ANZCTR search results

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

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32707 results sorted by trial registration date.
  • Rebate for an Adolescent Health Assessment Trial (RAd Health Trial)

    Adolescence and young adulthood (‘young people’) is a time when health-compromising (‘risk’) behaviours such as substance use emerge and sexual activity commences – 1 in 4 will have a mental health condition. The Royal Australian College of General Practitioners Guidelines recommend evidence-based health checks for young people to detect risk behaviours such as substance use, unsafe sexual practices, assess weight and diet, and identify mental health conditions early enough to reduce morbidity and prevent escalation of behaviours. GPs can intervene by counselling, STI screening, referring to dieticians, prescribing contraception and initiating mental health plans. Yet, general practice is failing young people: only 15% have an annual chlamydia test; only 6% are prescribed the most effective contraception, and; only one third of the those with a mental health condition have a mental health plan initiated. Consultation time is the key obstacle. To address this, there are calls for a Medicare rebate to fund a longer consult so that the assessment can done. However, without RCT evidence that such a rebate would be ‘value for the patient’ and ‘value for the health system’, a rebate is unlikely to be recommended. We will conduct a cluster RCT to determine whether a rebated health assessment for patients aged 14 to 24 years in general practice is cost-effective. A total of 42 clinics will participate and be randomised to receive a rebate payment the same as is available for the 45-49 year check. The primary outcome is detection of risks and health conditions because this is the first step required to get GPs to initiate an action to improve patient outcomes whether this be testing (e.g. STI screening), prescribing (e.g. contraception), managing (e.g. common mental condition), referral (e.g. mental health, dietetics) or education/counselling (e.g. alcohol).We will recruit a cohort of 1,000 16 to 24 year old patients from the clinics to collect information about the impact of the health assessment on their quality of life. This information will inform our economic modelling which will investigate the impact of rebates on downstream health outcomes.

  • Internet Delivered Skills Training for Chronic Pain

    In a recent pilot study (ACTRN: 12620000604909) evidence was promising for the feasibility, acceptability and efficacy of an online skills training for people in chronic pain (internet-delivered dialectical behavioural therapy skills training; iDBT-Pain). We now aim to further investigate the effectiveness of iDBT-Pain in a Randomised Control Trial (RCT). iDBT-Pain is an online training to teach skills for more effective emotion regulation. iDBT-Pain utilises evidence-based protocols for DBT skills training and will be administered according to the DBT Skills Training manual (Linehan, 2015). The intervention includes eight group-based sessions delivered to participants via Zoom, and access to a web app. It is hypothesised that the iDBT-Pain intervention will significantly reduce emotion dysregulation in people with chronic pain. It is further hypothesised that there may be changes in secondary outcomes related to chronic pain, including, pain intensity, pain interference, trauma, depression, anxiety, stress, sleep quality, harm avoidance, coping behaviours, and satisfaction with life.

  • Safety, feasibility and acceptability of a wearable electroencephalography (EEG) device

    Clinical safety study to assess the safety, feasibility and acceptability of a long-term, continuous monitoring, wearable electroencephalography (EEG) device in ischemic stroke patients. The device will be worn for 9 hours by 20 patients with acute ischemic stroke. Eligible participants will have already received treatment and will be in the stroke ward being monitored for at least 9 hours. Participants will be asked to complete a questionnaire at 1, 3, 6 and 9 hours to assess device comfort, acceptability and user experience. Safety will be assessed by the number of adverse events. Feasibility will be assessed as the number of hours of viable data as a percentage of the total recording time. The device will not interfere with standard care.

  • Online clinical trial on a novel topical gel for hand osteoarthritis pain

    This study will be conducted as an online trial. All treatment packages will be shipped to the participant's postage address. Recruitment, and treatment application will be conducted in the participant's residence. This trial will evaluate the effectiveness and safety of new gel (Soodox Active) to reduce pain in hand osteoarthritis. It will be compared to another gel (Voltaren) that is widely used in current practice for a range of pain types and is considered the gold-standard commercial product. The effects on pain will then be measured in both using a 0-100mm Visual Analogue Scale, 100 being the worst pain and 0 being no pain. The participant's quality of life and hand function will also be measured using standardised questionnaires.

