ANZCTR search results

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

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32856 results sorted by trial registration date.
  • Does online delivery of Emotional Freedom Techniques for Food Cravings work as well as attending treatment in person?

    Research combining imaginal exposure and cognitive procedures, with the manual stimulation of acupuncture points (e.g. Emotional Freedom Techniques [EFT]) for food cravings in overweight/obese adults has revealed significant improvements in weight, Body Mass Index, food cravings, subjective power of food, craving restraint and psychological coping for participants from pre- to 12-months after an 8-week treatment, and . These treatments are typically delivered in person, in a group format, so participants must attend in person. This study will investigate the delivery of the same 8-week treatment program for food cravings in overweight/obese adults, but via online delivery. Participants will receive a weekly video email of the treatment program (Dr Stapleton) which will teach the treatment process via pre-recorded video for that week. Weekly handouts and email support form the lead researchers will also be supplied. Web-based technologies offer enormous potential for increasing members of the public’s access to evidence-based health and wellbeing services, as well as offering psychologists increased choice and flexibility in delivering services to populations where previous access has been poor. Therefore the program will be: an email-based education intervention which is self-guided, but with human-support.The broadest and most comprehensive meta-analytic study of the efficacy of internet supported therapeutic interventions has revealed moderate to large effect sizes in targeted cognitions, emotions and/or behaviours (Barak, Hen, Boniel-Nissim, & Shapira, 2008).

  • Supporting people with complex trauma injuries and their families to maximise participation through community mobility.

    The purpose of the study is to evaluate the effectiveness of a community-based education and support program (CarFreeMe) developed in Queensland in improving community participation for people following traumatic injuries,

  • Mindfulness as a strategy to manage anxiety and maintain golf performance under pressure

    Mindfulness is the process of bringing deliberate attention to the present moment in a non-judgmental way (Kabat-Zinn, 1994), and has been argued by many to be a potential tool for improving sporting performance (Birrer, Rothlin, & Morgan, 2012; Gardner & Moore, 2012; John, Kumar, & Lal, 2012). A significant proportion of the research on mindfulness in sport has not looked at performance, but instead explored the influence of these approaches on presumed mediators of performance such as flow (Aherne, Moran, & Lonsdale, 2011) or self-confidence (Muangnapoe, 1998). Those that did look at performance tended to use case studies (e.g., Schwanhausser, 2009) or non-randomised designs (e.g., Hasker, 2011). These designs make it difficult to establish the efficacy of the intervention due to the number of confounding variable such at experimenter attention, the placebo effect, or different coaching staff. For the mindfulness component of this study, the primary objective is to explore the effectiveness of brief mindfulness program as a method of improving performance using a more internally valid, randomized and controlled design.

  • A smartphone application for people with cancer to help reduce distress and unmet needs.

    The primary purpose of this trial is to evaluate the efficacy and cost-effectiveness of the ACE smartphone application for reducing distress and unmet needs in cancer patients. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been newly diagnosed with any cancer type including both solid tumors and haematological cancer stages 1-3, attending day oncology centers for cycle 2-5 of adjuvant chemotherapy or fraction 2-5 for radiotherapy treatment for cancer. You must also speak English and have access to a Smartphone or similar tablet device (Android or iOS). Study details All participants enrolled in this study will be randomly allocated (by chance) to receive the ACE smartphone application or to receive standard care with no smartphone application. Those in the ACE group will receive access to the application for four months. The ACE application allows participants to view and amend their existing appointments, provides links to cancer information and improved access to the Cancer Council Information and Support Service helpline. The application will also ask participants to rate their level of distress once per month, and participants with elevated distress levels will be referred to the Cancer Council Helpline for a follow-up support phone call. All participants will complete a number of questionnaires relating to their distress, quality of life and use of healthcare resources at enrollment and 4 and 12 months after enrolment. It is hoped that this study will show that the ACE smartphone application is a cost-effective tool for reducing distress and unmet needs in cancer patients.

  • Current management of lifestyle related risk factors in atrial fibrillation

  • Thyroid tests in people who will be taking quetiapine.

    Quetiapine is a commonly-prescribed drug with a good safety margin that is prescribed in psychotic illnesses, agitation and anxiety. Thyroid function is commonly checked in patients with psychotic disorders and signs of anxiety. We have observed that some patients taking quetiapine have low results on measure of free thyroid hormone level in blood, even though there is no other evidence that their thyroid function is impaired. We suspect this is because the quetiapine is interfering with the laboratory test, but it might actually be a biological effect of the quetiapine and potentially important to quetiapine’s adverse effects on metabolism. We are asking 20 patients in whom their treating psychiatrist has already made the clinical decision to commence quetiapine as part of their management plan, to provide us with a specimen of blood to check thyroid function on 4 occasions (prior to quetiapine commencement, 1 day following commencement of quetiapine, and at weeks 3 and 6 ). We will firstly check to see whether our impression, that free thyroid hormone tests are reading lower in patients on quetiapine by the current test, is correct. The current test is an immunoassay. Then we will use the same blood specimens to measure free thyroid hormone level by another newer, highly specific test (LCMSMS) that is not open to interference in the way immunoassays may be. A comparison of the results will tell us whether the problem is simply immunoassay interference from quetiapine.

