ANZCTR search results

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

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32704 results sorted by trial registration date.
  • The Sun Wise Study: Examining the impact of a personalised skin cancer prevention strategy among people with a history of skin cancer

    The aim of this study is to evaluate the impact of a personalised skin cancer prevention strategy on UV exposure in adults with a history of skin cancer. Who is it for? You may be eligible for this study if you are aged 18 years and over, and have previously been diagnosed with skin cancer (including melanoma, basal cell carcinoma, squamous cell carcinoma). Study details Participants will be randomly assigned to either an intervention or control group. The intervention comprises 10-days wear of a Sun Watch, which displays the real-time UV Index and the wearer’s daily cumulative UV exposure alongside receiving personalised SMS sun protection reminders, and educational information on skin cancer prevention, early detection and treatment. The control arm will receive the educational information only. Participants will be asked to complete questionnaires on their sun protection behaviours, physical activity, psychosocial outcomes and their perspective on the intervention. It is hoped that findings from this study will help researchers understand the effect of a personalised skin cancer prevention strategy on primary prevention behaviours.

  • Evaluation of a short-term group intervention for parents with borderline personality disorder symptoms: Lifeboat

    Borderline Personality Disorder (BPD) is a common, yet complex, mental illness. People with a diagnosis of BPD experience significant distress due to difficulties relating to other people and the world around them, disruptions to family, social and work life. Symptoms of BPD may include difficulty regulating emotions, impulsive behaviours, self-harm, suicidal ideation/attempts, feelings of detachment from their own experiences, and/or intense and unstable relationships. Additionally, parents with BPD may face challenges responding to and bonding with their infants, which may negatively impact children throughout their lifespan. Although BPD is a long-term condition with high rates of relapse and crisis, recovery is possible with suitable therapy. Treatment approaches for people living with BPD are often intensive and lengthy, which can mean long waiting periods for patients to enter programs. Helen Mayo House and Borderline Personality Disorder Collaborative (BPD Co) have collaborated to develop a ten-week group therapy program (Lifeboat) for parents with DBT informed by the principles of Dialectical Behavioural Therapy (DBT) and Mentalization Based Therapy (MBT). Lifeboat aims to help parents living with BPD understand and connect their emotional, cognitive and behavioural experiences. The present pilot study will assess the appropriateness, feasibility and effectiveness of the program by comparing the severity of parental psychological symptoms and parenting attitudes and behaviours before and after attendance to the program, as well as six months post-intervention. Interviews with participants will also be conducted to explore the experiences of parents with BPD engaging with the Lifeboat program. Participants will be asked to complete an electronic survey and participate in an evaluation and interview before, after, and six months post-intervention. It will be made clear to participants that participation is voluntary and refusal to participate will in no way affect eligibility for the Lifeboat program, or any other health service.

  • Evaluating use of inhaled dexmedetomidine for pain management in adult burn injury dressing changes

    Study Title: The IDEAS-B STUDY Evaluating whether nebulized dexmedetomidine can be used for pain management in burn injury dressing changes.: A phase III pilot feasibility, randomized controlled crossover trial. This is a pilot phase III randomised controlled crossover trial that will be conducted in the burn’s unit at the Royal Brisbane and Women’s Hospital. The drug, Dexmedetomidine, will be used for its registered purpose, sedation and analgesia, however this study will be investigating the use of an alternative method of administration (nebulisation). Patients suffering from burns undergo procedures (dressing changes, de-stapling and burns baths) associated with pain and discomfort requiring analgesia/sedation. Inadequate analgesia/sedation causes complications such as patient discomfort, distress, noncompliance, difficulty nursing, and prolonged procedural time, adversely affecting wound healing and increasing hospital length of stay. Therefore, optimal procedural analgesia/sedation is vital for these patients. Currently, in RBWH burns patients, analgesia/sedation is provided by oral oxycodone 10mg and sublingual lorazepam 1mg with breakthrough inhaled nitrous oxide, but this is associated with several adverse effects (nausea, vomiting, and dizziness), and suboptimal clinical effect. Dexmedetomidine, a centrally acting Alpha 2 agonist with analgesic, anxiolytic and sedative properties commonly administered by intravenous route is also able to be administered via the inhaled route using a nebulizer. Due to its pleiotropic effects, intravenous dexmedetomidine is used as an analgo-sedative in clinical medicine. However, Intravenous dexmedetomidine is associated with side effects such as hypotension and bradycardia. Nebulization is a viable and effective alternative mode of drug delivery for systemic effects including analgesic agents due to the extensive surface area and perfusion of the lungs. Moreover, nebulized dexmedetomidine has been reported to have been used safely and effectively in other conditions. Nebulized dexmedetomidine can potentially achieve therapeutic plasma concentrations with lower peak (minimising adverse effects) and larger area under the plasma concentration-time curve, achieving adequate analgesia for a longer duration which is ideal for burns procedures in non-mechanically ventilated patients. However, currently there is no data supporting the use of nebulized dexmedetomidine for analgesia-sedation in burns patients. We plan to recruit 20 participants per for this study.