  • Medical Cannabis and Its Effects on Driving

    The aim of this study is to determine whether treatment with prescribed medicinal cannabis (containing delta 9-THC) for long-term symptom control impacts driving and cognitive/psychomotor performance. This will be assessed after 4, 8 and 12 weeks of treatment and examined relative to pre-treatment performance in a group of chronic non-cancer pain patients.

  • Injectable antiretroviral therapy feasibility study: JABS

    This is a single-arm, open-label study to evaluate the feasibility and effectiveness of long acting antiretroviral therapy in a "real world" setting, with inclusion of patients with complex social and medical needs and who have been under-represented in randomised clinical trials. Standard assessments of virological suppression and tolerability will be carried out however the study will primarily assess adherence to injections, qualitative aspects of the patient experience and satisfaction with injections as long-term therapy by both patients and providers, compared with patients' previously prescribed oral regimens. The study will also aim to describe the operational changes in clinical service required to deliver LA therapy and the patient and health-service characteristics associated with best outcomes.

  • Gathering patients’, carers’ and doctors’ opinions on the use of blood tests to monitor the treatment of oesophageal, stomach and bowel cancers- a qualitative study

    The aim of this study is to use focus groups to evaluate the acceptability of blood tests and other tests to monitor the treatment of oesophageal, stomach and bowel cancers. Who: You are eligible to join this study if you are aged over 18 years old and have either (1) had treatment for oesophageal, stomach or bowel cancer, (2) provided a support role for someone who has had one of these cancers, or (3) are a clinician who provides clinical care and treatment for these cancers. Study details: All consented participants will take part in a phone interview to collect background details, followed by a 45 minute focus group at the Flinders Centre for Innovation in Cancer, Bedford Park, South Australia. Focus groups will include discussions on the knowledge, trust and experience with tests for monitoring of treatment for oesophageal, stomach and bowel cancers, in particular, blood tests. This research will help to determine the acceptability of different test methods for clinical care, by patients, carers and clinicians. This will help to improve clinical care strategies for cancer.

  • Evaluating the impact of electronic exercise prescription software on compliance with a physiotherapy program

    This study aims to Assess if implementation of an electronic exercise prescription software in the form of a smart phone app improves patient adherence, outcomes, satisfaction and knowledge of their home exercise program compared to paper based exercise programs.

  • Inspiratory muscle training for people with Parkinson's disease

    There is growing evidence that Parkinson’s disease causes weakness of the respiratory muscles, and reduced strength of the inspiratory muscles has also been related to a range of respiratory dysfunctions such as dyspnoea. Substantial evidence shows that inspiratory muscle training has been shown to increase inspiratory muscle strength, reduce dyspnoea, increase exercise tolerance, and enhance quality of life in other populations. In this context, we seek to explore the effects of inspiratory muscle training in people with Parkinson’s disease. Inspiratory muscle training could be an effective intervention in rehabilitation programs for Parkinson’s disease. The potential benefits of such training could include not just increasing muscle strength but also improving daily living activities, reducing dyspnoea on exertion and improving quality of life. As respiratory abnormalities have been significantly associated with increased disability and reduced quality of life in various chronic conditions, any intervention with the potential to improve respiratory function deserves consideration.

  • The Promoting Resilience in Stress Management Intervention for Parents (PRISM-P): A pilot randomised controlled trial in parents of children with Type 1 diabetes

    This project aims to pilot the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention in parents of young children with T1D. PRISM-P consists of four skill-based modules: stress management, goal setting, cognitive restructuring, and benefit-finding. This pilot study aims to examine the acceptability, appropriateness, feasibility, and preliminary efficacy of PRISM-P.

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