ANZCTR search results

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

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31027 results sorted by trial registration date.
  • Promotion of social prescribing from within a general practice (a pilot study)

    Social prescribing is a relatively new way of linking patients with sources of non-medical support within the community. Studies have shown that non-medical activities are an effective way to manage psychosocial problems in the community. This pilot project aims to cooperate with existing service providers in the Huon area to increase the rate and effectiveness of social prescribing. The project will deliver a practice improvement module to GPs to highlight the benefits of social prescribing. Existing community networks ('hubs') in the Huon are used sporadically by GPs. The practice improvement module will provide a streamlined method of referring patients to hubs. The project will measure the feasibility and appropriateness of this model of referral by surveying GPs at the onset of the pilot and after 6 months. The number of referrals provided and number of "completed" social prescribing interactions will be compared. Patients' self-rated social connectedness and health literacy will be measured at the point of referral and after 6 months. Community hub leaders' receptiveness of the referral pathway will be assessed by survey at the end of the pilot study period.

  • The effect of changing eating behaviours on mood

    We aim to investigate the efficacy of a 4-week online diet intervention for improving depression symptoms in young adults aged 18-25. We hypothesise that the fresh food group will demonstrate great change on measures assessing nutrient composition, compared to the comfort cooking condition. Our previous work has shown that diet change can reduce symptoms of depression in young adults. However, it is not known what components of the diet change are required to observe improvement in mood. Furthermore, in our previous work, the resources were provided face-to-face, and it is not yet known whether providing the same resources in an online format will result in the same degree of change in diet.

  • Outcomes of proximal humerus fractures in children.

    Proximal humerus fractures (fractures of the upper arm) comprise approximately 2% of all fractures in children. While recent studies in adults have demonstrated no benefit of surgery for certain proximal humerus fractures, there remains a paucity of evidence to guide the management of proximal humerus fractures in children, and there is considerable debate in the literature regarding the indications for the different management options. The aim of this project is to analyse the functional and quality-of-life outcomes for a cohort of paediatric patients with proximal humerus fractures, in attempt to inform the management of the various types of proximal humerus fracture in children. A secondary aim is to determine the clinical factors that predict a poorer clinical outcome for paediatric proximal humerus fractures, including patient demographics, fracture pattern and treatment methodology. The hypothesis is that adolescent patients treated non-operatively have a higher risk of a poor clinical outcome, especially when the initial displacement of their fracture is greater.

  • Imagery Rescripting as an adjunct treatment for depression

    Research has shown that people with depression experience poorer treatment outcomes if they have had adverse childhood experiences; and that these experiences often intrude into their thinking, and at a rate similar to that of post-traumatic stress disorder (PTSD). Although cognitive behaviour therapy (CBT) has been found to be effective in the treatment of depression, a number of people treated with CBT do not recover, or relapse during follow-up. We wish to test the efficacy of an adjunct trauma-focused therapy — Imagery Rescripting (ImRs) – for the treatment of depressed patients receiving group CBT treatment. We hypothesise adjunct ImRs treatment will lead to a superior reduction in depression symptoms compared to control conditions of individual CBT and treatment as usual.

  • Evaluation of a Community-led nutrition and Lifestyle program for weight loss and metabolic Health

    High rates of chronic disease persist in remote Indigenous communities in North East Arnhem Land. A community-developed and led nutrition and lifestyle program, Hope for Health (HfH), has been developed in Galiwin’ku, Elcho Island, with promising preliminary results. This trial seeks to evaluate the effectiveness and acceptability of this program and provides a wider platform to work with partners and the community towards structural changes in understanding about healthy nutrition, healthy food availability, school education and community initiatives around healthy lifestyle. Diet modification leading to even moderate weight loss drastically improves cardiometabolic risk in overweight and obese people. This study is a single arm pre and post study designed to develop an evidence base for an innovative community-developed and controlled, experiential learning program (HfH) that is based on the premise that traditional values and kinship are fundamental to physical health for Aboriginal Australians. Primary objective is to determine if the proportion of participants achieving weight loss following HfH at the end of the program in overweight and obese adults is at least 10%, as measured by achieving weight reduction from baseline of at least 5%. The study is performed in Galiwin'ku, Elcho Island, Northern Territory including 70 indigenous residents.

