ANZCTR search results

The research project aims to conduct a multicentre trial with 204 caregivers (34 in each of the six study sites) in a 9 month period to evaluate the effectiveness and cost-effectiveness of the Chinese version of WHO iSupport program. The hypotheses tested in the study are described in the following: 1. The generic web-based Chinese iSupport version Carers receiving the iSupport program will report improved quality of life; improved self-efficacy and report improved social support compared to the usual care group at a 6-month follow-up. 2. Compared to those allocated to the usual care group, carers receiving the iSupport program will report reduced dementia related symptoms of the person they care for; report improved quality of life of the person they care for via proxy rating and report fewer unplanned hospital admissions, less emergency department use and less use of permanent residential aged care by the person they care for. 3. The iSupport program will be more cost-effective than the usual care support.

Fathers' perinatal mental health is a major public health issue, but few fathers seek or are offered mental health support. Emerging evidence suggests that fathers prefer informal, digital methods of perinatal support, but currently few tools exist for them to access. This research project aims to evaluate an app-based mindfulness-CBT intervention for fathers mental health using an RCT design. A secondary, exploratory aim is to investigate the usefulness of social media data for identifying fathers in-need of support. The hypothesis is: Participants allocated to the smartphone intervention will experience significantly greater reductions in mental health symptoms, parenting self-efficacy, and infant bonding at post-test (4 weeks from baseline) relative to participants allocated to the wait-list control.

Impaired hand function is a common cause of everyday disability for people with Parkinson’s disease (PD) and can contribute to difficulties in work and leisure activities and daily tasks such as personal care and dressing. Changes in dexterity are also closely associated with reduced quality of life. Despite this, there is little evidence to guide physiotherapy or occupational therapy management of this problem. The primary aim of this pilot randomised controlled trial is to investigate the whether this novel home-based training program, targeted to improving hand function in people with PD, is feasible and acceptable to participants. Participants will be randomly allocated into a training group or a usual care group. The training group will undertake a home-based hand training program and the control group will continue with their usual care. Participants in the training group will be provided with home exercise instructions using an online exercise prescription application with uploaded exercises and will be asked to complete the training for 30 minutes, three times a week for four weeks, The training program will be monitored remotely once a week via telerelerehabilitation. Following the 4-week program there will be two further 30-minute telerehabilitation coaching sessions at 8 and 12 weeks. Main outcome measures relate to feasibility and include recruitment and retention, participant adherence and satisfaction with the program, and adverse events. Secondary outcomes are associated with the effectiveness of the program and include assessment of fine hand skills and self-reported hand function. Participants will be assessed before randomisation (baseline), post-training (4 weeks), and at 12 weeks and 24 weeks. We hypothesise that the study will show good feasibility with strong retention, adherence and high satisfaction with the program.

The ADELE clinical trial seeks to improve outcomes for people with high-risk endometrial cancer, who have a significant risk of relapse after standard post-operative treatment with chemotherapy & radiotherapy. Who is it for? You may be eligible for this study if you are aged 18 or older, have been diagnosed with high-risk endometrial cancer, have completed prior surgical treatment with total hysterectomy, have not received any prior chemotherapy or pelvic radiotherapy, and are planned for adjuvant chemoradiation. Study details Participants will be randomly (by chance) assigned to one of two groups. One group will receive a sequential adjuvant treatment of pelvic chemoradiation, followed by 4 cycles of the new combination therapy with Tislelizumab and carboplatin plus paclitaxel chemotherapy, followed by Tislelizumab for another 8 cycles. The other group will receive the same treatment (standard treatment) without the addition of Tislelizumab. Participants will be followed up for 12 months to assess for relapse of endometrial cancer and symptoms of treatment. It is hoped that this study may improve relapse rates in high-risk endometrial cancer by adding Tislelizumab immunotherapy to standard treatment.

The focus of this research is on anterior drooling (spillage of saliva from the mouth that is clearly visible). Many children with cerebral palsy (CP) experience difficulties controlling saliva. Potential reasons for this clinical feature of CP include: a reduction in swallowing ability; oral motor dysfunction, and hypersalivation; resulting in anterior loss of saliva from the mouth. Drooling can be a disabling condition for children with CP, adversely affecting physical health, emotional health, social interactions and self-esteem. These health impacts include skin maceration and skin breakdown; aspiration pneumonia and significant respiratory compromise; and social rejection from peers. Drooling has also been shown to increase the care needs of the child, putting families under increased stress. Thus, drooling has the potential reduce the quality of life of both children with CP and their families. A treatment approach that holds promise in improving swallowing and reducing swallowing in children with CP is the Lee Silverman Voice Treatment Approach (LSVT LOUD®), which is founded on neuroplasticity- and motor learning principles. This intensive voice treatment approach has level IV efficacy in improving speech, and has also resulted in significant improvement in swallowing in adults with Parkinson's Disease. Early phase I clinical outcome research has shown similar speech improvements in children with CP; and it is therefore reasonable to hypothesis that similar improvements in swallowing ability may occur, which in turn may facilitate a reduction in drooling.

