ANZCTR search results

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

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31173 results sorted by trial registration date.
  • Patient power: Feasibility of a notepad-based intervention to encourage patients to ask questions about their care

    Patient engagement can result in the improvement of health outcomes, reduced healthcare costs and increased patient satisfaction. However, shortcomings in communication of care processes, treatment expectations and possible side effects from health professionals to patients persist. This project aims to test a behaviour change strategy involving the use of a specialised notepad to enhance the patient voice in early post-operative wound care. The notepad will be co-designed by patients, researchers, and hospital clinicians, It will provide patients with example questions, and will provide a place for patients to record their questions as they think of them, It will be provided to patients undergoing hip or knee replacement surgery at Frankston Hospital in Victoria, Australia.

  • Clinical study Of caNNabidiol in children and adolesCenTs with Fragile X Open-Label Extension (CONNECT-FX OLE)

    This study is evaluating the long term and safety and tolerability of ZYN002, a clear gel that can be applied to the skin (called transdermal application) twice a day for treatment of symptoms of Fragile X Syndrome (FXS) Who is it for? Patients who have been diagnosed with Fragile X Syndrome and are aged between 3 and 18 years old who have participated in the ZYN2-CL-016 double-blind study and meet certain eligibility criteria. Study details Eligible participants will undergo up to a 52-week treatment period. Participants who are taking anti-epileptic drugs may undergo an additional 1-2 weeks of treatment to taper off study drug treatment. All participants will be assigned to ZYN002. Parents/ caregivers will be instructed on proper application of the gel. The gel will be applied to clean, dry, intact skin of the upper arms/ shoulders. Participants whose weight changes during the course of the study may have their doses changed at the investigator’s discretion on or after the Month 1 visit, or reduced due to tolerability issues at investigator’s discretion. Blood samples will be collected for safety analysis of ZYN002. Additionally, the parents/caregivers will be asked to complete some questionnaires. There will be other questionnaires and scales that will be completed at the site by the study doctor and/or with the participant and their parents/caregivers. Participation in this study may help the child’s/ adolescent’s FXS symptoms; however, we cannot guarantee that he/ she will get any benefits from this study. The results of this study may benefit future patients.

  • A pilot study of a psychologically informed physiotherapy for people awaiting knee replacement surgery.

    This study is the first to test a new physiotherapy approach to preparing for knee replacement surgery. This new approach is called PACT- Physiotherapy informed by Acceptance and Commitment Therapy. This is a method often used by psychologists to help people experiencing a range of issues that affect their mental health. This study is a pilot study, testing the new approach in 51 people and assessing results from a patient, therapist and hospital perspective before we use this approach in a larger study or in clinical practice.

  • ParentWorks Spectrum: A parenting intervention for young children with autism

    This aim of this study is to establish the feasibility and preliminary efficacy for a brief parent mediated intervention for parents of children with autism aged between 2-6 years of age. The purpose of this research is to determine the effectiveness and acceptability of an integrated treatment approach that aims to improve maladaptive behaviours and core social communication symptoms in children with autism and parenting, parent-child interactions and parental well-being for their parents. It is hypothesised that this intervention will be acceptable to parents and effective in reducing child externalising behaviours, improving the quality of parent-child interactions and parenting practices.

  • Footwear for Osteoarthritis of the Lateral Knee: the FOLK Trial.

    We are conducting a research study to compare the effects of daily use of motion-control and neutral walking shoes on lateral tibiofemoral osteoarthritis clinical outcomes, over 6 months. To do this we will randomly allocate participants to receive either i) motion-control or; ii) neutral walking shoes. Participants will be provided a pair of shoes from their allocated group, to be worn daily for 6 months (minimum of 6 hours/day).

  • Development and evaluation of a nursing risk assessment manual handling training program for moving patients with a stroke and other conditions affecting mobility: The Risk Assessment for Moving Patients (RAMP) program

    Perceived gaps in patient manual handling practice by nursing staff exist and these relate to inconsistent knowledge, adherence and clinical applicability of the current program. The current manual handling program for nurses was reviewed by a working party that included subject matter experts where a new patient manual handling program, Risk Assessment for Moving Patients (RAMP), was developed for nursing staff and is focused on the patients with a stroke and other conditions affecting mobility. RAMP uses a risk assessment model and research shows this approach to manual handling may reduce staff injuries. RAMP is based on a process where staff are taught a baseline sequence of events as well as the contributing factors for a patient to be able to successfully participate in a movement / transfer. The staff are then up-skilled in how to risk assess for the patient in front of them through an analysis of the patients movement, the patient’s ability to participate (physically and cognitively), as well as observation and modification of the environment (where appropriate) and the staff resources available. The risk assessment brings together the baseline sequence of events with the risk assessment to guide safe choices for the movement / transfer as well as encouraging patients to move their own weight where safe and able to do so. The primary aim of the program is to change clinical practice of nursing staff at the bedside. The secondary aims of the program are nursing staff safety and patient falls prevention. The RAMP program is to be evaluated using the four levels of the Kirkpatrick model of evaluation, which includes reporting the participant reaction to the program (Level 1), the degree of learning achieved (Level 2), the transfer of the learning back into the workplace (Level 3) as well as the targeted outcomes of the education program (Level 4). It is hypothesised that the RAMP program will change clinical practice at the bedside and this change in practice may prevent patient-related musculo-skeletal injuries in nursing staff and reduce patient falls on the pilot wards.

