ANZCTR search results

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

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30148 results sorted by trial registration date.
  • Acceptability of balance-enhancing outdoor shoes compared to minimalist outdoor shoes in older women: a randomised crossover trial

    The primary objective of this project is to determine if balance-enhancing shoes are more acceptable than minimalist shoes in older women. The secondary objective is to determine if balance-enhancing shoes are more effective at improving balance performance and perceived risk of falls than minimalist shoes in older women. This study will utilise a randomised crossover study design. Participants will be women aged 65 years or older who are free from any conditions which may negatively impact their balance or ability to walk independently. Participants will be randomly allocated to two shoe conditions and will be required to wear the shoes from each condition for six weeks before crossing over to the alternate condition. Participants will attend the university for assessments over four sessions. We hypothesize that participants will find the balance-enhancing outdoor shoes more acceptable than the minimalist outdoor shoes.

  • A randomized trial of ten-session cognitive behaviour therapy (CBT-T) for eating disorders: Does personalisation of treatment lead to better outcomes?

    The overall aim of this randomised controlled trial is to evaluate the comparative effectiveness and acceptability of CBT-T for non-underweight clients with EDs aged 15 years and above to CBT-TA. To achieve this, participants will be randomised to either receive CBT-T or CBT-TA. We hypothesise that gradual responders in CBT-TA will have significantly lower disordered eating compared to gradual responders in CBT-T at end of treatment and that these gains will be maintained at the 3- and 6-month follow-up. We also hypothesise that remission will be higher in the former than latter group. We also hypothesise the same advantages for the rapid responder group in CBT-TA over rapid responders in CBT-T. We will also explore (1) change in health service utilisation, (2) engagement and completion data between the two conditions to establish the relative acceptability of the interventions, and (3) client’s experiences of therapy in the form of qualitative feedback.

  • BOLDER: Breast cancer decision making and outcomes in OLDER Australians

    This study aims to assess the clinical utility of a previously validated collection of geriatric assessment tools and its impact on clinicians’ treatment recommendations for first-line therapy. Who is it for? You may be eligible for this study if you are aged 70 years or over, of any gender and performance status diagnosed with metastatic, or inoperable histologically confirmed HR+, HER2-breast cancer. Decisions about first-line therapy not yet made at this time of consent. Study details Your study doctor will assess whether this research project is appropriate for you. If you are suitable and agree to take part in this research project, you will be asked to sign a consent form. You will undergo a geriatric assessment (questionnaires, quick bedside tests assessing falls risk and cognition) to help your study doctor make decisions about your treatment. You will also complete a survey within 6 weeks of your initial appointment with the doctor about what factors influenced your treatment decisions and how helpful the geriatric assessments were. You will have a follow-up appointment in 4-6 weeks to determine if you stay on the same treatment or if any changes are needed. It is hoped the finding from this study will determine the usefulness of geriatric assessment tools and its impact on clinical decision and patient outcomes.

  • Testing the effect of optical designs on short-term changes in eye length and vision

    The research questions this project seeks to answer are whether the optical power designs developed by Johnson and Johnson Vision Care (JJVC) for use in contact lenses have the ability to shorten the eye and how much those same designs affect vision levels. This will be a prospective, interventional data collection study comparing the relative effectiveness of the various designs that are tested. It is hypothesized that by varying the optical design and the amount of blur imposed on the eye, small temporary changes in the length of the eye can be measured. Short-term changes in eye length (30 minutes) are thought to be a biomarker for the longer-term growth of the eye and can therefore be used as a predictive tool for whether the specific design will slow or increase myopia progression in longer term clinical trials (over years).

  • Health4Life Parents & Teens Optimisation Trial

    The Health4Life Parents & Teens study aims to test a new digital intervention designed to support parents experiencing socioeconomic disadvantage to encourage healthy habits among their adolescent children. The intervention targets six key lifestyle risk factors for chronic disease: physical inactivity, poor nutrition, alcohol use, smoking/vaping, screen time, and poor sleep. Using the Multiphase Optimisation Strategy, this study will test the individual and combined effects of five parent-based intervention components in improving parental encouragement of adolescent health habits. The five components are: online modules, tailored feedback, stress management, text messages, and health coaching. Findings will be used to build a maximally effective and efficient intervention for parents, to improve youth health outcomes.

  • Restricting and then resuming certain behaviors and the effects on symptoms of anxiety and depression

    The proposed project further extends our systematic efforts to understand the relationship between symptoms of anxiety and depression, and daily actions (i.e., thoughts and behaviours - "Things You Do"). The primary objective of this trial is to compare the effects of restricting and then resuming the Things You DO (TYD). The research design is a parallel group randomised controlled trial. Participants (n = 60) will be Australian adults assigned to either the intervention group (behaviour restricted and then resumed) or a control group. Based on our earlier studies, the primary hypothesis is that restricting and then increasing the frequency of TYD actions will result in significantly greater increases and then reductions in symptoms of anxiety and depression, relative to a control condition.

  • The impact of immersive virtual reality-based nature exposure on the psychological distress of rehabilitation patients

    The overall objective is to test the efficacy of co-designed immersive virtual reality-based nature exposure to reduce psychological distress for inpatients in hospital rehabilitation, and understand how this might be implemented and adopted in a clinical setting. We propose a fully powered randomised controlled trial and process evaluation. We hypothesise that exposure to the virtual nature will significantly reduce symptoms of psychological distress compared with the control group which will complete standard care (with no or extremely limited access to nature).

  • Evaluating a sham diet for food-based interventional trials in ulcerative colitis

    This study aims to investigate the therapeutic appearance, nutritional content and participant acceptability of a sham dietary prescription in healthy individuals. The intent of the sham diet is to have the appearance of a therapeutic diet by excluding or substituting inert food items without altering overall nutrient intake compared to habitual diet. The sham diet has been designed for future use in placebo-controlled dietary advice trials for ulcerative colitis.

  • Addressing public health professionals' social media competency for effective health promotion, communication and advocacy

    To address the dearth of social media training opportunities for health promotion and public health professionals, we intend to evaluate the impact of a MOOC that aims to improve their knowledge and understanding of how to effectively frame health promotion messages and increase their perceived confidence in using social media for health promotion communication and advocacy. A mixed-methods approach, incorporating quantitative pre-and post-surveys and qualitative structured individual interviews, will be used to gain a deeper understanding of both the immediate and long-term effects of the MOOC on various outcomes.

  • Self-Collection or Practitioner-collection Evaluation 3 to compare the clinical performance of detecting HPV associated with cervical disease

    This study aims to assess whether vaginal swabs self-collected using the Abbott simpli-COLLECT kit and self-collected urine samples using the Novosanis Colli-pee device have similar clinical performance detecting HPV associated with cervical disease, compared with the reference practitioner-collected cervical samples. Who is it for? You may be eligible to participate in this study if you are a female aged 25 or above, and has colposcopy referral based on abnormal result of a test within the cervical screening program.. Study details All participants in this study will attend a single clinical appointment, during which time they will be asked to take two self-collected samples, one using a swab to collect a vaginal sample, and the other being a urine sample, and compare them against the standard of care clinician- collected specimen from the cervix for the detection of Human Papillomavirus (HPV) using any colposcopy biopsy findings as the reference for sensitivity and specificity for cervical disease. It is hoped that the results from this study will identify a new option for people wanting to participate in cervical screening.

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