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Randomized trial of medical therapy versus conduction system pacing with atrioventricular (AV) node ablation in persistent atrial fibrillation (AF) and heart failure with preserved ejection fraction
Expand descriptionIn patients with permanent AF and HFpEF the beneficial effects of conduction system pacing with left bundle branch area pacing (LBBAP) and AV node ablation remains unclear. In particular, there is a lack of data on invasive haemodynamic profiling, exercise capacity and natriuretic peptide changes in patients who undergo conduction system pacing with AV node ablation compared to medical therapy alone. Therefore the aim of this research project is to conduct a single centre, randomized controlled trial of conduction system pacing with AV node ablation, versus medical therapy, in an AF and HFpEF cohort. We will compare the structural and functional cardiac remodelling changes that occur over time in both groups utilizing exercise haemodynamic measurements.
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The role of pharmacological heart failure therapy in LV recovery following INDEX catheter ablation for patients with atrial fibrillation (AF) induced cardiomyopathy - the INDEX-AF Study
Expand descriptionWe propose a randomised control clinical trial to explore whether patients with AF-induced cardiomyopathy undergoing catheter ablation can avoid anti-heart failure pharmacotherapy. Patients will be randomised to recieve anti-heart failure pharmacotherapy (control) versus monitoring without anti-heart failure pharmacotherapy (intervention). The primary outcome will be difference in left ventricular ejection fraction at 6 months.
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Triggered Acute Risk Prevention (TARP): Effect of a Novel Model of Care on Cardiovascular and Mental Health Outcomes.
Expand descriptionCardiovascular disease (CVD) remains Australia’s leading cause of death. Current prevention strategies focusing on chronic risk factors and daily treatment fail to fully explain the risk of CVD. We and others have identified acute triggers in almost half of heart attacks, yet until now, this information has not been used for prevention. In a placebo-controlled double-blind study of 120 participants with cardiovascular disease (CVD) or >=2 risk factors, we will evaluate a Triggered Acute Risk Prevention (TARP) strategy for the triggers of acute emotional stress (anger and anxiety), physical exertion, heavy/fatty meals, respiratory infection and pollution. The TARP strategy will empower individuals to recognise these triggers and respond appropriately by taking preventative medication and/or accessing app-based trigger-related educational resources. The goal is to lower acute psychological stress responses and to reduce cardiovascular risk.
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Is Achilles tendinopathy pain education with or without exercise, more effective than usual care, in improving pain cognitions in those with midportion Achilles tendinopathy? A pilot and feasibility study
Expand descriptionAchilles tendinopathy is a common injury amongst both athletic and non-sporting populations. (1-3). Despite the best efforts of various rehabilitation approaches. there is evidence to suggest that 1 in 5 of those with Achilles tendinopathy will remain symptomatic after 10 years.(4). There is emerging literature supporting cognitive-based interventions in chronic pain conditions. (5, 6) It is thought that pain neuroscience education can assist patients in reconceptualizing their pain by improving knowledge regarding their condition.(5, 6, 7). However, whilst there is support for the use of education in other chronic pain conditions it is yet to be applied as a stand-alone intervention in Achilles tendinopathy. There is evidence to suggest that the psychological profile of those with Achilles tendinopathy resembles those with chronic lower back pain, with both conditions presenting with a similar prevalence of kinesiophobia. (6) Therefore, we wish to determine the feasibility of conducting a randomized controlled clinical trial that evaluates whether the addition of a previously developed Achilles Tendinopathy Pain Education (ATPE) (7) to usual care has added benefit in improving maladpative pain-related cognitions in Achilles tendinopathy. References: 1. Lopes AD, Hespanhol Júnior LC, Yeung SS, Costa LO. What are the main running-related musculoskeletal injuries? A Systematic Review. Sports Med. 2012 Oct 1;42(10):891-905. 2. Malliaras P. Physiotherapy management of Achilles tendinopathy. Journal of Physiotherapy 2022;68:17. 3. Visser ST, van der Vlist A, van Oosterom R, van Veldhoven P, Verhaar J, de Vos R. Impact of chronic Achilles tendinopathy on health-related quality of life, work performance, healthcare utilisation and costs. BMJ open sport & exercise medicine. 2021;7(1). 4. Lagas IF, Tol JL, Weir A, de Jonge S, van Veldhoven PLJ, Bierma-Zeinstra SMA, et al. One fifth of patients with Achilles tendinopathy have symptoms after 10 years: A prospective cohort study. Journal of Sports Sciences. 2022;40(22):2475-83. 5. Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016;32(5):332-55. 6. Smitheman HP, Lundberg M, Härnesand M, Gelfgren S, Grävare Silbernagel K. Putting the fear-avoidance model into practice – what can patients with chronic low back pain learn from patients with Achilles tendinopathy and vice versa? Brazilian Journal of Physical Therapy. 2023;27(5):100557. 7. Post AA, Rio EK, Sluka KA, Lorimer Moseley G, Bayman EO, Hall MM, et al. Effect of pain education and exercise on pain and function in chronic achilles tendinopathy: Protocol for a double-blind, placebo-controlled randomized trial. JMIR Research Protocols. 2020;9(11).
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Improving Access to Hernia Surgery: A Study of Same-Day Procedures in Public Hospitals
Expand descriptionThis study aims to evaluate the effectiveness of a dedicated short-stay hernia surgery service for adults undergoing elective repair of abdominal wall or groin hernias. The intervention involves performing laparoscopic or open surgical hernia repairs as same-day procedures, focusing on minimally invasive techniques and intraoperative nerve blocks to support early recovery. The study will assess postoperative outcomes, including complications and quality of life, through structured follow-up at 4 weeks and 12 months. The hypothesis is that same-day hernia surgery will improve access to care and patient outcomes in the public healthcare setting.
