ANZCTR search results

The study is a randomised controlled trial investigating the effect of 6 weeks of immuno-nutrition supplementation on post-procedure vascular complications and hospital length of stay in patients with peripheral arterial disease scheduled for revascularisation procedure. It is hypothesized that supplementation with an immuno-nutrient containing supplement will lead to improved clinical outcomes in patients with peripheral arterial disease through the attenuation of the inflammatory process component of atherosclerosis. Intervention participants will receive individualised supplementation for 2 weeks prior to the revascularisation procedure and 4-weeks post -procedure under the direction of an Accredited Practicing Dietitian. Control participants will receive usual clinical care where no immune-nutrition supplementation is provided. All participants will be followed up at 1-, 3-, 6- and 12-months post-procedure as apart of usual clinical care.

The aim of the study is to find out if oral antibiotics can be used instead of immunoglobulin (Ig) for preventing infections in patients with blood cancers, and if the oral antibiotics should be taken every day or only once symptoms of infection occur. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have an acquired hypogammaglobulinaemia secondary to a haematological malignancy, and have received Ig treatment for over 6 months. Study details Participants will be randomised (allocated by chance) to one of three treatment groups, as follows: - stop Ig, and be given oral antiobiotics (such as co-trimoxazole (Trimethoprim-sulfamethoxazole) 160mg/800mg) to take every day - stop Ig, and be given oral antibiotics (amoxycillin/clavulanic acid 1750-2000mg/250mg and ciprofloxacin 750 mg) to keep at home, and used only if infection symptoms occur - continue receiving their usual Ig treatment The duration of each treatment is for 12 months. Over the course of the 13 month study participation period, participants will be asked to return to the hospital for a study visit every 3 months, with monthly telephone visits to check-in on your progress between each in-person visit. Participants will also be asked to complete a study diary, recording treatment compliance and signs/symptoms of infection experienced throughout the study period. Types of assessments and data collected will include: medical history, demographics, physical examination, blood tests, stool sample, quality of life questionnaires, information about your general health, hospitalisations, medications and procedures. In order to assess and compare the cost-effectiveness of the treatment groups, the study team will also request authorisation from participants to access their Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Scheme (PBS), and Australian Immunisation Register (AIR) data. It is hoped that this study will confirm if Ig used to prevent infections can be safely stopped, and if oral antibiotics should be given as an alternative, thus improving treatment for people with blood cancer.

Draw-Care aims to improve the lives of culturally and linguistically diverse (CALD) family carers and people living with dementia using culturally-adapted, multilingual animations, digital fact sheets, and a chat-bot, collectively titled “The Draw-Care Intervention”. The first objective addressed in Study 1 is to develop the digital resources in English and translated versions and undertake checking and user-testing within a series of six online workshops each tackling a different theme related to caring for an individual living with dementia. The workshops therefore use a co-design approach and include carers, clinicians, health and service providers and people living with dementia from CALD backgrounds. The digital resources -- within the scope of this trial are a culturally adapted complement to the iSupport Programme designed by the WHO for carers of people living with dementia.

Most cases of liver cancer are preventable, with chronic viral hepatitis causing the majority. If people who are living with hepatitis B or hepatitis C can access increased testing, appropriate treatment and follow-up from their GP, their risk of getting liver cancer later in life may be significantly reduced. The HepLOGIC intervention includes a range of clinical decision support system (CDSS) tools that are integrated with clinical information systems in primary care. The current study aims to assess the feasibility and acceptability of using these tools to optimise liver cancer risk screening and care for patients with hepatitis B or hepatitis C. Who is it for? You may be eligible for this study if you are an adult aged 18 or older who is at risk of or has been diagnosed with hepatitis B or hepatitis C and you are attending one of the participating general practice clinics in Eastern Melbourne, South Eastern Melbourne, or Gippsland Primary Health Network (Victoria, Australia). Study details The HepLOGIC intervention will be implemented at 20 general practice clinics. The intervention will involve a series of electronic health tools including prompts for doctors to screen patients for liver cancer risk factors. Participants may be asked to provide further details regarding their medical history and ethnicity, and may undergo additional testing. It is anticipated that these procedures will take up to 10 minutes to complete in addition to a scheduled appointment. Patient will only interact with their general practice clinic in this study and will not be contacted or identified by the researchers in any way. It is hoped this research will demonstrate the feasibility and acceptability of targeted health practice tools for integration in standard care for patients with hepatitis B and hepatitis C. Future larger studies will aim to determine the efficacy of these tools in reducing liver cancer risk in hepatitis patients.

The primary objective of the Post-COVID Early Rehabilitation Trial is: To determine whether a 4-week telerehabilitation program for people post hospital discharge or who were managed in the community and who have persistent symptoms following COVID-19 infection, improves physical function and symptoms compared to usual medical care. The hypothesis is that people who receive a four-week telerehabilitation program post COVID infection, will improve physical function and symptoms more than those who receive usual medical care. People who meet the inclusion criteria will be invited to participate in a study comparing a 4-week, twice weekly, program of telerehabilitation with 4-weeks of usual medical care. Following consent and initial assessment of physical function, quality of life, symptoms, anxiety, depression, and cognition, participants will be randomised using stratification for sex (male/female) and age (less than or equal to 50 years or > 50 years). At the end of the 4 weeks all participants will be reassessed by an assessor blind to group allocation. The participants will be asked not to divulge to the assessor the group to which they were allocated, and the assessor will be asked not to seek this information. All the same measures taken at initial assessment will be repeated. Participants originally randomised to the control group of usual care will be invited to crossover into the intervention group of telerehabilitation. All the same assessments will be repeated at the end of the telerehabilitation period by an assessor blind to group allocation. All participants will be invited for follow-up assessment at 12-months after completion of the intervention or control periods to assess the longer term outcomes. At this timepoint all the same assessments will be repeated and one additional questionnaire to collect information about return-to-work. A random sample of people randomised into the telerehabilitation group will be invited to participate in a focussed interview to gain an in-depth understanding of their experiences of the telerehabilitation. It is anticipated that 20 people will be interviewed or until no new themes emerge.

