ANZCTR search results

Hip replacement is a commonly performed procedure for the treatment of arthritic conditions of the hip joint and since 2003 the number of hip replacement procedures has significantly increased by 46.5% in Australia. The procedure is intended to relieve pain, restore function to the hip joint and ensure maximal longevity of the implant. Different surgical approaches to hip replacement have been developed over many years with various levels of clinical support. However, anteriorly-based surgical approaches, which open the joint capsule from the front of the joint, have been increasingly used in recent times. The main aim of this study is to assess whether the surgical approach to hip replacement surgery impacts patient outcome. Three different surgical approaches will be assessed across a large patient sample, regardless of prosthesis type or surgeon. This will be assessed primarily by patient satisfaction with the surgery, following the collection of longitudinal functional (patient-reported outcomes), radiological data and gait analyses. The secondary aim of the study will be to define preoperative patient characteristics as predictors of outcome following different surgical approaches to THA. To illustrate any potential identifying criteria for future surgical approach selection.

Sleep is a very important physiological process that helps the body heal when sick. The ICU environment is not conducive to achieving good quality sleep. Loud noise levels and bright lights during the night time are some of the things that keep patients form achieving a good night sleep. This study will be a before and after trial where patients will be given the chance to answer a validated questionnaire about the quality and quantity of sleep that they achieved during every night spent in ICU. Sound levels and light levels will be measured inside patient rooms and at the nurses station at night. An intervention will then take place, which will be the implementation of a sleep management plan in ICU. This will include changing the culture of the unit to try and achieve low noise and light levels at night, implementing a schedule to decrease the volume of monitors and ventilators in the ICU as well as dimming and turning off lights at night. Patients will be offered eye masks and ear plugs to wear at night. Once the sleep management plan has become ingrained, a second period of data collection will take place where patient will answer the same questionnaire and noise and light levels at the nurses' station and patient rooms will again be measured. We hope to find a significant decrease in all measurements.

Haemodialysis remains a principal renal replacement modality for patients with end stage renal disease (ESRD). Despite the efficacy of haemodialysis as a treatment to replace essential kidney functions, such as fluid and acid-base balance, the morbidity and mortality of patients receiving haemodialysis remains high when compared with the general population. Of many factors, the inadequate removal of some uraemic solutes might play a role in this phenomenon. Middle molecules are a well described class of uraemic solutes which have been linked to both the reduced quality of life and survival associated with end stage kidney disease. To date larger middle molecules have been inadequately removed by haemodialysis strategies. The mid cut-off dialyser Theranova represents a new class of dialysis membranes with the ability to remove nearly all middle molecules. REMOVAL-HD is a pivotal, open label, non-randomized, single-arm, multi-center device study. The primary objective of the REMOVAL-HD study is to determine if regular haemodialysis using the Baxter Theranova dialyser in a chronic haemodialysis population can significantly decrease serum concentrations of large middle molecules without resulting in a significant loss of albumin. Participant will have 4 weeks wash-in period of high flux haemodialysis, then 26 weeks of treatment the mid cut-off dialyser Theranova and then 4 weeks wash-out with high flux haemodialysis. The primary study outcome is change in serum albumin at 6 months. Secondary outcomes include levels of uremic toxins over 6 months of treatment, the burden of HD related symptoms such as restless legs and general quality of life, functional measures of the 6-minute walk and rate of hospitalizations, infections and death.