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A comprehensive DIGITAL solution To Empower Asthma and comorbidity self-Management. The DIGITAL TEAM study.
Expand descriptionTo improve education, medication adherence, and symptom monitoring in people with asthma, a comprehensive digital program To Empower Asthma and comorbidity self-Management (DIGITAL TEAM) has been developed, to be implemented by Asthma Australia. This randomised controlled tele-trial aims to explore how effective this program is in improving asthma outcomes for Australians with Asthma, compared to enhanced usual care. 1100 adults with asthma will be recruited and randomised into one of two arms. Control arm participants will be provided with educational materials about asthma and a recommendation to see their GP. Intervention arm participants will be referred to Asthma Australia, who will provide access to the DIGITAL TEAM program, which includes 2+ telehealth sessions, a smartphone application, text messages and a website. Follow-up interviews will be conducted at 3-, 6-, and 12-months post-randomisation. The primary outcome of this study is Asthma Control over 6-months.
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Radioprotective effects of parthenolide lotion against skin injury caused by radiation in people with head and neck cancer
Expand descriptionWho is it for? You may be eligible for this study if you are a male or female, aged 18 or over, and diagnosed with locally advanced cancer of the head/neck, scheduled to received equal bilateral radiation+/-chemotherapy (cisplatin/5FU). Study details Participants will be given the skin lotion with 1%parthenolide, applied to one side of the head/neck, with the comparator (placebo) applied to the other side. [Describe what is involved for participants] During and after the intervention, participants will be assessed for radiation induced dermatitis (RID) using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and Radiation-Inducted Skin Reaction Assessment Scale (RISRAS tool) by reviewing of medical data. Skin samples will also be collected from willing participants using a non-invasive tape method which just collects the top layer of cells. This will be performed at baseline and 3 weeks into treatment. It is hoped that this research will demonstrate the effectiveness of a parthenolide-based skin cream in a safe and evidence-based solution to protect patients' skin during radiotherapy.
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Feasibility and Acceptability of a Digital Holistic Prehabilitation and Rehabilitation Program for Endometriosis Surgery Patients
Expand descriptionEndometriosis is a gynaecological syndrome that is associated with substantial pelvic pain and dysmenorrhea and is defined as the presence of endometrial-like tissue outside the uterus. This condition affects between 1 and 39% of women (including people assigned female at birth) during their reproductive years, and is associated with poor quality of life and sleep, anxiety, and depression. Endometriosis can directly cost each person between US$1459 and US$20,239 and indirectly cost as high as US$14,079 Diagnosis is often dependent on surgical findings, with a substantial number of people undergoing laparoscopic surgery to obtain a definitive diagnosis. To our knowledge, no studies exist that specifically compare pain, quality of life, self efficacy, and anxiety outcomes beyond the hospital stay, between people undergoing laporoscopic surgery for endometriosis that have and have not undertaken prehabilitation or rehabilitation programs. Thus, it is not known whether prehabilitation/rehabilitation programs can enhance recovery from endometrial laparoscopic surgery This study aims to assess the feasibility and acceptability of a holistic digital prehabilitation and rehabilitation program tailored to people undergoing surgery for suspected endometriosis, called the Matilda program( www.matilda.health). This aims to provide data for the planning of a larger scale clinical controlled trial. In addition, this study aims to determine whether any improvements to the intervention can be made. The methods include the use of a mixed method convergent feasibility study, delivered to participants undergoing laparoscopic surgery via three online surveys (one at baseline, one immediately prior to surgery and one 4 weeks after surgery). One group will be those that undergo the Matilda program (4 weeks of prehabilitation prior to surgery and 4 weeks of post surgery rehabilitation). The other group will be those that do not undergo the Matilda program. In addition, gynaecologists will also be invited to fill out a survey and provide number of participants that have been provided with recruitment materials. The outcomes that will be examined include pain, anxiety, rating of most troublesome symptoms, quality of life, self efficacy, surgical anxiety. In addition acceptability variables from a prior survey developed by Sekhon et al will also be examined, such as affective attitude, burden, ethicality, perceived effectiveness, intervention coherence, patient self efficacy, opportunity costs and general acceptability. In addition domains from Bowen's framework for acceptability and feasibility will also be examined.
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CogCoach-Health Randomised Controlled Trial - a lifestyle program targeting brain health in people with cognitive concerns
Expand descriptionThe aim of this project is to support healthy brain ageing and reduce dementia risk in older adults by providing education and strategies for implementing lifestyle modifications to improve cardiovascular, metabolic and cognitive health. This intervention could provide a widely accessible and cost-effective program to support healthy ageing and reduce dementia risk. We hope to be able to implement this program to the wider public and envisage that it could be a resource used in primary health care to support ageing Australians who express concerns about their cognition or who have demonstrated mild cognitive impairments.
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Identifying Factors Contributing to Variability in the Ovarian Response to Follicle Stimulating Drugs among Women Undergoing In-Vitro Fertilisation (IVF)
Expand descriptionThe purpose of the project is to understand the factors that influence how a woman undergoing IVF responds to follicle stimulating drugs. We know that the response to follicle stimulating drugs varies between women, and this impacts the number of eggs (oocytes) retrieved and resulting chance of a successful pregnancy. Using the data from this project, we hope to be able to better understand how a woman will respond to follicle stimulating drugs. This information will help us personalise treatment for IVF patients.