ANZCTR search results

There are multiple small observational studies suggesting that treatment of sleep apnoea has beneficial anti-arrhythmic effects. In this study we want to evaluate the impact of obstructive sleep apnoea treatment with continuous positive airway pressure on AF burden. We hypothesise that treatment of OSA improves AF burden.

The perinatal period is a risky time for the mental health of fathers and this has important implications for them and their families. Fathers who experience psychological distress in the perinatal period are often isolated, unsupported, and uninformed about the need to seek help and how to go about it. Following previous research demonstrating that message content, and the processes used to operate SMS4dads are acceptable to fathers during their transition to parenthood, this multi-centre randomised controlled trial (RCT) aims to test the efficacy of SMS4dads. In this study the investigators will assess, using validated scales, the influence that SMS4dads has on key indicators of how well a father is coping with the transition to parenthood. These indicators include paternal depression, anxiety and distress, a sense of co-parenting quality, perceptions of parenting confidence, and reported alcohol consumption. Fathers will complete surveys at entry to the study, after 6 months and at 12 months after their child is born. Participants will be randomised into either an intervention arm (where they will receive messages and links, identical to those used in the previous phases of this research from 16 weeks pregnant to 12 months after birth) or to a control – wait list – arm, where they receive generic health messages for six months before being switched to recive intervention messages.. The intervention messages will provide fathers with information, motivation and practical advice on his relationships with his child, his partner and himself. Fathers, in the intervention arm will also be asked to keep track of their mood during the study by submitting information to SMS4dads on how well they are travelling. When fathers submit this information they will receive texts, of encouragement or support, which have been tailored to the response options. If this information indicates that a father is experiencing high levels of psychological distress an escalation system will be activated linking him to perinatal services offering telephone based counseling and support. The aim of this component of the project is to offer appropriate services to those in need but to also test whether fathers who report high levels of distress take the opportunity to access these services. Mothers will also be invited to participate if their partner is enrolled. The project will assess maternal distress at one time point (entry) to determine interactions between the intervention and levels of maternal depression, anxiety, and distress.

Recent findings on aging, as opposed to older scientific account, argue that the cognitive decline experienced during the later years in life is not inevitable. A stimulating environment is a potent catalyst to facilitate learning among older adults and may contribute to improvement in cognitive functioning and promote successful aging (Greenwood & Parasuraman, 2012). Video game playing is one of the popular interventions aimed to improve cognitive function among older adults. Studies have shown that older adults may benefit from a regular 30 to 60 minutes of gaming per day (Anderson-Hanley et al., 2014; Whitlock, McLaughlin, & Allaire, 2012). Positive changes in cognitive domains such as executive function, processing speed, and memory observed through video game play (e.g. Jaeggi, Buschkuehl, Jonides, & Perrig (2008), Nouchi et al. (2012), Anguera et al. (2013)). Encouraging findings have been shown in an experimental study by Anguera et al. (2013) which revealed older adults who played a multitask simulation game for 4 weeks experienced brain activation exceeding young adults who have not played video games. The benefits of gaming are not limited to cognition, but include physical functions and wellbeing (Y.-Y. Chao, Scherer, & Montgomery, 2015). Exergame is a type of game that requires not only cognitive, but also physical involvement of its players. Therefore, it is no surprise that burgeoning literature on exergaming effect to not only cognitive, but also the physical benefits. For example, Maillot, Perrot and Hartley (2012) revealed a significant improvement in heart rate, muscle strength, and balance after 14 weeks of Nintendo Wii compared to a no-contact control group. Parallel with physical enhancement, cognitive benefits are also observed post-training with significant positive changes in executive functioning and processing speed among older adults. Interestingly, cognition is not the only function that received the beneficial impact of physical activity. A shorter sleep latency and higher sleep efficiency reported among older adults with aquatic exercise (Chen, Fox, Ku, & Chang, 2015). Additionally, gaming also has positive effects towards older adults’ quality of life indicated by a higher well-being score and fewer depressive symptoms after weeks of game playing (Ballesteros et al., 2014; Y. Y. Chao, Scherer, Montgomery, Wu, & Lucke, 2014). The aim of the study is to investigate the effects of video game playing in older adults on cognitive performance, physical performance, sleep quality, and quality of life. Based on the existing literature, the study came to hypothesize that there will be significant differences in cognitive and physical performance between the groups of older adults, as well as in their sleep and quality of life.

