ANZCTR search results

The Manchester Procedure (MP) and vaginal hysterectomy with vault suspension (VH) are two surgical options for the treatment of pelvic organ prolapse (POP). The evidence of benefit is currently limited to one prospective trial and several retrospective reviews. The two procedures have been studied in isolation though much more data exists for VH. Recent Danish registry data in a matched cohort study (n=590) suggested prolapse outcomes after Manchester repair were better than those after vaginal hysterectomy with vault suspension. In addition to the question of effectiveness of the procedure, the economic benefits of MP versus VH have been studied in the international literature. Costs for the first 20 months after the operation were higher in the VH group when analyzing the primary operation only, and higher still when including subsequent activities within 20 months. Given the MP is performed far less frequently in Australia, presumably due to patient selection and surgeon preference, there is a benefit for the local and international community to learn more about the differences in outcome between the procedures. Local data that shows equivalent outcomes may encourage increased uptake of the procedure which may lead to health gains for the patient and improved economic outcomes for hospitals.

Chronic pain is the leading cause of disability and disease burden globally. Multi-disciplinary pain management has shown effectiveness in chronic pain however the clinical importance of the observed effects is questionable. People with nociplastic dominant pain are a challenging group, with low self-efficacy where facilitation of graded activity/exercise and reinforcement of healthy behaviours are likely to be helpful. Motivational interviewing may be a useful adjunctive treatment for improving therapeutic alliance, barriers to engaging in graded activity/exercise, adherence and clinical outcomes including self efficacy. This trial evaluates whether in people with nociplastic dominant chronic pain, multi-disciplinary pain management plus motivational interviewing is more effective than multi-disciplinary pain management alone on improving pain self-efficacy and pain interference.

People with both Type 1 diabetes (T1D) and impaired awareness of hypoglycaemia (IAH) have a diminished ability to respond to hypoglycaemia and are hence more susceptible to severe hypoglycaemia. IAH occurs in at least 20-25% of individuals with T1D, and adds to the burden of the disease. The novel concept that IAH develops as a result of an adaptive learning response referred to as habituation. This theory suggests that the progressive diminishment of the counterregulatory responses (CRR) to hypoglycaemia following repeated exposure to hypoglycaemia is consistent with the principal features of a habituated response, and provides an explanation for IAH. Importantly, a habituated response can also be, at least temporarily, reversed. Presentation of another (usually strong) stimulus results in recovery of the habituated response by the introduction of a novel (heterotypic) stimulus, a process known as Dishabituation. High-intensity exercise (HIE) was shown to provide an effective dishabituation stimulus in a rodent model of IAH. In this pilot study, we seek to assess the acceptability and feasibility of HIE as a home-based intervention for people with IAH. The study will also aim to provide preliminary evidence of whether regular exposure to HIE can be used as a home-based therapeutic intervention to restore hypoglycaemia awareness in individuals with IAH.

The present study aim is to evaluate the safety, tolerability and feasibility of repeat SUSonly treatments in participants with AD using a bespoke low frequency transcranial SUS investigational device termed UltraTheraPilot.

Rationale: Multiple Sclerosis (MS) is a complex neurological disorder of the central nervous system which causes a wide variety of symptoms including problems with fatigue, mobility, muscle function, pain, cognition, speech, bladder function, and vision. Nearly a third of the total cost of MS in Australia results from a loss of income due to sickness and early retirement. An intervention that maximises work productivity and keep people with MS in the workforce for longer can provide a large societal cost saving and improve the quality of life of people with MS. Overall aim: Test the feasibility of delivering and evaluating a remotely delivered intervention called ‘MS WorkSmart’. Design: Two-arm randomised controlled trial (unblinded), comparing those receiving the MS WorkSmart package to those receiving usual care. Participants: Australians with MS who are employed (work 10 or more hrs/week, MS Work Instability Score>10, aged 18-60 years). Measures: Measures are assessed at baseline and 1-month post intervention. Primary measures include MS-related work productivity loss, and risk of job loss (using the MS Work Instability Scale). Secondary measures include MS work behaviour self-efficacy scale, health-related quality of life (EQ-5D-5L & QQ-5D-5L-Psychosocial), fatigue severity (MFIS-5), impact of symptoms on work, intention to retire due to MS, MS work difficulties (MSWDQ-23), and MS work change awareness scale. Feedback will be obtained 1-month post-intervention from those participating in the MS WorkSmart Program. Analyses: Descriptive analyses of the recruitment, adherence and fidelity; process evaluation of the experiences of participating in MS WorkSmart, and; calculation of measures of variations for future sample size calculations using linear mixed models.