  • Spinal Cord Stimulation in the treatment of chronic, intractable pain using the Nalu Neurostimulation System in adults

    The Nalu Neurostimulation System is indicated as an aid in the management of chronic intractable pain. The study will enroll adults between 21 and 80 years of age with chronic intractable pain in the legs and/or back, who meet the inclusion and exclusion criteria of the study. The primary study objective is to confirm the performance of the Nalu Neurostimulation System in patients with chronic pain. Additionally, multiple standard outcome domains will be captured to confirm system performance and patient responses to the device and therapy. Data will also be collected to support a safety endpoint. The study is a prospective, multicenter, open label, feasibility clinical study. The study will include three phases: Screening/baseline, SCS Trial, and Permanent Implant. Study subjects will be followed up for 12 months after device implantation. The study is expected to take 2 years from first enrollment to last follow up of last patient and subsequent study closure. Upto 40 subjects will be implanted with the device across 10 centers in Australia and New Zealand. Performance measures include Pain Scores(VAS, Numeric Rating Scale, in-office and at home); Quality of Life using the EQ5D, Activities of Daily Living (Oswestry Disability Index, ODI), Pain and paresthesia maps, pain medication use, procedure information, ease of use of the wearable components, Brief Pain Inventory and the Beck's Depression Index. This study is not formally powered as it is a feasibility study. basic statistical analyses will be completed on all endpoints including computation of average, variance , standard deviations and trend analysis. Secondary Objective data may be qualitative only.

  • The influence of snacking on promoting weight loss and protecting against weight regain in overweight and obese adults.

    The primary aim of this project is to investigate whether the inclusion of different types of snack foods in an energy restricted diet (i.e. a diet that provides fewer kilojoules than you currently consume) improves weight loss and limits weight regain. We are also interested in seeing whether there are improvements in cardiovascular, liver and gut health and quality of life and functional mobility. We hypothesize that consuming almonds as a snack, when compared to carbohydrate-rich foods, will lead to greater weight loss during the energy restriction phase and will be more effective at limiting weight gain during the weight maintenance phase.

  • The effect of early feeding into the gut on gut function after major colorectal surgery

    The purpose of this study is to determine whether early feeding can help decrease gut side effects in patients who have received surgery for the removal of all pelvic organs (called pelvic exenteration and includes removal of the bladder, urethra, rectum and anus) as a radical surgery for the treatment of cancer. Who is it for? You may be eligible for this study if you are an adult who is going to have a pelvic exenteration surgery for cancer and other curative reasons. Study details Participants in this study will undergo their surgery as normal, and then during the surgery, will be randomly selected to be one of two groups. Group 1: Will receive standard nutritional care after the operation. Group 2: Will receive a feeding tube during the surgery, which will commence providing food within 24 hours from the end of the surgery up until the participant commences a full fluid diet. Tolerance and delivery of nutrition will be monitored. It is hoped that this research will help determine if it is possible to commence feeding patients after their pelvic exenteration surgery and therefore reduce gut-related side effects.

  • Self-reported daytime sleepiness and sleep-disordered breathing in patients with Atrial Fibrillation

    Sleep-disordered breathing (SDB) is common in patients with atrial fibrillation (AF) and is associated with poor clinical outcomes. International AF management guidelines advocate for the interrogation for clinical signs of SDB when addressing AF risk factors given the important interplay between SDB and AF. Excessive daytime sleepiness is an important clinical consequence of SDB and its presence can be a key consideration in patient selection for SDB investigation and management. However, patients with cardiovascular disease report low levels of daytime sleepiness. Therefore, relying on self-reported daytime sleepiness in patient selection for diagnosis and management can potentially result in a significant proportion of patients not being identified with SDB or provided appropriate management opportunities. We hypothesise that in patients with atrial fibrillation, excessive daytime sleepiness is low and that self-reported sleepiness correlates poorly with the presence or degree of SDB. We aim to test this hypothesis by studying patients with AF who have undergone overnight sleep studies. We will assess the self-reported sleepiness and its correlation to the presence and degree of SDB. We will test the utility of the Epworth Sleepiness Scale, a widely used tool to quantify daytime sleepiness, to predict the presence of SDB. Further, we aim to characterise clinical features that can help identify patients with significant SDB, and assess the potential impact this would have on AF management.

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