ANZCTR search results

Patient-led screening for atrial fibrillation (AF) using handheld mobile electrocardiogram (ECG) devices at their homes may help in detecting AF. However, there is no established system to facilitate the diagnosis and management of AF when a suspected case is detected. Therefore, we aim to study whether we can implement an AF screening program using handheld mobile ECG devices integrated with a cardiac centre at Westmead Hospital, New South Wales, that is able to confirm the diagnosis and facilitate appropriate management of new AF. Participants are given a handheld mobile ECG device and they will receive training in using the device. They will involve in the study for a period of 12 months. Participants randomised to the intervention group will commence monitoring straight away while participants in the control group will wait for 6 months to receive the handheld ECG device. During the waiting period, they see their general practitioners (GPs) for usual care. Participants record a 30-second daily ECG on weekdays. ECGs will be automatically transmitted to Westmead Cardiology Department and monitored by trained technicians. Participants and their GPs will be notified of ECG abnormality and GPs can access support from cardiologists involved in this research. The primary outcome at 6-month follow-up (or when AF is diagnosed, whichever occurs first) is the proportion of participants’ reporting being very satisfied/satisfied that their heart rhythm was being monitored in the past 6 months in the intervention group compared to the control group.

To date, there is an absence of specific studies evaluating peer support services for individuals with BPD. This study aims to explore whether a peer support group model is helpful for individuals with BPD. Individuals with BPD will also complete a questionnaire prior to starting the group program to measure mental health symptoms before and after the group program. It is hypothesised that participants in the intervention group will experience an improvement in mental health symptoms and BPD symptoms, and that participants in the waitlist condition will experience no change.

This is an early phase pilot study designed to test the safety and feasibility of using a novel, wireless, wearable device (Leo) for assessing respiratory parameters (lung volume, respiration rate, heart rate and indices related to tidal breathing flow volume loop) in children with and without respiratory conditions (such as asthma) There is no product on the market currently that is comparable to this novel Leo device This study is a single visit to evaluate the correlation between breathing signals collected by the Leo device with those collected through lung function tests. 40 children will be included. 20 children with clinically stable asthma and 20 healthy children There will be no disease-specific intervention, nor changes to the participant’s care management program for their asthma

The PRESIDE Trial is a double-blind RCT of pharmacogenomically-informed prescribing of antidepressants on depression outcomes in patients with major depressive disorder in primary care. Participants who have depressive symptoms will be randomly allocated to one of two groups and neither they, nor their GP, nor the researchers will be aware of which group they are in. One group will receive recommendations for which antidepressant drugs may be most effective for them based on how their DNA impacts how they break these drugs down. The other group will receive recommendations for antidepressant drugs based on current Australian guidelines. All participants, regardless of which group they are in, will decide with their GP which antidepressant, if any, is best for them. This trial addresses significant knowledge gaps related to how clinically useful this type of pharmacogenomic (DNA) test may be in managing patients with major depressive disorder in primary care. It will create evidence about the efficacy, safety, and cost-effectiveness of this approach, working with health service delivery partners and research end-users to ensure the findings can be implemented into practice as quickly as possible.

The Be Well Plan comprises of five online group sessions (2 hours each) which are delivered by trained facilitaters. The program helps participants identify strategies to build and maintain strong levels of mental health, wellbeing and resilience. A particular strength of the program is that participants develop their own, personalised wellbeing plan including activities that they identify as beneficial during participation in the program. All activities in the Be Well Plan are evidence-based and were selected from an extensive meta-analysis of psychological interventions to improve mental wellbeing conducted by the team members. The proposed research aims to investigate the efficacy of the Be Well Plan in a cohort of Flinders university students. We plan to recruit 120 student who will be randomised to the interactive, online facilitated version of the Be Well Plan intervention or to a wait-list control condition. Validated measures will be used to assess psychological distress (i.e., anxiety, mood and stress), wellbeing (emotional, social and psychological), and resilience in order to evaluate pre- to post-intervention changes.

