ANZCTR search results

Australian and international research has found that same-sex attracted women (SSAW) are more likely to drink at higher levels than heterosexual women. Yet despite this evidence, limited research has focused on interventions specifically for SSAW to facilitate alcohol reduction. The absence of evidence-based services for SSAW is problematic as the current mainstream services assume the needs of SSAW match those of heterosexual women. Consequently, many SSAW are not receiving appropriate treatment and are left feeling frustrated and invisible. Therefore, this project will explore the efficacy of a short message service (SMS) intervention tailored to SSAW to reduce alcohol use, improve well-being, and increase help-seeking. To do this, two studies are proposed. The first study was approved by Deakin University Human Ethics Advisory Group, Faculty of Health (reference number HEAG-H 111_2016). It involved developing the content for the SMS alcohol intervention tailored to SSAW by designing and presenting SMS messages and the structure of the SMS intervention to two focus groups of SSAW, and using their feedback to inform the final SMS messages and intervention. The second study will involve conducting a Randomised Controlled Trial to implement and evaluate the intervention. This trial registration pertains to the second study; that is, the implementation and evaluation of the SMS alcohol intervention tailored to SSAW. The intervention and control groups will receive messages for four weeks and will provide follow-up data relating to their alcohol two time points after they have completed the intervention - post-intervention and 12 week follow-up. It is hypothesised that participants receiving the SMS alcohol intervention will report lower alcohol intake at intervention completion and 3 months post intervention than participants not receiving the SMS alcohol intervention.

Study design: Prospective, multi-centre, randomised, clinical study. The study will enrol 100 patients over a 12-month recruitment period between surgeons at up to three centres. Objectives: To determine the relationship between Surgical Technique (workflow) and patient reported outcomes after total knee arthroplasty (TKA) utilising computer navigation, comparing tibia cut first with ligament balancing technique to measured femoral cuts technique. To investigate if patient range of motion and component alignment is affected by the order of workflow. To investigate if the order of surgical cuts during total knee replacement affects other parameters such as patient satisfaction. The study will also demonstrate safety, and equivalent clinical outcomes on pain and function to other published data. Groups: Apex Total Knee Replacement using Computer Navigation utilising Tibial Cut First. Apex Total Knee Replacement using Computer Navigation utilising Measured Femoral Cuts First. Number of subjects to be enrolled: 100 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 BTS G-walk is a wireless sensor that is placed around the waist with an ergonomic belt to analyse the walking pattern. 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 preoperatively, and post-operatively at 6 weeks, 3months, 1 year, 2years. Published early results at 1 year then mid-term and long term results after 2 and more years Patient outcome assessments: The Oxford Knee Score and RAND SF36 operatively at 6 weeks, 3months, 1 year and 2 years. Radiographic evaluations: X-Rays will be assessed pre-operatively, post-operatively, at 12 months and 2 years to evaluate femoral and tibial components orientation and inclination.

FitSkills is an exercise program that matches a young person with disability with a mentor and the pair exercise together at their local gym, for an hour, twice a week for 12 weeks. The program comprises individually tailored exercise and information about on-going participation in exercise. Together with 7 partner organisations, we will complete a research translation project through a stepped wedge cluster randomised trial using a cohort design, with embedded health economics evaluation. The trial design sequentially introduces FitSkills to 8 sites in random order. After a control period, at regular intervals sites are randomised to cross from control to intervention phase until all sites have implemented FitSkills. We will recruit 160 youth with disability (any type) aged 13-30 years through our partner organisations. Data collection at 8 time points will continue throughout the trial at 3-month intervals (i.e. an assessment is conducted every 3 months for 24 months). We will collect data on: participant demographics and socioeconomics; participation; health-related quality of life; physical activity; attitudes to exercise; walking capacity; program feasibility; and attitudes to disability for mentors, gym staff and gym patrons at the participating sites.

