ANZCTR search results

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

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31604 results sorted by trial registration date.
  • Occupational therapy home assessment via videolink for patients recovering after hip fracture

  • First 2000 Days Care Connect (FDCC) – a holistic first 2000 days model of antenatal care for pregnant migrants or refugees

    The overall aim of the FDCC study is to evaluate: 1) impact, of FDCC (an integrated Child and Family Health (CFH) hub with navigation support) on attendance at CFH services and completion of CFH checks, support of child growth and development, breastfeeding and maternal wellbeing, and meeting family psychosocial needs. 2) process of implementing FDCC and: (implementation evaluation – future Phase 2 of study not applicable to current ANZCTR). 3) cost-effectiveness of FDCC. (economic evaluation – future Phase 2 of study not applicable to current ANZCTR). FDCC is a non-randomised study of newly arrived migrants and refugee women from culturally and linguistically diverse backgrounds who are:newly arrived migrant (< 10 years in Australia) or self-identified refugee (< 10 years in Australia); expectant mothers > 20 weeks gestation or or mother who has recently given birth at the abovementioned hospitals and has not been discharged from postnatal ward; attending antenatal clinics or postnatal wards in SESLHD (St George Hospital), NSLHD (Royal North Shore/Hornsby Hospital) and SWSLHD (Liverpool Hospital). Potential participants will be identified by the midwifery and, where available, the cross-cultural worker service. The study compares markers of attendance and completion of CFH checks, child health and development measured by Ages and Stages Questionnaire, Body Mass Index, and Emergency Department Presentations, rates of breastfeeding, and mother’s social and health needs (depression, quality of life and other psychosocial stressors) between those attending FDCC (an integrated CFH hub with navigation support) and those attending usual care not through FDCC.

  • Investigating the speech and psychological benefits of adding internet anxiety treatment to speech practice for adults who stutter

    Anxiety-related mental health disorders, particularly social anxiety disorder, are common comorbid conditions among adults who stutter. Our research has discovered that social anxiety disorder and other DSM-V disorders involving anxiety prevent effective speech treatment for adults who stutter. We have developed and trialled an innovative internet cognitive behaviour therapy (CBT) program specifically designed to target the social anxiety experienced by people who stutter. This internet CBT program has been shown to reduce the social anxiety experienced by adults who stutter and even eliminate social anxiety disorder diagnoses. The proposed study aims to investigate whether access to an internet cognitive behaviour therapy (CBT) program immediately after a period of speech treatment designed to reduce stuttering behaviours, improves psychological and/or speech outcomes. The research design is a randomised clinical trial of speech restructuring treatment or speech restructuring treatment plus internet CBT treatment for adults who stutter. The outcomes of this research will generate new knowledge about the benefits of concurrently controlling the speech problems and the anxiety related mental health disorders of adults who stutter.

  • The Breathe Easy study: Mask On, Mask Off (MoMo) sub study for diagnosis of respiratory illness

    The Breathe Easy Study is an observational study which has been conducted at Joondalup Health Campus (JHC) (and Perth Children’s Hospital (PCH)) since 2015. The objective of the study is to develop a suite of diagnostic tests for paediatric and adult respiratory diseases by evaluating patient-reported symptoms and sound-signatures emitted during a cough event. As part of approved study procedures, participants recruited to the study are required to cough at least five times towards the microphone of a standard smartphone (iPhone 6). Phones are wiped down between participants and research nurses are provided with personal protective equipment (PPE). However, with changing infection control procedures many patients are increasingly required to wear protective apparel such as surgical masks when presenting to healthcare facilities. We would like to know whether masks impede the sound collected by the phone’s microphone. Participants will be required to provide at five coughs, with and without impedance, and we will compare the diagnosis obtained in both instances.

  • Optimising symptom management in children with cancer using a novel mobile phone application

    This study aims to determine the feasibility and effectiveness of a novel mobile phone app for the monitoring and management of symptoms in children with cancer. Who is it for? You may be eligible for this study if you are a parent or caregiver of a child cancer patient aged 2-18 years currently receiving active treatment for blood cancer or solid tumors, and you have access to a smartphone. Active treatment for cancer is defined as receiving either planned cycles of chemotherapy or radiotherapy. Study details All participants who choose to enrol in this study will be asked to download an app to their phone that will enable the child's parent or caregiver to enter information regarding their current symptoms related to cancer. Participants will be asked to provide information every week via the app, it is anticipated that this will take 5-10 minutes each day. It is hoped this research will demonstrate that use of a mobile app to monitor symptoms is easy to use and acceptable to cancer patients and their caregivers. The app could then be used to help improve health outcomes for future cancer patients by giving them more control over their symptoms, as well as providing options for better management of their symptoms.

  • Delivery of an evidence-based therapy for posttraumatic stress disorder (PTSD): A combined analysis of clinical effectiveness and associated economic benefits.

