ANZCTR search results

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

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31320 results sorted by trial registration date.
  • Sleep health management for healthcare workers

    This study aims to develop and assess the effectiveness of an individual based intervention for sleep problems in shift workers, and will be conducted in operational settings (i.e., Austin Hospital and Flinders Medical Centre). The targeted sleep problems include poor shift work responsiveness, insomnia and obstructive sleep apnoea/sleep disordered breathing. The effectiveness of the treatment will be based on whether or not shift work responsiveness, insomnia, obstructive sleep apnoea, sick and carers leave, RiskMan data (e.g., staff and patient related incidents), symptoms of mental health problems (depression and anxiety), sleepiness and functionality decrease from before the treatment to after the treatment. The project will also determine whether or not those who have been randomly assigned to the intervention group (labeled program 1) have lower levels of the aforementioned than those randomly assigned to the control group (labeled program 2). The labels “program 1” and “program 2” will be used to help blind the participants to the intervention and control group. While laboratory and clinical studies demonstrate benefits from the proposed interventions, research has yet to assess the impact of comprehensive sleep health management for shift workers in an operational setting. Developing an individual-level treatment method to improve sleep health and to identify and manage sleep problems in hospital staff will lead to better health outcomes for staff, improved alertness and patient outcomes, and in turn reduced costs of days lost (e.g., from sick leave) within the workplace. Participants will be allocated to Program 1 or Program 2. Both groups will receive an educational presentation; the talk for Program 1 will focus on sleep health, circadian rhythms and scheduling, whereas the talk for program 2 will be designed to seemingly but not actually assist in improving sleep or scheduling. From here, both groups will be given a questionnaire that will take approximately 30 minutes. For those in the intervention group, the answers to the questionnaire will then be used to identify those who are at risk for poor shift work responsiveness, insomnia and obstructive sleep apnoea. Those who are identified with a potential sleep problem will then receive further treatment. Follow-up questionnaires that are identical to those answered originally will then be completed directly after the treatment procedures end for those in the intervention group. Sick leave data will be collected at the end of each financial year with help from the Austin Hospital and Flinders Medical Centre.

  • Appetite control and body composition in breastfed infants

    Background: Obesity is considered to be at epidemic proportions yet data is limited for the mechanisms of breastfeeding that reduce risk of obesity later in life. In particular the influence of breastmilk components on gastric emptying rate, appetite control and body composition in term infants is largely poorly understood. Furthermore an accurate non-invasive methodology to measure infant body composition is required to identify infants at risk of obesity. Aims: This study aims to investigate the relationship between infant gastric emptying rate and the composition of the consumed breastmilk, with the focus on milk proteins (whey and casein fractions), appetite hormones such as leptin and adiponectin and POPs. Further associations between breastmilk components and infant body composition will be investigated with the accent on longitudinal study. New methods of measuring infant body composition (ultrasound skinfolds) will be developed. Objectives: 1. To establish possible longitudinal associations between breastmilk macronutrients and components and both infant and maternal body composition. 2. To investigate and describe gastric emptying of term fully breastfed infants feeding on demand and establish possible associations with breastmilk composition. 3. To establish effect of milk intake and extracellular fluid reservoirs on bioimpedance in term breastfed infants I order to evaluate the possibility to use pre- and post-breastfeed measurements interchangeably. 4. To determine body composition (percent fat mass, %) of breastfed infants using bioimpedance spectroscopy and ultrasound skinfolds and to compare performance of these two methods in term breastfed infants. 5. To determine pesticide residues concentration in human milk during the first year of lactation and establish possible associations between pesticide residues in breastmilk and demographic factors of breastfeeding dyads.

  • A pilot study of gabapentin for managing pain in children with dystonic cerebral palsy

    The primary objective of this feasibility pilot study is to gather preliminary data on the use of gabapentin to reduce pain in children with dystonic CP to inform a future RCT including trialling the recruitment process and retention rate, the outcome measures, and to identify complications and side effects from the medication which could impact on the design of an RCT. The study will specifically examine the variability of results for different outcome measures to determine effect sizes that will be used to inform the planning of a future trial (choice of primary outcome measure, sample size planning).

