ANZCTR search results

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.

To date, there are no evidence-based and feasible physical activity interventions for reducing fatigue and risk of chronic disease within the hospital inpatient setting after stroke. This pilot study has been based on (1) published results that identifies a relationship between low levels of activity and increased fatigue in people with stroke (2) known benefits of physical activity on risk of chronic disease and (3) low levels of daily activity observed across all phases of stroke recovery. This pilot study explores an intervention which uses commerical accelerometer feedback within the hospital inpatient setting to assist stroke survivors in achieving activity guidelines for health benefits. 30 mild-moderately disabled stroke survivors will be randomised into an experimental or control group 2 to 28-days after their stroke. Participants in the experimental group will complete a 6-week activity program with a weekly review by a physiotherapist. At the review, activity goals will be set to gradually increase daily step count (based on the participant’s daily step count from the preceding week) and increase time in moderate intensity walking bouts >10minutes duration via a graded protocol (i.e. gradual increase in time spent in moderate intensity activity per day). Participants will wear a FitbitCharge HR daily, which will provide real-time feedback on steps and heart rate to assist participants in meeting daily activity goals. Participants in the control group will receive a weekly one-on-one 60-minute session with a physiotherapist to match dose of supervised sessions. This session will be a face-to-face session either within the rehabilitation gym, or when discharged home prior to the 6th week, within the participant’s home with a registered physiotherapist. Outcomes including fatigue severity, daily activity, risk of disease and functional recovery following stroke will be measured at baseline, post-intervention and 1-month follow-up. Feasibility of intervention and measurement protocols, participant adherence and satisfaction, adverse effects and ease of implementation will be determined.

Introduction: The STRoke Interactive Virtual thErapy (STRIVE) intervention provides community-dwelling stroke survivors access to individualised, remotely-supervised progressive exercises via an online platform. This trial aims to determine the clinical efficacy, effects on brain activity and user preferences of the STRIVE intervention in community-dwelling stroke survivors. Methods and analysis: In a multi-site, assessor blinded randomised controlled trial with a parallel mixed-methods implementation evaluation, 60 participants from 3 stroke support groups across Victoria and Tasmania will be equally randomised by location to receive 8 weeks of virtual therapy (VT) at a local community centre, or usual care. Participants allocated to VT will perform 3-5 upper-limb exercises (depending on initial impairment severity), whilst participants allocated to usual care will be asked to maintain their daily activities. The primary outcome measure will be upper extremity function and spasticity, as measured by the Fugl-Meyer upper extremity assessment and modified Ashworth scale respectively. Secondary outcome measures include task-related changes in bilateral sensorimotor cortex hemodynamics during hand reaching and wrist extension movements as measured by functional near-infrared spectroscopy. All measures will be assessed at baseline and immediately post-intervention.

Advance care planning (ACP) is a process between a person, their family/carer(s) and healthcare providers that supports adults at any age or stage of health in understanding and sharing their personal values, life goals, and preferences regarding future medical care. The Australian government funds a number of national initiatives aimed at increasing ACP uptake, however there is currently no standardised Australian data regarding formal ACP documentation or self-reported uptake. This makes it difficult to evaluate the impact of ACP initiatives. This study aims to determine the prevalence of ACP and completion of Advance Care Directives (ACDs) in hospitals, aged care facilities and general practices. It will also explore people’s self-reported use of ACP, and views about the process. Researchers will conduct a national multicentre cross-sectional prevalence study, consisting of a record audit and surveys of people over 65 years in three sectors, hospitals, general practices and aged care facilities. Up to 50 records from 48 participating Australian organisations will be audited (total of 2400 records). People whose records were audited, who speak English and have a decision-making capacity will be invited to complete a survey. Up to 50 people associated with each organisation (whose records have been audited) will be surveyed. The primary outcome measure will be the number of people who have formal or informal ACP documentation that can be located in records within 15 minutes. Other outcomes will include specific details of ACP documentation (including type and validity of document), and whether current clinical care plans are consistent with ACP documentation. People will be surveyed to measure self-reported interest, uptake and use of ACP/ACDs.

Background: Older people who present to the Emergency Department experience high rates of prevalent and incident delirium. This study aimed to determine whether an assistant workforce in the Emergency Department could effectively conduct screening to inform assessment and care planning of older persons as well as provide supportive care activities for prevention of delirium. Methods: This study used a pre-post design. Data was collected before and after the introduction of Older Person Technical Assistants (OPTAs) in the ED and included: recording of OPTA activity during the intervention period; a medical record audit undertaken prior to the implementation and 9 months after implementation; and focus group interviews with Emergency Department Staff. The data was analysed using descriptive statistics to describe the activity of the OPTAs. Weighted Kappa scores were calculated to compare the concordance between OPTA screening scores with Aged Services Emergency Team (ASET) Nurses; changes in the rates of documented screening and supportive care that is recommended in the prevention and care of people with or at risk of developing delirium. Qualitative descriptive analysis was used to examine focus group data. Results: 3542 people were seen on 4563 visits by OPTAs between 1st July 2011 and 2012. The reproducibility of all screening tools were found to be very high between the OPTAs and the RNs, with Kappas and ICCs generally all above 0.9. The medical record audit showed significant improvement in the rates of documented screening, including cognition from 1.5% to 38% (p<0.001) and review of pain from 29% to 75% (p<0.001). Supportive care related to delirium prevention also improved with patients being given fluids or food increasing from 13% to 49% (p< 0.001) and pressure care from 4.8% to 30% (p,0.001). Focus group interviews describe mixed response and support of the OPTA role in the ED. Conclusions: An assistant workforce deployed in an ED setting was found to provide comparable screening results and improve the rates of documented screening and supportive care provided to older people with or at risk of developing delirium in the ED. Implementation of such a model of care requires dedicated staff, robust screening, and comprehensive and systematic assessment and management of care and ongoing treatment.

The main focus of this study it to determine if giving immune activating anti-cancer therapy (Nivolumab) is safe in kidney transplant patients with incurable cancer. Who is it for? You may be eligible to join this study if you are a recipient of renal transplant (at least 3 months post- transplant) aged 18 years or above and have been diagnosed with an incurable cancer. Study details All study participants will receive Nivolumab (3mg/kg) as an intravenous infusion over 60 minutes every 2 weeks and study treatment will continue as long as there is clinical benefit up to 2 years. Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body’s immune system to work against tumour cells. That is using the body’s immune reaction to destroy cancer cells. Currently kidney transplant patients are excluded from clinical trials of this anti-cancer therapy - because they are taking anti-rejection medication. This trial is about trying to decide the balance between giving anti-rejection drugs and anti-cancer therapy.