ANZCTR search results

Waiting for publicly funded hip or knee joint replacements (arthroplasty) can take over 12 months, and low physical activity levels while waiting for surgery may contribute to development of secondary diseases and reduce health benefits post-surgery. The aim of the project is to quantify the benefits of combining a group exercise training program with targeted behaviour change counselling on ongoing physical activity participation and health related outcomes in patients on the hip or knee arthroplasty wait list. The objectives are to compare the effectiveness of this unique intervention compared to a usual care control group on daily physical activity (daily step count and percentage of day spent in sedentary activities), pain ratings and function as well as changes in clinical markers linked with potential common chronic diseases (diabetes and cardiovascular disease). This study seeks to determine if a novel intervention that combines effective behaviour change based on Social Cognitive Theory (SCT) with an exercise training program can elicit long term increases in physical activity in patients requiring hip or knee arthroplasty, and reduce comorbidity development while waiting for surgery. Such a model is likely to be of benefit through decreased disability, reductions in multi-morbidities, reduced pain and medication use, and earlier return to activities of daily living post-surgery. These benefits capitalise on the investment cost associated with surgery.

In this study, we plan to compare two different techniques of supplying oxygen to patients before they go to sleep under general anaesthesia for neurosurgical operation. The usual way of doing this procedure involves breathing oxygen through a facemask. In this study, a computer program will randomly allocate them to receive either oxygen via the facemask, or to have humidified oxygen delivered at high flow via two prongs in the nose. The study aims to test if the nasal oxygen method keeps oxygen levels higher compared to the usual practice, which is oxygen via the facemask. The nasal oxygen method has been used extensively in other parts of the hospital for many years. It has now become increasingly popular to be used in the operating theatre. However, there are limited studies on the use of this device in anaesthetic setting.

This research project will investigate the effect of physiotherapy treatments massage and acupuncture/dry needling on the symptoms of scars such as pain and itch. This study will provide treatment for symptomatic scars. It aims to assess change in scar symptoms over a four week period, with follow up at one and two months after that time. This will help us to evaluate these methods are for treating scar symptoms, and guide future treatment improvements. Participants will be randomly divided into two groups, both groups will receive scar massage, acupuncture and advice on self-massage, stretching and exercising. The only difference between the two groups will be the type of acupuncture/dry needling. During the study participants will be asked to complete surveys regarding their scar, and general wellbeing. They will also be asked to complete these one and two months after completion of physical treatments, and return the surveys by post or email. We expect that the scar being treated may show changes in physical characteristics and symptoms, but this is not guaranteed as everyone responds differently to treatment. The outcomes of the research may guide treatment of future patients with scars.

Sleep is important for health, quality of life and general well being. Patients in rehabilitation often sleep poorly but the reasons for this are not well understood. It is important to better understand why patients sleep poorly in rehabilitation and how this can be managed. Through this study, it is hoped that a “clinical pathway” which consists of guides for clinicians will help clinicians understand and better address sleep problems. Patients will be divided into two groups randomly, with one group receiving care based on the “clinical pathway” and the other group receiving usual care without use of the “clinical pathway”. Sleep is starting to emerge as an important consideration in the overall management of rehabilitation patients however there is paucity of current literature relating to the efficacy of treatment of sleep disorders to guide treatment. For clinicians who actively manage sleep issues, most rely on evidence obtained in non-rehabilitation patients and commonly use hypnotic agents, Behavioural interventions and where appropriate devices such as continuous positive airway pressure (CPAP). Currently available clinical pathways for the treatment of sleep disorders focus predominantly on the management of obstructive sleep apnoea and do not extrapolate well to sleep disorders in a rehabilitation setting. This study aims to determine the feasibility and effectiveness of a sleep optimisation clinical pathway within the rehabilitation setting when compared to usual care on sleep quality, patient satisfaction with sleep, engagement with rehabilitation therapy, fatigue and length of inpatient rehabilitation stay through a randomized controlled trial with blinded patients and outcome assessors.

The aim of this study is to evaluate whether a two-step distress screening process and a referral model can improve individuals’ use of supportive services and reduce their levels of distress after contacting the Cancer Council 13 11 20 Information and Support line. Who is it for? You may be eligible to join this study if you aged 18 years or above, have been diagnosed with cancer or care for someone with cancer, reside in Victoria or New South Wales, and are telephoning the Cancer Council 13 11 20 line. Study details Individuals affected by cancer (patients, family members, or friends) who call the Cancer Council New South Wales (NSW) or Victoria 13 11 20 services will receive distress screening as part of routine practice. CIS consultants will be randomised to deliver either: i) Treatment as Usual - provision of information, referral to emotional support or instrumental services based on a single distress question and consultants’ judgement; or ii) Structured care – an additional 4 screening questions and a referral model, based on the caller’s level of distress. Participants will be contacted at 3 and 6 months after this call to complete a survey exploring distress levels, service use, and the impact of health education. Structured care is not yet a feature of community-level cancer support services. The new knowledge that would be produced by this study will directly inform decisions about whether or not such a model is adopted by Cancer Councils in NSW and Victoria. The project will directly contribute to improving the performance of telephone support services for cancer patients nationally and internationally.