  • The use of mobile 'apps' as treatment for social anxiety in university students: A randomised controlled trial.

    Previous research has focused on guided self-help programs (GSH) - those that include scheduled contact with a mental health professional - or internet-based programs that differ from the 'app' platform in two ways. Firstly, with regard to GSH, 'app' based programs provide no additional contact point for users, and secondly internet-based programs were not readily convenient to users as access is restricted to a personal computer, whereas 'apps' can be used anywhere at the individual's convenience on their mobile phones. Additionally, the focus of past research has been on depression or anxiety in conjunction with another disorder such as panic disorder, which has lesser incidence compared to social anxiety. Therefore, the proposed study will focus on specifically on Social Anxiety Disorder (SAD) due to its higher prevalence and because of the nature of the disorder the lower likelihood of people with the disorder seeking professional treatment. The very nature of SAD makes it highly unlikely people will seek professional help as the treatment environment embodies the social situations they fear and research has shown that the majority of people who meet the diagnostic criteria for SAD fail to seek treatment or delay seeking treatment. This is where 'app' self-help programs become relevant as they provide a less stressful treatment option. During tertiary studies is a very stressful period for young adults. During this time, students are given new freedoms and exposed to things such as illicit substances and the responsibilities that come with becoming an adult. The current generation of university students have been exposed to technology in way never before seen, which has changed the way simple acts such as socialising are experienced. The nature of SAD means that people are likely to turn to alternate forms of communication where they feel less anxiety, such as the internet or mobile devices (Gary, 2008). The increased ownership and use of mobile devices and internet services has provided the current generation with unparalleled access to new forms of communication (ABS, 2015). This trend has decreased the need for face to face conversation and, therefore, also decreased the opportunity for young adults to develop social skills. Taking this into consideration it could be that the current generation of tertiary students may be experiencing higher levels of SAD as they encounter social situations they do not have the skills to cope with and learn. Primary Objective: To demonstrate the efficacy of a mobile based Cognitive Behavioural Therapy mobile ‘app’ versus a control group, as treatment for Social Anxiety Disorder. Secondary Objective: To demonstrate the efficacy of a mobile based Acceptance and Commitment Therapy ‘app’ as treatment for Social Anxiety Disorder.

  • A comparison between lung ultrasound and chest X-ray for the diagnosis of pneumonia in a paediatric emergency department.

    We are undertaking research into the use of ultrasound to diagnose pneumonia in children. Currently, doctors may order a chest X-ray if they are concerned a child has pneumonia. Studies that have looked into this in children and adults suggest that ultrasound of the lungs may be as good as chest X-ray at identifying pneumonia and it has the added advantage of being at the patient’s bedside and not exposing the child to radiation. We aim to perform a lung ultrasound on children in the emergency department who have had a chest X-ray ordered by their treating doctor. We will then compare the results of the X-ray and the ultrasound to see whether the ultrasound has similar findings. Lastly, we will perform a follow-up phone interview 2-3 weeks after each child has been discharged from the emergency department to document if they improved, whether or not they needed antibiotics, or subsequently needed to consult another doctor. We hope our study will provide support to the growing idea that lung ultrasound may is useful for diagnosing pneumonia. In addition, we hope that we may begin to understand when it would be a good idea for the child to still have a chest X-ray and when the findings of a lung ultrasound are sufficient. This information may guide future research into using lung ultrasound to diagnose pneumonia.

  • REAcH: Rehabilitation Exercise At Home. A trial of telerehabilitation for chronic respiratory disease.

