ANZCTR search results

Dose could have a direct response on the engagement of participants with mHealth programs, however currently there is minimal evidence regarding the optimal dose of messages in a parent targeted mHealth (text-messaging) intervention. This study aims to explore how dose of text messages can influence the acceptability, engagement, effectiveness and cost of a parent targeted mHealth text messaging program, HB4HNEKids. We hypothesise that the higher dose of text messages will have a lower acceptability and engagement, similar effectiveness and higher cost compared with the lower dose text message arm.

Clinically significant obstructive sleep apnoea (OSA) affects approximately 30% of the middle-aged population and contributes to long term poor health. Four main physiological mechanisms cause OSA, but current treatments typically only address one of these mechanisms and they are not well tolerated. A pharmaceutical therapy for OSA is desired by patients and has the potential to treat more than one of the mechanisms causing it. This study will examine the effect of a commonly prescribed medicinal cannabis product (delta-9-tetrahydrocannabinol, THC) on the mechanisms that contribute to OSA, its impact on OSA severity and effects on psychomotor and cognitive function. We hypothesise that compared to placebo, 10mg of medicinal THC will decrease the severity of OSA and beneficially alter some of the mechanisms which cause OSA without having a detrimental effect on next-day psychomotor and cognitive function.

This study is a pilot trial testing two brief online interventions for young adults (18-25 years) with high concerns about their weight and body shape. The goal is to see if these single-session interventions (SSIs) are feasible and acceptable, and to explore their effects on mental health and help-seeking attitudes. Participants, who are first-year psychology students at Flinders University, will be randomly assigned to one of two interventions: a help-seeking SSI or a behavioural activation SSI. The help-seeking SSI provides participants with a better understanding of what negative body image is and motivational strategies to promote help-seeking, whereas the behavioural activation SSI aims to improve mood by emphasising the importance of positive action. Participants will complete baseline measures, followed by their allocated single session intervention and post-treatment measures straight after.

People with pulmonary fibrosis (PF) are 70% less active than healthy individuals. Low levels of physical activity increases fatigue and worsens breathlessness and quality of life. Pulmonary rehabilitation is a recommended intervention to improve physical function, breathlessness, and quality of life in people with PF. Finding strategies that prolong the benefits of pulmonary rehabilitation such as improving physical activity are needed. This study will explore whether a physical activity counselling session, combined with using a physical activity tracker can increase physical activity levels and make pulmonary rehabilitation benefits last longer in people with PF.

Aim: These studies aim to investigate the feasibility and acceptability of a novel music and text messaging intervention in individuals with endometriosis. It also aims to evaluate the efficacy of this intervention in improving pain, stress, depression, anxiety and and emotional health-related quality of life. Design: There are 2 phases of this study involving a co-development phase and pilot randomised controlled trial of the intervention. Participants: A total of 62 individuals living with endometriosis (5-6 for co-design of the intervention; and 56 for the pilot trial). Methods: Participants will be asked to listen to self-created music playlist every day for 28 days. Participants will also receive psychologically-focused text messages co-designed to improve management of symptoms/emotional wellbeing (Sherman et al., 2022, 2023, 2024). Participants will complete pre- and post-study surveys, as well as a brief 5-minute survey each day throughout the intervention. Outcome: Participants will perceive the EndoSMS x music intervention as acceptable and feasible.

The research is to check the improved safety features of a modified airway device called a laryngeal mask airway. The modification to the device is suction enhancement to allow for suction of secretions and blood that usually collect to the upper (supraglottic) surface of the airway device during oral and nose surgery. Suction of the blood and secretions is anticipated to result in improved patient safety.

This study compares the effectiveness of using virtual reality during outpatient colposcopy in decreasing anxiety in pain compared to colposcopy without it. Willing patients will be randomly allocated to either arm and asked to complete a pre and post procedure questionnaire on the day of colposcopy to assess their pain and anxiety scores. Our hypothesis is that virtual reality by creating an immersive experience can distract patients during colposcopy and decrease their pain and anxiety. 200 patients are required to show such a difference, 100 patients in each arm.

The WoundView pilot study responds to the urgent need to develop a digital solution bringing together wound analysis within video telehealth and increase access to wound care in Residential Aged Care Homes (RACHs). A set of digital tools that use simple and affordable technology to collect, analyse, and track wound images will be tested, and included in an existing secure video telehealth platform (Coviu). The tool, WoundView, will allow for timely access and improved wound care. The aim of this study is to determine the feasibility of WoundView to improve chronic wound management for people living in RACHs. The results of the pilot will inform a future research to further assess the utility of WoundView.

This is a Phase 1, open-label, placebo-controlled, randomized crossover study evaluating the pharmacokinetics (PK), safety, tolerability, and adhesion performance of multiple formulations of the TRX-248 transdermal system (TS) in healthy female volunteers. The study consists of two parts: Part A: Subjects receive single doses of three different TRX-248 formulations in a crossover design, with PK and safety assessments after each 24-hour application. Part B: Based on Part A results, one optimized formulation is selected for further evaluation, where subjects receive either three patches of the selected formulation from Part A or a newly optimized Formulation D. The TRX-248 Transdermal System is expected to provide the convenience of a once-daily needle-free delivery system, steady and continuous delivery of treprostinil, which provides optimal efficacy and safety.

ENABLE is a two-phase study involving implementation of a Digital Wound Model of Care (digital wound platform and specialist wound care service). Phase one involves co-development of implementation strategies and understanding current care with seven partner sites guided by the Consolidated Framework for Implementation Research. Baseline data will also be collected in Phase One. Phase Two will involve a stepped-wedge, cluster randomised trial, followed by a post-implementation data collection period evaluating clinical efficacy, cost-effectiveness, and implementation. There will be a staggered entry for each site. Patients greater than or equal to 18 years with a chronic or complex wound (wound that has not healed within 30 days as defined by NSW Health Value-Based Health Care Wound Tranche 2 and Value-Based Health Care High Risk Foot Service Tranche 1) will be included. Clinician (doctors, nurses, podiatrists, occupational therapists) from our partners sites will be included. This current clinical trials registration covers Phase 1 and Phase 2.