Background and aim: Lack of knowledge on heart attack symptoms and delay in seeking medical treatment are evident in the literature. Because 47% of the Australian general public is functionally illiterate, gaining medical information through traditional booklets and brochures can be challenging for those with a low literacy level. This project aims to evaluate an interactive, avatar-based education application (the app) to improve patients’ knowledge on and response to heart attack symptoms. Design: A pragmatic randomised controlled trial with a six-month follow-up Method: A total of 70 participants will be recruited from the cardiac care unit of Flinders Medical Centre. Patients are eligible to participate if they 1) have a confirmed heart condition diagnosis and previous chest pain experience, 2) are clinically stable and 3) can communicate in English and follow the study protocol. Patients who 1) are clinically unstable, 2) are significantly cognitively impaired and 3) unable to give informed consent will be excluded. Written consent will be obtained from all the participants. Eligible patients will be randomly allocated to either the usual care or intervention groups by a computer-generated random allocation sequence that is accessible only to the administration staff responsible for randomisation. Usual care: Usual care means the healthcare services received by a patient specific to his/her diagnosis. The participants will receive in-patient cardiac rehabilitation, a part of the usual care at the study site, such as medical and nursing management, advice on lifestyle and behaviour modification and receipt of the ‘My Heart My Life’ booklets. Intervention: In addition to usual care, the intervention group participants will be asked to use the app before they are discharged from the hospital. The app is an interactive iPad-based education resource that utilises avatar, animation, voices and touch screen responses to teach patients about heart attack symptoms and response. Minimal text and medical terminology are used in the app. Outcome measurements: Previously validated surveys and researcher-developed questions will be administered to the participants at baseline, immediately after using the app (intervention group only) and at one and six months of telephone follow-up to assess their knowledge on and response to heart attack symptoms. Intervention group participants will also complete a satisfaction survey to assess their perceptions of the app. Between-group comparison will be performed for baseline, one-month and sixth-month survey scores to evaluate the effect of the app. Data analysis will be conducted by a senior statistician.

Varenicline remains the most effective pharmacological agent in supporting smokers to quit, though its effectiveness in promoting long term abstinence is inhibited by a number of issues 1. A recent meta-analysis reported that varenicline caused an increase in discontinuation compared to placebo as a result of adverse events, negatively impacting medication adherence and the likelihood of a quit attempt being successful 2. As adherence to varenicline is a major predictor of success during a quit attempt, ensuring completion of the prescribed regimen is needed to optimise the likelihood of a successful quit attempt 3. An additional issue during varenicline treatment is the resurgence of cravings and withdrawal symptoms at the end of the prescribed treatment period. Experiencing these symptoms increase the likelihood of lapse and relapse after achieving initial abstinence 4. The primary objective of this clinical study is to compare differences in safety and efficacy outcomes of three different varenicline regimens for smoking cessation over a treatment period of 16 weeks, followed by 12 weeks of follow-up. The regimens are designed to reduce the frequency and severity of adverse effects, cravings and withdrawal symptoms. The secondary objectives are a comparison of carbon monoxide (CO) confirmed continuous abstinence rates (CAR), 7-day point prevalence abstinence rates, and adherence to the study medication throughout treatment. The primary endpoints are the frequency, severity and duration of adverse events, cravings and withdrawal symptoms. The secondary endpoints are 7 day point prevalence and CO confirmed continuous abstinence rates from weeks 12-16, and weeks 16-28, and medication adherence. This study is a phase 4, randomized, double-blinded, placebo-controlled single-center study designed to evaluate the safety and efficacy of varenicline in motivated, smoking subjects allocated to a control group, step-up intervention group, or step-down intervention group. A total of up to 201 participants will be enrolled in to this study at a single site, with 67 participants randomly allocated in a 1:1:1 ratio to one of the three treatment groups. This will provide at least 80% power to detect a moderate effect in the primary endpoints. Participants meeting eligibility criteria will enter the 16-week double-blind treatment phase, followed by a 12-week follow-up phase, with the study completing at week 28. Follow-up will continue for participants who cease treatment early. Participant enrollment will run from December 2016 to December 2017, with data analysis occurring during and after this period.

This study will qualitatively and quantitatively assess MRI and PET-CT for the surveillance of patients with early stage Non-Small Cell Lung Cancer (NSCLC) or pulmonary oligometastatic disease treated with SABR. Similarly, it will also qualitatively and quantitatively assess the changes that occur in normal tissues after delivery of SABR. We intend to assess the validity of current recommendations that utilise CT and PET-CT, and to explore whether or not MRI adds anything to current recommendations. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with Stage I or II NSCLC or pulmonary oligometastatic disease. Study details: All patients who are enrolled in the study will receive the standard pre-treatment work-up, treatment and post treatment surveillance. In addition patients will be subjected to six additional MRIs and two additional PET-CTs and PFTs. In addition patients will be subjected to six additional MRIs and two additional PET-CTs and PFTs, conducted up to 24 months following radiotherapy treatment. This will best identify patients and/or circumstances where PET-CT and/or MRI are of additional value to the standard surveillance protocol currently recommended.

The purpose of this study is to determine whether there are any significant differences between amateur cricket pace bowlers and a healthy control population in side to side differences of lumbar multifidus resting thickness and recruitment between sides.