The period of pregnancy and early motherhood is a substantial life change associated with psychological turbulence. During this period, some women experience symptoms of anxiety and depression of sufficient severity to warrant professional psychological assistance. Psychosocial and psychological interventions are key therapeutic approaches for women at this life stage. There is growing evidence of the value of the arts in prevention and treatment of mental health problems. Evidence suggests that women prefer psychological interventions that provide social support and shared space for reflection. Cognitive Behavioural and Art-based Intervention (CB-ART) is a novel therapy for prevention and treatment of perinatal mental health problems. The aim of this study was to implement and evaluate CB-ART for acceptability, feasibility, safety, and preliminary efficacy among women admitted to a residential early parenting unit. The pilot study used a single-centre, mixed-methods pre- and post- test design to evaluate CB-ART among women admitted to a 5-day residential early parenting service in Melbourne, Australia. Participants completed questionnaires before and after attendance at two, one-hour CB-ART group sessions on day 2 and day 5 of admission during which field notes were taken. Evaluation interviews were conducted by telephone one week after discharge. The Short Profile of Emotional Competence and the Edinburgh Postnatal Depression Scale were used to assess emotional insight and symptoms of depression, respectively. Feasibility, acceptability and safety were assessed using an analysis of field notes, with quantitative data collected by telephone questionnaire and qualitative data by telephone interviews.

Resilience describes a person’s capacity to “bounce back” from stressful events. Research in some populations indicates that adaptive self-reflection on daily stressors can facilitate the development of resilience. We are exploring whether this might be true for staff who work with stressed parents – and whether training in this method might also be adapted for new parents themselves. This project will apply the Systematic Self-Reflection model of resilience development to: (1) enhance capacities for resilience in staff who work with parents experiencing challenges in the early parenting period, using an existing intervention designed to enhance human resilience - Self-Reflection Resilience Training; and (2) develop professional recommendations for adapting this intervention for use with new parents.

This project aims to investigate the feasibility of a habits based physical intervention (Harnessing Automatic Behaviours Intervention Trial (HABIT)) for elderly participants with mild cognitive impairment or subjective cognitive decline. We hypothesize that the HABIT intervention will be acceptable for participants, feasible, and efficacious, resulting in increased physical activity levels for participants during the intervention, and maintenance of those changes over 12 weeks following the completion of the intervention. The intervention will include an education workshop on the importance of physical exercise, how habits work and how habits can be utilized to increase physical activity uptake. This will be followed by an interview with a physiologist who will tailor the habit-based approach to each participant and set clear individualized exercise goals. Participants will receive apple watches for the duration of the intervention. The HABIT intervention will be evaluated against baseline verse follow-up rates of movement and heart rates changes tracked by the watches, along with participant reports of habit uptake, recruitment and completion rates (number enrolled, number of withdrawals, completion rate), participant safety (number and severity of adverse events) and program compliance (agreed versus actual physical activity completed).

Primary dysmenorrhea (PD) is a common menstrual complaint with a high prevalence and significantly impacts physical and mental health. Low-level laser acupuncture (LLLA) has been used in a few health conditions with positive outcomes. However, the evidence in the use of LLLA for PD is still limited and inconclusive. LLLA is a non-invasive, painless, and safe modality that could be an option for PD management. This study aims to investigate the feasibility and therapeutic effect of LLLA for manage PD.

Australia is currently in the midst of a syphilis epidemic which began a decade ago. Benzathine penicillin G (BPG) is the treatment of choice for non-CNS syphilis infections. Primary, secondary or early latent syphilis is treated with 2.4 million units (MU) of BPG, while late latent syphilis requires 2.4 MU weekly for 3 weeks in total. BPG is typically administered by IM injection which is associated with significant pain and distress in the recipient. This has been shown to negatively impact adherence, especially where multiple doses are indicated. Subcutaneous (SC) administration of BPG is a potentially more efficacious alternative to IM injection. Prior work done by our group in healthy adult volunteers have demonstrated acceptable tolerability and a superior pharmacokinetic profile. Our study aims to demonstrate the safety and tolerability of a single 7.2MU dose of BPG given as a subcutaneous infusion for treatment of syphilis. Secondary objectives are to demonstrate efficacy of SC BPG and estimate duration that plasma penicillin concentrations remain above the target of 18mg/mL. Primary outcome is the assessment of safety and tolerability including serious adverse events or reactions. Secondary outcomes are the change in nontreponemal specific serology titre at 6 months, plasma penicillin concentrations at 3 weeks and proportion of patients with treatment failure requiring re-treatment at 6 months. We will recruit 40 adult patients with confirmed syphilis infection from those referred to the sexual health service at Fremantle Hospital. The study will also incorporate a qualitative component exploring patient's experience and perception of receiving subcutaneous infusion. Participants will be followed up for 6 months from day of treatment. If we are successful in demonstrating safety, tolerability and efficacy of SC high dose penicillin in non-CNS syphilis infections, this has the potential to radically transform the treatment paradigm.