ANZCTR search results

Babies with low birth weight, thinness or short body length at birth have increased risk of cardiovascular disease and Type 2 Diabetes in adult life. The foetal origins hypothesis suggests that these diseases originate through changes that the foetus makes during pregnancy when it is undernourished. These changes can permanently alter the structure and function of the developing body. Prevention of these diseases may depend on optimising foetal growth and nutrient supply to the foetus. Sleep can alter energy balance. Short sleep (<7 hrs) during pregnancy has been linked to higher rates of caesarean section, preterm birth, intrauterine growth restriction, risk of gestational diabetes mellitus and postnatal depression. No research has examined the relationship between sleep, diet and maternal child weight related outcomes or tested the benefits of increasing sleep opportunity in pregnancy. The aim of this study is to test the benefits of increasing sleep opportunity during pregnancy on maternal glucose tolerance, gestational weight gain and foetal body composition from 12 to 37 weeks gestation in a randomised controlled trial. Pregnant women booked to deliver at the Monash Medical Centre Clayton will be randomised to: (i) Intervention group: night sleep opportunity increased to 10hr time in bed, with tailored advice around sleep practices; or (ii) Control group: normal sleep patterns. After a 1week baseline period, women will be evaluated seven times during pregnancy from 12 weeks gestation (i.e. at 12,18,22,25,28,31 and 37 weeks). Sleep data will be collected using Inhome Electroencephalography Sleep Monitoring. Adherence to the intervention will be monitored through Actigraphy and sleep diaries. Glucose tolerance, gestational weight gain and foetal body composition will be measured at each visit. This is the first RCT to test the effect of increased sleep opportunity in pregnancy. Findings will provide high quality evidence for the effect of sleep in pregnancy on important prenatal predictors of maternal and child obesity, a noval insight into the feasibility of increasing sleep in pregnancy and a cost effective intervention to improve sleep practices.

Cigarette smoking produces inflammation in small airways and development of emphysema in about 20-40% of susceptible individuals. The presence of small airway pathology leads to uneven distribution of ventilation in the lungs as well as excessive airway closure which may produce excessive biomechanical stress leading to further progression of pathology. These changes produce a greater than the normal age-related rate of decline of lung function as measured by the FEV1 and this can lead to the clinical features of COPD. We hypothesise that: 1. The early pathological changes can be identified by tests derived from the multiple breath nitrogen washout (MBNW) and these tests may identify individuals at risk of developing COPD. 2. Bronchodilatation will reduce airway closure and normalise the distribution of ventilation thereby reducing biomechanical stress and may thus lead to reduction in the rate of decline of lung function. The primary objective is to asses the rate of decline of FEV1 during and at the end of a 12 month intervention with or without active study treatment. The secondary objective is to assess the change from baseline in small airway function and ventilation heterogeneity, change in FOT, and the effect of bronchodilators on spirometry, DLCO and BCSS symptoms. The study is a double-blind, placebo controlled, parallel design study comparing: 1. Umeclidinium bromide with vilanterol (Anoro) via the Ellipta dry powder inhalation device at a dose of 62.5mcg/25mcg once daily with 2. Matched placebo once daily A total of 100 participants will be randomised from four centres in NSW, Australia. Subject will attend clinic visits at screening, randomisation, 26 weeks and 52 weeks. Monthly telephone calls will be made to each participant to record adverse events, concomitant medications, adherence to medication and current smoking status. Study measurements will include spirometry pre and post bronchodilator, body plethysmography to measure lung volumes and DLCO, MBNW, FOT and BCSS symptoms. The student t-test will be used to compare the annual rate of decline of the FEV1 between the active treatment and placebo groups. Statistical methods for analysing the secondary outcomes will be by a linear regression model adjusted for baseline measurements if applicable

