ANZCTR search results

INFORM-AF II is a pilot prospective, randomised, open-label, blinded endpoint (PROBE), multicentre trial of a digital atrial fibrillation (AF) education program delivered via QStream™ versus the Stroke Foundation ‘Living with AF’ booklet. The aim of the study is to evaluate the effectiveness of the digital AF education program delivered via QStream™ on re-hospitalisation rates within 12-months of the primary indexed AF diagnosis, all-cause mortality, cardiovascular-related hospitalisation, medication adherence, AF-related knowledge, and quality of life as well determine the cost-effectiveness of the intervention. The mHealth application is a smartphone-based spaced learning intervention and consists of six case scenario-based AF questions, based on a spaced timing algorithm, delivered over a 6-week period. The mHealth-based intervention is delivered by the QStream digital platform and was co-designed in consultation with stakeholders including patients living with AF, healthcare providers of AF patients and key opinion leaders from the Stroke Foundation, Heart Foundation, non-government organisations and cardiovascular peak bodies. This trial is informed by our foundational qualitative research which explored the educational and self-management needs of adults living with AF and a recently completed single group feasibility and acceptability study (INFORM-AF) which demonstrated significant improvements in AF knowledge and quality of life at 12 months (yet to be published). Data collection will be completed through an electronic survey delivered by the study nurse over the phone at 6 weeks, 3 months, 6 months, and 12 months post intervention.

Diuretics are commonly used in the intensive care unit with the aim of achieving a negative fluid balance; yet remarkably little is known about their pharmacodynamic properties in critically ill patients. The most frequently used class of diuretic drugs are the loop diuretics, and furosemide is the most commonly used loop diuretic. However, loop diuretics may have a number of undesirable side effects, including electrolyte derangements and metabolic alkalosis. This pilot trial will randomly allocate 40 patients (20 in each arm) to receive Furosemide only or Furosemide and Acetazolamide. The primary outcome is urinary output occurring in the 6 hours after diuretic administration while in the intensive care unit. Results will inform future clinical trials and the outcomes that will be selected for these future trials.

This is a pilot study which aims to assess the response to the use of prednisolone in people with artificial stone associated silicosis. The pilot study will assess safety, feasibility, and explore the effect of prednisolone on clinical outcomes (markers of disease activity) before and after treatment. Participants will include people with artificial stone-associated silicosis who have elevated indicator(s) of inflammation despite cessation of exposure to silica dust. Participants will be treated with 25mg prednisolone daily for three months.

The purpose of this study is to evaluate clinical efficacy of incorporating Epcoritamab into the salvage regimen for relapsed-refractory aggressive B-cell lymphoma, followed by autologous stem-cell transplantation (ASCT) and consolidation Epcoritamab. Who is it for? You may be eligible for this study if you are aged 18 and above and are transplant-eligible with diffuse large B cell lymphoma that has relapsed or progressed after at least one line of immunochemotherapy. Study details This study design involves phases for Epcoritamab-Salvage treatment, ASCT and Consolidation treatment. 1. Epcoritamab-Salvage treatment: Salvage treatment consists of 3 cycles of R-DHAOx (rituximab, dexamethasone, cytarabine, oxaliplatin) plus Epcoritamab, given in 21 day cycles. Epcoritamab is commenced in cycle 1, consisting of weekly dosing on days 1, 8 and 15, three doses per cycle. Priming (0.16mg) on C1D1 and intermediate (0.8mg) C1D8 dosing will be administered prior to full dose (48mg) on C1D15 and ongoing. Response assessment will be performed after 2 cycles of Epcoritamab-salvage according to Lugano Criteria 2014. • Patients who achieve complete remission (CR) may proceed directly to ASCT or may receive 1 further cycle of combination Epco-R-DHAOx and then proceed to ASCT. • Patients who achieve partial response (PR) will receive 1 further cycle of combination Epco-R-DHAOx and proceed to ASCT or may cease protocolised therapy based on physician choice and enter the Post Treatment follow up phase. • Patients achieving less than PR will not receive further protocol therapy and will enter overall survival (OS) follow up. 2. Autologous stem cell transplant: Stem cell collection will occur following either the second or third cycle of salvage Epcoritamab as per institutional policies. Stem cell recollection is allowed in the event of unsuccessful first collection. Pre-autograft eligibility assessment for ASCT will be performed according to local practice. ASCT may be administered at local referring centre and will follow local standard operative procedures. • Note: Patients who respond to salvage-Epcoritamab treatment but are not considered eligible for the transplant procedure for reasons other than insufficient response (e.g. due to toxicity or failed stem cell mobilisation) may proceed directly to the Consolidation Phase instead of proceeding to ASCT BEAM chemotherapy will be used for conditioning as per institutional guidelines. 3. Consolidation treatment: Consolidation treatment consists of six 28-day cycles of subcutaneous Epcoritamab, commencing between 6 and 12 weeks post ASCT. Other testing that will be performed includes physical examination, neurological examination, ECOG performance, ECG, haematology, biochemistry and monitoring of adverse events. It is hoped this research will prove the safety of Epcoritamab in this “sandwich” design with ASCT in relapsed-refractory aggressive B-cell lymphoma

With advances in medicine, more people are surviving critical illnesses. The psychological impact of critical illness and intensive care units (ICU) on survivors is considerable. Psychologists have a unique opportunity to contribute to early rehabilitation in ICU. However, there is a need to evaluate whether providing psychological services early in a patient's recovery can be done. The current research aims to study whether implementing a psychology service in the Logan Hospital ICU is feasible and accepted by both patients and staff. Recruited patient participants will be screened for psychological distress using validated measures at different times in their recovery, and they will receive psychological care as required. Evaluation of the implementation of the ICU psychology service will involve collecting feasibility outcomes, the degree to which patients find the model of care acceptable, as well as staff perceptions of the service after its implementation. The current research findings will inform future research regarding the implementation of embedded psychology services within ICU and guide the development of such a service within the Logan Hospital.

