ANZCTR search results

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

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31301 results sorted by trial registration date.
  • Effect of Small Particle Size Bronchodilator Aerosol on Small Airway Function in Asthma

    Targeting peripheral airway dysfunction with small particle bronchodilator in asthma This study aims to determine whether the small airways, a site of physiological dysfunction in asthma, can be targeted with bronchodilator therapy, by using a small particle size aerosol that reaches the lung periphery. Current clinical management of patients with asthma includes an array of inhaled therapies. However, there is no consensus relating to the efficacy of different particle sizes for inhalation, despite particle size being the main determinant of where the drug deposits in the airway. Participants with asthma will be invited to participate in two study visits. Both study visits will involve physiological assessments (lung function tests) and ventilation scans completed at baseline and post-bronchodilator. At one visit the standard medication salbutamol will be administered via a conventional vibrating mesh nebuliser (Aerogen solo), at the other visit the salbutamol will be administered via the Aerogen PDAP which will create a fine particle aerosol. The aim is 2 recruit and test 30 participants and compare their response to small and large particle bronchodilator.

  • Mothers Heart Study: an observational study of early pregnancy cardiometabolic risk factors and risk for cardiovascular diseases in later life

    The Mothers Heart Study is an observational prospective cohort study. In this study we recruit pregnant women prior to <16 weeks of gestation to study the association between early pregnancy cardiometabolic risk factors and risk for coronary heart disease at 6 months postpartum.

  • Fruits and Vegetables for Chronic Obstructive Pulmonary Disease (COPD): A Cross-Sectional, Observational Study

    Purpose of study: Fruits and vegetables are known for their many health benefits, with research suggesting they may improve respiratory and inflammatory outcomes in people with COPD, However the relationship between fruits and vegetables and COPD is still being explored. This study aims to compare fruit and vegetable intake in participants with COPD versus healthy control participants, with the goal of identifying any significant differences in fruit and vegetable intake between the two groups. By comparing fruit and vegetable consumption levels, this study aims to explore whether individuals with COPD tend to consume fewer servings compared to people without COPD, potentially due to factors related to their COPD, such as reduced appetite, physical limitations, or lifestyle changes influenced by symptoms of their condition. We hypothesise that participants with COPD consume significantly fewer serves of fruits and vegetables compared to healthy controls, and a higher fruit and vegetable intake is associated with fewer respiratory symptoms in individuals with COPD.

  • Evaluating the effect of a digital health app for self-management and telehealth support for high-risk asthma patients on the frequency of hospital visits

    Asthma is a serious but manageable condition. We will evaluate whether a digital platform and mobile app co-designed by consumers, clinicians, and researchers reduces asthma hospitalisation in a disadvantaged community. Our model of care empowers patients, their families, and health care professionals to optimise the management of asthma, thus improving outcomes, saving lives, and reducing healthcare costs.

  • Cognitive Fluctuations in Delirium

    This research project aims to obtain information to better diagnose delirium, which commonly affects older adults. Delirium is often poorly diagnosed and result in many negative consequences for the affected person. This research project will aim to first determine how many people living in the three participating residential aged care facilities are diagnosed to suffer from delirium on one selected day. It will then examine some people with delirium more closely and compared them with people suffering with dementia but not delirium.

  • Can a nerve block during surgery reduce pelvic pain and opioid use in women with endometriosis?

    This study is testing whether a targeted nerve block performed during laparoscopic surgery can help reduce pelvic pain after surgery in women with endometriosis. The nerve block, called a Superior Hypogastric Plexus (SHP) block, is a low-risk anaesthetic injection given while the patient is asleep during surgery. The goal is to see if it reduces the need for strong pain medications like opioids and improves recovery. The study will compare two groups: one receiving the SHP block and one receiving a placebo injection. We believe the SHP block group will have lower pain scores and require fewer medications after surgery.

  • Wearable Technology and Fatigue study

    Sophisticated wearable sensors now exist that can collect an almost continuous stream of physiological data. These sensors have evolved from simple fitness tracking devices to multifunctional, compact, and versatile sensors, which can be integrated into clothing or attached to the body to monitor our physiology & interact and communicate. While the sensors have rapidly evolved & become highly sophisticated in recent years, there remains many issues with the algorithms used to analyse the sensor data. They are imprecise, often inaccurate & frequently misinterpret data, incorrectly labelling movements as ‘steps’ or reading a book as ‘sleep’. This incongruity creates a reluctance to use & rely on these wearable sensors, even though their potential to provide increased awareness about physiological and mental state is tremendous. The standard software also frequently relies on averaged and aggregated data for any predictions about state, rather than tailored to the individual. If wearables are to be used in a variety of complex, austere environments (those where access to resources is significantly limited or unavailable) personnel must be able to trust not only the sensors to measure signals accurately but also the algorithms & software to analyse & interpret the data correctly. There is a need for more accurate, sophisticated algorithms to take advantage of the next generation sensors on the market and a more personalised, individual approach is needed to build trust and increase acceptance. Using deep expertise in understanding individual performance dynamics over time, under different environments and conditions to refine novel algorithms.

