ANZCTR search results

The present study aims to evaluate the clinical impact, effectiveness and feasibility of implementing a structured journal club that is Tailored according to Research Evidence And Theory (i.e., TREAT journal clubs) within a group of allied health professionals compared to usual journal club participation. A randomised controlled design will be used with up to 10 existing allied health journal clubs within Gold Coast Health being randomised to receive either the (1) TREAT journal club format or (2) usual journal club format. Questionnaires will be provided across baseline, post-trial and a 6 month follow up to measure impact on clinical practice, individual evidence based practice (EBP) proficiency, satisfaction and sustainability, as well as the use of post implementation focus groups. The project may provide much needed knowledge in the area of how to effectively undertake journal clubs within allied health, potentially leading to greater clinical impact of clubs and enhanced EBP proficiency of clinicians.

Parallel randomised controlled trial of different methods of application of cohesive bandage for the management of hand burn oedema, against a control method of an off the shelf compression glove. Primary outcome measures will be change in oedema as measured by Bioimpedance Spectroscopy and volumetry, which will also be a validation of BIS for the measure of hand oedema in a burns population, Secondary outcomes include hand range of movement, integrity of compression, pressure exerted by compression application technique, and patient self-reported hand function.

Pilates is a popular form of exercise for Australian women (Baggoley 2015) during pregnancy, however there is a paucity of evidence for the efficacy, safety and feasibility of the Pilates method for improving outcomes for healthy pregnant women. The Pilates approach to exercise, movement and wellness has growing appeal to women as a form of exercise and relaxation (Baggoley 2015). It is arguably a suitable physical activity for healthy pregnant women because movements and exercises can be tailored to the physiological changes associated with pregnancy including ligamentous laxity and increased joint range of movement (Balogh 2005, Robinson 2007). Pilates is purported to benefit lumbopelvic stability, joint stability and movement, and lower and upper extremity muscular control, strength and endurance (Cruz-Ferreira, Fernandes et al. 2011). For pregnant women, these health benefits may enable them to more easily adopt active birth positions, which may reduce the duration of labour and enhance their experience of birth (Lawrence, Lewis et al. 2013). The objective of this pilot study is to evaluate 1) the safety, feasibility and practicality of Pilates for low risk pregnant women, 2) associations between participating in a Pilates intervention for labour/birth and maternal health outcomes and 3) elucidate women’s experiences and perspectives of participating in a Pilates intervention during their pregnancy. The overall study will include two research phases: 1) feasibility analysis and a 2) quantitative evaluation of therapy outcomes.

The AXILLARY project aims to explore the relationship between the use of an axillary roll during surgery performed in the lateral decubitus position and the presence or absence of post-operative shoulder and neck pain. The sample population of this trial will be those patients who meet the eligibility criteria and who are to have an elective total hip replacement at selected site. This project is a randomised controlled single-blinded trial where participants will be assigned to the group who receive an axillary roll, or the group that does not. Patients will then be asked to rate their shoulder and neck pain post-operatively on two separate occasions. The results of this project will provide scientific evidence to support or not support the use of an axillary roll during surgery in the lateral decubitus position.

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.