  • The ALLEVIATE study. A prospective observational comparative plasma and cerebrospinal fluid pharmacokinetics study of levetiracetam in aneurysmal subarachnoid haemorrhage and traumatic brain injury.

    The ALLEVIATE study aims to determine what level of levetiracetam concentrations are achieved in the blood and brain, in ICU patients with bleeding in the brain due to severe traumatic brain injuries or ruptured aneurysms. Although research suggests that there needs to be a certain amount of levetiracetam in the blood to stop or prevent seizures, it is currently unclear, whether the amount in the blood results in the right level in the brain (the site of injury). The purpose of this study is to determine how best to dose levetiracetam so that adequate levels are achieved in the brain in patients at high risk of seizures. We hypothesise that there may be significant differences in levetiracetam brain fluid concentrations between the two groups of patients. Patients who are receiving Levetiracetam for the treatment or prevention of seizures as part of their standard care for bleeding in the brain will be considered for participation. Participation will involve sampling of blood and brain fluid over one dosing interval on one day only, to measure the concentration of levetiracetam. Blood samples will be collected from an existing arterial line. The brain fluid is collected from an external ventricular drain that is already in place as part of usual care to relieve pressure in the brain. A prolonged electroencephalogram (EEG) recording will be undertaken prior to administration of levetiracetam dose and continuing until the next dose on the day of sampling. EEG is a non-invasive procedure that studies the brain’ electrical activity and is used to evaluate seizures.

  • Development, implementation and evaluation of the Spaced Retrieval and Montessori-based activities (SPREMON) mealtime intervention for individuals with dementia living in nursing homes: a pilot study

    This pilot study aims to examine the efficacy of the Spaced Retrieval and Montessori-based activities (SPREMON) mealtime intervention on eating difficulties, mealtime engagement, and affect in individuals with dementia living in an Australian nursing home. A quasi-experimental design (single group) will be undertaken for the pilot study. The pilot study will recruit 35 individuals who are in the mild to moderate stage of dementia, have eating difficulties, and scored above 5 on the Edinburgh Feeding Evaluation in Dementia Questionnaire. The intervention will consist of Spaced Retrieval and Montessori-based activities, 45 minutes per session, three times per week, for a total of 20 sessions over seven weeks. The outcomes will be measured three times: prior to first intervention session, immediately after completion of the intervention program and 3 months follow-up post-completion of the intervention program.

  • Abdominal drains for ascites

    Chronic liver diseases, from any aetiology, progress over time to cirrhosis if untreated. Ascites-related readmissions are the predominant cause of hospitalisations in these patients, especially in the last few months of life. Large volume paracentesis is the only therapeutic option in those who cannot undergo LT. LVPs are typically performed every week or two in medical day-care units (MDU) as elective procedures, or as emergency hospital admissions. There are practical difficulties in organising LVPs due to bed limitations in the medical day-care unit, and this situation often leads to emergency room presentations and hospitalisations. Since ascites drainage in patients unsuitable for LT is a palliative procedure, it is best done in the comfort of their homes on a regular basis. This study explores the possibility of an alternative procedure via a catheter inserted in the abdomen and repeated small-quantity drainages (simply, long-term abdominal drains or LTADs).