The 2019/2020 bushfire season has had a widespread impact on the health and wellbeing of people in Australia. Exposure to air pollutions, such as bushfire smoke, during pregnancy and early childhood is associated with health impacts later in childhood. Additionally, pregnant and breastfeeding women with respiratory conditions, such as asthma, are particularly vulnerable to bushfire smoke exposure. The purpose of the research is to investigate the impacts of bushfire smoke exposure on health outcomes of vulnerable groups (pregnant and breastfeeding women) with and without asthma, particularly evaluating the impact of smoke on respiratory symptoms, wellbeing, and maternal concerns and behaviours ( e.g. exposure reduction strategies, medication use, and infant feeding practices). The information from this project will inform guidelines and health messages (developed and disseminated with our partner groups) for pregnant and breastfeeding women with and without asthma, and healthcare providers. Further, it enhances bushfire preparedness and responses by explaining effective preventive strategies to reduce smoke exposure and treatment. Women who agree to participate in this study will fill out a baseline survey online, via telephone or a paper-based copy. After completing the baseline survey, participants will be invited to complete two follow up surveys during and after the next bushfire season in 2020/202. The follow-up surveys will also be via online, via telephone or paper-based options.

The objective of the study is to assess the safety and feasibility of using the Millipede System to remove occlusive thrombus and improve blood flow in subjects experiencing an ischemic stroke due to large vessel occlusion.

This study aims to pilot an intervention (SIBS-ONLINE) for siblings of children with chronic illness to ensure it: 1) addresses the ongoing realities of siblings’ potential caregiving responsibilities; 2) addresses issues unique to being a sibling of a child with chronic illness; 3) allows siblings to meet and interact with other siblings; 4) improves family communication and family functioning. The original intervention (called SIBS) was developed by Prof Fjermestad and Dr Vatne and their team in Norway. We are working with consumer representatives from Canteen Australia to modify the intervention for an Australian audience. Part of the modification has been to deliver the intervention via video-conferencing. This new, updated version of the intervention for Australian families is called SIBS-ONLINE. Who is it for? Eligible participants will be adolescents aged at least 12 years and at most 18 years of age, who live with at least one brother or sister with a chronic illness who has been diagnosed greater than or equal to 6 months prior to the study. One of the siblings’ parents will also be eligible to participate. Participants must be able to give informed consent and speak/read conversational English. All participants will be required to have access to the internet and a computer/smartphone/tablet with web-cam and microphone. Details of the study The SIBS-ONLINE intervention consists of four sessions delivered via video-conferencing (e.g. Skype) by group leaders (two with only parents and two with only siblings) and two homework and feedback sessions at home. The sibling sessions will focus on discussing emotions, thoughts, and feelings about their siblings’ chronic illnesses and questions they might ask of parents. The parent sessions focus on learning about challenges common to siblings and encouraging open-exploratory communication with their children. The homework and feedback sessions will be conducted with siblings and their parents together. Clinical staff and psychosocial researchers from BSU and Canteen will be trained and act as group leaders for the parent and sibling groups.

This study tests patient-led surveillance which is a new way of following up people who have had an early melanoma (in situ melanoma or stage I or II invasive melanoma). Patient-led surveillance combines skin self-examination and teledermatology, which involves taking pictures of skin lesions on your body with a device attached to your smartphone and uploading these images for a dermatologist to review remotely. This study will investigate if this type of follow-up can diagnose new or recurrent melanoma earlier than if regular clinic visits with the patient’s doctor is used alone. Who is it for? You may be eligible for this study if you are 18+ years old, have previously had surgery to remove a melanoma in-situ or early invasive melanoma (stage I or II), own a smartphone, are being followed up at a recruiting dermatology clinic, skin cancer specialist clinic or general practice clinic, and have a suitable study partner (spouse, partner, family member, friend) to help with skin self-examination. Study details Participants will be screened via questionnaire, asked to view videos on skin self-examination and to upload test photos via the secure web-based platform. On satisfactory completion of these tasks they will be randomly allocated to either a patient-led surveillance or clinician-led surveillance arm. Clinician-led surveillance: Educational booklet, regular scheduled appointments with treating clinician, access to unscheduled appointments as required. Patient-led surveillance: All components of clinician-led surveillance as well as a mobile dermatoscope and smartphone app for taking detailed photos of skin lesions, training in skin self-examination and in using the dermatoscope, and access to timely remote dermatology review of any concerning lesions. Participants will be asked to complete online questionnaires and patient diaries. Their clinical data and any relevant diagnoses will also be collected. Information from this study will allow investigators to document the efficacy of patient-led surveillance in terms of melanoma diagnoses and resource use.

MEMOIR aims to evaluate the efficacy of oral memantine and the effectiveness of Graded Motor Imagery (GMI) on pain intensity and pain interference at 16 weeks in people with chronic Complex Regional Pain Syndrome, in a 2 x 2 factorial RCT. Participants will be randomised to one of 4 groups: memantine plus GMI; memantine plus usual care; placebo memantine plus GMI; placebo memantine plus usual care. We hypothesise that memantine and GMI will produce clinically meaningful reductions in pain intensity and pain interference.