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.
  • Community Jury: Case finding for dementia, what do community members think General Practitioners (GPs) should do?

    Government policy on health care should seek to reflect the views of the community but current methods for community engagement are limited. Strategies such as opinion polling, community forums, and engaging consumer representatives on decision making panels may not be able to fully consider issues that are complex, require a greater understanding of potential benefits and harms, and may provide only a limited number of viewpoints from the community. A community jury is a deliberative process that can help to establish the community’s preferences and values on a particular topic. This research team has successfully conducted the first randomised controlled trial of a community jury process in health and demonstrated proof of concept that this form of public engagement could be potentially beneficial to health policy. Our findings demonstrated a community jury was capable of considering complex information on the harms and benefits of screening, and to distinguish individual from community choices. Our community jury also identified an innovative solution to the question being deliberated. Cognitive impairment ranges from mild impairment to severe dementia. It causes problems with memory, learning, and organising and mild cognitive impairment can be a precursor for dementia. The benefit evidence for case finding for dementia is scarce, the medication benefits not significant, and the nonpharmacological interventions mostly ineffective. We will conduct a community jury to consider the potential benefits and harms of case finding for dementia in primary care and ask the jury to propose a recommendation for the question, “Should the health system encourage GPs to practice ‘case finding’ of dementia in people over 50?”

  • A study to determine the safety, maximum tolerable dose and ability to provoke an immune response of the Codavax Influenza Vaccine in healthy volunteers.

    CodaVax, the study drug being researched in this project, is an experimental vaccine being developed by Codagenix, Inc. This means that it is not an approved treatment in Australia, and is not yet approved anywhere else in the world. CodaVax is a vaccine that is intended to prevent influenza. The primary objective of this study is to determine the safety and tolerability of CodaVax influenza vaccine compared to active and placebo controls when administered to healthy adults.

  • Can placebo pills improve well-being even when you know you're taking a placebo?

    This study will investigate the role of dose in open-label placebo administration. Recent studies have found that open-label placebo treatments are effective in improving symptoms of IBS, depression, ADHD, and low-back and migraine pain. These findings suggest the possibility of generating a placebo effect without deception. Participants will be recruited to take part in a study investigating the effect of open-label placebo administration on well-being and randomly assigned to one of three conditions: no-treatment control, low dose (1 pill per day), or high dose (4 pills per day) placebo administration.

  • Evaluating a Computer-based Inhibitory Smoking Training (INST) program to assist individuals to quit or reduce smoking.

    Despite the supports and treatments available to assist smoking cessation, relapse remains high amongst smokers who attempt to quit. An important factor that has been identified to contribute to relapse is difficulties with impulse control, also known as response inhibition. Smokers have been found to exhibit reduced response inhibition, that is, difficulties inhibiting an automatic response such as smoking, Difficulties with response inhibition has been hypothesised to be a predictor of relapse following a quit attempt. Therefore, it would be beneficial to target response inhibition during this time period to assist in achieving and maintaining abstinence. While response inhibition interventions have not yet been investigated in smokers, other studies have found it to be effective in changing unhealthy behaviours in heavy drinkers, dieters and overweight adults. This Randomised Controlled Trial aims to investigate whether response inhibition training is effective for reducing smoking in those who are dependent on nicotine, It will also examine how a number of mediators and moderators. Our research group is collaborating with Dr Natalia Lawrence to adapt her program which was developed and evaluated in the UK in relation to food inhibition training. Participants will be allocated to either a treatment group or an active control group. The response inhibition group will complete two weeks of the smoking response inhibition training program, while the control group will complete a general response inhibition training program. All participants will complete fourteen online training sessions over a two-week period and will provide follow-up data relating to their smoking status three time points after they have completed the training - post intervention, one and three month follow up.

  • Comparing home infusion devices for antibiotic treatment - CHID Study

    The purpose of this study is to compare and contrast patient and nurse satisfaction with the Baxter(Registered Trademark) device and the Ambit(Registered Trademark) device for delivery of intravenous antibiotics in the home setting. The secondary aims are to examine any complications that occur with this these infusion pumps, the quantity of medication they deliver and the temperature during storage and use of these devices. The proposed research design is to allocate patients to receive home antibiotic infusion with one of two infusion devices for one week, then continue that treatment with the other device for one week. At the end of both periods the patients will be asked to fill in a questionnaire regarding their satisfaction with the device and any problems that arose. A survey will also be conducted of RDNS nursing staff that have provided home care to these patients to assess nurse satisfaction. In addition to the surveys, all infusion devices/bags will be weighed after their use to determine the quantity of any drug remaining. Each pump/bag will be equipped with a temperature sensor to determine the storage temperature of the drugs when kept in patients’ homes, as well as the ambient temperature during pump use. A temperature sensor will be placed on each patients arm to measure skin temperature during pump use, as this has an impact on elastomeric infusion pump accuracy. Patient case note data will also be monitored to collect statistics on infusion related complications, such as occlusions, disconnections, infections or repairs required.

  • Biofeedback gait training in stroke patients.