    Chronic lung diseases, including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), bronchiectasis and asthma, are characterised by breathlessness, reduced exercise tolerance and impaired quality of life. ‘Flareups’ of chronic lung disease are common in people with this condition and often lead to admission to hospital and decline in lung function, imposing considerable burden on patients and the healthcare system. Pulmonary rehabilitation is known to be effective at improving exercise tolerance and function, and helping to prevent ‘flareups’ particularly for people with COPD. However, it is often difficult for people to access these group exercise training programs due to issues surrounding transport and lack of access to programs, particularly in regional areas of Australia. Advances in internet technology and accessibility have made it possible for people to receive specialist medical care and rehabilitation therapy directly to their home. By using readily available equipment such as an exercise bike and iPad it is possible for people with chronic lung disease to undertake a supervised pulmonary rehabilitation program in their own home. However, whether this kind of training is as effective as hospital-based pulmonary rehabilitation is unknown. This project aims to determine whether pulmonary rehabilitation undertaken at home, using internet-based technology, is at least as effective as centre-based pulmonary rehabilitation in improving quality of life, breathlessness and exercise capacity in people with chronic lung disease. People who agree to take part in the study will be randomly allocated to undertake pulmonary rehabilitation at either a hospital-based group or in their home, with internet-based supervision. At the beginning and end of the 8 weeks of the intervention phase, and at 12months post completion of pulmonary rehabilitation, participants will undergo measurements of health status and exercise capacity. Hospital medical records and GP records will be reviewed to determine the frequency of acute chest infection and to identify hospital admissions and treatment of acute infections. This will be tracked for 12 months for all participants. It is hypothesized that: 1. Home-based telerehabilitation will provide clinically significant improvements in health-related quality of life, exercise capacity and symptoms which are equivalent to those seen in centre-based rehabilitation. 2. Telerehabilitation, delivered using our low cost model, will be more cost-effective from a societal perspective when compared to centre-based pulmonary rehabilitation for chronic respiratory disease.

  • Comparison of post-operative mobility recovery in participants undergoing keyhole colorectal surgery treated with intraperitoneal ropivacaine/placebo for post-op pain management.

    Most colorectal surgery is now performed laparoscopically. Therefore most pain is deep inside the abdomen rather than the small incisions on the abdominal wall. This study would like to use a pain management technique that uses local anaesthetic infused via plastic catheters into the intraperitoneal space in the abdomen, close to the internal incisions. It is hoped that by doing this patients will need to use less opioid drugs and thereby avoid the side effects of these drugs and possibly recover more quickly from the surgical procedure with less pain. Currently there are many different pain management techniques used after surgery and include: -Intravenous pain medication with opioid drugs such as Morphine or Fentanyl. -Epidural (small plastic tube inserted near spinal cord where medication can be given) with a combination of local anaesthetic drugs +/- morphine-like drugs. -Local anaesthetic blocks via small plastic tubes placed between the abdominal muscles at the time of operation and allow for local anaesthetic to be given between these muscles. -Oral pain medication such as paracetamol and oxycodone. -A combination of any of the above techniques. These techniques can have side effects especially with the Morphine-like drugs that can be a problem in patients having surgery on the bowel and include: -Nausea and vomiting -Reduced bowel function (constipation or bowel temporarily stops working - ileus) -Drowsiness or sleepiness -Slowed respiratory rate and reduced cough -Reduced mobility leading to prolonged bedrest -Increased risk of blood clots due to immobility Because of these side effects the study is designed to see if the local anaesthetic infused intraperitoneally will result in improved pain relief, mobility, earlier return of gut function and less complications,

  • Can an emailed questionnaire successfully ascertain information about falls in people over 60 years?

    Over 40% of older people living in the community fall each year. In clinical practice, recent guidelines recommend that older people be regularly asked about falls and their circumstances. Ascertaining falls is also important to measure the success of any intervention. In research settings previous studies have found that asking about falls 3- or 12-monthly results in under reporting of falls compared with a daily calendar returned monthly with telephone or paper-based questionnaire follow-up to determine the circumstances of falls. This method of a daily falls calendar and monthly follow-up by questionnaire or telephone call has been well validated and is now considered to be the gold standard in falls ascertainment. However, this method is labour and cost intensive as every month there are postage costs, need to manually check that the calendar has been returned (previous studies have reported 30% need follow-up), telephoning to determine circumstances of falls and data or medical file entry by a research assistant or clinician. Therefore there is an important need to improve the way falls ascertainment is conducted. We aim to undertake the world first testing of a novel emailed electronic falls ascertainment tool (TASeFALL) that reminds participants to complete the electronic questionnaire, with responses automatically fed into a database or clinicians email.

