ANZCTR search results

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

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33055 results sorted by trial registration date.
  • Informing state-wide policy on the use of non-slip socks for preventing falls in admitted patients

    Accidental falls due to slips and trips are among the most commonly reported hospital adverse events, accounting for between 20 and 40% of all incidents. Older inpatients are especially predisposed to falls due to multiple risk factors, including gait and mobility problems. Consequently, ensuring safe patient mobilisation is a central priority for inpatient fall prevention programs. Current fall prevention guidelines and best practice evidence promote the use of well-fitting closed footwear among older inpatients. Unfortunately, in acute settings, many patients do not have access to suitable footwear, due to factors such as unplanned admissions, patient oversight, or foot pathology. Due to the short average length of acute hospital stays, it can be challenging for wards to resolve patient footwear needs in a timely fashion. As a result, many Australian facilities have begun adopting the practice of providing non-slip socks (NSS) to all older admitted inpatients; yet, the value of this practice is unclear. NSS are otherwise similar to conventional socks but provide various forms of rubberised tread on the sole. Commercial providers of NSS have advanced claims of reduced fall rates after implementing an NSS strategy although reliable, controlled studies have not been undertaken. Despite a continuing lack of evidence on the effect on falls rates, usage of NSS in the state of Queensland has escalated from one facility in 2008, to >10 in 2014. Ipswich Hospital is among the few facilities where NSS are not routinely used. It is possible that NSS could be effective in reducing inpatient falls due to factors such as lower slip resistance than no or alternate footwear, acting as an alert for high risk patients and reminder to staff about falls prevention, however the diffusion of practice despite the lack of effectiveness data is a cause for increasing concern. In order to provide clear guidance to facilities on the use of NSS, reliable data is required. The primary aim of the proposed research is to investigate the effect of a pragmatic, ward-level implementation of NSS on rates of falls and fallers in an inpatient population at a regional hospital in Ipswich, Australia and understand the implementation of the intervention. The secondary aim is to evaluate the likely cost-effectiveness of this approach.

  • Heel lift shoe inserts versus calf muscle eccentric exercise for Achilles tendinopathy

    The primary aim of this research project is to compare the effectiveness of heel lift shoe inserts versus rehabilitation therapy (calf muscle eccentric exercise) for the treatment of Achilles tendinopathy. This study is a parallel group, pragmatic randomised controlled trial with a 12 week follow-up. Participants will be randomised to receive treatment with heel lift shoe inserts (Clearly Adjustable®) or a calf muscle eccentric exercise program. Primary and secondary measures will be collected at baseline and at 2, 6 and 12 weeks. The primary outcome measure will be the total score of the Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire. Secondary measures will include Achilles tendon structure (assessed using ultrasound imaging), calf muscle function, self-reported global change in symptoms, severity of pain at the Achilles tendon during the previous week, self-reported physical activity, health-related quality of life, as well as use of paracetamol rescue medication and co-interventions.

  • Geelong Exercise and Nutrition Training Study (GENTS): Examining the Effects of Exercise and/or Calcium-Vitamin D on Bone Health in Older Men

    The aim of this randomised controlled trial is to investigate whether milk fortified with calcium and vitamin D3 combined with high intensity resistance training and weight-bearing impact exercise can lead to a greater effect on BMD at loaded sites than the sum of each factor alone in community-dwelling men aged over 50 years. It is hypothesized that the combination of exercise + calcium-vitamin D fortified milk will lead to greater gains in bone density at the hip than either exercise or calcium-vitamin D alone. This is an 18-month factorial design intervention with a 12-month follow up in which men will be randomised to one of four groups: (1) exercise + fortified milk; (2) exercise alone; (3) fortified milk alone; or (4) a usual control group. The primary outcome is femoral neck bone mineral density. Secondary aims (outcomes) are to: 1) evaluate the effects of the intervention on DXA total hip and lumbar spine BMD, QCT bone density, structure and strength at the spine, femur and tibia, body composition (lean and fat mass and muscle size), muscle strength and function, blood pressure and blood lipids, inflammatory and bone turnover markers, health related quality of life and mood, and 2) evaluate the long-term residual effects (12 months post intervention). The results from this trial will provide important information as to whether food-based nutritional supplementation (calcium-vitamin D enriched milk) can enhance the effects of exercise on musculoskeletal health and function in older men with normal to low bone density.

  • A Phase II Trial of Safety, Tolerability and Efficacy Study of Topical AKP-11 Administration to Participants with Arthritis.

    A primary purpose of this study is to evaluate Safety, Tolerability and Efficacy of Topical AKP-11 Administration to Participants with Arthritis. AKP-11 is a Sphingosine-1-phosphate receptor 1 (S1P1) agonist developed to treat multiple pathological events common in arthritis. The study consists of 2 parts: PART A investigates two doses of AKP-11 over 7 days in 20 participants (2 cohorts of 10 participants each) with arthritis. Each cohort will have 8 participants on AKP-11 and 2 participants on placebo. PART B will select the dose identified in PART A and will be conducted with treatment over 21 days in 80 participants with arthritis, The dose of AKP-11 will be selected after the safety profile and efficacy of AKP-11 has been determined. The participants will be randomized to receive AKP-11 or Placebo in a ratio of 1:1.