The project aims to explore the efficacy, acceptability and feasibility of an internet-delivered mindfulness-enhanced cognitive behavioural therapy (MEiCBT) program for depression and anxiety. Up to 30 people with elevated depression and/or anxiety will be assigned to the active treatment group. The treatment group will commence the Mindfulness-Based Program for Depression and Anxiety immediately. The efficacy of the program will be determined by comparing the depression and/or anxiety symptom levels before and after treatment, and at 3 month follow-up.

The present study aims to increase our understanding of post discharge follow up processes in trauma patients with predominantly minor injury. The aim of the study is to determine whether a post discharge follow up clinic results in earlier return to work and baseline health status in patients sustaining minor injury.

ETOH-AF trial: While the association between binge drinking and atrial tachyarrhythmias is well-established, even moderate alcohol consumption has recently been identified as a significant risk factor for atrial fibrillation and/or flutter (AF) in a dose-dependent manner. To date, there have been no randomised-controlled trials looking at the impact of alcohol abstinence on AF outcomes. Moreover, we are keen to look at the overall effects of alcohol abstinence on other cardiovascular outcomes (inc. blood pressure, cardiac structure and function, sleep apnoea) and non-cardiovascular outcomes (inc. quality of life, mood). We hypothesise that alcohol abstinence will reduce AF recurrences, AF burden, AF symptoms and AF hospitalisations, as well as resulting in reductions in LV size, LA size, sleep apnoea parameters and blood pressure, and improvements in LA & LV function, mood and quality of life. We intend to recruit at least 140 patients and randomise them to either an alcohol Abstinence or Control arm, and follow them up for 12 months (with a 1 month run-in phase prior). Alcohol consumption in both arms will be monitored using weekly alcohol diaries, urine ETG (pending funding) and blood tests (inc. MCV, GGT). Monitoring for AF recurrences will occur by either: (i) Insertion of an implantable loop recorder OR (ii) Wearing a 7-day Holter monitor every 3 months +/- ECG transmission using the AliveECG smartphone app (if available) +/- ECG during symptoms of AF (iii) Interrogation of permanent pacemakers/defibrillators every 3 months in those with pre-existing dual chamber devices. Baseline and follow-up data collected includes: 12-lead ECG - 0 and 12 months. Blood pressure and weight - 0,3,6,9,12 months. Sleep study - 0 and 12 months. Basic bloods (lipids, glucose, FBE, UEC, LFT, BNP) - 0,6,12 months. Transthoracic echocardiogram (inc. LV size & EF, LA size, LA strain) - 0 and 12 months. AF symptom severity questionnaire (AFSS) & Medical questionnaire - 0,3,6,9,12 months. Mood & quality of life questionnaires - 0 & 12 months. Cardiac MRI substudy (pending funding) - 0 and 6-12 months. We will also be looking at a subgroup of patients who have had a previous pulmonary vein isolation (ABSTAIN-PVI substudy) to determine whether alcohol abstinence is beneficial in this sub-population. The trial protocol is unchanged (inc. outcomes) for these patients.

This pilot study will explore the effect of a type of non-invasive brain stimulation on the ability of older adult stroke survivors to participate in inpatient rehabilitation therapy. Clinicians in the stroke unit at Bentley Health Service (BHS) have identified that after a stroke, many people complain of feeling fatigued and being unable to concentrate during their therapy sessions. This is a problem since rehabilitation is typically offered only in the initial months post stroke, and therefore it is essential that patients are able to take best advantage of the available therapy during their inpatient stay. Fatigue is common post stroke, and is a complex impairment which may be partly due to reduced excitability of parts of the brain. Research has suggested that a type of non-invasive brain stimulation called ‘transcranial direct current stimulation’ (tDCS), in combination with therapy, can increase brain activity which may facilitate recovery after a stroke. All stroke admissions to BHS would be screened for eligibility, and consenting individuals will be randomly allocated to receive tDCS or sham tDCS for 10 days (20 minutes immediately prior to 10 therapy sessions), then cross over to the other group for a matched duration and number of sessions. Only the person applying tDCS will be aware of group allocation. The primary measures will be whether the first therapy session of the day is completed as intended. The duration of this session will be recorded, along with reason(s) for failure to complete the session. This outcome has been chosen as it is unambiguous, addresses the identified clinical problem and is an important surrogate of rehabilitation outcomes. Secondary measures will be patient reported fatigue using the Fatigue Assessment Scale, alertness/vigilance measured using the Go/NoGo test and alertness (numerical rating scale) reported by staff at set times during the day. It is hypothesized that patients receiving tDCS will be more likely, at the end of the series of ten tDCS sessions, to remain alert and engaged for the planned duration of the therapy session immediately following tDCS, perform better on a test of alertness, report feeling less fatigued and be observed by staff to be more alert during the day, than those receiving an equal number of sham tDCS sessions.

