ANZCTR search results

Chronic constipation and faecal incontinence carry significant health and economic burdens on individuals as well as the health system. Initial treatment remains conservative including medications and dietary modifications. However should these be ineffective, guidelines recommend investigating for physiological abnormalities by anorectal physiology testing including ARM and BET. The results of these are subsequently used to guide prescription of second line management including biofeedback therapy, neuromodulation and surgical interventions which when used appropriately demonstrated positive outcomes. Given the central role of anorectal physiological testing, there remains a lack of standardisation when conducting these procedures and subsequently, we remain uncertain whether the results produced are comparable. This applies to the study protocol itself, the equipment used during testing and analysis of results. Literature has even suggested that in cases of faecal incontinence, it may be beneficial for individual units to have their own range of values for defining abnormalities. The sensory component of defaecation, namely alterations in visceral perception and rectal compliance has also become increasing studied and tested. Determining type and degree of dysfunction in these have implications on provision of treatment. Barostat methodology is now widely used to assess sensory components of defaecation but different protocols exist, mainly with varying duration and equipment for the procedure. As a result, normal cut-offs remain unclear.

The aim of this RCT is to assess whether interventions addressing the thoracic spine are effective in reducing shoulder impingement pain. Participants with shoulder impingement pain will be randomised to receive one of: sham treatment, manual therapy to the thoracic spine, or manual therapy to the thoracic spine and shoulder treatments. All treatments will be delivered by a registered osteopath using pragmatic standard osteopathic manual therapy techniques. Outcome measures will be shoulder pain and disability questionnaires, visual analogue scales ,global rating of change diagram, patient-specific function scale diagram, and thoracic posture measure and thoracic range of motion measured with an inclinometer.

This project aims to improve care for adults with heart disease by building the evidence for meditation as an adjunct non-pharmacological self-management strategy to improve health-related outcomes for adults after an acute cardiac event. This meditation intervention aims to provide an avenue for optimising self-management of depression and anxiety symptoms, known to be high after an acute cardiac event or hospitalisation, which may enhance the capacity for adults to adhere to conventional exercise-based CR, self-manage their symptoms and reduce re-hospitalisation rates. The proposed study design is an open-label parallel group pilot RCT with post-intervention follow up. The researchers hypothesise that a meditation intervention will improve self-reported depression and anxiety at 6 weeks, which will be sustained at 3-month follow-up. Post-intervention follow-up will be undertaken to better understand consumer perspectives of meditation as an adjunct strategy for the alleviation of depression and anxiety symptoms. Findings from this study will inform a phase III randomised controlled trial (RCT) that will be used to inform future policy and guideline development.

Exposure and Response Prevention (ERP), delivered individually, is the gold-standard treatment for Obsessive-Compulsive Disorder (OCD). However, there are significant barriers to accessing this form of treatment such as a limited number of specialists skilled in the provision of the treatment and long wait-lists. As such,attention has been given to exploring alternative modes of delivery of ERP. These alternatives include provision of ERP via the Internet and provision of ERP in a group format. A recent meta-analysis (Schwartz et al., 2016) found that ERP provided in a group format has equivalent effect sizes to individually administered ERP. The 12 studies in the meta-analysis were controlled trials comparing group ERP to wait-list and to individual ERP. The results of this meta-analysis lend support for the provision of ERP in group formats in clinical practice. However, most studies to date have been conducted in highly controlled settings (e.g. university clinics) and so little is known about how effective group ERP is in typical clinical settings. The aim of this study is to evaluate the effectiveness of group ERP in a ‘real-world’ clinical setting.

Maternal sleep disturbance is a significant and widespread complaint during the postpartum period. Though some aspects of sleep eventually improve over time, some mothers continue to experience poor sleep with persistent difficulties in initiating and reinitiating sleep. These postnatal sleep complaints have been associated with a range of deleterious outcomes, including fatigue, sleepiness, and symptoms of depression/anxiety. Despite the prevalence and associated negative outcomes of postnatal sleep disturbance, research investigating potential interventions to promote maternal sleep is scarce, representing a significant gap in the current literature. We plan to examine the efficacy of non-pharmacological interventions to improve sleep and wellbeing in sleep-disturbed mothers: (1) Cognitive Behavioural Therapy (CBT) and (2) Light and Dark Therapy (LDT). The CBT arm will involve strategies to target healthy sleep habits and management of daytime symptoms (including fatigue), delivered via emails with therapist assistance. The LDT arm will involve participants wearing light glasses each morning and adhering to recommendations for appropriate light exposure at night. Interventions will be personalised in an orientation call with a researcher in which specific recommendations will be made based on the participants’ individual needs. There will be four conditions: (1) a CBT-only group; (2) a LDT-only group; (3) a combined CBT-LDT group; and (4) a waitlist control that will receive CBT emails following trial completion. The active intervention phase will be six weeks, with four assessment time-points: (1) baseline; (2) mid-point – Week 3; (3) post-intervention – Week 6; and (4) follow-up – Week 10. This aims of this study are to: 1) Investigate the efficacy of CBT, LDT, and the combinations of LDT and CBT in the reduction of maternal sleep complaints as the primary outcome, and maternal fatigue, sleepiness, and mood as secondary outcomes. 2) Explore predictors and mediators of treatment effects. 3) Evaluate whether the combination of CBT and LDT supersede the effects of either intervention delivered alone.