Older people in hospital are commonly prescribed multiple medicines, some that may cause side effects such as drowsiness, confusion, dry eyes. dry mouth, constipation and falls. The Drug Burden Index (DBI) is used to find out if the medications being prescribed might impact on a person's day-to-day activities. It takes into account all the medications that someone is using; in particular the medicines that cause sleepiness and side effects like dry mouth and confusion. If someone has a high score on the DBI, there is a higher risk of falls, frailty, hospitalisation, more visits to their local doctor, and overall poorer outcomes. We hypothesise that there is a missed opportunity in hospital to identify and reduce the burden of medications in older people which can be addressed using the DBI. The primary purpose of this study is to find out what happens in hospital when the pharmacist provides a report on the DBI to a patient's treating doctors, mainly to see if the report changes the medicines that the doctors prescribe. We will also look at patients' outcomes, like falls and repeat hospital visits, as well as ask staff and patients for their opinions of the report.

This study is to measure the effect of a functional balance training program on gait, endurance, balance and fatigue in people with MS performed by the participant in a group setting or by the participant independently at home twice per week. The secondary aim is to investigate any predictors of adherence to exercises.

The existing treatments to treat atopic dermatitis have limitations with side effects and long-term use. The medication called AKP-11, is an experimental topical formulation being investigated for its potential as a treatment for atopic dermatitis. The use of AKP-11 in this study is purely experimental. AKP-11 as ointment was applied to 10 psoriasis and 8 atopic dermatitis participants and no serious side effects were reported. The primary purpose of this study to to further determine a safety, tolerability and efficacy of topical doses of AKP-11 when administered to participants with atopic dermatitis.

Background The Cambridge Diabetes Education Program (CDEP) is an online inter-professional competency based Continuing Professional Development (CDP) programme underpinned by the UK’s national diabetes competencies frameworks and has been adapted to the Australian context as AusCDEP. Objectives We aim to pilot a trial comparing the effect of AusCDEP, face to face diabetes education, and ‘usual’ staff education on length of stay and management of inpatients with diabetes.. Study Plan This is a pilot cluster randomized controlled trial(CRCT) conducted in Campbelltown Hospital over 22 weeks. The unit of randomisation is the medical ward. Patient length of stay is the primary outcome. Secondary outcomes include glycaemic control, medication errors, patient experience, and appropriate referrals to hospital based diabetes specialist services This pilot CRCT will also evaluate the feasibility, adherence and fidelity of undertaking in the future a larger CRCT . Three wards will be randomized to either 1) three hours of protected time to undertake AusCDEP (and ongoing external access) with one hour of face to face education sessions 2)four hours face to face sessions or 3) professional education as usual. A daily census of all the patients on the three wards with pre-existing diabetes will be conducted and length of stay calculated post-discharge. The charts of all patients identified as having pre-existing diabetes in the previous week will be reviewed using the Diabetes Inpatient Audit Form. As a pilot, no power calculations have been undertaken. Data will inform a larger RCT. We predict 400 patients (130 per group) in this pilot within this time limit. The time limit has been chosen to allow run in, implementation of the whole educational programme and sufficient time to test all components of the trial.

Chest pain is one of the most common reasons adults present to the emergency department and efficient diagnosis of life threatening conditions such as heart attack is of primary concern to patients and physicians alike. Accelerated diagnostic protocols assist doctors to efficiently exclude cardiac causes of chest pain, decreasing the time patients wait for diagnosis. The ImpACT (Improved Assessment of Chest pain Trial) Protocol is an evidenced based accelerated diagnostic protocol which fasttracks chest pain assessments in 75% of patients. Currently standard practice in a major Brisbane metropolitan hospital, the protocol is undergoing implementation at Cairns Hospital as a quality assurance exercise (HREC/16/QRBW/262). Aboriginal and/or Torres Strait Islander patients were underrepresented in the original ImpACT Study. A landmark 2006 report by the Australian Institute of Health and Welfare identified that Aboriginal and Torres Strait Islander people are three times more likely to have a major coronary event (such as a heart attack) compared with other Australians. The higher burden of disease in this cohort of patients may lead to emergency physicians to consider these patients at higher baseline risk of Acute Coronary Syndrome when presenting with possible cardiac chest pain. However, to date there is no robust clinical research to support this assumption. The study aims to identify if Aboriginal and/or Torres Strait Islander status is an independent risk factor for acute coronary syndrome (ACS) in patients otherwise identified as low risk by the ImpACT protocol. The health service costs for Aboriginal and Torres Strait Islander patients with suspected coronary syndromes will be evaluated. Researchers hope to provide preliminary data contributing to the development of a safe, efficient, evidenced based pathway of care for Aboriginal and Torres Strait Islander patients presenting to Emergency Departments with suspected Acute Coronary Syndrome. All patients who identify at triage to be of Aboriginal or Torres Strait Islander origin will be assessed and managed under a modified Impact protocol risk stratified as either Intermediate or High risk; but not low risk of Acute Coronary Syndrome. Treatment and management of patients will remain unchanged regardless of participation in the study. Conservatively over 8 months the researchers anticipate recruiting 160 Aboriginal and Torres Strait Islander patients. Initial patient clinical data collation and follow up patient contact will be conducted by a dedicated clinical research officer. Retrospective analysis of patient outcomes and health services costs will be evaluated.

