ANZCTR search results

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

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31182 results sorted by trial registration date.
  • Comparing the acceptability and treatment fidelity of digital pre-operative education to face-to-face physiotherapy pre-operative education in patients awaiting elective thoracic surgery: A pilot feasibility randomised controlled trial.

    The objectives of this feasibility pilot study are to investigate whether pre-operative physiotherapy education delivered via digital video has similar acceptability and treatment fidelity as face-to-face pre-operative education and to pilot the conduct of a randomised controlled trial comparing these two modalities. This study will provide preliminary data to guide the design of a more definite study evaluating the clinical effectiveness of digital versus face-to-face education.

  • The Sleep Course: A trial of an online transdiagnostic sleep intervention for adults with sleep difficulties

    The Sleep Course is a remotely-delivered psychological treatment that has been designed to help people improve their sleep and waking patterns, and daytime functioning (e.g. fatigue, emotional wellbeing). It is designed for adults who report sleep difficulty. It involves four lessons delivered over a 6 week period. Participants also receive telephone support from trained psychologists. The aim of our study is to evaluate the efficacy of the Sleep Course in a group of diverse individuals who experience a sleep difficulty. We hypothesise that people in the Sleep Course will report improvements across the outcome measures.

  • The effect of Polyethylene Glycol in prevention of constipation in patients undergoing laparoscopic surgery for non-cancerous gynaecological reasons

    Constipation after surgery is common and causes bother for patients. This study aims to investigate whether the use of an over-the-counter laxative (scientific name Macrogol) helps to prevent constipation in patients undergoing a gynaecological laparoscopy for non-cancerous reasons. Participants will be given either the laxative or a placebo for 7 days. It is a double-blinded randomised controlled trial which means the participants and research team will not know which treatment has been assigned. Constipation rates and side effects will be assessed with patient questionnaires upon entering the study, and at 7 days and 6 weeks following surgery.

  • Clomiphene in male infertility (CIMI) trial: A double-blind randomised placebo-controlled trial of clomiphene in normogonadotrophic idiopathic male infertility

    The purpose of this study is to evaluate whether clomiphene improves sperm quantity and quality in men with unexplained infertility and low sperm counts. Eligible men recruited from fertility clinics will be randomised to either clomiphene or placebo for 6 months. Both clomiphene and placebo will be taken as a once daily oral capsule. Both groups of men will also receive a men’s fertility multivitamin (Menevit). We hypothesise that clomiphene will increase sperm production compared to placebo.

  • Impact of Catheter Stabilization on Catheter Micro-Motion and Function

    The supplier of a new peripheral intravenous catheter (PIVC), BBraun, have engineered a new type of catheter called the ‘Introcan Safety 3’ that contains a new type of stabilisation technology. The investigators would like to test this device against BBraun’s existing device (Introcan Safety) to determine if there is an improvement in devices’ stability and whether this reduces blood clot formation and improves how long the devices work for. We propose to use bilateral cannulation (i.e., cannulate both your left and right lower arms) and allow these PIVCs to stay within your arms for up to 72-hours to determine whether any advantage exists when using the different catheter types. This study will be performed in human participants that meet the study screening criteria. The position and motion of the two catheter types will be monitored using ultrasound, as well as standard observations to document whether the devices are working, whether blood clots, local swelling, redness/pain, and device motion is observed. Participants will also record their experiences with the devices to determine whether using either catheter is associated with improved patient comfort.

  • Teleorthodontics & Artificial Intelligence in Orthodontic Screening and Treatment (Part 2)

    This study evaluates teledentistry and artificial intelligence (AI) in the screening of new orthodontic referrals as well as during braces treatment in Australian adolescents and adults. Its goal is to improve access to public orthodontic services. Participants will submit photos using a smartphone-compatible platform called Dental Monitoring (DM). . 30 participants treated with braces will be recalled every 6 weeks and another 3o will be recalled when DM recommends it. Groups will be compared by number of appointments needed to complete the levelling and alignment stage of treatment . Patient satisfaction, reduction in waiting lists and the costeffectiveness will also be assessed.