    This study aims to examine the benefits to society of providing effective PTSD therapy to clients (i.e., does reducing PTSD have economic and social benefits) while also examining the cost-benefit ratio of training costs and client outcomes. Client clinical outcomes (PTSD and depression symptoms) will also be indexed however the focus of the study is on quality of life and health utilisation variables. 30 clinicians, where ‘clinicians’ encompass psychologists, social workers or counsellors or other suitable health professionals, across multiple sites and services in Adelaide (e.g., SA health sites, NGOs), will receive training in an evidence-based trauma therapy, known as Cognitive Processing Therapy (CPT). These clinicians will then engage with 5-10 clients over the course of the study and provide CPT. Economic variables (e.g., training costs, self-report health service utilisation, Pharmaceutical benefits scheme and Medicare Benefit Schedule data) and clinical outcomes (PTSD severity, mood) will be measured. This study will provide an economic analysis of the downstream benefits associated with treating PTSD relative to the initial costs of training and supervising clinicians. The findings will lead to improved understanding of these critical issues and has significant implications for health services and policy makers who require high quality data when making decisions regarding allocating scarce health resources. We anticipate that the cost-effectiveness of CPT will fall within a range that government/policy makers deem acceptable for a mental health treatments. Additionally, we anticipate that client's PTSD symptoms will reduce after receiving CPT.

  • Reward learning and Cognitive Remediation

    Cognitive remediation is an evidence based therapy to address the thinking problems (e.g. trouble attending, remembering or planning) associated with schizophrenia and related disorders. The exact mechanism of benefit is unclear. This pilot study explores one potential mechanism of effect and that is reward learning ( the rewards that follow learning experiences). Reward learning will be measured before the 12 week intervention and post intervention using clinical measures, pen and paper measures as well as images of the brain that reflect reward learning.

  • High-flow nasal oxygen (HFNO) vs standard oxygen therapy in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI)

    This is a study of two different methods of providing oxygen to patients having a transcatheter aortic valve implantation (TAVI) under conscious sedation. TAVI is a type of treatment for patients who have a narrowing of the aortic valve in the heart (aortic stenosis). Traditionally treatment of aortic stenosis has required open-heart surgery but with this procedure doctors can place a new valve in the heart through one of the large blood vessels in the leg (transfemoral TAVI). Usually patients having a TAVI recover from their treatment faster and can go home sooner. Also, unlike patients having open-heart surgery, patients having a TAVI will be under conscious sedation, meaning they will have been given medication to make them relaxed and sleepy but will be awake. Sometimes during a TAVI the patient’s blood oxygen levels can become too low (known as hypoxaemia). Therefore all patients having a TAVI under conscious sedation need to be given oxygen. This study is investigating two different methods of providing oxygen to patients having a TAVI under conscious sedation. These are: Standard oxygen therapy: via nasal cannula (tube) at low flows in the nose vs High Flow Nasal Oxygen (HFNO) at much faster rates of delivery. The two devices are compared to see if either is better at preventing hypoxaemia (low oxygen levels in the blood) as well as improved patient comfort, a decreased need to go to a high dependency unit after the procedure and a reduced risk of changing to a general anaesthetic during the procedure.

  • A telehealth program targeting addictive overeating for Australian adults with food addiction

    Twenty percent of adults meet criteria for food addiction, with 70% reporting four or more symptoms of food addiction. Food ‘addicted’ individuals have significantly lower diet quality, higher intakes of junk foods and higher weight status. The personality characteristic of impulsivity is a common risk factor for substance use and food addiction. There are currently no evidence-based interventions run by clinicians for food addiction. Current treatment options largely stem from online self-help groups such as Food Addicts Anonymous and Overeaters Anonymous which have 10 000+ members, demonstrating the clear need for services and evidence-based programs. Interventions targeting personality risk factors and motivational interviewing for other addictions, such as alcohol use, are effective. This project builds on an existing pilot study (ACTRN12619001540101) utilising a personality-based intervention for the targeted treatment of addictive overeating in individuals with food addiction. The current study will determine the effectiveness of a personality-based intervention targeting addictive overeating to improve individuals’ symptoms of food addiction and associated dietary behaviours, when compared to active and passive control groups. The primary intervention will be delivered by phone/ telehealth. It is hypothesised the intervention group will have reduced food addiction symptoms and better/improved dietary behaviours than both the active and passive control groups at 3 and 6 months follow up. If successful, this project will provide an evidence-based treatment for those individuals with food addiction and addictive overeating behaviours in the community and clinical services.

  • Australian 3,4-Methylenedioxymethamphetamine (MDMA)-assisted Psychotherapy Study for the Treatment of Posttraumatic Stress Disorder (PTSD)

    The objective of this investigator-initiated study is to determine whether an Australian treatment team can safely and effectively deliver 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy to patients with treatment-refractory posttraumatic stress disorder (PTSD) through training and ongoing mentoring from the Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS is a non-profit research and educational organisation working to obtain approval for the prescription use of 3,4-methylenedioxymethamphetamine (MDMA) as an adjunct to psychotherapy in patients with posttraumatic stress disorder (PTSD). It uses an open-label design to assess the feasibility of safely and effectively providing MDMA-assisted psychotherapy in Australia by treating four Western Australian adults with chronic treatment-resistant PTSD.

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