Synergy-enabled Spanish version of the Mental Health eClinic is a real-time primary care online clinic that offers young people immediate self-report assessment, as well as timely support and programs, via a ‘video-visit’ with a health professional that results in a share plan. By using the Internet, this online clinic aims to deliver best practice clinical services to native Spanish-speaking young people (aged 16 to 30 years) currently living in Australia. Primary objective: To naturalistically evaluate (engagement, efficacy and effectiveness) the MHeC-S. Secondary objectives: To inform the beta build of the MHeC-S (which in turn informs the original version of the MHeC); and, to evaluate social return on investment (SROI) of the MHeC-S. The study design includes three parts: 1. The naturalistic (clinical trial) evaluation wherein potential participants (n=100 young people aged 16 to 30 years; native Spanish speakers currently living in Australia; with regular access to a smartphone [iPhone or Android] and the Internet) will be given access to the MHeC-S to use of their own accord for a period of up to 30 days. Participants are then able to navigate the online clinic at their own accord, naturally engaging with the self-report assessment, dashboard of results, ‘video visit’ and recommended apps, etools and other resources. At two time points (Day 1 and Day 30) participants will be asked to complete a pre/post- questionnaire using LimeSurvey – this questionnaire will include items regarding engagement with, efficacy and effectiveness of, the MHeC-S. 2. One-on-one 90-minute user-testing sessions where young people/ supportive others and health professionals will be invited to test the MHeC-S using scenarios and lists of tasks. (n= 15) 3. A total of four (three-hour) focus groups will be conducted to explore SROI via Theory of Change (including inputs, activity, outputs, outcomes and impacts). Two focus groups will be conducted prior to the naturalistic (clinical trial) evaluation of the MHeC-S – one with young people/ supportive others and one with health professionals; and two focus groups will be conducted post the naturalistic (clinical trial) evaluation of the MHeC-S – one with young people/ supportive others and one with health professionals. (n= 15)

Does the Alexis Wound Retractor increase the risk of conjunctival contamination from blood splashes during surgery? Background: Blood splashes to the face/ eyes are a recognised risk to the surgeon and assistants Alexis retractor is commonly used during laparotomy, laparoscopic operations and caesareans Increase exposure, protect wound, reduce wound infection Concern: blood droplets spraying into the air/ face/ eyes during removal Aim: Assess whether there is an increased risk of blood splashes during operations when the Alexis retractor is used Design: Double blinded randomised trial including all abdominal operations in which Alexis retractor may be used Surgeons and assistants will wear visors Randomised to Alexis or no Alexis End point: number of blood splashes on visors Power calculations 44 in each group Aim to recruit 50 in each group

The central purpose of this research is to examine the feasibility of a self-administered mobile intervention (App) for traumatic stress in humanitarian emergencies. The intervention will be initially examined with African refugees in Australia that meet the clinical or subclinical diagnostic criteria for posttraumatic disorder (PTSD). The App was created as part of this project, and comprises of body stabilization, cognitive mindfulness and interpersonal exercises across seven blocks. Objective electrophysiological and cognitive measures have been selected to predict intervention outcome alongside clinical measures.

This is a prospective, randomised controlled trial designed to investigate the effect of a standardised Tai Chi intervention on psychological stress and cardiovascular function in patients with coronary heart disease and/or hypertension. The primary outcome will be psychosocial status of stress measured by Perceived Stress Scale 10-item (PSS-10). The secondary outcomes will include psychosocial status of anxiety measured by Zung Self-Rating Anxiety Scale (SAS), and depression measured by Beck Depression Inventory-II (BDI-II), cardiovascular function including blood pressure, heart rate, heart rate variability (HRV), blood tests (lipid and glucose profiles and C-creative protein (CRP), quality of life measured by Seattle Angina Questionnaire (SAQ), and physical fitness using the 6-Minute Walk test. Approximately 126 participants with coronary heart disease and/or hypertension will be included in this trial to participate a 24-week Tai Chi intervention, comprising of a 12-week intensive intervention and 12-week sustained intervention. This study will be conducted in Sydney, Australia and Beijing, China.

Study design: Prospective, single-centre, patient-blinded, non-randomised, clinical study. The study will enrol 80 patients over a 12-month recruitment period between three surgeons. Objectives: To determine the relationship between ambulation (daily step count) preoperatively/post-operatively and patient reported outcomes after total knee arthroplasty (TKA). To investigate if component alignment affects ambulation and clinical outcomes after TKA. To investigate if post-op ambulation after total knee replacement affects other parameters such as return to work and patient satisfaction. The study will also demonstrate safety, and equivalent clinical outcomes on pain and function to other published data. Group: Apex Total Knee Replacement (single study group) Number of subjects to be enrolled: 80 patients will be enrolled into this study. Medical Devices: The Apex Knee is intended for use as a primary total knee replacement device consisting of a femoral, tibial, tibial bearing and optional patellar component. The Vivofit is an activity tracker, a wrist-worn band that counts steps and monitors active time. Regulatory status: The Apex Knee is CE marked, TGA approved and has a rebate code on the Prostheses List. Clinical evaluations: Standard, functional parameters will be assessed pre-operatively, and post-operatively at 6 weeks, and 12 months. Patient outcome assessments: The Oxford Knee Score, The Knee Injury and Osteoarthritis Score (KOOS), Forgotten Joint Score and VAS satisfaction scale will be assessed pre-operatively, and post-operatively at 6 weeks, and 12 months. Radiographic evaluations: X-Rays will be assessed pre-operatively, post-operatively and at 12 months to evaluate femoral and tibial components coronal and saggital orientation. A CT-Scan will be performed preoperatively and at 6 weeks post-operatively to verify implant positioning axially.