  • The effectiveness of an online team-based step tournament to promote active ageing

    The study aims to test the acceptability, engagement and physical activity changes of a web-based physical activity program utilizing social support to promote active ageing. The study will be a pre-post trial of a 10,000 steps tournament in older adults. The 10,000 steps team tournament will involve community group team members syncing their tracker recorded steps on the 10,000 steps website to compete with other community groups on average team steps over a 6-week period. Each team will be coordinated throughout the tournament by the project staff who will send tournament updates weekly (e.g. leaderboard updates and time left in tournament). Physical activity information (e.g. physical activity guidelines for older adults) and behavior change information (benefits and barriers, goal setting, environment, habit formation) will also be emailed weekly and participants will be encouraged to engage in a moderated online social networking group specific to their tournament. Local community groups with members predominantly 55+ years will be recruited. Individuals will sign up to their local groups' team. At baseline the trial participants will be asked to start recording their steps through an activity tracker, then complete a brief online baseline survey to assess participant demographics, self-reported physical activity and social support. Participants will complete a brief post-intervention online survey in week 7 to assess intervention acceptability (intervention group only) and reassess physical activity and social support. Participants will compete a follow up online survey in week 14 to reassess physical activity and social support. Intervention engagement (e.g. log ins, days steps synced, time on website) will be recorded via the 10,000 steps website throughout the 14-week trial. The primary outcome will be physical activity changes between baseline, post-intervention, and follow up.

  • Efficacy of the SMILESup mobile health intervention on oral health literacy and early childhood dental caries.

    Early childhood dental caries remains a complex childhood problem that affects more than 600 million children worldwide. Our research group has previously found that in NSW currently, one in every 250 children require hospitalisation each year, with a 9% repeat admission rate within a two-year period2 for dental caries. Most of these children attend the safety-net service offered by the public health system. Improving the oral health literacy of parents remains a strong predictor that can shift the barriers to improved oral health outcomes for the child across the lifespan. The latest WHO definition on health literacy is more comprehensive and represents the cognitive and social skills which determine the motivation and ability of individuals to gain access to, understand and use information in ways which promote and maintain good health. When applied to the prevention of tooth decay this definition moves beyond providing a pamphlet and includes elements of motivation and empowerment related to the skills (tooth brushing) and self-efficacy required to maintain sustained preventive behaviours. Whilst, previous oral health literacy tools have focused on word recognition and understanding appointment visitations, our study will directly measure oral health literacy for behaviour change. We hypothesise that co-designed text message interventions will improve oral health literacy, self-efficacy, and behaviours (tooth brushing) of parents with children waiting for a hospital admission for dental caries more effectively than usual care. This randomised control trial, aims to co-design, assess the effectiveness, and evaluate a text message program to support oral health behaviours, increase the oral health literacy and self-efficacy of parents, compared to usual care. We also aim to evaluate fidelity, barriers, and enablers which will inform potential scale-up of the intervention.

  • Investigating the impact of an online course on buying and saving behaviour

    Australia is the thirteenth largest contributor of household waste per capita in the world (Organisation for Economic Co-operation and Development, 2022), spending over $10.5 billion annually on goods and services that are never or rarely used (Australia Institute, 2005). This wasteful behaviour contributes to costly landfills, environmental degradation, and rising household debt. Given society’s overconsumption, a handful of commercial programs currently exist to help people strive for minimalism and to declutter their homes. To the best of our knowledge, none of these commercial programs have been scientifically evaluated to see if they actually work, although many testimonials regarding their effectiveness can be found on the Internet. Thus, there is a clear need to develop an evidence base for such interventions. The purpose of this study is to investigate the effectiveness of a new online educational course that was developed to help people buy and save fewer possession in order to save money, reduce clutter, and safeguard the planet. This new course, Breaking up with Belongings, is based on scientific research regarding object attachment, possession ownership, and behaviour change. The course is self-paced and comprised of 6 hours of content (videos plus workbook activities). Eligible participants will be randomly assigned to receive this program immediately or after a three month delay. We ask that participants complete the course within 7 weeks of receiving it, so that they can spend the rest of their time working toward reaching the goal(s) they set during the course. Participants are assessed at baseline and three months later. We expect that those who recieve the Breaking up with Belongings course immediately will report greater improvements than those who receive access to it after a three month delay.

  • Optimising support for Chinese carers of people with dementia by embedding iSupport in routine care services

    The research project aims to (1) to determine the effectiveness of the ‘Tailored iSupport’ intervention for carers and people with dementia; and (2) to evaluate the effectiveness of the implementation strategies applied to embed the ‘Usual support’ and the ‘Tailored iSupport’ into the routine services of aged care organisations in real-world settings. The study will also explore the experiences of carers, frontline staff and facilitators in the project. The hypotheses tested in the study are described in the following: 1. Carers receiving the ‘Tailored iSupport’ will report 1) a higher level of QoL; 2) a higher level of Self-Efficacy; 3) a significantly higher level of QoL for the person they care for via a proxy rating; 4) fewer unplanned hospital admissions, less emergency department use and a lower level of permanent admission into residential aged care by the person they care for; 5) better quality care experiences of persons with dementia via proxy ratings, compared to those in the ‘Usual iSupport group’.

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