    The aim of this project is to demonstrate the effectiveness of using visual feedback to increase toe clearance during walking in people with stroke. This new intervention has the potential to improve walking safety and reduce the risk of trips and falls. One important gait variable in these types of trips is minimum toe clearance (MTC). Reduced MTC can increase the risk of tripping. 150 participants will be required to attend 16 sessions (two baseline assessments (one clinical assessment conducted by a Physiotherapist and practice walking on the treadmill, the other is biomechanical assessment to determine MTC), 10 gait training only, and 4 post-training assessments (one after completing the final training, and then 1 month, 3 months and 6 months post-training follow up session). Half of the participants (n=75) will be randomly assigned to an Experimental group who will receive treadmill-based gait training with toe clearance feedback and half will comprise a Control group who will undertake assessment and training trials exactly as the Experimental group but will NOT receive the corrective real time feedback. The ten training sessions will occur over a 5-6 week period, with at least one rest day between sessions. Six assessment sessions will be about 90 minutes duration. The training sessions will take approximately 60 minutes. At all sessions, participants will be required to walk on a treadmill for up to 10 minutes. They will wear a safety harness which will prevent them from falling. Participants will also have markers placed on their lower limbs, and a special camera (Optotrak) will record the movement of these markers while participants walk. Data will be recorded during assessment sessions, and additional clinical data will also be obtained. Participants will be asked some questions about their risk of falls. During the training sessions, data from markers will provide ‘real time’ feedback to Experimental participants about their affected leg toe clearance during the swing phase of walking. Using this information, participants will be asked to modify their walking pattern to match a “target” increased toe clearance. Feedback will be provided continuously for the first 6 sessions and then progressively reduced (faded) across the last 4 sessions.

  • Wellbeing Intervention for Chronic Kidney Disease (WICKD): A Trial of the Aboriginal and Islander Mental Health Initiative (AIMhi) Stay Strong App.

    Aboriginal and Torres Strait Islander people with chronic kidney disease (CKD) may suffer distress and poor mental health from living with a chronic illness, travelling away from family and country to receive treatment, poor access to housing and accommodation and big changes to their lifestyle. The WICKD Study is a randomised controlled trial to test the effectiveness of a culturally-adapted, electronic mental health intervention (i.e. Motivational Care Planning (MCP) using the AIMhi Stay Strong App) in improving psychological distress, depressive symptoms and quality of life among Indigenous Australians on haemodialysis in the NT. People with ESKD on dialysis are a group in which distress is likely to be unacceptably high, yet relatively untreated. The highly structured MCP intervention can be used by a wide range of healthcare workers and provides a high-fidelity treatment that can be integrated into a primary health care or chronic disease management setting. This coordinated approach, combining mental health prevention and intervention within a chronic disease setting could substantially reduce the impact of mental illness among Indigenous people with CKD and may have broad applicability across CKD and other chronic disease populations, both Indigenous and non-Indigenous. Demonstrating the effectiveness of this intervention will provide evidence for best practice intervention for managing distress for people on dialysis and facilitate integration of treatment for psychological distress within a chronic disease management setting. HYPOTHESES We hypothesize that: Compared with the control interventions, MCP using the AIMhi Stay Strong App will elicit greater reductions in psychological distress as measured by the Kessler distress scale (K10) at 3 months post-baseline. 1. Compared with the control interventions, MCP using the AIMhi Stay Strong App will elicit: a. Greater reductions in severity of depressive symptoms as measured by the Indigenous adapted Patient Health Questionnaire (PHQ-9) at 3 months post-baseline. b. Improved QoL as measured by the EQ-5D (5 level) at 3 months post-baseline. c. Greater adherence to treatment as measured by higher attendance at scheduled dialysis sessions and fewer hospitalisations at 3 months post-baseline 2. Similar improvements from baseline on psychological distress, depressive symptoms, QoL and adherence to dialysis will be seen in the three conditions at 6 months post-baseline, when all will have received the MCP intervention. 3. Compared with the control interventions, MCP using the AIMhi Stay Strong App will be cost effective, from the health service provider perspective, as measured by the cost per quality-adjusted life year (QALY) gained, and the cost per additional patient achieving a clinically meaningful improvement in the K10 at 3 months and 6 months.

  • Dispensing study to assess the visual performance of optimised prototype contact lenses

    This study aims to find out the visual performance of different prototype contact lenses compared to commercially available contact lenses. The prototype lenses use different optical designs to standard contact lenses by increasing depth-of-focus, and may offer an improved wearing experience.

  • Is there educational value in providing individualised feedback in addition to generic feedback to online course participants?

    This study aims to assess the effect of providing individualised feedback in addition to generic feedback compared to generic feedback alone on learning outcomes of a web-based educational course related to falls prevention.

  • Effects of early motivational interviewing on post-stroke depressive symptoms: a pilot randomised controlled trial of the Good Mood Intervention program.

    Depression is a frequent consequence of stroke that affects recovery adversely and can lead to greater mortality; however, it is often undetected or treated inadequately. While antidepressants can be used to treat post-stroke depression (PSD), they increase the risk of side-effects which complicate recovery. This randomised controlled trial evaluates a new brief intervention, the Good Mood Intervention program. The aim of the study is to investigate if motivational interviewing (MI) improves patients’ mood post-stroke. It will be conducted at the Stroke Unit, Western Hospital, Melbourne and will recruit inpatients with acute stroke.

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