ANZCTR search results

Insomnia is a highly prevalent chronic illness with approximately 30% of Australian adults classified as having insomnia or insomnia symptoms. To date, there is a paucity of research in insomnia treatments options in primary care, which is surprising considering the number of patients with insomnia who are managed by GPs. The current study will test the feasibility of a mobile application (SleepFix) delivering behavioural therapy for insomnia in primary care.

The LEISURE Study aims to assess the efficacy of a 12-week multimodal lifestyle intervention program incorporating exercise, diet, mindfulness and sleep compared to care-as-usual to reduce dementia risk in a group of healthy older adults. Participants’ risk profile will be assessed using novel biomarkers in conjunction with comprehensive neuropsychological and neuroimaging techniques. The rationale for the trial is founded upon a body of evidence that now suggests AD may be classified as an age-related metabolic neurodegenerative and vascular disease, wherein aberrant metabolic and inflammatory signalling leads to a cascade of neurotoxic changes that result in impaired cognitive function. Using this framework, each component of the multimodal lifestyle intervention has been chosen to target specific metabolic or vascular regulatory systems to promote neurogenesis, leading to improved cognitive function and reduced dementia risk. The LEISURE study aims to assess whether such multimodal lifestyle interventions are more efficacious than care-as-usual in reducing multiple risk factors implicated in the aetiology of dementia, particularly AD. The LEISURE study is unique in combining leading neuroimaging techniques with novel biomarker identification to develop a new model of dementia prevention through non-pharmacological lifestyle approaches. While the field of lifestyle interventions for dementia prevention is in its infancy, the LEISURE study will provide crucial insight into the biomolecular mechanisms underpinning healthy brain ageing.

RAFT is an SMS-based, brief contact intervention for people who have recently presented to hospital in suicidal crisis. RAFT sends a series of ‘caring contact’ messages with links to online therapeutic content. This trial will assess the benefits of linking participants with the RAFT online content relative to sending text messages alone and will also assess the benefit of sending information to a nominated support person. We hypothesise that linking participants with RAFT’s online content and including a nominated support person in the intervention will be associated with the greatest reduction in suicidal ideation.

Hip replacement demand continues to rise with the ageing population. There are several surgical approaches to perform hip replacement. The posterior approach is the most commonly performed approach, with several variations. Recently, there has been an increasing interest in the Direct Anterior Approach, due to the belief that it may result in decreased pain, faster recovery, improved hip stability and decreased risk of dislocation. Whilst some small early studies have reported decreased narcotic consumption, shorter length of stay and earlier independent mobilization; other have suggested increased rates of persistent pain, increased dislocation rates, component malposition and a comparable dislocation rate. Most studies already described in the medical literature are small numbers <50 patients and have short follow-up (<1year ) The aim of our study is to determine the long term patient outcomes and complication profile for the direct anterior approach in Total Hip Replacement using a large cohort. Hip function, hip pain, walking aid use, complications and patient satisfaction will be assessed by means of a patient survey completed 2 year and 5 year anniversary of their surgery. The survey will take approximately 10 minutes to complete and may be returned electronically or via reply paid envelope.

Obstructive sleep apnoea (OSA) is a surprisingly common disorder and occurs due to upper airway obstruction. OSA is characterised by repetitive periods of obstructed breathing during sleep and is an independent risk factor for coronary artery disease, affecting 40%-60% of cardiac patients. Furthermore, untreated moderate to severe obstructive sleep apnoea (OSA) in patients with established coronary disease is associated with increased cardiovascular morbidity and mortality. Therefore, treating OSA in isolation is key for cardiovascular risk reduction. The purpose of this trial is to determine whether optimized OSA therapy can be achieved in a cardiovascular population using best-practice compliance enhancement strategies including digital patient engagement tools. Furthermore, we will assess the impact of optimized OSA therapy on surrogate markers of cardiovascular health. Collectively, we hypothesise, that optimised OSA therapy will be accepted and treatment adherence can be optimised in patients with coronary artery disease and that treatment will improve surrogate markers of cardiovascular health.