Crohn's disease (CD) is a chronic inflammatory condition of the bowel that carries a 70% lifetime risk of requiring surgical resection due to stricture formation or bowel perforation. CD often requires prolonged courses of immunosuppressive medications in order to induce remission, and these medications in themselves carry their own sets of risks. Exclusive Enteral Nutrition (EEN) has proven successful in inducing remission in pediatric CD patients. EEN is a polymeric supplement feed that is meant to provide all of the daily requirements of macro and micro nutrients. It is intended that patients consume this polymeric supplement feed for at least 80% of their daily nutritional requirement. Uncontrolled studies and small controlled trials suggest that there are benefits of EEN in adult CD patients as well but to date there has been no large controlled trial to formally test this hypothesis. The proposed study will seek to test in a randomized controlled trial the hypothesis that EEN can improve outcomes in patients with severe CD affecting the terminal ileum, which is a part of the bowel that is most commonly affected by CD. The study will have two phases. Phase 1, will see participants randomized into two groups, either EEN or standard of care calorie matched diet for 6 weeks prior to their planned operation. The primary outcome compared between the two groups at the end of phase 1 is both clinical disease remission and reduction of bowel wall swelling of the terminal ileum as measured by Magnetic Resonance (MR) enterography, an imaging modality commonly used in CD. Other secondary outcomes which will be assessed at the end of Phase 1 include quality of life, nutritional status, microbiome comparison, mean intestinal permeability, tolerability of diet, health economics and predicative markers for response. Following their surgical resection, participants will be re-randomized for phase 2 of the trial. Phase 2 of the trial will seek to test the hypothesis that partial enteral nutrition for 6 months as compared to standard of care calorie matched diet results in improved outcomes following surgical resection of the terminal ileum. The primary outcome at the end of phase 2 will be assessment of recurrence via colonoscopy after 6 months of the prescribed diet. Other secondary outcomes which will be assessed at the end of Phase 2 include quality of life, nutritional status, microbiome comparison, tolerability of diet and health economics.

The project aims to evaluate the acceptability and clinical efficacy of an online Pain Program Management program, 'Reboot' online. And to examine the moderators and mediators of change during the Reboot program. Up to 100 people with chronic pain will be randomly assigned to either the active treatment group or a Treatment as Usual (TAU) control group. The treatment group will commence the Reboot program immediately, whereas the TAU group will commence once the treatment group has completed and a 3 month follow-up period has been completed. The efficacy of the Reboot program will be determined by comparing the pain severity, disability and interference levels of the two groups at the time the treatment group completes treatment. Mediation analyses will be used to explore the role of variables that may influence positive change.

Approximately 68% of adults worldwide own mobile phones, with an estimated 1.08 billion of these being smartphones. Studies have shown that more people own a smartphone than a computer. Mobile health allows for the provision of evidence-based therapeutic techniques to a greater proportion of the population. Anxiety disorders are the most common mental disorders and the current study aims to evaluate the efficacy of a smartphone application ("app") designed to reduce worry by giving users greater control over it. Participants will be randomly assigned to use one of two apps. Measures of worry, depression, anxiety, negative metacognitive beliefs and repetitive negative thinking will be taken pre-, post- and follow-up intervals, with weekly measures of anxiety and negative metacognitive beliefs during the intervention.