ACCESS will investigate a novel model of care designed to address specific barriers to access to the services Aboriginal children need to reach their maximum potential in life, as is their right. This co-designed innovative model will support Aboriginal children and their families access and navigate prevention, early intervention and treatment services, and address underlying social determinants of health. It will establish a foundation on which Aboriginal Community Controlled Health Services (ACCHS) partners can build a sustainable model of care with potential to be expanded to other child health priority areas and to other ACCHS partners to improve Aboriginal child health outcomes at a national level. The Aboriginal Child Health Navigator can be described as an “educator, liaison, buffer, collaborator, and friend” and is “responsive to an Indigenous holistic health and social and emotional well-being model” (CI Sherwood). The health navigator will assist families to access services, navigate referral pathways, translate knowledge and provide holistic support.

Around 1 in 5 people have chronic musculoskeletal pain that frequently causes extreme suffering and incapability for individuals and substantial costs for society. People with chronic pain report high levels of pain-related emotional distress, suggesting it is critical to integrate mental wellbeing with chronic pain management. Mindfulness-Based Stress Reduction (MBSR) is a mind-body approach developed to help people manage the stress associated with long-term conditions. It promotes self-management via reducing anxiety, leading to improvements in pain intensity and pain self-efficacy. MBSR is typically delivered face-to-face in group sessions. However, in-person interventions restrict access. By offering MBSR online, people from any location can access the course at a reduced cost. The feasibility and acceptability of an online MBSR intervention have not yet been evaluated for chronic musculoskeletal pain. The proposed study aims to assess the feasibility and acceptability of an online MBSR program for people with chronic musculoskeletal pain. MBSR training is traditionally delivered via in-person group sessions. However, access to in-person group sessions can be difficult for many reasons, such as disability and poor accessibility, cost, availability, and COVID-19 physical distancing measures. The aim of this research study is to evaluate the feasibility and preliminary efficacy of an online MBSR training program for people with chronic musculoskeletal pain.

The primary purpose of this observational study is to check whether frailty predicts mortality/death in patients who are in the hospital for an upper gastrointestinal bleeding (UGIB) episode. We hypothesize that frailty is an independent predictor of death in patients with UGIB and other important hospital outcomes.

The Quit by Phone Study (QPS) is parallel, two-group, single-blind, randomised controlled non-inferiority trial with an aim of determining, in a low socioeconomic population of smokers, the effectiveness and cost effectiveness of a tailored text message (TTM) program at achieving 6-month continuous biochemically validated smoking abstinence rates, compared to standard Quitline support services (SQ). Secondary outcomes include self-reported abstinence, reduction in number of cigarettes between baseline and follow up, and the acceptance and maintenance rate of each intervention. The QPS aims to recruit 1246 participants from NSW that are at least 18 years of age; in receipt of a government pension or allowance (proxy for low-SES); current daily smoker wanting to quit tobacco smoking; willing and interested to make a quit attempt in the next week; own a mobile phone that can receive and send text messages; agree to use the allocated behavioural quit support service (TTM or SQ). The primary analysis is based on intention-to-treat and will compare the quit rates between groups (TTM "and" SQ) in a Bayesian framework. Participants lost to follow-up or not providing biochemical verification result or participants with a CO level > 5 ppm will be included as non-abstainers (smokers).

The Tuned In program was developed in 2012 by Dr Genevieve Dingle as an experiential music-based program designed to increase emotion awareness and regulation for young people. Research to date indicates that the Tuned In program is effective in increasing emotion awareness, identification and regulation for young people (Dingle, Hodges & Kunde, 2016; Dingle & Fay, 2016; Vidas, Nelson, & Dingle, in prep). This research project will expand on work to date to examine the effectiveness of a modified version of Tuned In for university students. The program will be run via videoconferencing due to general health recommendations during the global pandemic. It is hypothesised that the Tuned In program, in comparison to the control group, will improve participant’s emotion regulation ability, improve wellbeing, and decrease emotional distress. This research will inform the existing evidence base regarding the efficacy of Tuned In as an emotion regulation program for university students with a variety of health and wellbeing presentations.