  • The right to rehabilitation for people with dementia: Implementation and evaluation of the "INCLUDE" interventions

    There is evidence for rehabilitation interventions to reduce disability and improve wellbeing for people with dementia. However, experiences of people with dementia with rehabilitative treatments are almost non-existent. There are barriers and challenges at multiple levels: 1) Health professional stigma about the value of rehabilitation for people with dementia and their ability to engage in therapy, 2) Low levels of knowledge about the evidence for dementia rehabilitation exist, which is also likely to contribute to stigma, 3) People with dementia and their care partners find services hard to navigate and report needing information to empower them to ask for rehabilitation and support to access it, 4) No clear model or pathway in the system for providing rehabilitation for people with dementia. Given the evidence for rehabilitation interventions to reduce disability and improve wellbeing in people with dementia, there is much need in addressing stigma and low knowledge, to overcome challenges to promote rehabilitation access for people with dementia. Co-design workshops have been held to determine strategies to address stigma and challenges to rehabilitation access for people with dementia. A package of solutions “INCLUDE” has been decided on (A dementia rehabilitation e-module, a community of practice, and GP/GP practice nurse dementia training). We will test and evaluate their implementation in the South Eastern and Eastern Melbourne Primary Health Network areas. The specific aims are to determine: 1. The number, type, work setting, and proportion of health professionals (GPs, practice nurses, allied health professionals (AHPs) and other professionals) who agree to participate in the study and partake in any of the INCLUDE solutions 2. The effect of the INCLUDE solutions (e-module, GP training and Community of Practice) on change in stigma and knowledge about dementia rehabilitation 3. The effect of the e-module and community of practice on change in: a. social networks b. number of people seen with dementia by allied health professionals and c. number of advocacy actions and changes to practice by members in their workplace 4. Acceptability, satisfaction and perceived sustainability with each of the INCLUDE solutions

  • An elastic knee brace for patients with ongoing symptoms following anterior cruciate ligament reconstruction: a pilot study

    The primary aim of this pilot study is to determine the feasibility of wearing an elastic knee brace (Genutrain, Bauerfeind) for 6 weeks on clinical and biomechanical features of early knee osteoarthritis after ACL reconstruction. Together with a pilot cross-over study to estimate the immediate-effects of the brace (separate trial registration), this pilot study will inform a future full-scale RCT.

  • Optimising Transition to Residential Aged Care

    The problem: A staggering 50% of the 190,000 residents living in aged care in Australia have depressive symptoms, while 35% have a diagnosis of depression. Evidence-based interventions exist to (i) reduce depression in residents (ii) improve mental health outcomes in their family members, (iii) improve the quality of care provided by Residential Aged Care Staff. However, despite their existence, these interventions are not widely available or systematically implemented. The transition into living in aged care is recognised as a critical time point for the onset and exacerbation of depression. Despite this, there is currently no consistent approach to inform access to, and the provision of, mental health support when a person transitions from community living into a residential aged care facility. The solution: We will implement a sustainable, evidence-based, and innovative approach to prevent depression in aged care residents. We will achieve this by embedding processes to deliver a suite of interventions that will work synergistically to prevent and reduce depression, targeting all involved in the care triad: the resident, their family/carers, and the residential aged care facility (RACF)staff. Specifically, this will include embedding processes to deliver (i) the PEARL intervention for new residents adjusting to residential aged care, (ii) the adapted START intervention to support family/carers; and (iii) the Dignity of Choice training program to upskill RACF staff in person-centered mental health care provision. This will be a world-first approach, setting the foundations for a definitive cluster randomised controlled trial to assess the cost-effectiveness of this suite of programs, which if proven effective will transform the residential aged care living and working experience. The improvement of mental health in aged care residents, families/carers, and staff will be a major step forward in addressing the recommendations of the Commission, and extending healthy, active years of life for those living in RACFs.

  • Effectiveness of the 'LeapForward' program on return-to-work and injury-related outcomes: a pragmatic randomised controlled trial

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