ANZCTR search results

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

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32707 results sorted by trial registration date.
  • The Optimise Study - randomised trial of the use of a decision aid to improve informed choice regarding the benefits of low-dose aspirin to prevent cardiovascular disease and colorectal cancer

    The purpose of this study is to assess the effect of the 'Optimise' decision aid on choices regarding taking low dose aspirin for the prevention of cardiovascular disease and colorectal cancer. Who is it for? You may be eligible for this study if you are an adult aged 50-70 years who has not been diagnosed with a serious illness. Study details Participants will be recruited through their GP and randomised to one of two groups. All participants will complete a baseline questionnaire which involves individual risk calculations for cardiovascular disease and colorectal cancer. In one group patients will be taken through the 'Optimise' decision aid to consider the use of regular low-dose aspirin, weighing up the health benefits and the risk of side effects of aspirin, including gastrointestinal bleeding, along with personal preferences regarding taking aspirin. The other group (the control group) will receive general information about prevention of colorectal cancer. Participants will then be followed up after three months by telephone survey, including a measurement of informed choice regarding taking low - dose aspirin, and adherence to aspirin. They will also be followed up by SMS every 3 months for one year to assess adherence to aspirin. Patient data regarding health outcomes will be collected from health data sets for up to 10 years after enrolment. Outcomes It is hoped that the use of the Optimise decision aid will increase the proportion of participants making an informed choice about the use of aspirin to prevent cardiovascular disease and colorectal cancer.

  • Efficacy of Morosil® on weight loss in overweight but otherwise healthy men and women. A randomised double-blind placebo-controlled study.

    This is a single-site, double-blind, randomised, clinical trial for 6 months treatment duration and utilising active and placebo arms with baseline data collection. 150 overweight male and female participants aged between 20 and 65 years will be recruited from databases and public media outlets. Following preliminary screening via telephone, potential participants will attend the clinic for an information session and will be required to provide their consent for inclusion in the trial. Consenting participants will undergo a health assessment including lifestyle, current medications and medical history; this data will be used for the comprehensive screening and to provide contextual data for the study. Once enrolled in the trial, participants will be randomly allocated to either the placebo comparator group (n=75) or the active intervention group (n=75 per group). Dietary intake and body measurements (weight, height, hip circumference, waist circumference, blood pressure and heart rate) will be assessed at enrolment. Within the week pre-treatment, participant’s blood will be collected for analysis of pre-treatment blood markers. Participants will also be required to have a DXA scan. All participants will receive the same standard advice regarding physical activity. Specifically, participants will be asked to undertake 30 minutes of walking 3 times per week and record all physical activity in their diaries. In terms of dietary advice, participants will be asked to follow a kilojoule controlled diet. The amount of kilojoules to be consumed daily by each participant will be calculated using the basal metabolic rate score from their DEXA scan. Participants will be asked to record their daily food intake in a kilojoule counter app and submit a 24hr food recall every two months during the study. Guidance in the form of example meal plans will be provided. Participants will be asked to take the allocated product according to the dose prescribed. In addition, participants will be asked to attend the study site at months 1, 2, 3, 4 and 5 for a body measures, dietary intake and tolerance assessment. At the completion of the study (month 6), an assessment identical to that undertaken at baseline will be carried out. Participants will be monitored for compliance with the protocol by a combination of telephone and email communications in addition to during each scheduled site visit.

  • VERILY - Virtual Dementia Friendly Rural Communities: Using technology to improve support for carers of people living with dementia in rural communities

    The VERILY project aims to trial and evaluate a set of strategies for increasing online support for rural carers of people living with dementia. Participants will include carers, volunteers, and staff, who will be asked to use a website or mobile app and participate in videoconference support groups and then provide feedback about their experiences by completing surveys, a focus group, or an interview, and by responding to follow-up telephone calls from researchers.

