ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32856 results sorted by trial registration date.
  • Walking away fatigue and disease after stroke.

    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.

  • Interactive Virtual Therapy for community-dwelling Stroke survivors

    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.

  • A national prevalence study of advance care planning documentation and self-reported uptake in Australia

    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.

  • OPTAmising prevention of delirium and other risks for older people in the ED through use of an assistant workforce: a pre- post study.

    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.

  • Nivolumab in renal transplant recipients with cancer

    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.

  • Group exercise for people with chronic physical impairment.

    To determine whether participation in a weekly exercise group can maintain or improve physical function and falls rate for people with chronic physical impairment.

  • Stress in people recovering from stroke

    This cross sectional study will be conducted on stroke survivors with a diagnosis of stroke in the last 12 months or longer. This study will aim to determine the stress levels in patients with stroke. This information will be compared with age matched control participants to determine the differences in stress levels between stroke survivors and the control population. This study aims to measure subjective and biological stress loads in patients recovering from stroke, 12 months or longer post event, and to explore the relationship between chronic stress, in stroke patients compared to age matched controls.

  • The Move, Eat & Sleep study: an app-based physical activity, diet and sleep health weight loss program.

    Overweight and obesity is highly prevalent among Australian adults and being overweight or obese increases the risk of developing stroke, coronary heart disease and type 2 diabetes mellitus. For optimum health and to prevent the development of chronic diseases individuals should aim to maintain Body Mass Index in the range 18.5 to 24.9 kg/m2. For individuals who are overweight or obese, weight loss of >5% is a key prevention and treatment recommendation to reduce the risk of type 2 diabetes. Traditional weight loss interventions combining physical activity and dietary behaviour change are only modestly effective, as interventions often fail to achieve the weight loss target of 5%, on average achieving only 3.3% weight loss. Consequently, the efficacy of behavioural weight loss interventions need to be improved. One potential way to enhance the efficacy of traditional weight loss interventions is to concurrently target improvements in sleep health. The Move, Eat & Sleep Study is a 3-arm randomised controlled trial to assess the relative efficacy of a physical activity, dietary behaviour, and sleep health intervention (enhanced), compared with a physical activity and dietary behaviour only intervention (traditional), and wait-list control for weight loss, in overweight/obese adults. The primary outcome of weight change will be assessed after 6 months and followed up at the 12 month time point. It is hypothesised that both the enhanced and the traditional interventions will achieve a statistically significant reduction in weight relative to the wait list control at 6 months primary time point, and that the enhanced intervention will achieve a statistically significant greater reduction in weight relative to the traditional intervention at 6 months. The Move, Eat & Sleep study is a technology-based, multi-behavioural intervention to promote weight loss. This will be achieved by increasing physical activity levels, improving dietary quality and reducing energy intake to promote weight loss, and in the Enhanced group also improving sleep health. Participants will receive access to a modified version of the Balanced app, body weight scales to self-monitor weight, a Fitbit to self-monitor activity and sleep behaviours, a participant handbook and additional email and text message based support, and personalised dietary counselling.

  • Levels of distress and anxiety in patients after trauma and their next-of-kin while in hospital

    The purpose of this study is to investigate the levels of distress and anxiety of patients (and their next-of-kin) who are admitted to the Intensive Care Unit at the Royal Adelaide Hospital following trauma, under the auspices of the Acute Surgical Unit and/or Neurosurgery Department over the duration of their hospital stay. The aim is to ascertain the levels of distress and anxiety of patients’ and next-of-kins’, whether these levels change over time and, if so, what they attribute this to. It is anticipated that the results will impact on the clinical practice of social workers at the Royal Adelaide Hospital by helping us to provide better and more focused services to this client group.

  • Promoting job-seeking behaviour in adults with a physical disability

    Research indicates a low employment rate among adults with spinal cord injury (SCI) or multiple sclerosis (MS) despite many feeling capable of engaging in paid employment. Resuming employment provides an opportunity to interact with others and has been shown to contribute to general wellbeing and life satisfaction. Though specialist vocational rehabilitation services exist, barriers to accessing these services have been identified. These barriers include (but are not limited to): delays in the timeliness of vocational interventions, transportation and/or financial difficulties, and social stigma. In this context, time-efficient, cost-effective and accessible methods of vocational service delivery present clinical appeal. This includes the use of information and communication technologies (i.e. Internet) to supplement face-to-face rehabilitation. Specific aims of this study will be to: 1. Develop and evaluate an online vocational resource for working-age adults with SCI or MS 2. Identify facilitators of, and barriers to, online learning We expect to demonstrate that access to online services will facilitate and promote vocational behaviours and, potentially, contribute to positive mental health outcomes.

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