BACKGROUND: The ‘artificial pancreas’ or hybrid closed-loop (HCL) insulin pump has been shown to be effective in improving glucose control in individuals with type 1 diabetes. The HCL system has been further modified from previous prototypes resulting in the advanced-HCL (A-HCL) system. The A-HCL system aims to increase time-in-target glucose range and improve user acceptability. The impact of the modifications implemented in A-HCL systems have yet to be evaluated. AIMS: The study aims to generate preliminary data regarding glucose control using A-HCL systems, and challenged by meal interventions, exercise and sensor miscalibrations. METHODS: The study is a prospective, three-stage study, incorporating ‘in-hotel’, ‘in-hospital’ and ‘free-living’ stages over a 5 week duration. Pump-experienced adults with type 1 diabetes will be recruited. All participants will be assigned the A-HCL system. Interventions in the supervised ‘in-hotel’ and ‘in-hospital’ stage aim to challenge glucose control and A-HCL system performance. Thereafter, participants will return home in the ‘free-living’ stage for 3 weeks using the A-HCL system. OUTCOME MEASURES: Glucose control including CGM time-in-target glucose range, and time in hyperglycaemic and hypoglycaemic ranges. Safety end points including number of episodes of hypoglycaemia and ketoacidosis, and system performance.

Purpose The purpose of this study is to evaluate the safety, tolerability, immunogenicity and anti-tumour activity of BIL06v/Alhydrogel in patients with advanced solid tumours. Who is it for? Adults who have locally advanced or metastatic solid tumours. Study details This is a two-cohort study which means approximately 10-15 participants assigned to 1 dose of BIL06v/Alhydrogel®, and a different cohort of 10-15 participants assigned to a different dose of BIL06v/Alhydrogel®. In total, approximately 20-30 participants will be enrolled in this study at 2-4 sites in Australia. Participants will be assigned to a cohort and dose level by the study doctor. The study treatment will take place in two parts depending on the number of treatments each participant receives (see below). Participants who are continuing to benefit from the study treatment, according to the study doctor, may continue to receive study treatment, as appropriate, for up to approximately 2 years. Part 1 In Part 1, BIL06v/Alhydrogel® is administered every 14 days up to the 12th treatment (22 weeks) as subcutaneous injections (a short needle is used to inject the drug under the skin). Dose Level 1: 1.0mg each dose Dose Level 2: 1.5mg each dose A maximum of 15 participants will be enrolled in each dose level group. Dosing at the next level will occur sequentially, after completion of enrolment of participants in the first dose cohort. Treatment will be monitored by the study doctor/s, and the medically qualified Safety Review Committee (SRC) to ensure safety is maintained. The SRC may choose to change the planned dose schedule based on results from the previous groups. Part 2 Once a participant has received 12 injections of BIL06v/Alhydrogel®, which will occur at the end of Cycle 6, the participant will enter Part 2 of the study. In Part 2, which will start in Cycle 7, study treatments will be given at 28 day intervals. Participants will continue to receive the same dose once every 28 days until the study doctor determines participants are not benefiting from treatment or if participants are not compliant with the study protocol. Participants will be required to attend a Screening Visit to assess their eligibility for the study up to two weeks before being given BIL06v/Alhydrogel®. Participants will need to return to the study site for a Treatment Visit (Day 1) for administration of BIL06v/Alhydrogel® and to have a number of assessments performed to check their general health. During the treatment period, participants will be required to attend the study site for BIL06v/Alhydrogel® administration every 14 days (treatment cycles 1-6) and every 28 days thereafter (cycles 7 and beyond), for ongoing safety, tolerability, immunogenicity and clinical assessments to be conducted. Biosceptre hopes this treatment may extend overall survival for some participants.

