blood profiles and aspects of cognition will be assessed before and after the 12 week period. Vascular function will be assessed fortnightly during the 12 week period in a subgroup of participants.
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Expansion, evaluation and sustainability of a new paediatric weight management service
Expand descriptionThis pragmatic research project aims to expand and evaluate a recently established paediatric multidisciplinary weight management service and investigate, develop and support proposals for ongoing sustainability. This service focuses on the treatment and management of obesity in children and adolescents, and is being disseminated under real-world conditions by specialist clinicians at the Lady Cilento Children's Hospital in Brisbane, Queensland. It is anticipated that this dedicated, multidisciplinary tertiary clinic for children who are overweight and obese will improve measures of body composition, anthropometric measures, nutritional intake, self-reported physical activity, and health-related quality of life over an intensive four month management period, with positive outcomes maintained at 6 months, 12 months and 24 months. Patient satisfaction with the service is anticipated to be both positive and constructive. This model of service will also be transferable to other non-tertiary hospital sites, to help in continuing to improve the health and well-being of children, adolescents and their families. Evaluation of the model will also ensure its sustainability
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ART & DEMENTIA: Does an art program enhance wellbeing and markers of neuroplasticity in people with dementia?
Expand descriptionThe study is a pilot randomised proof-of-concept trial that aims to identify potential cognitive markers by utilising a 10-week social and creative, gallery-facilitated "Art & Dementia" program to examine its relationship with memory and learning tasks in adults with dementia. Specifically, we hope to ascertain whether: a) there are clinical predictors of benefit associated with an art program, b) there is improvement in visuospatial cognitive skills associated with an art program, and c) an art program is associated with improved wellbeing and reduced carer burden. We will compare the efficacy of this program to a waitlist group.
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Staged Treatment in Early Psychosis (STEP): A sequential multistage randomized clinical trial (SMART) of interventions for Ultra High Risk (UHR) of psychosis patients.
Expand descriptionPsychotic illnesses usually first emerge in young people and result in widespread suffering, protracted disability, premature death, and a huge economic burden. Early intervention represents a vital strategy to reduce this burden. Psychotic disorders are preceded by a prodromal period of distress, impaired functioning and subthreshold psychosis. Although the evidence from 11 Randomised Controlled Trials indicates that interventions can reduce the risk of transition to psychotic disorders by more than 50%, clinicians remain unclear how to select the best sequence of treatments to prevent progression and maximize recovery. This research will conduct a sequential multistage randomized clinical trial to build individualised “adaptive” treatment strategies to reduce the risks for a range of outcomes. Ultra high risk of psychosis participants will be recruited from Orygen Youth Health and four ‘headspace’ youth mental health services. The ‘headspace’ youth mental health service has already delivered care to over 100,000 young people with emerging mental disorders, of whom 40% are considered as having an ultra high risk of developing psychosis. Orygen is Australia’s largest mental health research facility, and specialises in early intervention in young people. The main aim of this study’s sequential multi-stage design is intended to produce evidence to guide a stepwise clinical approach to treatment of ultra high risk of psychosis patients and reduction of risk for psychosis and other deleterious clinical and/or functional outcomes.
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The effect of dexmedetomidine given as a premedication or intraoperatively on post-hospitalisation behavioural change in children: a randomised controlled trial
Expand descriptionThe aim of this project is to assess whether the administration of dexmedetomidine either before or during a child's operation affects the incidence of post-hospitalisation behavioural change (PHBC). It has been reported that PHBC occurs in over 50% of children undergoing a general anaesthetic(1) and manifests as behaviours such as sleep and eating disorders, defiance of authority, nightmares, enuresis and temper tantrums. The effect is usually short-lived, however in 5-10% of children these behaviours can last up to 12 months. The risk factors for developing PHBC include underlying anxiety in the child or parent, a traumatic experience at induction of anaesthesia, emergence delirium and pre-school age. A recent meta-analysis of alpha-2 agonists found that they effectively reduce the incidence of emergence delirium but none of the studies looked at longer term outcomes (2). This study aims to answer the question of whether dexmedetomidine, an alpha-2 agonist, can reduce the incidence of PHBC. Pre-school age children requiring general anaesthesia for common day-case procedures will be randomly assigned to one of three groups: A dexmedetomidne pre-medication group, an intraoperative dexmedetomidine group and a control group. Baseline anxiety levels of the child and parents will be recorded using validated tools and the anxiety of the child during induction of anaesthesia will also be recorded. The primary outcome will be maladaptive behaviours after hospitalisation and these will be measured using the Post Hospitalisation Behaviour Questionnaire for Ambulatory Surgery (PHBQ-AS) and the Strengths and Difficulties Questionnaire (SDQ). These questionnaires on children's behaviour will be administered to the parents by a blinded researcher at day 3, 14 and 28 post surgery. 1. Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children:Predictors and outcomes. Arch Pediatr Adolesc Med. 1996; 150:1238-45. 2. Pickard A, Davies P, Birnie K, Beringer R. Systematic review and meta-analysis of the effect of intraoperative a2-adrenergic agonists on postoperative behaviour in children. BJA. 2014; 112(6):982-90.
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Long term impact of targeted drug counselling intervention on medication adherence in Inflammatory Bowel Disease patients
Expand descriptionPsychological factors are often underrepresented although important in medication adherence. Interventions geared towards education may help facilate 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. The 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 on a three-monthly basis for a maximum of two years or until the study period had elapsed. The primary outcome was adherence measured by the MARS score. Secondary outcomes were medication necessity, concerns and acceptance. Medication acceptance was defined as high necessity >15/25 and low concerns score <16/25.
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A single dose, randomised, double-blind, placebo-controlled, dose escalation study to evaluate the safety, pharmacokinetics and pharmacodynamics of M012 administered by subcutaneous injection to healthy male volunteers
Expand descriptionThis research project is testing the safety, tolerability and pharmacokinetics (looking at the amount of drug in your blood to evaluate the way the body processes the drug), pharmacodynamics (the response of your body to the drug) and immunogenicity (your immune response to the drug) of a new drug called M012 when it is given as a single dose. M012 is an injection into the skin of your abdomen to be administered by a trained professional.
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Occupational and symptom outcomes of combining vocational rehabilitation and cognitive remediation in people with schizophrenia
Expand descriptionDespite 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.
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A pilot study of a novel Sternal Protection Device to evaluate its safety in 12 patients requiring a cardiothoracic surgery
Expand descriptionThe 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.
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Improving translation of intensity and quality of upper limb rehabilitation provided by occupational therapists to children with cerebral palsy
Expand descriptionCongenital 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.