Psilocybin is a natural compound found in some mushroom species known to act on the brain pathway involved in depression. It is administered orally as capsules and is usually given during a psychotherapy session. A growing number of studies have shown that psilocybin can be safely given to humans for the treatment of depressive symptoms and can induce a profound psychedelic experience (a temporary altered state of awareness and responsiveness to your surroundings). Major depressive disorder (MDD) is a very common chronic mental health illness that can interfere with social, occupational and family relations. It can lead to disability and can even have life-threatening consequences. Although very variable, some factors may influence MDD such as genetic risk factors, recent negative life events, alcohol abuse and lack of family and social support. It has been reported that most MDD patients have problems with multiple areas of family functioning that are not usually considered during treatment. Most people diagnosed with MDD will relapse after their first episode of depression, and that risk increases with every subsequent episode. The primary goal of any MDD treatment is to control its symptoms and restore the person’s functionality. It usually involves a combination of medication and psychotherapy. However, despite modern advances in drugs and psychotherapeutic treatments, approximately 1 in 3 people with MDD do not respond to antidepressant therapies. Treatment-resistant major depressive disorder (TRMDD) can be defined as a failure to achieve remission to at least two proven antidepressants with adequate dosing and duration. Psilocybin has been used in multiple studies in people with TRMDD for more than 10 years. It has a different way of interacting in the brain than the current available antidepressant medications and it has shown promise as an aide to psychotherapy, especially for those with TRMDD. It has been studied at various doses and there have been no significant serious side effects. This study aims to show that there is an increased benefit to TRMDD participants that receive PAP and to see if involving family members who can be defined as a person with a close relationship to the participant such as a friend, relative, significant other, and/or cohabitant, may provide a more effective treatment and fewer relapses.

By conducting this study we hope to 1) evaluate the feasibility of a One Day Expedited Treatment for anxiety disorders; and 2) examine the dropout rates in the One Day Expedited Treatment. This results from this study will inform us if this is an acceptable and effective way to deliver cognitive behavioural therapy, and may result in additional treatment options for individuals with anxiety disorders.

Regular physical activity plays a key role in cardiovascular disease and stroke prevention, yet over one third of Australians are insufficiently active. This project aims to establish the impact on physical activity of a novel incentives-based strategy to increase public transport use through a single-blinded parallel group randomised controlled trial. Findings will provide public health and transport authorities with evidence to inform decisions around the use of incentives-based strategies. We hypothesise that a public transport incentives scheme will increase daily steps compared to a control group.

This proposal is a type-1 hybrid randomised controlled trial, focussing on effectiveness and implementation. Our aim is to grow the capacity of parents of children with neurodevelopmental disabilities (NDD) to continue to effectively implement and manage ongoing interventions for their children, with an easily translatable online/telehealth intervention: E-PACT. Parent capacity is underpinned by multiple factors including physical and mental health and is associated with multiple child outcomes. Our primary outcome is parent capacity itself, specifically the core parenting competency: emotional availability measured on the Emotional Availability Scale (EAS). Secondary outcomes include parent and child physical and mental health. Tertiary outcomes will measure the cost and consequences, barriers and facilitators of E-PACT delivery compared to Care as usual to inform implementation. We will conduct a phase III RCT of an online/telehealth intervention E-PACT with 300 families of children with NDD. This is a two-arm RCT in which families of a child (0-10 years) with a diagnosis of an NDD or assessed as increased chance of a NDD will be randomly assigned to E-PACT or Care As Usual (CAU) with follow-up until 6 months post baseline. All families will complete pre-intervention assessment at baseline (T1), post-intervention assessment (T2), and 6 months follow up (T3 6 months post baseline). Families in the CAU group will then be provided with E-PACT after completion of the six months follow up (wait-list control).

Depression is the top leading cause of disability, yet existing treatments leave many people with a shortfall in recovery. In addition, medical and particularly cardiovascular comorbidity dramatically shortens the lives of people with depression, and there are no routine strategies to reduce this burden. Current evidence suggests a possible aetiological role for inflammation in the genesis and pathophysiology of depression and comorbid medical disorders especially cardiovascular disorder. Statins and metformin reduce inflammation and have established benefits for medical comorbidity. Both agents show antidepressant effects in preclinical models. Multiple epidemiology studies and preliminary clinical trial data suggests an antidepressant effect of both agents. Hearts and Minds is a 3-arm multicentre, randomised, double-blind, trial of atorvastatin (40 mg daily) and metformin (2000 mg daily) for the treatment of depression in people who remain symptomatic after a trial of established therapy. This will be a 16-week placebo-controlled trial with a 6 month follow up period.