This study will investigate the efficacy of a modified shorter duration (6-week) combined training-based cardiac rehabilitation program on functional capacity (physical and cardiac function) versus a standard-care longer duration (12-week) cardiac rehabilitation program. Combined training refers to an intervention combining progressive resistance training with aerobic training. Previous meta-analyses have shown that combined training is superior to aerobic training alone for enhancing physical function and that improvements in physical function are enhanced over a shorter duration in this population. However, whether the improvements in physical function are comparable between a shorter-duration (6-week) combined training cardiac rehabilitation program and a standard-care longer duration (12-week), aerobic-based, cardiac rehabilitation program is unknown. Project Aims: The overarching aim of this study is to compare the efficacy of a modified shorter duration cardiac rehabilitation program to a standard-care longer duration cardiac rehabilitation program on functional capacity (physical and cardiac function). It is expected that this study will provide important information on the efficacy of shorter duration combined training-based cardiac rehabilitation programs, potentially a superior model than standard-care longer duration cardiac rehabilitation. Research Design and Methods: Participants in this study will be recruited as outpatients, who have recently experienced an acute cardiac event, and have been referred to outpatient cardiac rehabilitation. Participants will undergo a standard nursing assessment from cardiac rehabilitation staff to be cleared for exercise before participating in this study. Participants will undergo baseline testing before being randomised to complete either a modified shorter duration (6-week) combined training cardiac rehabilitation program or the standard-care longer duration (12-week) cardiac rehabilitation program. Participants will undergo follow-up testing at 7-weeks, 13-weeks, 19-weeks and 31-weeks into the protocol. Tests include anthropometric measurements, aerobic capacity, muscle strength, heart rate variability, vascular compliance, body composition, quality of life, and physical activity monitoring. Adherence and compliance to cardiac rehabilitation will also be monitored. Within each group, changes in the aforementioned outcome measures will be analysed from baseline, before cardiac rehabilitation, to the conclusion of cardiac rehabilitation and at two extended follow-up time-points. Changes in the outcome measures will also be analysed between the two groups.

The primary purpose of this trial is to evaluate the feasibility, efficacy and toxicity of continuous lignocaine for the treatment of neuropathic pain in cancer patients. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over, have been diagnosed with cancer (solid tumour or haematological) and have neuropathic pain related to the cancer or its treatment with a worst pain score of at least 4 out of 11 in the past 24 hours. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either lignocaine or sham treatment with saline. Participants will receive the allocated treatment as a continuous subcutaneous injection for 72 hours. The participant must be admitted to hospital during this treatment. The dose may be altered at 24 and 48 hours if the participant still experiences moderate or worse pain and has no serious adverse effects.. All participants will have assessments daily for the three days of treatment and weekly by phone up to 29 days after the start of treatment. Assessments will include sensory testing to test pain levels, questionnaires and blood samples. It is hoped that the findings of this trial will provide information to inform a larger trial on whether the administration of lignocaine/sham treatment, and the trial assessments are feasible, as well as providing some initial information on the efficacy and safety of this treatment for neuropathic pain in cancer patients.