  • Changing driver behaviour during floods using an e-health imagery intervention

    The current project will evaluate the effectiveness of a theory-based intervention utilising implementation imagery to reduce Australian drivers’ intentions to attempt to drive through floodwaters–a behaviour that carries significant risk of drowning. The aim is to develop an effective intervention that can be used as content by stakeholders with interests in drowning prevention to minimise risky driving behaviours and drowning risk. Hypotheses Hypothesis 1: We hypothesise that drivers assigned to the intervention condition will report significantly lower intentions to drive through floodwater, relative to the control condition immediately post-intervention at T2 (primary outcome). Hypothesis 2: With regard to the secondary outcomes, we hypothesise that drivers assigned to the intervention condition will report significantly less favourable attitudes and reduced perceived social pressure to drive through floodwater, as well as greater perceptions of behavioural control, risk perception, perceived susceptibility, perceived severity, and anticipated regret toward driving through floodwater, relative to the control condition immediately post-intervention at T2. Hypothesis 3: We further hypothesise that that drivers assigned to the intervention condition will report significantly greater barrier self-efficacy and action planning regarding avoiding driving through floodwater, relative to the control condition immediately post-intervention at T2. Hypothesis 4: We also expect that the effects of the intervention will be maintained four-weeks later at T3. Given our previous research has identified sex differences in changing beliefs (Hamilton, et al., 2018), we will also test for gender differences in the effects of the intervention on study outcomes. Timepoints: Baseline (T1), immediately post-intervention (T2), 1-month follow-up post-intervention (T3).

  • Factors affecting insulin dose requirements for treatment of prednisolone induced hyperglycaemia.

    Prednisolone is an oral glucocorticoid used in the acute treatment of many inflammatory diseases. Glucocorticoid excess leads to hyperglycaemia. There is wide variability in the degree of hyperglycaemia associated with oral prednisolone use. We aim to define how clinical features and different times of day are associated with insulin requirement in hyperglycaemic hospitalised patients taking prednisolone. We will recruit 50 consecutive participants who are admitted to general medical or medical sub-specialty inpatient teams at Flinders Medical Centre or Lyell McEwin Hospital who meet eligibility criteria. This is an open interventional study. Eligible, consenting participants will receive 24 hours of intravenous insulin infusion. Flash glucose monitoring will be used to measure hourly blood glucose concentration. Use of intravenous insulin infusion will follow Flinders Medical Centre infusion protocol. We expect to be able to characterise how clinical features and time periods throughout the day predict for insulin requirements in hyperglycaemic hospitalised patients taking prednisolone.

  • A Randomized, Placebo-Controlled, Sequential Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers

    This is a double-blind, placebo controlled, ascending dose, multi-cohort trial. The study will be conducted with a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase. In SAD, participants will receive one dose of BT-11 or placebo. In MAD, participants will receive multiple doses of BT-11 or placebo for 7 consecutive days. In both parts, sequential cohorts will be exposed to increasing doses of BT-11. In SAD, five doses will be evaluated, in MAD 3 dose levels will be evaluated.

  • feasibility of Innovative photography technology (The VISIA facial imaging system) to monitor the effect of 5-flurouracil treatment for people with solar/actinic damage to their face.

    Patients already under the care of specialist dermatologists or referred to a dermatologist at The Princess Alexandra Hospital will be recruited during attendance for their full skin examination. Should a patient require topical field therapy and the clinician deems 5-fluroruracil the treatment of choice – the patient’s usual doctor or nurse will introduce the study to their patient and gauge their interest in participating. A member of the study team will be available to answer any questions or concerns a patient may have regarding the trial, before ensuring informed consent is granted. The member of the study team will also record information on demographic, and relevant medical history from the patient, as listed below. Baseline clinical photographs will be taken using the specialised facial photography machine (VISIA®, Canfield Scientific). Once enrolled, patients will be flagged by the study team and followed at their subsequent reviews. As part of standard care, patients are requested to present for review at 2weeks after commencing treatment and again at the conclusion of treatment (4 or 6 weeks depending on indication). Patients are also requested to present 12weeks after the commencement of treatment for final evaluation. At any stage, but particularly at 12weeks after commencement of treatment – careful examination is performed to determine of any field-treatment failures so that subsequent management may be initiated (e.g. formal excision). At the conclusion of their usual clinical follow-up appointment, the participant will be ushered into the adjunct research room for repeat/progress specialised facial photography as described above (VISIA®, Canfield Scientific).