  • CO-Sprout: Broccoli sprout powder pilot trial for COVID-19 positive pregnant women on the duration of symptoms

    CO-Sprout clinical trial will investigate whether broccoli sprout powder capsules given to pregnant women infected with SARS-CoV-2 (COVID-19) can help reduce the duration of COVID-19 associated symptoms. Additional outcomes measured will include hospital admissions, maternal respiratory outcomes, obstetric and birthing outcomes, as well as neonatal outcomes. It is hoped that providing pregnant women with this natural supplement during COVID-19 infection, will help reduce the levels of inflammation and improve their symptoms hopefully leading to reduced need for hospital and ICU admissions. Broccoli sprout powder contains the naturally occurring phytonutrient sulforaphane which is hoped to improve maternal and neonatal outcomes during pregnancy from infection with the SARS-CoV-2 virus.

  • Feasibility, Acceptability and initial Outcomes of a Psychological Adjustment and Reintegration Training Program for Ex-Service Personnel

    The aim of this program is to target psychological adjustment and cultural reintegration to civilian life. Research questions are: 1) Is the developed reintegration program feasible for delivery within an ex-service population? 2) Is the developed reintegration program acceptable to an ex-service population? 3) What are the initial psychosocial outcomes for participants of the reintegrating program? 4) What are the participant preferences and uptake of an online vs in-person ‘booster’ session? As this is a feasibility study, there are no specific hypotheses, however the following outcomes will be assessed: 1) Is there an overall change in participants Military-Civilian Adjustment and Reintegration Measure (M-CARM) scores and number of M-CARM needs. 2) Is there an overall change in psychosocial outcomes for depression, stress, anxiety, PTSD, and quality of life measures.

  • A Double-Blind, Randomised, Vehicle-Controlled Phase 1b Study to Evaluate the Safety and Pharmacokinetics of GDD3898 Topical Gel in Over-weight or Obese Subjects with Presumed Nonalcoholic Fatty Liver Disease (NAFLD)

    This is a single-center, double-blind, randomised, matched vehicle-controlled study designed to assess the safety, tolerability, and pharmacokinetics of GDD3898 topical gel following twice daily application for 12 weeks in over-weight or obese subjects with presumed NAFLD. The study will enrol 24 adult male or female over-weight or obese subjects including those with presumed Nonalcoholic Fatty Liver Disease who are 18 to 70 years of age. Subjects will be enrolled in two cohorts and will be treated with 1.75% GDD3898 topical gel twice daily or identical vehicle gel twice daily. After completion of treatment, all subjects will have a follow up visit 14 days after last application of study drug.

  • Predicting perioperative risk in patients in aged 90-100 years.

    The Charlson Comorbidity Index (CCI) is a validated risk score for clinicians in predicting perioperative mortality and morbidity in comorbid patients. The CCI has been further refined with the Age-Adjusted Charlson Comorbidity Index (ACCI), adjusting the existing CCI score for increasing age. The ACCI has subsequently been validated in predicting short term and long-term outcomes including mortality, function outcomes and hospital length of stay across different surgical populations. The aim of this study is to assess if the ACCI is valid in patients aged greater than 90 years i.e. nonagenarians. Who is it for? You may be eligible for this study if you were aged > 90 years who underwent any surgical procedure for for any indication. Study details This study will be conducted using a review of medical records, and no patient contact is required. The study will review the medical records of nonagenarians who underwent any surgical intervention at the Austin Hospital over a 13-year period between 25 August 2008 and 8 June 2021. It is hoped that this research will help to provide a better understanding of predicting risk in nonagenarians undergoing minor and major surgery.

  • LISTEN - Low Intensity mental health Support via a Telehealth Enabled Network for adults with diabetes and CVD: Effectiveness and scalability

    Around half of all people with diabetes and cardiovascular disease (CVD) experience mental health problems. This has devastating consequences for clinical outcomes, quality of life, as well as for the healthcare system. LISTEN (Low Intensity mental health Support via Telehealth Enabled Network) provides a telehealth solution for integrated low-intensity mental health and diabetes and CVD self-management support. LISTEN will be delivered by allied health professionals servicing the National Diabetes Services Scheme (NDSS) Helpline, including diabetes educators, nurses, and dieticians, who have undertaken our brief, evidence-based training program. Adults with diabetes and CVD will have access to up to four (45-60 minute) LISTEN sessions. In this trial we will evaluate if LISTEN is a feasible, effective and cost-effective solution for improving mental health outcomes in adults with diabetes and CVD. This important research will generate robust evidence needed by our partners (Diabetes Australia/NDSS and Diabetes Victoria) to inform clinical and commercial translation of LISTEN into a sustainable service, designed to have immediate and lasting positive impact on the mental health of people with diabetes and CVD.

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