  • Validating the impact of an alternative, shared-care pathway on waiting times for patients referred for eye examination to a public ophthalmology clinic

    In the face of the progressive disease burden associated with an ageing population, public hospitals must face the challenge of providing cost-effective, accessible, and timely care for patients with chronic disorders, especially so that the need for inpatient care is reduced. Within the eye health care sector, shared care models are increasingly utilized to facilitate comprehensive care for all patients. These models integrate optometrists in the care of patients with chronic stable conditions, or in need of long-term at-risk disease monitoring, thus effectively focusing specialist and hospital care for patients with urgent or complicated conditions. Establishing effective triage and collaborative care schemes, however, requires careful validation to ensure that implemented alternative care pathways improve patient management. The Centre for Eye Health (CFEH) in Sydney has already established active collaboration with the Prince of Wales Hospital (PoWH) eye clinic resulting in a shared-care glaucoma management clinic. The knowledge and expertise gained from this collaboration provide the foundation to initiate the current project aiming at an expansion of the current eye health care model to patients waiting for over 12 months to be seen at the PoWH eye clinic. Successful outcomes will result in significantly reduced wait times for patients leading to timely implementation of patient care plans and improved efficiency with regard to eye health care specialist appointments within the public health system.

  • The Role of Vitamin D in Fertility and In Vitro Fertilisation (IVF) Outcomes

    Variability in oocyte quality is a major contributor to pregnancy rates during IVF . We wish to measure the concentration of various steroid and hormones including vitamin D in the follicle fluid and serum of IVF pateints during oocyte recovery and relate this to patient factors, stimulation and ovulation protocols to provide a better indication of their impact on oocyte and embryo quality and on pregnancy and implantation and live birth delivery rates.

  • Evaluation of the Child/Adolescent and Parent Emotion Regulation (CAPER) Program for At-Risk Youth

    The objective of the current study is to develop and evaluate an emotion regulation (ER) child and parental treatment program for children and adolescents (aged 6 to 14 years) who are experiencing ER difficulties as evidenced by recurring emotional/anger outbursts and impulsive maladaptive behaviours. Specifically, the objective is to conduct a proof-of-concept, pilot ER intervention study for at-risk youth of developing chronic internalising and/or externalising disorders. Primary Aim: To develop and test the efficacy of an individual, 6-session, ER child and parental program using an A-B design with a one-month follow-up. The manualized intervention will comprise a) parental training specific components (initial/ session 1 and final/booster Session 6) and child/ adolescent with active parental dyadic intervention phase (4 sessions; conducted weeks 2 to 5).

  • Sodium Selenate as a treatment for patients with possible behavioural-variant Fronto-Temporal Dementia

    This study will investigate the safety and tolerability of sodium selenate in patients with behavioural variant frontotemporal dementia. All participants will be given sodium selenate for 52 weeks, and assessed regularly to investigate any negative reactions to the drug, as well as any positive effects on the symptoms of their dementia, as measured by biological samples, cognitive tests and brain scans.

  • The effectiveness of Complete Decongestive Therapy including an occupational therapy lymphoedema exercise protocol for individuals recovering from head and neck cancer treatment

    Aim The aim of this study is to determine the effectiveness of a lymphoedema exercise protocol in individuals recovering from head and neck cancer treatment. Who is it for? You may be eligible to join this study if you are aged 18 years or above, treated for head and neck cancer at the Sir Charles Gardiner Hospital and experiencing head and neck cancer related lymphoedema. Study details Participants in this study are randomly allocated (by chance to one of two groups. Participants in one group will receive a complete decongestive therapy protocol (usual treatment) for 6 weeks, whilst participants in the other group will receive an exercise protocol in addition to usual treatment for 6 weeks. Assessments (stage and amount of lymphoedema; body image; swallowing; health and wellbeing) will administered pre-intervention (0 weeks) and at post intervention (6 weeks). The proposed study will expand the limited knowledge of lymphoedema for people recovering from head and neck cancer and determine the effectiveness of complete decongestive therapy in conjunction with an exercise protocol.

  • A comparison of lifestyle patterns in children with/without Attention Deficit Hyperactivity Disorder

    Background and purpose: Attention deficit hyperactivity disorder (ADHD), a neurodevelopmental disorder, which has relatively high prevalence and incidence of comorbidity among children. Medication is usually the first-line treatment for ADHD; however, the adverse effects of medication may cause other medical issues. Healthy lifestyle pattern (diet, physical activities, reducing screening time) may ameliorate disease severity. To discover suitable interventions, comprehensive investigations of lifestyle patterns will be conducted in both western and eastern countries among primary school children with or without ADHD. The aims of present studies are: to compare the lifestyle patterns in children with ADHD and typically developing children, to determine cultural differences of children with ADHD in western and eastern countries, and to develop a suitable lifestyle modification program for children with ADHD. Methods: The first phase of this study will investigate the lifestyle patterns in Australian and Taiwanese children with or without ADHD. All participants and their parents will be given a series of questionnaires to examine: dietary pattern, physical activity, sleep quality, screening time, demographic data, disease severity, and pressure of their caregiver. These data will be using multiple regression methods to determine the best predictors of the symptoms of ADHD.

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