Clinical management of asthma involves tailoring medication to minimise the frequency and intensity of symptoms and prevent exacerbation's. However, management is currently based on subjective patient recall of symptoms, rather than objective and personalised measures of current status and predictors of future risk of exacerbation's. A potential solution may be offered by daily home monitoring using Forced Oscillation Technique (FOT), which patients can measure unsupervised at home due to its ease of use compared to peak flow or spirometry. We have shown potential clinical utility of advanced analyses to study the day­-to-­day variability in lung function in asthma in a series of retrospective studies, including the ability to predict future exacerbation's within a month in an individual. This project aims to adapt such analyses to FOT data as the basis of a home telemonitoring system, and initiate a prospective study investigating the potential benefit of long-­term FOT home monitoring in Australian patients with both well­-controlled and uncontrolled asthma. We aim to show that FOT variability (i) predicts occurrence of exacerbation's, (ii) is related to asthma control, and (iii) is sensitive to treatment changes. We will demonstrate this by studying moderate-to-severe asthma patients in a pragmatic, observational study in well­-controlled asthma patients who are being considered for reduction of their inhaled corticosteroid treatment dose. Treatment is initiated by the physician according to Australian guidelines independent of participation in the study, and we will study these relationships regardless of the nature of treatment. We will monitor unsupervised FOT measurements and symptoms over a period of 10-­24 weeks. Data will be uploaded automatically via mobile internet to encrypted servers and regularly checked for quality. We will also monitor exacerbation's and asthma control via weekly telephone interviews and questionnaires. From these results, we eventually hope to develop an automated alert system which can signal to the patient whether or not they are about to deteriorate and to initiate self-treatment, enabling them to gain control of their disease.

Hypermobility Spectrum Disorder is characterized by generalized joint hypermobility and musculoskeletal pain (Pacey 2014) and is now the recommended name for the condition previously referred to as Joint Hypermobility Syndrome (Castori 2017). It is diagnosed using the Beighton Scale, in individuals presenting with 6/9 hypermobile joints in addition to at least one painful joint for at least 3 months following exclusion of other heritable connective tissue disorders such as Ehlers Danlos Syndrome (Malfait 2017). The prevalence of Hypermobility Spectrum Disorder in children is variably reported, ranging from 2% to 64% depending on age, ethnicity and the defining criteria used (Murray 2006). Children with HSD experience a range of chronic symptoms and life impacts including: • Joint laxity which can lead to bony subluxations and dislocations and chronic joint instability. • Pain in joints or surrounding muscles and soft tissue. • Deconditioning of musculature surrounding joints causing ongoing exacerbation of symptoms. • Limited endurance with mobility and physical activities such as walking longer distances or negotiating stairs which impacts function at school and in the community. • Poor school attendance due to chronic pain which impacts negatively on academic learning. • Reduced, or absent participation in physical activity leading to poorer health outcomes such as bony development and cardiovascular fitness. • Any of the above factors can cause personal distress, decreased social interaction and isolation which can lead to mental health issues including anxiety and depression. Recent research has suggested that providing a physiotherapist-led exercise program is significantly effective in reducing pain, improving health-related quality of life, and increasing muscle strength in children with HSD and knee pain (Pacey 2013). However, it was also noted that there is limited research evidence about optimal type of exercise in adults and even less research available regarding children. This study focuses on researching the potential benefits of Physiotherapy-led Pilates as an effective alternative exercise program helpful in the management of children with HSD. The study design will involve a single case experimental design (SCED), with repeated measures during baseline and treatment phases, and a multiple baseline design (MBD) for the introduction of treatment to allow a smaller number of subjects to be studied in greater detail to provide a high level of evidence (Level II). The study hypothesis is that the study will show that: a) Children and young people will show a decrease in pain and an increase in their strength and endurance, which will improve their ability to participate in everyday activities such as school, sport and social activities. b) This improvement will be maintained for a period of at least 3 months following the intervention.

The primary purpose of the current study is to evaluate whether a brief behavioural treatment for insomnia (BBT-i) improves sleep for adolescents (aged 12-17 years). We will also monitor mood and behavioural changes using self- and parent-reports. Around 10% of 13-18 year old Australians meet DSM-5 criteria for insomnia and up to 70% of teenagers are sleep deprived. The current solution to this highly prevalent condition is often hypnotic pharmacotherapy, despite substantial evidence that drugs are only marginally better than placebo and recommendations against long term drug therapy. Behavioural interventions are recommended as the front-line treatment for sleep disordered behaviour for adolescents, yet both prescription and non-prescription medications are widely used, often in the absence of medical advice. BBT-I provides a potentially effective alternative. BBT-I includes psychoeducation around sleep hygiene, stimulus control (i.e., learning healthy associations with sleep cues), and sleep quality (regulating sleep patterns to enhance sleep quality). Literature supports the appropriateness of behavioural sleep strategies for adolescents. The methods to be used in this study have been used extensively in past child and adolescent research involving various formats/sequences of delivery, albeit in ways that differ to the brief format that is to be evaluated here. Importantly, the specific components of the current sleep program have been used for children as young as 6 years. We expect that adolescents will experience improved sleep after the 3-week intervention period. We also anticipate positive changes in mood (e.g., depression, anxiety and stress) and behaviour (e.g., interactions with parents) after the 3-week intervention period. We will evaluate if any changes are maintained 2-months after the 3-week intervention period.