  • Smart phone applications in the conservative management of shoulder dislocation rehabilitation (SPACS): An orthopaedic trial in the efficacy of smart phone applications as an adjunct in the rehabilitation of shoulder dislocations

    The purpose of the SPACS study is to determine the efficacy of smart phone applications as adjuncts in the rehabilitation of orthopaedic patients, in this particular instance - shoulder dislocations. Hypothesis: That smart-phone applications used in conjunction with an industry standardised rehabilitation program will improve patient outcomes represented by comparatively better Oxford stability and instability scores Design: The study will be a simple RCT with two parallel cohorts. One with access to the app. and regular questionnaires and the other with questionnaires only. At the completion of 18 months data collection via the smart-phone apps. the scores between the two cohorts will be compared and analysed Outcomes: the "constant", Orford stability score and Oxford instability scores will used to assess the patients recovery and rehabilitation before being compared to assess the efficacy of the intervention

  • The Pharmacy Diabetes Screening Trial: a comparison of three community pharmacy based approaches to screening for type 2 diabetes on proportions of newly diagnosed type 2 diabetes cases.

    The objective of the Pharmacy Diabetes Screening trial funded under the Sixth Community Pharmacy Agreement (6CPA) Pharmacy Trial Program (PTP), and developed in partnership with the University of Sydney and Deakin University is to assess the comparative effectiveness and cost-effectiveness of alternative pharmacy-delivered models of opportunistic assessment for diabetes in an asymptomatic, previously undiagnosed population. The three groups to be compared include: Group A: screening based on Australian Diabetes Risk Assessment Tool (AUSDRISK) alone with referral to a GP if AUSDRISK greater than or equal to 12 Group B: AUSDRISK assessment tool + HbA1c point-of-care (POC) test in patients with AUSDRISK greater than or equal to 12 followed by the referral to a GP if HbA1c greater than or equal to 5.7% (39 mmol/mol is detected Group C: AUSDRISK assessment tool + small capillary blood glucose test (scBGT) in patients with AUSDRISK greater than or equal to 12 followed by the referral to a GP if fasting blood glucose (FBG) greater than or equal to 5.5mmol/L or random blood glucose (RBG)greater than or equal to 7.0mmol/L is detected. The primary outcome is the difference in proportions of newly diagnosed T2DM cases between the two interventions and the comparator arm to be identified by the subsequent GP assessment and blood tests results. The secondary outcomes to be assessed include: a) proportion of new diagnosed cases of pre-diabetes; b) proportion who take up the referral to the GP; and c) proportion of people referred to the GP. It is anticipated that this project will take approximately 20 months during which there will be approximately seven months of service provision. The primary economic objective of the study is to assess the technical efficiency of alternative models of pharmacy-delivered screening for T2DM. The broader objective of determining the value-for-money of pharmacy-delivered screening versus current practice (which does not involve pharmacy-delivered screening/referral), as would, for example, be required in a submission to MSAC requesting subsidy of pharmacy-delivered screening, is not addressed by the trial protocol. There is nonetheless an important value-for-money element to this trial. In the context of opportunistic screening to improve detection of T2DM, the population that visits GPs is different to the population that visits community pharmacies in one important aspect – people can just walk into pharmacies without an appointment, whereas this would be unusual for GPs. This difference in target populations potentially adds an allocative efficiency aspect to the ‘how to screen’ question.

  • The "Say No" study - a study to reduce indulgent foods in adults.

    The aim of this study is to examine the feasibility of two variations of a pragmatic behavioural intervention titled “Say No” to reduce the number of indulgent foods or beverages and improve control of eating. The study design is a three arm feasibility randomised controlled trial with participants allocated to a comparator group, the “say no” intervention group or the “say no” intervention plus feedback group. Participants will have measures taken at baseline and eight weeks later. A total of 45 participants (15 in each group) will be asked to record the number of self defined indulgences for seven days at the beginning of the study and for seven days sat the end of the study. Participants will be asked to record the time of the indulgence and a description of the indulgence. The participant’s weight will be measured at baseline and eight weeks and height will be measured at baseline. Other measures that will take place at baseline and eight weeks include completion of the "Control of eating questionnaire"; "Self regulation questionnaire" and "factor of eating questionnaire". We will also ask participants to report any medications they are taking and ask if they have been diagnosed with any comorbidities. This is to enable us to describe the population and to identify whether the inclusion/ exclusion criteria is appropriate. Interventions Group one will be instructed to make ratings of their hunger motivation, mood, control of eating and food cravings in an electronic record every four days. A link to the online record will be by sent by email or text message. Group two will also make ratings of their hunger motivation, mood, control of eating and food cravings in the exact same way as group one. In addition they will be instructed to self-monitor the number of times they have “said no” and what they have “said no” to (self defined indulgences) recording it each day in a booklet. Participants will also be given methods and tips of how to implement the “say no” intervention at baseline. Group 3 will receive the same intervention as group two but will also be asked to send a photograph or detailed description of what they have “said no” to via text message (self-monitoring of behaviour). Participants will then receive feedback about how many kilojoules they have saved by “saying no”. The text messages will be tailored to the individual as this is associated with greater behaviour change than generic messages. As this is a feasibility trial results will be analysed descriptively.

  • Advanced Medical Imaging in Subpatent Malaria: a pilot study

    Functional nuclear medicine imaging techniques such as PET/MRI imaging are commonly used in fields such as oncology to look at the bioactivity and biodistribution of disease. These techniques have previously been applied to infectious diseases, although data is limited. We propose a pilot study to investigate the use of 18F FDG PET/MRI imaging in malaria infection. Participants taking part in malaria challenge studies will be invited to undergo whole body PET/MRI imaging before and after malaria inoculation.

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