Ventricular tachycardia (VT) is a life-threatening electrical disorder in patients with heart disease. Current methods treat VT by widespread ablation of damaged regions in the heart. We aim to test a strategy of focused ablation limited only to those areas that have electrical properties prone to facilitate VT. This will reduce procedural time and improve safety.

This study aims to evaluate the use of temozolomide in different regimes for Glioblastoma. The trial is testing two changes to the usual schedule of treatment. Who is it for? You may eligible for this study if you are a male or female aged 18 years or older, with newly diagnosed, histologically confirmed grade IV malignant glioblastoma. For the initial questions of interest, participants will be randomly allocated (50/50) chance to one of two treatment groups, to either QUESTION 1: Intervention Arm 1: After surgery, start temozolomide as soon as possible prior to chemoradiotherapy Control Arm 2: After surgery, start temozolomide at the same time as radiotherapy QUESTION 2: Intervention Arm 1: After chemoradiotherapy, take adjuvant temozolomide until disease progression Control Arm 2: After chemoradiotherapy, take adjuvant temozolomide for 6 cycles For participants that choose not to be randomly allocated treatment will be at patient/doctor discretion. All participants will be asked to have blood tests and scans as you would for usual treatment, the extra things requested are to fill out questionnaires and donate extra blood tests. It is hoped this research will help identify if starting temozolomide earlier than usual and/or continuing treatment with temozolomide for longer than usual will improve the outcomes of people with glioblastoma and assist development of future treatments.

A randomised controlled trial to evaluate whether osteopathic light touch manual therapy care has an impact on reducing crying time in infants (under 10 weeks old) with colic. The comparator arm is non-specific light touch. We will need to randomise 112 parent(s)/carers and their infants. Parents will be blinded to whether their infant receives the usual osteopathic therapy care or not. This study will provide information about the clinical and social relevance of osteopathic care for excessively crying, unsettled and distressed infants and their parents.

The purpose of this research is to determine the effectiveness of an individualised, fruit and vegetable rich diet on weight loss and on the changes in markers of inflammation that occur in response to a bout of exercise, as many people combine changes in diet and exercise for weight loss. Participants will receive individualised feedback on their diet and gain an increased understanding of how having a diet high in fruit and vegetables can be used for weight loss. Participants will also receive a weeks worth of fruit and vegetables at the commencement of the study to demonstrate target consumption.

Sudden cardiac death (SCD) due to recurrent ventricular tachycardia (VT) is an important clinical sequela in patients with structural heart disease. VT generally occurs as a result of electrical re-entry in the presence of arrhythmogenic substrate (scar). Scar tissue forms due to an ischemic cardiomyopathy (ICM) from prior coronary obstructive disease or a non-ischemic cardiomyopathy (NICM) from an inflammatory or genetic disease. AADs can reduce VT recurrence, but have significant limitations in treatment of VT. For example, amiodarone has high rates of side effects/toxicities and a finite effective usage before recurrence. ICDs prevent cardiac arrest and sudden death from VT, but do not stop VT occurring. Recurrent VT and ICD therapies decrease QOL, increase hospital visits, mortality, morbidity and risk of death. Improvement in techniques for mapping and ablation of VT have made CA an alternative. Currently, there is limited evidence to guide clinicians either toward AAD therapy or CA in patients with NICM. This data shows significant benefit of CA over medical therapy in terms of VT free survival, survival free of VT storm and VT burden. Observational studies suggest that CA is effective in eliminating VT in NICM patients who have failed AADs, resulting in reduction of VT burden and AAD use over long term follow up. Furthermore, there is limited data on the efficacy of CA in early ICM with VT, or advanced ICM with VT. RCT data is almost exclusively on patients with modest ICM with VT, and this is not representative of the real-world scenario of patients with structural heart disease presenting with VT. Therefore the primary objective is to determine in all patients with structural heart disease and spontaneous or inducible VT, if catheter ablation compared to standard medical therapy with anti-arrhythmic drugs results in a reduction of a composite endpoint of recurrent VT, VT storm and death at a median follow up of 18 months.