  • Increasing physical activity in individuals with hypertrophic cardiomyopathy: A pilot study

    This project aims to assess the effectiveness and feasibility of a program to increase physical activity in individuals with the most common inherited heart disease, Hypertrophic Cardiomyopathy (HCM). A sample of 22 patients will be recruited from the HCM and Genetic Heart Disease clinics at the Royal Prince Alfred Hospital. They will undertake a survey to establish baseline measurements of moderate-vigorous physical activity (MVPA, measured by IPAQ-Long), mental and physical health (SF-36v2), and self-efficacy and barriers to physical activity; and wear an accelerometer for 7 days. A motivational interview, including discussion of barriers and goal setting, will be conducted with a member of the research team. Participants will also be provided with a FitBit Charge device to self-monitor their physical activity. Over the following study period of 12 weeks, participants will receive phone calls (weeks 2, 4, 8 and 12) and weekly text messages from the research team to encourage them to meet their goals and to offer support that is personalised and consistent with Control Theory principles. At the completion of the intervention, participants will undergo the same evaluation as at baseline, and also provide process evaluation feedback regarding the intervention.

  • The effect of high intensity interval training on insulin resistance in metabolic syndrome

    Research Plan This research will examine the benefits of HIIT on IR metabolic syndrome and polycystic ovarian syndrome women. A controlled trial was conducted in Armidale for 12 weeks. Metabolic syndrome women with or without PCOS aged between 18 to 70 years were recruited to the high intensity interval training group (HIIT G) or the control group (CG). The primary purpose of this study is to examine the benefits of HIIT on insulin resistance in men and women with metabolic syndrome. Research Hypothesis HIIT induces metabolic changes and improves IR, glucose homeostasis and lipid metabolism HIIT induced regulation of insulin will reduce androgen production HIIT enhances skeletal muscle oxidative capacity Aims To accomplish the primary purpose of this study the following assessments will be conducted:- 1. Evaluate the percentage of change in body composition parameters. 2. Assess the level of change in hormonal parameters. 3. Assess the level of change in blood glycaemic parameters 4. Evaluate the level of change in blood lipid profile 5. Evaluate the percentage of improvement in parameters of cardiovascular fitness, heart rate variability and telomere length. Research Plan This research will examine the benefits of HIIT on IR metabolic syndrome and polycystic ovarian syndrome women. A controlled trial was conducted in Armidale for 12 weeks. Metabolic syndrome women with or without PCOS aged between 18 to 70 years were recruited to the high intensity interval training group (HIIT G) or the control group (CG). Two information and screening sessions will be conducted for participants before the intervention. Information regarding HIIT, exercise testing procedures, blood tests and the intervention study will be discussed. Participants will be asked to complete a health questionnaire. Based on the information provided by the participant and the health questionnaire, decision will be made on eligibility for participation. During the screening session consent forms will be signed. HIIT G participants will undergo supervised high intensity exercise training on bicycle ergometers 3 times/week. A HIIT session will be a 5 min warm up, 3 sets of HIIT for 20 seconds (3×20), 2 minutes of low intensity exercise after each HIIT set, 5 min cool down period and stretching. Participants assigned to the control group will continue with their usual care and will not participate in supervised exercise sessions. Both intervention groups will be provided with an activity journal to record their daily physical activity. Pre training assessment for peak VO2 will be done using an incremental exercise test on an exercise bike. Heart rate will be monitored during each exercise session. Measurements for body composition, blood essays for glycaemic markers, hormones and lipids will be conducted at baseline, 6 weeks, 12 weeks and 6 week post intervention completion.

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