Major issues impacting survivors of stroke & their carers are reduced quality of life & depression. The period of transition from hospital to home is a critical time for recovery for survivors of mild stroke; bridging hospital discharge to community integration. It has been identified that stroke survivors feel ill-prepared mentally and physically to return to their lives after discharge from hospital (Cott et al., 2007; Turner et al., 2009; Rittman, Boylstein, Hinojosa et al., 2007). A discharge care plan developed by the stroke team focusing on the needs & goals of the person with stroke facilitates the transition home inclusive of medical management, ongoing rehabilitation, and education around lifestyle modification. However, a recent clinical audit of the Australian facilities revealed that less than 50% of survivors of stroke discharged from acute care received this (National Stroke Foundation, 2014). Survivors of mild stroke, typically present with minimal impairments & are often discharged home without inpatient rehabilitation. Recent research highlights that the impact of stroke only becomes obvious on returning home when re-engaging in previous life roles (e.g. work, leisure). The overarching aim of this research is to determine the efficacy of a new allied healthled model of care for individuals with mild stroke discharged from acute care. The primary aim is to assess the efficacy of MiStrEnGTH as compared to usual care on quality of life (QoL) and client mood. A secondary aim is to assess the efficacy of MiStrEnGTH as compared to usual care on daily activity, community participation, carer mood and strain. It is hypothesized that clients and carers receiving MiStrEnGTH will have improved QoL, mood and community participation, with lower levels of carer strain as compared to usual care. A study design of a randomized controlled trial with intention-to-treat analysis will be used. All participants with acute mild stroke will be randomized to one of two intervention arms at discharge: 1) control 'standard care'; 2) intervention 'MiStrEnGTH'. Data collection from participants will occur at baseline (recruitment), and 1-, 3- and 6-months post-discharge from hospital.

This study will be a randomised crossover trial in sedentary adult couples or individuals.The aim is to compare the acute effects of watching TV whilst sitting uninterrupted with sitting time interrupted by light-intensity simple resistance activities (during TV commercials) on post-meal metabolites (glucose,insulin, lipids), blood vessel function, and perceived hunger and fatigue. Overweight/obese adult couples or individuals aged between 25-40 years will be recruited for the study. Eligibility will be based on: having a BMI more than or equal to 25 kg/m ^2 but less than 40 kg/m ^2, currently watching more than 2 hours of TV per day and be English-speaking. The study will involve two experimental conditions (each of approx 4 hours duration), separated by a 1-day break period. Both conditions will occur in the evening (between 6 and 10pm) as a large amount of TV viewing often occurs following the evening meal. In condition 1 participants will sit for the entire duration of the movie (approximately 3 hours), after consumption of an evening meal, including during intermittent (every 20 minutes) advertisement breaks (of 3 minutes). Condition 2 will be identical to condition 1, except that participants will get up and perform light-intensity simple resistance exercises during the advertisement breaks. In both conditions participants will be provided with the same evening meal (based on 40% estimated energy requirements). Participants will be instructed to minimize excessive movement when sitting; only rising from the seated position to void. Participants will be fitted with a continuous glucose monitor (CGM) for a minimum duration as possible to limit discomfort (afternoon Monday to morning Friday; primary outcome). A number of other assessments performed will form the secondary outcomes and include; endothelial function via Flow Mediated Dilation (FMD); venous blood samples analysed for a range of markers of cardio-vascular health, like blood fats (lipids), sugar (glucose) and, insulin at regular intervals; 24 hour ambulatory blood pressure monitoring (24 ABPM) and hunger and fatigue perceptions.

The PEARL-CF study is a multi-center, double-blind, randomized, placebo-controlled trial comparing three cohorts: (1) Children with cystic fibrosis (CF) taking a probiotic daily for 1 year, (2) Children with CF taking a placebo daily for 1 year, and (3) Healthy non-CF controls (HC) not on probiotics or placebo (age and gender matched). The hypothesis is that: (i) Probiotics restore the abnormal gut microbiota in children with CF, which in turn reduces intestinal inflammation. We also hypothesize that when: (ii) Probiotics are administered daily for 1 year, they will have clinical benefits for patients with CF. (iii) Probiotics are administered in early life (0-3 years), the effects, even when ceased, are sustained compared to when probiotics are given after the gut microbiota has become established (~3 years old).