Insomnia is a very common sleep disorder, which is defined as difficulty initiating or maintaining sleep, early awakening, and interrupted or non-restorative sleep. Additionally, there is clinically significant impairment in daytime function, including poor concentration, memory, and work efficacy. Stress is a strong predict factor and thus closely associated with the onset of chronic insomnia, and its related anxiety forms a vicious cycle to further affect sleep quality and daytime efficiency. While 85% of the general population reports a complaint of difficulty falling and/or staying asleep, about 10% present chronic insomnia and seek medical help. The common side effects of sleeping aids or sleeping medication prescribed by the GP or provided by the pharmacist are drowsiness and headache during the day, which significantly affects daily time performance of tasks. This side effect prevents the patients from continuing such treatment, if no dependence has been developed. Abuse can happen by using such medications. Traditional Chinese medicine (TCM) uses different theoretical system explantion and thus has a different approach to address insomnia due to stress. It is considered to be due to heat in the heart, liver and kidney, which causes restless nerves. Additional symptoms recognised by the TCM diagnosis include uneasy dreams, waking up between 1 -3am, and not feeling refreshed in the morning. According to the herbal practice by our team members, we have developed three new herbal concoctions which aim to calm the body and nerves. The concoctions were developed based on the characteristics of the individual herbs as well as the ancient concoction recorded in the Chinese Pharmacopoeia. In addition, a TGA listed concoction for stress management will also be used, which can improve sleep quality in patients with stress. We want to know which one works most effectively to carry out a large scale clinical trial on it.

In this study, 43 people with diabetes referred to a community nursing organisation which visits patients in their home will be recruited in a prospective study. The current diabetes management of this group will be described. Participants’ individual needs will be assessed by a Diabetes Team, consisting of an endocrinologist linked to an in-home credentialled diabetes educator (CDE) through video-conferencing. The impact of individualised management on outcomes important to older people, that is, quality of life, wellbeing, treatment satisfaction, as well as biomedical markers will then determine the resources needed to undertake the assessments and management.

Control of low blood sugar following a meal is a priority in many patients with T2DM, particularly in those with better overall glycaemic control (HbA1c <~7.5%). The rate of gastric emptying is a pivotal determinant of postprandial glycaemia in type 2 diabetes. Gut peptides released in response to meals; glucagon like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), modulate postprandial glycaemia through their insulinotropic effects; GLP-1 also inhibits glucagon release and slows gastric emptying. The suggestion of abnormalities of the exocrine pancreas in patients with diabetes was reported over half a century ago. The pathophysiology of pancreatic exocrine insufficiency (PEI) in patients with type 1 and type 2 diabetes remains unclear, however possible mechanisms include exocrine dysfunction due to diabetic neuropathy or vasculopathy, a shared common pathway of damage to both islets and exocrine glands and a loss of the direct trophic effects of insulin. This 'pancreatogenic' form of diabets mellitus classified as type 3c, can result from a variety of conditions involving the exocrine pancreas, e.g. chronic pancreatitis, fibrocalculous pancreatopathy or haemochromatosis. Traditionally, type 3c diabetes has been thought to comprise of only ~1-2% of all cases of diabetes, but it has been suggested that more careful evaluation of cases yields a proportion of 8% or more. The presence of PEI in patients with diabetes is important, because it potentially impacts on glycaemic control, as well as nutritional status, bone homeostasis and gastrointestinal symptoms. In particular, ingested fats must be digested in the small intestine in order to stimulate GLP-1 and GIP secretion and induce feedback mechanisms that slow gastric emptying; as discussed, the rate of the latter is a major determinant of the postprandial blood glucose excursion. Our group showed in patients with cystic fibrosis who had documented PEI, that a high fat/carbohydrate meal emptied abnormally rapidly from the stomach, associated with deficient incretin hormone secretion and marked postprandial glycaemia. PERT addition slowed gastric emptying, augmented GLP-1 and GIP secretion, and substantially lowered the blood glucose excursion. Few studies have evaluated the role of PERT in diabetes and there have been conflicting results. Of note, there is limited information on postprandial hyperglycaemia and in those patients with T2DM. We therefore propose to study patients with a diagnosis of T2DM, who have evidence of PEI on a faecal elastase assay. We will evaluate the effects of PERT versus placebo on postprandial glycaemia, gastric emptying and incretin responses following a high fat/high carbohydrate meal.