Patients with non-obstructive coronary artery disease, who have had a comprehensive invasive coronary physiology assessment, will be asked to undergo a research cardiac MRI within two weeks of their invasive assessment. The results of the MRI will be compared to the invasive assessment. This will provide information on the utility of the new MRI method for diagnosis of coronary microvascular dysfunction.

This study is investigating the safety of administering heated (42 degrees Celsius) versus normal temperature (37 degrees Celsius) chemotherapy during surgery for ovarian cancer patients. Who is it for? You may be eligible for this trial if you are a female aged 18-75 years who has been diagnosed with primary stage III epithelial ovarian, fallopian tube or peritoneal cancer with disease that is limited to the abdominal cavity. You must have had 3-4 cycles of pre-operative platinum-based chemotherapy and be fit for surgery. Study details Participants will receive cisplatin chemotherapy administered intraperitoneally to the abdominal cavity during surgery. They will randomly be allocated to either a hyperthermic arm, who will receive the chemotherapy drug heated to 42 degrees Celsius, or a normothermic arm who will receive the drug at normal body temperature of 37 degrees Celsius. Follow-up information about adverse events, quality of life and disease outcomes will be collected following the surgery. Information from this study will be used to design future trials evaluating the efficacy of heated chemotherapy.

This pilot, feasibility randomised controlled trial (RCT) will recruit 42 people with knee osteoarthritis who have completed the GLA:D® Australia program. Consenting participants will be randomised to an additional intervention to promote physical activity (motivational interviewing and web-based support), or usual care (continuation of exercises and self-management learnt in GLA:D®). Objectives: The primary objective is to determine the feasibility (eligibility and recruitment rates; adherence to motivational interviewing sessions, drop-out rate, credibility of the intervention) of conducting a fully powered trial to evaluate the clinical effectiveness (i.e. increasing physical activity) of using SUpported Motivational InTerviewing (SUMIT) targeting physical activity following completion of a widespread exercise-therapy program (GLA:D®) in people with knee osteoarthritis. Secondary objectives include: • To determine if a worthwhile treatment effect could be observed for physical activity, physical endurance, joint-related quality of life (QoL), health-related QoL and pain. • To refine SUMIT through qualitative feedback from participants.

Alyra Biotech Pty Ltd is an Australian-owned biopharma company that wishes to develop an optimal intrauterine contraceptive device (IUCD) for young women with period or pelvic pain. We wish to determine the priorities of two end-user groups: women who may choose an IUCD for contraception or other health concerns, and Health Practitioners who advise women regarding the risks and benefits of IUCD use. Intrauterine devices are chosen as a form of contraception by 14% of women worldwide, with use of levonogestrel-releasing intrauterine devices increasing globally. However, some women experience increased pelvic pain in the 3-6 months after insertion. We wish to research the experiences, perspectives and preferences of both end-user groups to assist us in planning an optimal device for women with pain. The views and experiences of our end-user groups will guide our product development. Finally, to ensure that our product is commercially feasible, we wish to determine the cost premium that users, or prescribers, of the device would accept for such a device. The primary objectives of this study are: 1. To determine the market potential for an intrauterine device that reduced pain in the first 3 months post-insertion by 50%. 2. To determine whether these women whether these women would be prepared to pay a price premium for such a device sufficient to justify device commercialisation. 3. To determine whether Health Practitioners who offer intrauterine contraceptive devices would prefer a device that reduced pain by 50% in the first 3 months post-insertion. 4. To investigate whether Health Practitioners believe their patients with dysmenorrhea or Chronic Pelvic Pain would pay a price premium for an IUCD that reduced post insertion pain compared with their patients who are pain free.

Inadequacies in nursing assessment practices and clinical handover communication compromises early identification of risk of clinical deterioration, inpatient falls and pressure injury. The aim of this trial is to implement and evaluate the feasibility and effectiveness of a ward-level intervention (ACCELERATE) to improve bedside patient assessment and clinical handover. The ACCELERATE Intervention requires nurses to: i) undertake comprehensive assessments on every patient at the beginning of every shift; ii) communicate findings to the multidisciplinary team and iii) implement strategies to monitor and manage at an early stage clinical deterioration and risk of pressure injury and falls. Expected study outcomes are a reduction in the incidence of deteriorating patients, medical emergency team calls (rapid response and cardiac arrest); unplanned intensive care unit admissions; and hospital-acquired complications of falls, and pressure injuries. Evidence-based strategies will be used to implement the ACCELERATE intervention, including: formal education; barriers and facilitator analysis; multi-level multidisciplinary clinical leadership, external facilitation, audit and feedback, and reminders. Regular follow-up meetings will be conducted throughout implementation, as well as ongoing educational/facilitated outreach visits and audit and feedback progress sessions to assist in embedding change and addressing barriers.