Current measures of cognition utilised in rehabilitation are valuable diagnostically but often do not fully address the functional implications of cognitive deficits. One primary concern at discharge from hospital is predicting the ability of a patient to function independently or to estimate the degree of assistance required to do so. The focus of this study is on the use of the Kettle Test as a quick performance measure that is based on a complex everyday task and is designed to tap into basic and higher-level cognitive processes to predict cognitive function. The participant group would be recruited from patients participating in rehabilitation at the Sir Charles Gairdner Hospital (SCGH), Geriatric Evaluation and Management Unit (GEM). The study design is a Prospective Cohort Study. The Mini Mental Status Examination (MMSE) and Cognitive FIM Instrument are cognitive assessment tools currently used with inpatients on GEM. They are standardised tools involving a series of questions and paper based assessments. The Kettle Test is a new cognitive assessment tool, which utilises a functional task. We wish to assess the Kettle Tests accuracy in detecting cognitive impairment, when compared to traditionally used assessment tools. Also we will assess all tools capacity to predict a patient’s functional capacity. Functional capacity will be measured via the motor component of the Functional Independence Measure (mFIM). The study also includes questions from a Daily Living Self-Efficacy Scale to assess the level of individual’s belief in their functional abilities and confidence to return home. Participants or their caregivers would receive a phone call within their first week post discharge to review their functional status (via the mFIM), management at home, caregiver support, community service use and representation rates. The participants would receive an additional phone call at one month post discharge to review functional status (via the mFIM), management at home, caregiver support, community service use, representation rates, medical status and deaths. We will also collect data concerning age, gender, length of rehabilitation stay (LOS) and diagnoses. It is anticipated that the Kettle Test will accurately detect cognitive functional deficits in adults with suspected cognitive impairments, and that the Kettle test will give clear and specific information about the functional abilities and impairments of the patient once discharged to the home environment.

The serratus anterior is an important muscle that assists in the control of the shoulder blade and movement of the arm. We know that serratus anterior muscle activity is affected in painful shoulders, and is often targeted by physiotherapists for the treatment of shoulder pain. We are conducting this study to compare if Real-time ultrasound (RTUS) is more effective than manual facilitation in the rehabilitation of serratus anterior muscle. We expect that both interventions will improve activation of the serratus anterior, but that there will be better activation of the muscle with RTUS

The survival of an organism in the face of internal and external events requires a measured and appropriate stress response. It has been hypothesised 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 the primitive brain structures of the diencephalon and brainstem in response to somatosensory inputs and comprises a broad range of neuro-hormonal and immune 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 haemodynamics, metabolic disturbances and organ dysfunction observed in critical illness. The large multi-centre randomised-controlled SPICE-III study 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. We aim to conduct a substudy to determine whether a strategy of EGDS and the resultant reduced sedation level results in a differing physiological stress response in critically unwell patients as measured by a panel of blood-borne markers. We hypothesise that the application of an early goal directed sedation protocol and the resultant reduced sedation level in the first 5 days of critical illness will result in a differing pattern of stress as measured by metabolic, sympathetic, hormonal and inflammatory responses. All-SPICE will be a prospective parallel-group multi-centre observational sub-study of the the SPICE-III study. The SPICE-III study is a prospective, un-blinded, randomised controlled trial of Early Goal-Directed Sedation compared with Standard care. The SPICE-III study will recruit patients who are intubated and ventilated in a participating ICU, are expected to remain intubated the day after enrolment and need immediate and ongoing sedation. Due to the immediate need to choose a sedative regimen for ongoing patient safety and comfort, it is proposed that study enrolment will occur using deferred consent. A total of 100 patients from approximately 4 ICUs will be enrolled in All-SPICE. Immediately following randomisation on day 1, patients will have blood samples taken, which will be repeated on days 2, 4 and 6. These samples will be assessed for various blood-borne markers which are considered to be potentially affected by the coordination of the stress response.