Hearing voices are a phenomenon experienced in a number of mental disorders, especially schizophrenia, mood disorders and trauma-related disorders. Voice hearing can be persistent for many, resulting in a potentially distressing and disabling experience. Existing psychological treatments are effective for some, but costly to deliver, and require specialist expertise that is not widely available. New interventions have been called for that are simpler and more targeted, and which empower people to self-manage their own experiences. Such interventions may be enhanced by recent developments in e-mental health, particularly the use of smartphone technology. These technologies can increase accessibility, reduce costs, and promote autonomous recovery. An important development in e-mental health is the use of ecological momentary assessment (EMA) and intervention (EMI) in the context of treatment. EMA utilises mobile devices to collect multiple recordings of momentary experiences through self-monitoring in the context of the person’s daily life. This can provide individualised feedback on how symptoms evolve in real time in relation to the person’s environment, psychological processes, and how the person responds to them. EMI extends the use of smartphones to delivery of reminders and symptom self-management instructions during daily life. The aim of this work is to develop and evaluate a new intervention which unifies the unique monitoring capabilities of EMA with the momentary intervention capabilities of EMI in a coping-focused intervention for distressing voices (SAVVy: Smartphone-Assisted coping focused interVention for Voices). The second aim is to investigate variables which influence fluctuations in voice hearing experiences in daily life using EMA, in addition to increasing understanding of the nature and use of coping strategies in the daily life of voice hearers. The design of the current study is a randomised controlled trial (RCT) comparing a group of participants who will complete the SAVVy intervention whilst receiving regular treatment (17 participants), with a group only receiving regular treatment (17 participants). The intervention will involve receiving four, one-to-one sessions with a therapist whilst completing smartphone-based EMA and EMI between sessions. Information gathered during initial EMA monitoring of voice hearing experiences will be provided as feedback to participants during therapy and will inform the choice of specific coping strategies for self-managing the voices. The coping strategies will then be sent to participant via EMI reminders from the smartphone app between remaining sessions. Assessments will be taken before the intervention and 8 weeks following randomisation (post assessment blinded). The primary focus of this trial is to establish feasibility and acceptability of the intervention, and a preliminary indication of efficacy.

Home-based care is generally seen as the most humane and cost effective means of providing dementia care. Such ageing-in-place is supported by 2.5 million informal caregivers in Australia, however, increasing cognitive and physical frailty are a threat to ageing-in-place, and exacerbate caregiver burden. Importantly, caregiver depression and stress markedly increase the risk of institutionalisation of their loved one, independently of the actual level of disability or behavioural difficulties. Increasing interest has been given recently to Mindfulness-Based Stress Reduction (MBSR), which has shown promise for improving caregiver burden. Notably, such stress reduction efforts do not directly address a large component of the strain: the progressive physical dependency or behavioural disturbance of the frail elders themselves. Slowing this decline is thus critical. This is the explicit purpose of the HOMeCARE project. Research have demonstrated that exercise programs for those with dementia may improve physical and cognitive function, behavioural disturbance, sleep, and thus caregiver stress, although results and interventions varied. One study found that promotion of regular walking in dementia caregiver/cared for dyads did not improve the behavioural and psychological symptoms of dementia, but attenuated caregiver burden. However, uptake of this community-based walking was suboptimal and not sustained. What is missing is an evidence-based, sustainable program that can integrate these disparate approaches by simultaneously targeting modifiable functional and behavioural disturbances in the individual with dementia, while providing caregivers the means to cope with stress and improve their own health. In other cohorts, Internet delivery of Mindfulness training is efficacious for a variety of mental health outcomes, although this approach has never been tested in dementia caregivers specifically. Internet delivery would markedly extend reach and viability, given the difficulties inherent in traveling to a centre. Similarly, delivery of robust exercise in the home setting would also be a leap forward in terms of translation of successful exercise trials to the community. We will conduct the first randomised controlled trial investigating the efficacy of HOMeCARE: a completely novel e-Health system for the dementia caregiver/cared-for dyad. HOMeCare begins with a Mindfulness-based Stress Reduction Training program for the caregivers. This will be followed by home-based, strength and balance training intervention, designed to improve functional mobility and psychological wellbeing in the person with dementia, during which time the Mindfulness practice will continue to be reinforced. We hypothesize that together, these 2 complementary, remotely monitored interventions will combine to reduce caregiver burden and improve function in the participants with dementia compared to usual care.