  • Introducing Best Practice Oxygen therapy for Infants with Bronchiolitis

    This study aims to determine the benefit, effectiveness, and sustainability of a facilitated and structured educational support program versus no facilitation or educational support program in the uptake and adherence to NHF therapy guidelines for infants less than 12 months old admitted with bronchiolitis. The key stakeholders (nursing and medical workforce) have been familiarised with the use of NHF therapy within the boundaries of the completed NHMRC PARIS I trial, 2013-2016. Our study group has developed a comprehensive education program, which includes visual education, paper and signage resources, face to face teaching and online video postings.

  • A study investigating safety, dosing and effectiveness of medicinal cannabis for symptom relief for patients with advanced cancer

    Recently there has been a growing interest in the use of cannabis to try and relieve symptoms of pain, nausea, shortness of breath, anxiety, and depression, in patients with advanced cancer. The purpose of this study is to determine an appropriate dosing regimen, safety and efficacy for THC and CBD (both components of cannabis) for symptom relief in patients with advanced cancer. Who is it for? You may be eligible for this study if you are over the age of 25 and have been diagnosed with advanced cancer. Study details Participants will be allocated into 1 of 2 treatment arms. Group 1 will be receiving CBD (cannabidoil) and Group 2 will be receiving THC (Delta-9-Tetrahydrocannabinol). Determination of the treatment given to the participant will be based on the participant, the treating doctor, and the supply of the medication. Participants will be asked to take increasing doses of the study medication for 14 days, with the dose increasing until participants are satisfied with the symptom improvement and are experiencing no unacceptable side effects. After these 14 days, participants will be asked to take a steady dose of the medication for another set of 14 days. Participants will be required to have a blood test and if any females are of child bearing potential a urine test to determine eligibility. It is hoped that this research will be effective in determining a safe and effective dose for symptom relief in patients with advanced cancer.

  • A model of culturally-informed integration of diabetic retinopathy screening and diabetes education assessment in Indigenous primary care settings.

    Diabetic retinopathy is a major public health problem in Australia, particularly among Indigenous Australians. For this reason, national guidelines in Australia were first developed for diabetic retinopathy. Despite efforts over two decades aimed at timely detection and early treatment of diabetic retinopathy, about half the Indigenous population with diabetes in Australia is not screened in accordance with the guidelines. Novel approaches to screening for diabetic retinopathy are needed, particularly in Australia's remote, under-resourced and Indigenous communities.The aim of this project is to implement an imaging-based telehealth diabetic retinopathy screening program managed by a diabetes educator in Indigenous primary care clinics. Objectives 1) To develop a model of integrated DE and DRS assessment in regional Indigenous primary care services. 2) To develop culturally-informed DE and DRS programs with input from Indigenous stakeholders. 3) To improve DRS coverage in Indigenous primary health care services. 4) Use DRS images and vision status to reinforce importance of diabetes self-management for reducing risk of all diabetes complications. 5) Facilitate timely referral pathways to ophthalmic services and diabetes specialist services. Research Design Proof of concept trial using a qualitative and quantitative approach. Up to three rural/regional trial-sites and approximately 250 T2DM participants aged older than 18 years of age Pre-post trial design: diabetic retinopathy screening, assessing health literacy, clinical and lifestyle risk factors, social/emotional well-being, satisfaction with diabetes education, perceived barriers/motivators to access and follow-up services. Baseline visit: Diabetic retinopathy screening, Smoking, Nutrition, Alcohol, Physical (activity) and Emotional (well-being) [SNAPE] and Vision Impairment Questionnaires to will be administered. HbA1c, lipids and blood pressure will also be measured to gauge patient’s baseline diabetes self-management. Surveys will assess a patient’s diabetes knowledge and health literacy, Final visit: Diabetic retinopathy screening repeated to assess adherence to annual screening recommendation, administration of the Diabetes Knowledge Questionnaire to gauge if patient’s diabetes knowledge has increased and self-care has improved over the intervention period, repeat measurement of patient’s HbA1c, lipids and blood pressure to see if diabetes risk factor control has improved. Patients will also have administered the Diabetes Treatment Satisfaction Questionnaire that will gauge patient’s satisfaction with the intervention over time. With integration of diabetes education and diabetic retinopathy screening, it is expected that engagement with self-management [risk factor control and adherence to retinopathy screening recommendations] will improve.

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