  • THE PRIMARY BREATHE AUSTRALIA TRIAL: Breathlessness Self-Management in Primary Care

    This study aims to evaluate the effectiveness of the ‘Primary Breathe Australia self-management intervention’ for chronic breathlessness. Who is it for? You may be eligible for this study if you are a male or female, aged 18 or over, and expected survival of 3 months at time of recruitment. You must have a clinician-confirmed diagnosis of at least one of the following CRDs: chronic obstructive Chronic obstructive pulmonary disease (COPD), Interstitial lung disease (ILD), Chronic asthma, Bronchiectasis, and lung cancer. Study details Participants will be randomly assigned to either intervention arm (Primary Breathe Australia self-management intervention) or treatment as usual. The Primary Breathe Australia self-management intervention consists of at least 2, but up to 3, one-on-one clinical consultations delivered over an 8-week period (or shorter period according to patient preference) by the Primary Breathe Australia nurse who is embedded within the primary care or residential aged care site. Each consultation is expected to last 20-60 minutes. The content of the interventions will involve patient assessment, general chronic breathlessness education, non-pharmacological self-management education, and provision of digital resources developed for the intervention. During and after the intervention, participants will be assessed using questionnaires for breathlessness, qualify of life, distress, anxiety, depression and fatigue. It is hoped that this research will demonstrate a scalable approach to improving the management of chronic breathlessness, leading to better symptom control and quality of life for people living with chronic respiratory conditions and other diseases.

  • The FAST WALK Study - Functional assessment for surgery by a timed walk.

    The FAST Walk study is a multicentre prospective cohort study that aims to enrol 1672 participants in Canada and Australia. The FAST Walk study will evaluate the association of 6MWT distance and 3 tests completed before surgery with outcomes assessed at 30 days and 90 days after major non-cardiac surgery. The primary aim of the study is to determine whether preoperative 6MWT distance adds prognostic value to usual clinical factors for predicting 30-day major postoperative complications. We hypothesise that a 6MWT will improve prediction of complications are elective non-cardiac surgery.

  • Implementation of a digital insomnia treatment pathway for co-morbid insomnia and sleep apnoea (COMISA) in Australian sleep clinic settings.

    Comorbid insomnia and sleep apnoea (COMISA) is a prevalent and debilitating disorder in Australian sleep clinic settings. The recommended treatment for insomnia is Cognitive Behavioural Therapy for insomnia (CBTi). CBTi is effective in patients with comorbid sleep apnoea. However, very few patients with COMISA access CBTi. Digital CBTi programs are an effective and potentially scalable intervention to manage insomnia. There are currently no publicly-available self-guided digital CBTi programsin Australia that provide personalised weekly behavioural therapy recommendations, and no programs tailored for COMISA. This randomised controlled implementation trial will recruit two sub-groups of patients with COMISA; 1. At least 140 patients that have been recommended Positive Airway Pressure (PAP) therapy by a treating clinician, and 2. Up to 140 patients that have not been recommended PAP therapy. This trial aims to investigate the feasibility and effectiveness of a digital CBTi referral pathway for people with COMISA in Australian sleep clinic settings. Patients that are referred, eligible and consent to participate will be randomised 1:1 (stratified by sub-group) to a digital brief CBTi program, versus waitlist education control. The RE-AIM framework will be used to investigate the effectiveness and implementation of the intervention. Reach o Sleep and Respiratory Physicians in all States/Territories of Australia will participate. o At least 50 Sleep and Respiratory Physicians will be recruited. Effectiveness o The CBTi group will report a greater improvement in symptoms of insomnia, depression, and fatigue from baseline to 8-weeks, and baseline to 24-week follow-up (primary time point), compared to the education control group. o Among a sub-group of 140 patients recommended PAP therapy, the CBTi group will report greater nightly average use of PAP therapy at 24-week follow-up (primary time point) compared to the education control group. Adoption o There will be an increasing number of patients referred to the study per month of the study. o At least 400 patients with suspected COMISA will be referred. o At least 80% of patients allocated to the intervention group will commence the digital CBTi program. Implementation o Qualitative interviews with Physicians and patients will indicate that the pathway and CBTi program is acceptable and feasible. o At least 60% of patients allocated to the intervention group will complete the full 5-session program. Maintenance o There will be an increasing number of patients referred to the study by participating sleep physicians per month of the study. o Improvements in insomnia, depression, and fatigue following digital CBTi will be sustained by 24-weeks. o Qualitative interviews with Physicians and patients will indicate interest in sustained access to the pathway after conclusion of the study.

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